Development and Testing of a Nurse Practitioner …...Patients with acute myocardial infarction...

Development and Testing of a Nurse Practitioner Secondary Intervention for Patients after Acute

Myocardial Infarction

by

Patricia Harbman

A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy

Faculty of Nursing

University of Toronto

© Copyright by Patricia Rose Harbman 2011

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Development and Testing of a Nurse Practitioner Secondary Intervention for Patients after Acute

Myocardial Infarction

Patricia Harbman

Doctor of Philosophy

Lawrence Bloomberg Faculty of Nursing

University of Toronto

2011

Abstract

Patients with acute myocardial infarction (AMI) are at high risk for reinfarction and death,

with the highest rate of death and reinfarction occurring within 30 days of AMI. Therapies

that have been shown to reduce these risks (secondary prevention) continue to be

underutilized. Nurse practitioners are well positioned to provide secondary prevention during

and following hospitalization. The purpose of this pilot study was to examine the feasibility,

acceptability, and preliminary effects of an NP delivered secondary prevention intervention.

The specific objectives were: 1) to describe NP activities when delivering the secondary

prevention intervention; 2) to evaluate the effect of the NP intervention on the rate of

implementation of evidence-based secondary prevention treatment strategies and the

patients‘ achievement of secondary prevention target goals; and, 3) to examine the

relationship between the NP activities delivering the intervention and secondary prevention

goal achievement by patients.

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A prospective cohort design was used, in which patients‘ achievement of target goals were

compared between patients who received secondary prevention care from an NP and those

who received usual care. The sample of convenience consisted of 65 patients with AMI. Data

on practice activities and implementation of secondary prevention by the NP were collected

before discharge from hospital and one week, two weeks, six weeks and 3 months after

discharge. Data on patients‘ achievement of goals were obtained before discharge from

hospital and 3 months after discharge from both groups. This study‘s results provide

preliminary evidence that an NP delivered secondary prevention intervention, beginning

prior to discharge and continuing for three months post myocardial infarction, significantly

improves the implementation and uptake of guideline based secondary prevention treatments

and risk factor reduction strategies. NP-led interventions such as this warrant replication. The

unique contribution of the NP with this patient population is the training and skills needed to

deliver all aspects of secondary prevention, including pharmacological and

nonpharmacological therapies, without the immediate availability of a physician.

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Acknowledgments

My inspiration for this work is my great grandmother, Laura Campbell, who went back to

university at the age of 65 to complete a Master‘s degree. Although I never had the privilege

to meet her, her legacy of accomplishment happily lived on to reach me.

I would like to thank my supervisor, Dr. Souraya Sidani, for her expert guidance and wise

counsel, always given with gentle kindness. To my brilliant dissertation committee: Dr. Alba

DiCenso, Dr. Ann Tourangeau, Dr. Jack Tu, and to reviewers Dr. Michael McGillion and Dr.

Alexander Clark. Their thoughtful feedback was always a pleasure to receive and learn from,

and served to make the dissertation better.

Special acknowledgment to Dr. Alba DiCenso in her role as the CHSRF/CIHR Chair in

Advanced Practice Nursing. She not only provided a much valued long-term mentor relationship,

but also enabled the financial support for conducting this research study.

To my best friend and sister, Debbie Schneider, who has helped and encouraged me

throughout my life, especially in my pursuit of this goal. To my student colleague Dr.

Christine Covell, for sharing the ups and downs of the doctoral journey with me; a humbling

experience, but not without much laughter.

To my husband and chief proof reader, Chris Stoate, the love of my life, to whom all things

are possible. For his unfailing love and support in doing whatever is necessary to help me

reach my goals and potential. I am forever thankful.

Lastly, I dedicate this dissertation to my amazing daughter Hayley. She is my greatest gift

and proudest accomplishment in life, and my inspiration to pass on the legacy of lifelong

learning which came down to me.

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Table of Contents

Abstract....................................................................................................ii

Acknowledgments...................................................................................iv

Table of Contents.............................................................................................................v

List of Tables..................................................................................................................... x

List of Figures........................................................................................xv

List of Appendices.................................................................................xvi

Chapter 1- Introduction............................................................................1

Problem Statement .................................................................................1

Background..............................................................................................2

Current environment.......................................................................3

Secondary prevention.....................................................................3

Evaluation of secondary prevention use in practice........................5

Remaining gaps..............................................................................5

Barriers to implementation and use of evidence-based

Therapies………………………………………………………………..6

Initiatives to improve secondary prevention.….………………..…...8

Cardiac secondary prevention programmes…………………..…..10

Secondary prevention programme components…..............11

Nursing roles in secondary prevention…………………….............11

Nurse practitioners in secondary prevention………………...........12

Rationale for evaluating the NP role in secondary

prevention…………………………………………..…………………13

Purpose of the Study…………………………….……………………….....14

Chapter 2- Literature Review……..…………………………...…………...16

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Search strategies…………………………………………….……….16

Overview of Secondary Prevention Strategies.......................................17

Individual Secondary Prevention Strategies..........................................19

Smoking cessation........................................................................19

Blood pressure control..................................................................20

Lipid management........................................................................21

Physical activity and cardiac rehabilitation....................................22

Weight management.....................................................................23

Diabetes management..................................................................24

Antiplatelet agents/anticoagulants................................................25

Angiotensin-converting enzyme (ACE) inhibitors..........................27

Beta-blockers................................................................................28

Multi-Component Secondary Prevention Strategies..............................30

Meta-analyses...............................................................................31

Individual clinical trials..................................................................36

Summary of the Evidence of Secondary Prevention Programmes........39

Nurse Practitioner Delivered Secondary Prevention..............................40

Nursing case management to increase guideline adherence.......41

Screening and counselling............................................................46

Transitional care...........................................................................49

Summary of NP Evidence in Secondary Prevention..............................51

Research Question................................................................................53

Conceptual Framework..........................................................................54

Chapter 3- Methodology.........................................................................56

Design………………........…………………………………………….........56

Setting......................................…………………………………...............59

vii

Sample ...............……..…….................………………………..............…60

Sample Size...........................................................................................60

Measures..…...................………………..............………….....................61

NP Secondary Prevention Intervention………..…………..............….....63

Control Group.........................................................................................67

Procedure for Data Collection………......……………............…………...67

Plan for Data Analysis………...……………........……………..........…….69

Baseline characteristics................................................................70

NP practice activities....................................................................70

NP implementation of secondary prevention................................70

Patient achievement of secondary prevention goals....................71

Ethical Considerations…………….…………………............…................71

Risks.............................................................................................72

Benefits.........................................................................................73

Ethical Approval............................................................................73

Chapter 4 - Results................................................................................74

Participation Rates.................................................................................74

Attrition...................................................................................................75

Characteristics of Participants................................................................77

Demographic.................................................................................77

Clinical characteristics..................................................................78

Outcome Variables at Baseline..............................................................80

Health Care Provider Variables..............................................................82

NP Practice Activities.............................................................................82

NP Implementation of Secondary Prevention........................................86

Post-Test Outcomes..............................................................................87

Continuous outcome variables......................................................88

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Dichotomous outcome variables...................................................89

Paired t-tests: within group changes............................................92

Predictors of Outcome Achievement: Multiple Regression Results.......94

Summary of regression analyses…............................................109

NP Activities as Predictors of Outcome Achievement..........................109

Summary of Results.............................................................................114

Chapter 5- Discussion..........................................................................116

Acceptability and Feasibility of Secondary Prevention Delivered by

NP........................................................................................................116

Enrolment....................................................................................116

Attrition........................................................................................117

Characteristics of Participants..............................................................118

NP Practice Patterns............................................................................119

Practice activities........................................................................119

Contact time with NP..................................................................122

NP Implementation of Secondary Prevention Strategies.....................123

Achievement of Treatment Goals.........................................................126

Overall effectiveness...................................................................126

Individual secondary prevention strategies and NP practice

patterns.......................................................................................129

Smoking.............................................................................129

Blood pressure..................................................................129

Physical activity.................................................................130

Diabetes management......................................................132

Statin use post-discharge..................................................132

Secondary prevention strategies: outcomes with no difference

between groups..........................................................................133

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Relationship between NP Activities and Outcome Achievement.........134

Strengths and Limitations.....................................................................136

Implications..........................................................................................138

Research implications.................................................................139

Suggestions for practice.............................................................140

Conclusion...........................................................................................141

References..........................................................................................142

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List of Tables

Table 1. Summary of Major Secondary Prevention Cholesterol

Trials…...........................................................................................22

Table 2. Summary of Large ACE Inhibitor Cardiovascular

Trials...............................................................................................28

Table 3. Summary of Large β-Blocker Trials Acute /Post

MI....................................................................................................29

Table 4. Summary of Clark et al. (2005) Programme Outcome

Results….........................................................................................33

Table 5. Summary of Reasons for Non-

eligibility...........................................................................................75

Table 6. Baseline Characteristics of Those who Dropped Out of the

Study and Those who Completed the Study...................................76

Table 7. Demographic Characteristics.............................................78

Table 8. Clinical Characteristics......................................................79

Table 9. Outcome Variables at Baseline..........................................81

Table 10. Mean Number of Health Care Provider Visits (SD).........82

Table 11. Distribution of NP Clinical Visits.......................................83

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Table 12. Mean, Standard Deviations and Range for Total Number of

Contacts and Total Number of Minutes with NP in each Secondary

Prevention Strategy...........................................................................84

Table 13. Mean, Standard Deviations and Range for NP Time Spent in

Each Practice Category Per Patient...................................................85

Table 14. NP Implementation of Secondary Prevention Guideline

Activities for the Intervention Group....................... ............................87

Table 15. Achievement of Secondary Prevention Goals at 3-Month

Follow-up, Continuous Variables, Controlling for Covariates ............88

Table 16. Achievement of Secondary Prevention Goals, Dichotomous

Variables.............................................................................................91

Table 17. Within Group Changes between Baseline and 3 Months for

Continuous Secondary Prevention Outcome Variables.....................93

Table 18. Relationships between Provider Variables, Group Membership

and Outcomes for Blood Pressure......................................................96

Table 19. Relationships between Provider Variables, Group

Membership and Outcomes for LDL-C, HDL-C, and Triglyceride Blood

Measurements....................................................................................96


and Outcomes for BMI and Waist Circumference..............................98

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and Weeks to Cardiac Rehabilitation..................................................98


and Smoking Outcomes....................................................................101


and LDL-C Outcome Goals........................ .......................................102


and Outcomes for Blood Pressure.....................................................103


and Continuous Outcomes for Physical Activity, Attendance to Cardiac

Rehabilitation and Return to Work......................................................104


and Diabetes Management.................................................................106

Table 27. Relationships between Baseline Characteristics, Provider

Variables, Group Membership and Outcomes for Medications..........106


and Outcomes for Nutrition Consultation and Diabetes Clinic

Attendance..........................................................................................108

Table 29. NP Practice Activities as Predictors of Outcome Achievement,

Continuous Variables..........................................................................109

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Table 30. NP Practice Activities as Predictors of Outcome Achievement,

Dichotomous Variables.......................................................................111

xiv

List of Figures

Figure 1. Conceptual Framework for Evaluating NP Care in Delivering

Secondary Prevention Post AMI...........................................................56

Figure 2. Overview of Study Design.....................................................58

xv

List of Appendices

Appendix A. NP Clinical Log................................................................171

Appendix B. Rates of Achievement of Secondary Prevention Treatment

Goals....................................................................................................173

Appendix C. NP Intervention Protocol……...............................…........175

Appendix D. Script for Recruitment ............. .......................................176

Appendix E. Baseline Data Collection Form........................................177

Appendix F. Outpatient Clinic Data Form............................................179

Appendix G. Consent Form.................................................................180

Appendix H. Correlation Coefficients Representing Relationship

Between Baseline Variables and Post-Test Outcome Variables........184

Chapter 1

Introduction

Problem Statement

Coronary heart disease (CHD) is a leading cause of death in Canada (Health Canada, 1998;

Statistics Canada, 2008). Health Canada has identified heart disease as the most costly

disease in Canada, placing the greatest burden on our health care system (Health Canada,

1998; Heart and Stroke Foundation of Canada, 2003). Acute myocardial infarction

(AMI/heart attack) is an acute presentation of CHD. Despite the dramatic fall in CHD

mortality rates over the last three decades (Cooper et al., 2000; Every, Fihn, Sales, Keane,

Ritchie, 2000), the actual number of hospitalizations for AMI has been increasing, and is

projected to continue to do so into the next century due to the aging population (Heart and

Stroke Foundation of Canada, 2003). The decline in mortality caused by CHD is thought to

be largely due to improvements in treatment and secondary prevention (Lenfant, 2003).

Secondary prevention is defined as strategies aimed at decreasing future risk in those with

established CHD.

In spite of conclusive evidence that specific secondary prevention strategies significantly

reduce morbidity and mortality in AMI survivors, a significant proportion of patients in

whom therapies are indicated are not receiving those therapies, or are receiving those

therapies in suboptimal doses (Anderson et al., 2007; Jackevicius, Li, & Tu, 2008;

Jackevicius, Tu, Filate, Brien, Tu, 2003; Smith, 2006; Tu et al., 2005; Yan et al., 2006). In a

recent study in Ontario, risk factor control outperformed improvements in medical and

surgical treatments as the source of the decline in age-adjusted CHD mortality over an eleven

year period (1994-2005) (Wijeysundera et al., 2010). Similar results were reported in the

United States examining the period between 1980 and 2000, in an era with dramatic

advances in new treatments (Ford et al., 2007). The similarities in the two study results,

spanning two and a half decades, demonstrate that efforts in developing innovative ways to

improve the uptake of treatment must also include strategies to improve cardiovascular risk

factors in those with established CHD.

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Patti

Typewritten Text

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There is strong evidence that structured secondary prevention programmes, with and without

exercise components, significantly improve outcomes in patients with CHD (Clark, Hartling,

Vandermeer, McAlister, 2005; McAlister, Lawson, Teo, Armstrong, 2001). Secondary

prevention cardiac programmes which are exercise-based are available in most urban and

suburban communities, but are utilized by less than 20% of the patients who are eligible

(Gravely-Witte et al., 2010). For those who enter into a cardiac rehabilitation programme,

the wait for entry into the programme is 6-12 weeks in most centres. There are limited

numbers of secondary prevention programmes which are not exercise-based available in

Canada, with most limited to large tertiary care medical centres. Examination of secondary

prevention programmes reported in the literature reveals multiple types of care providers in

these setting (e.g., nurses with varying levels of education, physiotherapists, nutritionists) and

high variability in specific program components. Which particular care providers and

activities are necessary to achieve desired outcomes is yet to be determined.

This pilot study examined the nurse practitioner (NP) as a provider of secondary prevention

care (compared to usual care) for patients after AMI, beginning before discharge from the

hospital and continued for 3 months post AMI, in an outpatient follow-up clinic. This study

identified the activities in which the NP engages when delivering the secondary prevention

intervention and evaluated the effect of the intervention on the rate of implementation of

secondary prevention treatment strategies and the patients‘ achievement of secondary

prevention target goals (outcomes). The study also examined the relationship between the

activities in which the NP engaged when delivering the secondary prevention intervention

and rates of treatment goal achievement by patients, with the goal of determining which

specific NP care activities are associated with desired outcomes.

Background

This chapter first describes the current environment of coronary heart disease (CHD) in

Canada and its impact on our healthcare system. The current state of knowledge on the

benefits of secondary prevention is then reviewed, followed by a discussion on what is

known about how well we are currently delivering secondary prevention care to patients with

known CHD. Gaps in care that have been identified and the initiatives that have been

undertaken to improve care are then discussed, including an overview of the current state of

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knowledge of secondary prevention programme delivery. Lastly, nursing roles in secondary

prevention are reviewed, which include the rationale for evaluating an NP delivered

secondary prevention intervention.

Current environment.

Cardiovascular disease (disease of the circulatory system) is responsible for more

hospitalizations among men and women than any other health problem in Canada (Heart and

Stroke Foundation of Canada, 2003). Coronary heart disease (CHD) ranks first as a specific

cause of death from cardiovascular disease (CVD) (Cooper et al., 2000). Acute myocardial

infarction (AMI/heart attack) is an acute presentation of CHD. The overall crude in-hospital

mortality rate for AMI in Canada is 12.3% (Tu et al., 2003). The mortality rate is 15% within

30 days of the event, and 23% within one year of the event (Heart and Stoke Foundation of

Canada, 2003).

CHD mortality rates dropped by over 45% for both men and women from 1970 to 1989

(Manuel, Leung, Nguyen, Tanuseputro, Johansen, 2003; Every et al., 2000; Cooper et al.,

2000). Despite the dramatic fall in mortality, the actual number of hospitalizations for AMI

has been increasing, and is projected to do so into the next century due to the aging

population (Heart and Stoke Foundation of Canada, 2003). Life expectancy has increased by

six years between 1970 and 2000, with nearly two thirds of that increase attributed to

reductions in mortality due to CHD (Lenfant, 2003). These declines since 1990 have slowed.

Age-adjusted CHD mortality rates decreased by over 3% per year for the 20-year period

between 1970 and 1990. In the 7- year period between 1990 and 1997, the rate of decline was

2.7% (Cooper et al., 2000). The most recent data on 30-day mortality rates for AMI in

Ontario show a 2% increase in death rates from the period from1998-1999 to 2002-2003

(11% and 13% respectively). The average age of AMI patients also increased from 67.8 to 69

years during that same time period (Tourangeau et al., 2007; Tourangeau & Tu, 2003).

Secondary prevention.

Up until the early 1980s, vascular events (AMI or stroke) were not considered preventable.

The treatment of AMI has been redefined during the past 20 years, with the incorporation of

evidence from multiple large-scale clinical trials which have established that specific lifestyle

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changes and therapies can lower the risk of future vascular events (Roe et al., 2005). For

example, clinical trials have demonstrated that smoking cessation can reduce the risk of all-

cause mortality by 36% in patients with CHD (Critchley & Capewell, 2006), and the use of

aspirin, β-blockers, ACE-inhibitors, and lipid-lowering therapies lowers the risk of future

vascular events by about 25% each in high risk patients (e.g., multiple risk factors; previous

MI or stroke) (Antithrombotic Trialists‘ Collaboration, 2002; Freemantle, Young, Mason,

Harrison, 1999; Flather et al., 2000; LaRosa, He, Vupputuri, 1999). It is thought that the

benefits of each intervention are largely independent, so that when used together in

appropriate high risk patients, two-thirds to three-quarters of future vascular events could be

prevented (Yusuf, 2002). The potential gains of combining preventive strategies in reducing

the impact of cardiovascular disease, including CHD, on morbidity and mortality are thus

potentially enormous.

Patients with established cardiovascular disease constitute one of the highest risk groups for

future vascular events (myocardial infarction and stroke). Nonfatal reinfarction has been

identified as the most powerful predictor of subsequent cardiac death after a first AMI

(Kornowski et al., 1993). Strategies aimed at decreasing future risk in those with established

cardiovascular disease, including CHD, are described as secondary prevention. Secondary

prevention incorporates identifying, treating, and rehabilitating these patients to reduce their

risk of recurrence, decrease their need for interventional procedures such as coronary artery

bypass surgery, improve quality of life, and extend overall survival (Cooper et al., 2000).

Secondary prevention strategies include smoking cessation, blood pressure control, lipid

management, physical activity, weight management, diabetes management, antiplatelet

agent/anticoagulant use, and long-term use of angiotensin-converting enzyme inhibitors and

beta-adrenoceptor blockers (Antman et al., 2008; Smith et al., 2006). These risk reduction

therapies are based on compelling evidence from recent clinical trials and are the foundation

for the Amercian College of Cardiology/American Heart Association/Canadian

Cardiovascular Society (ACC/AHA/CCS) guidelines for preventing heart attack and death in

patients with cardiovascular disease (Antman et al., 2008; Smith et al., 2006)

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Evaluation of secondary prevention use in practice.

Multiple studies have been undertaken to examine the extent to which these secondary

prevention strategies are integrated into practice (Daneman, Austin, Tu, 2001; Jackevicius et

al., 2008; Jackevicius et al., 2003; Tu et al., 2005; Tu, Austin, Rochon, Zhang, 1999). For

example, in 1999, the Institute for Clinical Evaluative Sciences (ICES) in Ontario published

the first cardiac report card ever released in Canada. The Atlas Report on acute myocardial

infarction (AMI) showed moderate and unexplained variations in short and long-term

survival at both the institutional and regional levels. They suggested that outcome differences

may be due to variations in follow-up and secondary prevention prescribing patterns. For

example, the report concluded that rates of beta-blocker use, ACE inhibitors, and statins in

AMI survivors may reflect significant under-use of these medications (Tu et al., 1999).

The conclusions of the Ontario report card are consistent with those of multiple studies on

the use of recommended therapies in patients with cardiovascular disease. These studies

clearly support the conclusion that a significant proportion of patients in whom therapies are

indicated are not receiving those therapies, or are receiving suboptimal doses, in clinical

practice (Jackevicius et al., 2008; Tu et al., 2005; Yan et al., 2006). For example, Jackevicius

and colleagues (2008) conducted a population-based cohort study using an AMI registry in

Ontario to track prescriptions filled after discharge from hospital. Only 73% and 79% of

prescriptions were filled within 7 days and 120 days respectively (excluding aspirin which

can be obtained without prescription). Only 74% of patients with AMI filled all of their

prescriptions six months after discharge.

Remaining gaps.

Although utilization rates of evidence-based therapies have improved significantly over time,

target levels have not yet been achieved in each category of medication, and there is still

much room for improvement in the initiation of and adherence to non-pharmacological

therapies, such as smoking cessation, referral to cardiac rehabilitation (Tu et al., 2005), and

the long-term adherence to medications (Petrilla, Benner, Battleman, Tierce, Hazard, 2005).

For example, 42% of patients who smoked prior to AMI (data from 1999/00 to 2000/01 in

Ontario) had no record of having received smoking cessation counseling during their hospital

admission (Tu et al., 2005). Among patients who begin statins, observational studies have

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reported 1-year discontinuation rates of 15%-60%, with only 26% of patients compliant 5

years after initiating statin therapy. Although the duration of treatment required to achieve

significant risk reductions is debatable, studies suggest that long-term therapy for 3-5 years

or more yields the greatest benefit (Petrilla et al., 2005).

Cardiac rehabilitation (CR) post MI is defined as comprehensive, long-term programs

involving medical evaluation, prescribed exercise, cardiac risk factor modification,

education, and counseling (Thomas et al., 2007; Gravely-Witt et al., 2010). Under-utilization

of CR post MI is another example of the gap between evidence and clinical practice in

patients with heart disease. The benefits of exercise-based rehabilitation are well established,

with statistically significant improvements in all-cause and cardiac mortality (20%-32%)

when compared to usual care. Usual care in this context is care without any structured

exercise training or advice, but may include standard medical care such as drug therapy

(Taylor et al., 2004). CR has also demonstrated effectiveness in improving ischemic

symptoms, functional capacity, promoting compliance, decreasing emotional distress,

improving quality of life and reducing risk of subsequent coronary events. Despite this,

fewer than 20% of all potentially eligible cardiac patients have utilized CR services in

Ontario (Cardiac Care Network of Ontario [CCN], 2002). Similar participation rates have

been reported in the United States (10%-20%) (Leon et al., 2005; Suaya et al., 2007).

Factors that are thought to contribute to this under-utilization include low patient referral

rates, poor patient motivation and geographic limitations to accessibility of programme sites

(Leon et al., 2005; CCN, 2002). A recent synthesis of the literature examining strategies to

increase patient enrolment in CR conducted by Grace et al. (2011) reported that on average

only 34% of those eligible are referred to CR.

Barriers to implementation and use of evidence-based therapies.

Attempts to narrow the gap between evidence and clinical practice in patients with

cardiovascular disease must address the known barriers to implementing clinical practice

guidelines (CPGs), and maximize practices which can facilitate or improve adherence to the

CPGs. Barriers to the successful implementation of and adherence to evidence-based clinical

guidelines can be identified at the level of the clinician, the patient, or the practice setting

(McAlister, Campbell, Zarnke, Levine, Graham, 2001). Implementation and adherence at the

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level of the clinician may be related to accessibility (e.g., wait times to see a physician) or to

what has been described as clinical inertia, which is described as the failure of health care

providers to initiate or intensify therapy when indicated (Phillips et al., 2001). Nonadherence

at the level of the patient may be related to patient preference, lack of knowledge, or medical,

social and emotional factors that undermine the patient‘s willingness to adhere (Kravitz &

Melnikow, 2004). Examples of this are inability to afford medications or enrolment fee to

CR, lack of confidence to make changes in behaviour, and fear of doing themselves harm

with exercise. The practice setting can contribute to nonadherence when resources are limited

(e.g., clinic space, teaching materials, dietician, and cardiac rehabilitation), and when there is

inadequate time during the clinical visit to assess risk factors, initiate or intensify therapy, or

make a persuasive case for adherence (Majumdar, McAlister & Furberg, 2004). With the

current fee for service mechanism for reimbursement for most physician services in Ontario,

spending lengthy amounts of time with one patient on a recurrent basis would not be

financially feasible.

It is likely that most clinical practice settings have a combination of these identified barriers

to the implementation of and adherence to evidence-based CPGs related to secondary

prevention strategies post AMI. With respect to access to physician care following AMI in

Ontario, one in eight patients are not seen by a family physician within six months, and one

in four will not see a specialist at all. In southwest Ontario, the median number of days to the

first visit with a cardiologist or internist after discharge from hospital following AMI is 36

days. The proportion of patients with no cardiologist or internist follow-up is 22% (CCN,

2002). As well, only 20% of Ontario hospitals provide cardiac rehabilitation (CCN, 2002).

The average time from cardiac event to referral to cardiac rehabilitation in Ontario is 71 days,

and from the event to intake into the CR programme is 111 days (CCN, 2002). This evidence

suggests that lack of (or delayed) access to secondary prevention care is a component in the

underutilization of evidence based therapies.

Failure of health care providers to initiate or intensify therapy when indicated is supported by

epidemiologic evidence and analysis of physician behaviour during patient visits (Phillips et

al., 2001). For example, blood pressure control is adequate in approximately 50% of patients

treated for hypertension (Egan, Zhao, Axon, 2010) and low-density lipo-protein (LDL)

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cholesterol levels are reduced to goals consistent with National Cholesterol Education

Program (NCEP) guidelines for high risk patients in only 51% of patients (Yan et al., 2006).

Not achieving treatment goals in treated patients must logically be attributed to therapeutic

failure or clinical inertia. Therapeutic failure is less likely, as attainment of treatment targets

has shown effectiveness of present therapies for hypertension and dyslipidemia in large

clinical trials (Heart Protection Study Collaboration Group, 2002; The ALLHAT Officers

and Coordinators for the ALLHAT Collaborative Research Group, 2002; The Heart

Outcomes Prevention Evaluation Study Investigators, 2000). This suggests that clinical

inertia is responsible for not achieving target goals in treated patients.

Initiatives to improve secondary prevention care.

Numerous initiatives have been undertaken worldwide to improve the implementation of

evidence-based secondary prevention care therapies by providers. These include: quality

improvement projects utilizing guideline-oriented tools designed to facilitate adherence to

quality indicators (Eagle et al., 2005; Lewis et al., 2008; Mehta et al., 2002; Mehta et al.,

2004; Ornstein et al., 2004; Redfern, Briffa, Ellis & Freedman, 2009; Safer Healthcare Now,

2007; Tu et al., 2005); hospital-based discharge medication programmes (Lappe et al., 2004;

Fonarow, Gawlinson, Moughrabi, Tillisch, 2001); examination of coronary heart disease

registers to improve systems to inform practitioner decision making (Clark et al., 2005); and

clinical performance measures for physicians (ACC/AHA/Physician Consortium for

Performance Improvement, 2005).

Many of these initiatives are thought to contribute to improvements in the use of evidence-

based therapies, particularly medication use after AMI, by providing feedback on relative

performance over time which can be used to target quality improvement efforts in areas of

suboptimal performance. These tools are designed to improve provider and practice setting

adherence to CPGs. For example, the Institute for Healthcare Improvement has undertaken

an initiative within Canada which identifies six key care components which should be

provided to all AMI patients. Included in these care components are 1) early administration

of aspirin; 2) aspirin at discharge; 3) beta-blocker at discharge; 4) timely initiation of

reperfusion (thrombolysis or percutaneous intervention); 5) ACE-inhibitor or angiotensin

receptor blockers (ARB) at discharge for patients with systolic dysfunction; and 6) smoking

9

cessation advice, counseling and/or pharmacological therapy and/or referral to cardiac

rehabilitation programme during hospital stay (Safer Healthcare Now, 2007). Participating

hospitals complete measurement worksheets for monitoring their progress toward the goals

identified as Canadian quality indicators for the care of AMI patients (Tran et al., 2003).

These quality indicators reflect the use of evidence-based secondary preventions strategies.

The most recent report available on how well we are achieving identified goals was gathered

from data obtained in the EFFECT Study (Enhanced Feedback for Effective Cardiac

Treatment). The study is also tracking process of care indicators using clinical data collected

from patient charts. The EFFECT study was designed to determine if publishing report cards

based on clinical data leads to greater use of evidence-based therapy. The results indicate

suboptimal use of secondary prevention strategies (Tu et al., 2005; Tu et al., 2009). For

example, approximately 1 in 5 AMI patients did not receive acetylsalicylic acid (ASA), β-

blocker, angiotensin-converting-enzyme inhibitor (ACE) or statins at hospital discharge

when clinically indicated (Tu et al., 2005).

The Safer Healthcare Now programme and the EFFECT Study were both developed to

improve the quality of cardiac care in Ontario. Both initiatives are designed to provide

feedback on performance of delivering evidence-based care, so that areas of suboptimal

performance can be identified and improved.

From the patients‘ perspective, other initiatives that have been undertaken to improve the

uptake and adherence to secondary prevention recommendations include psycho-educational

programmes encompassing health education and stress management (Dusseldorp, van

Elderan, Maes, Meulman & Kraaij, 1999) and structured outpatient cardiac secondary

prevention programmes (Giallauria et al., 2009; Redfern et al., 2009). A review examining

the effectiveness of psycho-educational programmes in reducing long term mortality and

recurrence of MI in cardiac patients (37 studies, 28 RCTs) demonstrated a 34% relative

reduction in cardiac mortality in the long term (>2 years) (combined results from 6 studies), a

29% relative reduction in MI recurrence at 2-10 years of follow-up (7 studies), as well as

improved risk factor profiles for systolic BP (8 studies), total serum cholesterol (7 studies),

weight (8 studies) and smoking in the short and medium terms (6 weeks to 2 years) (21

studies; p <0.025 for all comparisons) (Dusseldorp et al., 1999). The available data have

10

several limitations. Most patients were men in their 50s, which makes it difficult to

generalize results to other subgroups of patients. Additionally most studies gave only vague

descriptions of the psycho-educational interventions, making it difficult for clinicians to

determine which intervention components would most benefit their patients.

Cardiac secondary prevention programmes.

Secondary prevention programmes have been increasingly advocated as a way to improve the

management and outcomes for patients with coronary heart disease. These programmes have

been described as disease management programmes (McAlister, Lawson et al., 2001), which

combine patient education, use of clinical practice guidelines, appropriate consultation, and

supplies of drugs and ancillary services for a particular chronic disease within one setting

(Hunter, 2000).

It is well established that exercise-based secondary prevention programmes reduce mortality

in patients with coronary artery disease (Taylor et al., 2004). As well, a recent meta-analysis

examining secondary prevention programmes for patients with coronary artery disease

(n=63) provides strong evidence that secondary prevention programmes, with and without

exercise components, reduce the risk of all cause mortality by 47% at 24 months, with a

sustained benefit after 5 years. These programmes were also shown to reduce the risk of

recurrent MI by 17% after a median of 12 months (Clark et al., 2005).

These results confirm findings of an earlier systematic review, which examined secondary

prevention programmes that were not single modality interventions (such as exercise

programmes or telephone follow-up), and demonstrated improvements in risk factor profiles,

use of efficacious therapies, functional status, and quality of life (McAlister, Lawson et al.,

2001). This earlier review did not, however, detect significant differences between

intervention and control groups‘ rates of death or recurrent MI. The difference in the results

of the two reviews may be related to the difference in length of patient follow-up. The

median follow-up was 12 months in the first review, and did not show a mortality benefit. In

the more recent review (Clark et al., 2005), a mortality benefit was not evident at 12 months,

but was 15% overall and 47% at 2 years. Clark et al. (2005) postulate that 12 months is not

enough time to show a clear effect on mortality given that changes in risk factors would not

11

be expected to produce improvements in coronary artery plaque stability in the short term.

Surprisingly, in spite of this evidence, limited numbers of secondary prevention programmes,

outside of cardiac rehabilitation programmes, are available in Canada. With fewer than 20%

of all potentially eligible cardiac patients utilizing cardiac rehabilitation services (CCN,

2002; Gravely-Witte et al., 2010), and strong evidence that secondary prevention

programmes with and without exercise significantly improve morbidity and mortality (Clark

et al., 2005), it is reasonable to question why secondary prevention programmes have not

been implemented in communities across Canada.

Secondary prevention programme components.

Review of the components of the programmes evaluated in the individual randomized

clinical trials of the recent meta-analysis (Clark et al., 2005) is clinically informative and

relevant to efforts aimed at improving the availability of secondary prevention programmes

and making improvements in secondary prevention care (all programmes included in the

earlier systematic review were included in the meta-analysis). Other than the programmes

that were restricted to exercise alone, all other programmes included risk factor education or

counselling. The most frequent features of the 23 programmes without exercise included:

nurses leading or managing the programme (n = 19), individual counselling and education

about risk factors (n = 19), and frequent telephone contact (n = 10). In the 24 programmes

with exercise the most frequent features were: nurses leading or managing the programme (n

= 6), relaxation or stress management (n = 6), and individual counselling (n = 4).

Nursing roles in secondary prevention.

To date, the level of training that nurses possess in secondary prevention practice settings is

not well defined. Nurses in these roles have been described as nurses, specialist nurses,

expert nurses, case managers, advanced practice nurses (APNs), and nurse practitioners

(NPs). Describing the type of training a nurse has in these roles is important because the

level of autonomy in delivering secondary prevention care varies widely in registered nurses

(RNs) with different levels of education. For example, prescriptive and diagnostic authority

in nurses is limited to those nurses who are trained (post-baccalaureate or Master‘s level) as

nurse practitioners (NPs). Therefore, the level of training that the nurse possesses dictates

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the extent to which secondary prevention strategies, both pharmacological and non-

pharmacological, can be implemented in settings where a physician is not immediately

available. For example, clinical settings that do not have a provider with the authority to

titrate medications to target levels, order smoking cessation pharmacotherapy aids, make

referrals to cardiac rehabilitation, or order diagnostic tests (such as cholesterol levels, liver

function and renal function tests necessary in monitoring progress and response to secondary

prevention medications) will be limited to exercise supervision, education and counselling,

and thereby miss the opportunity for delivering comprehensive secondary prevention in one

setting, at the most opportune time.

Nurse practitioners in secondary prevention.

Nurse practitioners (NPs) who participate in expanded clinical practice, including some

prescriptive, diagnostic and treatment authority, are potentially well suited to deliver multi-

component interventions, as their responsibilities can span the traditional medical and

nursing domains of the practice components described in most secondary prevention

programmes. For example, NPs have the authority to diagnose and treat hyperlipidemia,

hypertension and angina; and can refer patients to cardiac rehabilitation and psychiatric

services in Ontario. The Canadian Nurses Association describes NPs as having the advanced

knowledge and skills to deliver comprehensive preventive care, which includes assessment,

diagnosis and treatment of chronic diseases (Canadian Nurses Association, 2009).

Although NPs have not been specifically evaluated in this role, results of many studies have

demonstrated improvements in outcomes (patient health, quality of life, coordination and

continuity of care, use of health services, access times, wait times, patient and family

satisfaction and health care costs) when advanced practice nursing (APN) roles that include

NPs complement existing care provider roles and are designed to address gaps in the delivery

of health care services (Brooten et al., 2002; Corner, Plant, A‘Hern, Bailey, 1996; Corner,

Plant, Warner, 1995; Bredin et al., 1999). Additionally, there is evidence that: (1) NPs are

more effective than physicians in areas related to patient compliance (Horrocks, Anderson &

Salisbury, 2002); (2) significant reductions in LDL cholesterol levels can be achieved in NP-

run lipid management programmes (DeBusk et al., 1994; Allen et al., 2002; Mason, 2005);

(3) APN transitional care improves outcomes such as readmission rates in cardiac patients

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(Naylor et al., 2004); (4) high quality chronic disease management (based on composite

chronic disease management scores) is associated with the presence of a nurse practitioner as

reported in a recent study in Ontario which examined four primary healthcare delivery

models (Russell et al., 2009); and (5) nurse-led (―specialist nurses‖) secondary prevention

clinics improve adherence to secondary prevention strategies when compared to usual care

(Murchie, Campbell, Ritchie, Simpson & Thain, 2003). The study by Murchie and colleagues

(2003) showed significant improvement in all main measures of secondary prevention

(aspirin use, blood pressure management, lipid management, healthy diet, exercise, total

mortality and coronary events) except smoking at one year, with all improvements except

exercise sustained after 4 years.

Use of dedicated NPs to implement practice guidelines is an example of a system-oriented

approach to improve outcomes in patients with heart failure. In a study which utilized an NP

intervention in improving β-blocker use in patients with heart failure, the authors (Ansari et

al., 2003) concluded that the success of the intervention was related to the NP‘s ability to

overcome specific common barriers to guideline implementation (proportion of patients on

target doses at the end of the study: 43% in NP group compared with 10% in control group,

p<0.001). In this case, the implementation of β-blockers was viewed as difficult and time

consuming, because it requires frequent visits for uptitration (gradual increases in dosage)

and close monitoring of symptoms and side effects, and assessment by physical examination

(Ansari et al., 2003). The addition of the NP in assisting with guideline implementation

provided a helpful service for the patient and physician, making it possible to initiate beta-

blockers without additional monitoring and time expenditure on the part of the physician

provider. The authors explain that a NP was selected to deliver the intervention because

physical examinations played an important role in patient selection and monitoring during β-

blocker initiation (Ansari, 2003).

Rationale for evaluating NP role in secondary prevention.

The research evidence suggests that an NP role in secondary prevention could potentially

further improve implementation of secondary prevention strategies and outcomes in patients

with CHD. This is based on what is known about the current barriers to the successful

implementation of and adherence to proven secondary prevention strategies and how the NP

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role can address those barriers. For example, with the issue of delayed access (wait times to

cardiologist, internist, cardiac rehabilitation) or geographic limitations to care providers and

services (no cardiologist, internist or cardiac rehabilitation within proximity to patient

residence), an NP delivering secondary prevention could see patients within two weeks of

discharge from hospital. This timing is ideal for monitoring symptom and activity

management and maximizing the potential of reaching secondary prevention target goals

because this is a period of time in which the patient is at highest risk for reinfarction.

Reinfarction occurs most frequently within the first six months after hospital discharge, with

23%, 43%, and 61% occurring during the 1-, 3-, and 6-month periods after discharge,

respectively (Kornowski et al., 1993). This additional access to secondary prevention

expertise would be especially beneficial for those patients who do not have access to a

cardiologist or internist (or this access is delayed due to busy practices), and for those who

would not be attending cardiac rehabilitation (up to 80% of patients). In addition, NPs can be

available to speak to patients and troubleshoot problems over the telephone, which is more

difficult for physicians (particularly specialists) who have additional responsibilities such as

cardiac catheterizations.

The NP would have the time, skills and authority to initiate and titrate secondary prevention

medications. The NP would also have the expertise and research knowledge to implement

comprehensive treatment plans centered around the patient‘s preferences and the social,

medical or emotional factors that may undermine their willingness to adhere to both

pharmacological and non-pharmacological evidence-based therapies. These skills would

enable the NP to help patients achieve their goals while minimizing clinical scenarios that are

frequently linked to clinical inertia (lack of time or training focused on attaining therapeutic

goals).

Purpose of the Study

The overall purpose of this pilot study was to examine the feasibility, acceptability, and

preliminary effects of an NP delivered secondary prevention intervention. The specific

objectives were: 1) to describe the NP activities when delivering the secondary prevention

intervention; 2) to evaluate the effect of the NP intervention on the rate of implementation of

evidence-based secondary prevention treatment strategies and the patients‘ achievement of

15

secondary prevention target goals; and, 3) to examine the relationship between the NP

activities delivering the intervention and secondary prevention goal achievement by patients.

The ultimate aim was to understand the association between NP care activities and successful

goal achievement.

The NP delivered secondary prevention intervention consisted of activities in which the NP

can autonomously engage to implement the pharmacological and non-pharmacological

strategies for secondary prevention. The intervention activities reflected processes of care

because they are within clinician control or influence (NP or usual care provider) and

because they can be measured in frequency and intensity or dose (e.g., time spent) in relation

to each secondary prevention strategy. The outcomes of the intervention encompassed

patient achievement of secondary prevention goals; these goals are well defined in the

literature and can be measured and compared to specific target goals specified in the

ACC/AHA/CCS guidelines for the management of patients with AMI (Antman et al., 2008).

Psychosocial health, including risk factors including depression, hostility, global or financial

stress, life events and locus of control, are also known to be associated with increased

cardiovascular risk, independent of other risk factors (Rugulies, 2002; Wulsin & Singal,

2003; Kent & Shapiro, 2009). The evaluation of the NP intervention in this study was limited

to those risk factors which are specifically targeted in the clinical practice guidelines for

preventing heart attack and death in patients with CHD, to allow for comparisons on

outcomes achieved by study participants to those in other quality improvement initiatives.

Chapter 2

Literature Review

A review of the literature was undertaken with the objective of gaining a comprehensive

understanding of: 1) the current state of knowledge of evidence-based secondary prevention

strategies for patients with a history of AMI; 2) the range and rates of success of quality

initiatives that have been explored and tested to improve delivery of secondary prevention

and outcomes for patients with AMI; and, 3) the current state of knowledge, based on the

best available evidence, of the role of nursing in secondary prevention care, with an emphasis

on how the nurse practitioner (NP) role has been implemented or evaluated in settings that

deliver secondary prevention care.

Search Strategy to Locate and Categorize Relevant Literature

The primary databases used in the search for relevant literature included MEDLINE and

CINAHL. The time period covered was 1990 – 2009. This time period was selected because

literature prior to this time would not reflect advances in cardiovascular care related to

secondary prevention. Studies cited prior to 1990 were included if they support the literature,

or are frequently cited foundation studies. Only articles available in English were reviewed.

The following key words were used in the search, alone and in combination: secondary

prevention, myocardial infarction, cardiac, prevention, cardiac rehabilitation, management,

quality indicators, pharmacotherapy, disease management, case management, nurse

practitioner, advanced practice nurse, and advanced practice nursing. Document types

included reports of randomized controlled trials, systematic reviews, meta- analyses, quasi-

experimental design studies and observational studies, as well as clinical practice guidelines

and consensus statements. Additional sources searched included Evidence-Based Medicine,

Evidence-Based Nursing, Cochrane Library, National Guideline Clearinghouse, Directory of

Clinical Practice Guidelines, ACP Journal Club, and references cited in selected studies and

articles.

Articles were selected based on the following criteria: included a patient population with

established CHD, and implemented at least one component and/or examined at least one

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outcome of secondary prevention care. Preference was given to studies with comparison

groups and those that included a nursing role. The literature was reviewed and synthesized

according to topic: individual secondary prevention strategies, secondary prevention multi-

component programmes, and nurse practitioner delivered secondary prevention. Significant

methodological limitations will be discussed by topic.

Overview of Secondary Prevention Strategies

Patients with established coronary heart disease are at serious risk for subsequent ischemic

vascular events and/or death (Smith, Blair & Criqui, 1995). As previously described,

nonfatal reinfarction has been identified as the most powerful predictor of subsequent cardiac

death. Determining what constitutes effective strategies and treatment for the prevention of

future vascular events, decreasing the need for interventional procedures, improving quality

of life and extending survival in those with established CHD have been a priority in

cardiovascular research over the last three decades (Cooper et al., 2000).

The cardiovascular research and clinical communities are in general agreement that there is

conclusive evidence supporting the effectiveness of specific strategies in reducing morbidity

and mortality outcomes in patients with CHD. This is evident with the development,

publication and periodic updates of clinical practice guidelines and quality indicators for

preventing heart attack and death in patients with CHD, from sources such as: the American

Heart Association/American College of Cardiology (AHA/ACC), the Canadian

Cardiovascular Society (CCS), and the Canadian Cardiovascular Outcomes Research Team

(CCORT) (Antman et al., 2008; Smith et al., 2006; Tu et al., 2005).

Clinical practice guidelines are systematically developed statements designed to help care

providers and patients make decisions about healthcare for specific clinical circumstances.

These statements are based on scientific evidence and are written and peer reviewed by

clinical experts in the field. Clinical practice guidelines provide clinical advice presented in a

variety of forms, such as protocols, algorithms or policy documents (Woolf, 1990). Only

national guidelines and guidelines developed by major cardiology-related specialty groups

through an extensive consensus process with a working group or advisory committee are

included in the discussion here on cardiac secondary prevention.

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Typewritten Text

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Consensus statements and clinical practice guidelines for preventing heart attack and death in

patients with CHD include the following secondary prevention recommendations, with the

targeted goal included in parentheses:

1. Smoking cessation (goal: complete cessation);

2. Blood pressure (BP) control (goal BP <140/90 mmHg or <130/80 if diabetes

or chronic kidney disease);

3. Lipid management (primary goal: LDL<100 mg/dL or <2.5mmol/L

(<70mg/dL or <1.79mmol/L is reasonable); if triglycerides are greater than

or equal to 200mg/dL or 2.2 mmol/L then non-HDL should be <130 mg/dL

or 3.4mmol/L);

4. Physical activity (goal: 30 minutes 7 days a week (minimum 5 days a week);

medically supervised programs for high-risk patients);

5. Weight management (goal BMI 18.5-24.9 kg/m2; waist circumference ≤40

inches in men and ≤35 inches in women);

6. Diabetes management (goal HbA1c <7%);

7. Antiplatelet agents/anticoagulants (ASA if not contraindicated; clopidogrel

or warfarin when clinically indicated);

8. ACE inhibitors (goal: treat all patients post AMI indefinitely; consider long-

term therapy for all other patients with coronary or other vascular disease

patients unless contraindicated);

9. β-blockers (goal: treat all patients post AMI indefinitely unless

contraindicated; Antman et al., 2008; Smith et al., 2006).

Quality indicators for AMI care are also included in this review. Indicators are distinct from

practice guidelines in that indicators are designed to measure aggregate patterns of care

(which ultimately can be linked to patient outcomes), whereas guidelines make suggestions

for optimal practice for individual patients (Tu et al., 2005). Quality indicators are used to

evaluate the effectiveness of care.

Process and outcome indicators have been developed to evaluate secondary prevention.

Indicators developed by the Canadian Cardiovascular Outcomes Research Team (CCORT),

which form the basis of a randomized trial of cardiac report cards currently underway in

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Ontario hospitals include: β-blocker prescribed at discharge; ACE inhibitors prescribed at

discharge; statin prescribed at discharge; and counselling regarding smoking cessation

provided before discharge (Tu et al., 2005).

The scientific evidence supporting the need for each of these practice recommendations will

be discussed separately in the subsections below in the order presented by ACC/AHA/CCS

guidelines. Priority was given to evidence from systematic reviews, meta-analyses and

randomized controlled trials.

Individual Secondary Prevention Strategies

Smoking cessation.

Continued smoking after cardiovascular events such as AMI is associated with significant

harmful effects to the cardiovascular system. These include increased susceptibility to

clotting, impairment in flow-mediated dilation of the coronary arteries, increases in blood

pressure, heart rate and peripheral vascular resistance, increases in catecholamines, and

reduction in high-density lipoprotein (HDL)-cholesterol (Rigotti & Pasternak, 1996).

There is strong consensus that patients who smoke should be counselled to stop smoking

based on the deleterious physiological effects of smoking on general health and the

cardiovascular system. Numerous studies have found an association between cigarette

smoking and cardiovascular disease, with risk of cardiovascular disease proportional to the

number of cigarettes smoked. A recent Cochrane systematic review of 20 cohort studies of

patients with a diagnosis of CHD showed that there was a 36% reduction in crude relative

risk (RR) of mortality for those who quit smoking compared with those who continued (RR

.64, 95% CI 0.58 to 0.71) (Critchley & Capewell, 2006).

Smoking cessation rates in middle-aged and older adults with CHD range from 20% to 70%

one year post AMI (Taylor et al., 1990). Although most physicians recognize the importance

of smoking cessation counselling, studies have demonstrated that less than half of primary

care physicians routinely counselled their patients on smoking cessation during the 1980‘s

and 1990‘s (Cooper et al., 2000). These findings are similar to results found in an Ontario

study, which reported that 42% of patients who smoked on admission for AMI had no record

20

of having received any smoking cessation counselling (Tu et al., 2005). Reasons posited for

low rates of smoking cessation counselling include lack of time and training by health care

providers (Grable & Ternullo, 2003). A recent Cochrane review examining the effectiveness

of nurse-delivered smoking cessation interventions compared to a control group or usual care

(31 RCTs) found that nursing interventions significantly increase the likelihood of quitting

(RR 1.28, 95% CI .1.18-1.38). The authors concluded that the most successful nursing

interventions were ones with multiple contacts with nurses in health promotion or cardiac

rehabilitation. Most of these interventions included individual counselling and education on

the benefits of smoking cessation, follow-up clinic appointments, multiple telephone contacts

with participants and nicotine replacement therapy (NRT) if appropriate (Rice & Stead,

2008; Smith & Burgess, 2009). This evidence supports the ACC/AHA/CCS guideline

recommendation that all patients recovering from AMI should be encouraged to quit

smoking, with strategies including counselling, nicotine replacement and formal smoking

cessation programs, as appropriate (Antman et al., 2008).

Blood pressure control.

Extensive clinical and epidemiologic studies have clearly demonstrated that hypertension is

associated with progressive coronary atherosclerosis, the development of congestive heart

failure, and up to a six-fold increase in stroke risk (McMahon et al., 1990; Hemmelgarn et

al., 2004). The Seventh Report of the Joint National Committee on Prevention, Detection,

Evaluation and Treatment of High Blood Pressure (Chobanian et al., 2003) recommends that

patients who have had an AMI be treated with ACE inhibitors, β-blockers, and if necessary,

aldosterone antagonists to a target blood pressure of < 140/90 mmHg, or < 130/80 mmHg for

those with diabetes or chronic renal disease. If BP is more than 20/10 mmHg above goal BP,

consideration should be given to initiating therapy with two agents, one of which should be a

thiazide-type diuretic (Antman et al., 2008; Chobanian et al., 2003). These recommendations

are based on RCT evidence that treatment of hypertension (with doxazosin, an α-blocker;

cholthalidone, a diuretic; or ramipril, an ACE-inhibitor) reduces morbidity and mortality in

high risk patients (Campbell et al., 2009; Goldberg et al., 2004; The ALLHAT Officers and

Coordinators for the ALLHAT Collaborative Research Group, 2002; The Heart Outcomes

Prevention Evaluation Study Investigators, 2000).

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Lipid management.

Raised total cholesterol and low density lipoprotein (LDL) and low levels of high density

lipoprotein (HDL) are predictive of coronary events, especially in those with pre-existing

CHD (Carlsson, 1998). Lipoprotein and its products modify endothelial functions by

inducing an inflammatory reaction and impairment of the vasoregulatory functions of the

endothelium. High levels of HDL cholesterol protect vessels from this process.

Compelling scientific evidence, including data from meta-analyses and large scale

randomized clinical trials, have demonstrated that lipid lowering therapies (diet and/or drug

treatment) result in improved angiographic measurements, reductions in clinical events, and

reductions in cardiovascular and all-cause mortality in patients with CHD (Cholesterol

Treatment Trialists‘ Collaboration, 2010; Heart Protection Study Collaboration Group, 2002;

LaRosa et al., 1999; Ornish et al.,1990; Ornish, Scherwitz & Billings 1998; Sacks et al.,

1996; Scandinavian Simvastatin Survival Study Group, 1994). These benefits have been

seen even in patients with normal to ―average‖ cholesterol levels (Sever et al., 2004; Sacks et

al., 1996). Compelling evidence from recent clinical trials unequivocally recommends

treating elevated cholesterol levels with diet, exercise and drug therapy to target levels for

the secondary prevention of CHD (Prospective Studies Collaboration, 2007; Ridker et al.,

2009). Implementation of a diet low in saturated fats and cholesterol can be expected to

lower LDL-C by approximately 11% to 15%. With the inclusion of weight loss, a decrease of

LDL-C of 20% to 30% can be expected (Fletcher et al., 2005). Exercise-induced

improvement in HDL-C (the protective cholesterol) ranges from 4% to 22%.

In-hospital initiation of lipid-lowering therapy clearly improves long-term treatment rates and

patient compliance (Fonarow et al., 2001). After adjusting for other potential confounders,

initiation of a lipid-lowering drug during hospitalization has been shown to be the strongest

independent predictor of use at 6 months (Aronow et al., 2003). Table 1 provides a summary

of the results of major secondary prevention cholesterol trials.

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Table 1

Summary of Major Secondary Prevention Cholesterol Trials

Study Intervention Average

baseline LDL

% decrease in

mortality

% decrease in

cardiovascular

events

4S (1994) Simvastatin 20-40 mg/d

4.9 30% 34%

CARE (Sacks et al., 1996)

Pravastatin 40 mg/d

3.6 NS* 24%

LIPID (1998) Pravastatin 40 mg/d

3.9 22% 24%

HPS (2002) Simvastatin 40 mg/d

3.4 13% 27%

LaRosa (1999) Meta-analysis

4.24 (5 studies)

21% 31%

JUPITER (Ridker et al., 2009)

Rosuvastatin 20 mg/d

2.9 (primary

prevention)

55%

Note. 4S = Scandinavian Simvastatin Survival Study Group; CARE = Cholesterol and Recurrent Events trial; LIPID = The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study; HPS = Heart Protection Study Collaborative Group; JUPITER = Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial.

Physical activity and cardiac rehabilitation.

The goal of an exercise intervention in patients with CHD includes improved functional

capacity with improvements in activity-related signs and symptoms (i.e., shortness of breath

on exertion, angina, and fatigue). In the population-based Cardiovascular Health Study

(5201 men and women, mean age 73 years), level of physical activity was found to be an

independent predictor of 5 year mortality in adults ≥ 65 years old (Fried, Kronmal &

Newman, 1998). In the presence of coronary atherosclerosis, exercise-induced increases in

blood flow can be limited by atheroma and by an abnormal vascular endothelial response that

results in vasoconstriction on exertion. Angina and ischemic left ventricular dysfunction

result from an imbalance between the supply and demand for myocardial oxygen. As well,

abnormalities of left ventricular diastolic flow, which is particularly common in older

patients with CHD, frequently leads to exertional shortness of breath and a decrease in

exercise capacity (Hambrecht, Wolf & Gielen, 2000). In addition to these physiologic

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changes which occur in CHD, patients are also frequently fearful of potential harm from

exercise, which creates a cycle of inactivity and deconditioning; these in turn further limit

usual functioning and quality of life (Neill, Branch & Dejong, 1985).

Findings from two published widely cited meta-analyses (Oldridge, Guyatt, Fischer & Rimm

1988; O‘Connor et al., 1989) of over 4000 patients demonstrated that patients randomized to

exercise-based cardiac rehabilitation after MI had a 20 to 25% reduction in all-cause

mortality compared to patients receiving conventional care. A more recent Cochrane

systematic review, which included 8440 patients, was undertaken to determine the

effectiveness of exercise alone or as part of a comprehensive cardiac rehabilitation

programme on the mortality, morbidity, health related quality of life and modifiable cardiac

risk factors (smoking behaviour, blood pressure and blood lipid levels) of patients with CHD

(Jolliffe, Taylor, Thompson, Oldridge & Ebrahim, 2000). The type of exercise interventions

varied across studies from gym-based aerobic exercise twice a week for 4 weeks to an

intervention lasting 30 months with inpatient stays. The pooled estimate for total cardiac

mortality was reduced by 31% (OR 0.69, 95% CI 0.51 to 0.94) and 26% (OR 0.74, 95% CI

0.57 to 0.96) in the exercise only and comprehensive rehabilitation groups respectively. The

patient populations included in both these meta-analyses were predominately middle aged

(65 years of age or younger) men at low risk for cardiac death (Jolliffe et al., 2000).

The ACC/AHA/CCS guidelines for the management of patients recovering from AMI

recommends that all patients should be encouraged to exercise for 30 minutes, 7 days a week

(minimum 5 days per week), in addition to an increase in routine lifestyle activities such as

household work and gardening (Antman et al., 2008). These guidelines further recommend

cardiac rehabilitation or secondary prevention programmes, when available, for those

patients with multiple risk factors and/or those at moderate to high risk where supervised

exercise training is warranted (Antman et al., 2008).

Weight management.

According to data from the Framingham Study, obesity is an independent risk factor for

CHD events (Hubert, Feinleib & McNamaram, 1983). Obesity has significant adverse

effects on CHD risk factors, including: increasing blood pressure, promoting the

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development of left ventricular hypertrophy, worsening insulin resistance, and negatively

affecting lipid levels (particularly increasing triglycerides and reducing HDL-C). Obesity is

also thought to lead to a more sedentary lifestyle (Lavie & Milani, 1996).

When weight loss is achieved, it is associated with improvements in lipid levels, insulin

resistance, blood pressure and clotting abnormalities (Lavie & Milani, 1996; Ornish et al.,

1990). A combination of dietary intervention and exercise has been shown to reduce body

mass index by 4 to 9%. The effect of exercise alone, without nutritional counselling, is less

successful in achieving body weight and body fat goals (Brochu, Poehlman, & Ades, 2000).

One study of obese patients with CHD examined the effects of an American Heart

Association step I diet and weight loss programme (weekly sessions with a dietician, without

an exercise component). The results demonstrated a mean weight loss of 11 kg, a 10%

decrease in both total and LDL-cholesterol, a 24% reduction in triglycerides, and an 8%

increase in HDL-cholesterol (Katzel, Coon, Dengel & Goldberg, 1995). With these

improvements in risk factors with weight loss, a reduction in secondary coronary events is

expected.

This evidence supports the ACC/AHA/CCS recommendation that patients recovering from

AMI should be advised about strategies for weight reduction (i.e., diet and exercise) with a

plan to monitor the response to these strategies through measurement of body mass index

(BMI) and waist circumference. This recommendation acknowledges that these strategies

would usually be provided within the context of cardiac rehabilitation, and does not make a

recommendation for those who do not attend cardiac rehabilitation (Antman et al., 2008).

Diabetes management.

The presence of diabetes mellitus is a powerful predictor of secondary coronary events in

patients with CHD (Vokonas & Kannel, 1996). The relationship between glucose levels and

the risk of heart disease is curvilinear, with glucose being considered a cardiovascular risk

factor. For example, people with fasting blood sugar levels of 110 mg/dL (6.05 mmol/L)

have a 33% increased risk of cardiovascular events, whereas those with a 2-hour postprandial

glucose of 140 mg/dL (7.7 mmol/L) have a 58% increase in risk (Friedewald et al., 2006).

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In a large trial examining type 2 diabetes and prior MI in relation to mortality among 51,316

men aged 40 to 75 years in the Health Professionals Follow-up Study,

comparing men without diabetes or prior MI at baseline during 10 years of follow-up, RRs

for fatal CHD were 3.84 for those with diabetes only, 7.88 for those with MI only, and 13.41

for those with both diabetes and MI (Cho, Rimm, Stampfer, Walter & Hu, 2002).

The benefits of improved glucose control on cardiovascular risk were first demonstrated in

the long-term follow-up of the Diabetes Control and Complications Trial/Epidemiology of

Diabetes Interventions and Complications (DCCT/EDIC) (Nathan et al., 2005). This study

compared intensive versus conventional treatment for type I diabetes in the long-term

incidence of cardiovascular disease. Intensive treatment was defined as greater than or equal

to three insulin injections per day or an external insulin pump, with dose adjustments based

on four or more self-monitored glucose measurements to reach target glucose levels.

Conventional therapy was defined as one or two insulin injections per day. This study

represented the first convincing evidence that lowering glucose reduces cardiovascular events

(Friedewald et al., 2006).

Strategies to improve the management of patients with diabetes include intensive

pharmacological therapy to optimize glucose control, exercise and weight control. It has been

reported that in middle-aged CHD patients, even short-term exercise training improves

hyperinsulinemia. In older CHD patients, the effect of exercise training on glycemic control

appears to be related more to its positive effects on fat mass and body fat distribution. This is

due to the fact that glucose and insulin levels are more closely related to total body fat mass

in older coronary patients (Williams et al., 2002). Appropriate hypoglycaemic therapy, as

well as weight management and exercise, to achieve near-normal fasting glucose with the

goal of a glycosylated haemoglobin level less than 7% is recommended in the AHA/ACC

guidelines for preventing heart attack in patients with CHD (Antman et al., 2008).

Antiplatelet agents/anticoagulants.

Disruption of an atherosclerotic plaque which results in formation of platelet and fibrin-rich

thrombi, plays a fundamental role in the pathogenesis of AMI and sudden death. The goal of

platelet inhibition or anticoagulant therapy is to decrease thrombus formation (Fuster, Dyken,

26

Vokonas & Hennekens, 1993). Clinical and empirical evidence for the use of antiplatelet

agents in patients following AMI is conclusive. Antiplatelet agents significantly reduce the

risk of recurrent infarction, stroke or vascular death in patients receiving prolonged

antiplatelet therapy (Antithrombotic Trialists‘ Collaboration, 1994; 2002).

In a meta-analysis of 287 studies involving 135,000 patients comparing antiplatelet therapy

versus control and 77,000 patients comparing different antiplatelet regimens, antiplatelet

therapy reduced nonfatal MI by one-third, nonfatal stroke by one-quarter, and vascular death

by one-sixth in high-risk patients (e.g., previous MI, AMI, previous stroke/TIA, acute

stroke). Aspirin was the most widely studied antiplatelet drug, with doses of 75-150 mg at

least as effective as higher daily doses; daily doses lower than 75 mg were less certain. The

absolute benefits substantially outweighed the absolute risks of major extracranial bleeding

in each of the five high risk categories of patients studied (Antithrombotic Trialists‘

Collaboration, 2002).

A more recent systematic review and meta-analysis of randomized controlled trials

comparing combined aspirin and anticoagulant therapy versus anticoagulant therapy alone

found no difference in all-cause mortality or risk of thromboembolism with either treatment

in patients with CAD. The risk of major bleeding was significantly higher in patients

receiving the combined treatment (OR, 1.43, 95% CI, 1.00-2.02) (Dentali, Douketis, Lim &

Crowther, 2007).

With respect to the combination of aspirin and clopidogrel, results of the large randomized

controlled trial CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events)

demonstrated a small but significant reduction in serious ischemic events with clopidogrel

compared to aspirin (8.6%, p = 0.043). However, the addition of clopidogrel to aspirin did

not produce any significant further reduction in vascular events compared to aspirin alone

(CAPRIE Steering Committee, 1996). In patients with unstable angina without ST-segment

elevation, the efficacy and safety of early and long-term use of clopidogrel plus aspirin and

aspirin alone was studied in the CURE trial (Clopidogrel in Unstable Angina to Prevent

Recurrent Events). The results showed a statistically significant reduction in the primary end

point of death from cardiovascular causes, nonfatal MI or stroke in patients treated with both

27

clopidogrel and aspirin (p < 0.001) but higher rates of major and minor bleeding (p < 0.001)

(Yusuf, Mehta, Chrolavicius, Tognoni, & Fox, 2001).

Guidelines from the Canadian Cardiovascular Society, the American Heart

Association/American College of Cardiology, and the European Society of Cardiology

recommend that following AMI, all patients receive 75 to 162 mg of aspirin daily if not

contraindicated. In patients who do not tolerate aspirin, clopidogrel 75 mg/day (or warfarin)

is recommended. For those who are not able to take aspirin or clopidogrel, warfarin can be

an alternative for patients less than 75 years of age who are at low risk of bleeding and can be

monitored adequately to maintain a target international normalized ratio (INR) of 2.5 to 3.5

(Antman et al., 2008; Van de Werf et al., 2003).

Angiotensin-converting enzyme (ACE) inhibitors.

ACE inhibitors improve the function of the arterial endothelium and slow the progression of

atherosclerosis. These vasculoprotective effects include direct antiatherogenic effects,

inhibition of platelet aggregation, protection from plaque rupture, improved arterial

compliance and tone, and antioxidant and anti-inflammatory effects (Lonn, 2001).

Compelling evidence supports the long-term use of ACE-inhibitors for the purpose of

secondary prevention post AMI (Yusuf et al., 2000; Fox et al., 2003). Early studies

examining the benefits of ACE inhibitors in secondary prevention were limited to their use in

patients with heart failure or reduced left ventricular function. These studies demonstrated a

reduction in the rate of myocardial infarction and the need for revascularization in patients

with heart failure and left ventricular dysfunction (Flather et al., 2000; Pfeffer, Braunwald &

Moye, 1992; The SOLVD Investigators, 1993). Two randomized controlled trials, the Heart

Outcomes Prevention Evaluation (HOPE) study (Yusuf et al., 2000) and the European trial in

reduction of cardiac events with perindopril in stable coronary artery disease (EUROPA)

(Fox et al., 2003), demonstrate that ACE inhibitor-based therapy provides substantial

protection against recurrent vascular events in high risk patients with no apparent heart

failure. A subsequent meta-analysis which included these two trials demonstrated persistent

beneficial effects even in those without left ventricular dysfunction (Dagenais, Pogue, Fox,

Simoons & Yusuf, 2006). Table 2 presents the summaries of the results of these studies.

28

Table 2

Summary of Large ACE Inhibitor Cardiovascular Trials

Study Mean length of follow-up

ACE-inhibitor

(n) patients Mortality decrease from cardiovascular causes

Decrease in all major cardiovascular events

HOPE (Yusuf et al., 2000)

5 years

Ramipril

9,297

26%

EUROPA (Fox et al., 2003)

4.2 years

Perindopril

12,218

20%

Meta-analysis (Dagenais et al., 2006)

4.5 years

29,805

18% (including cardiovascular mortality)

Based on this evidence, the ACC/AHA/CCS guidelines recommend that patients post AMI

should be prescribed an ACE inhibitor prior to discharge from hospital, and continued

indefinitely, unless they have a condition (e.g., angioedema, renal artery stenosis) that

contradicts ACE inhibitor use (Antman et al., 2008).

Beta-blockers.

β-blockers reduce the risk of reinfarction, arrhythmias, and mortality both early and long

term post MI. β-blockers provide cardioprotection by reducing heart rate, systemic arterial

pressure and myocardial contractility which decreases myocardial oxygen demand. These

actions are thought to limit the damage to the injured myocardium (Fonarow, 2006).

Significant mortality reductions have been achieved with long-term β-blocker therapy. This

has been demonstrated in three large-scale (> 1000 patients) RCTs – the Beta-Blocker Heart

Attack Trial (BHAT), the Norwegian Timolol Trial (NTT), and the Carvedilol Post-Infarct

Survival Control in Left Ventricular Dysfunction (CAPRICORN) trial. Table 3 summarizes

these trials‘ results (Beta-Blocker Heart Attack Trial Research Group, 1982; CAPRICORN

Investigators, 2001; Norwegian Multicenter Study Group, 1981).

29

Table 3

Summary of Large β-blocker Trials Acute/Post MI

Study Mean

Length

of

Follow-

up (mo)

Β-blocker (N)

Patients

Mortality

% decrease

Fatal/Non

Fatal MI

%

decrease

CHF or

LVD

BHAT (1982)

25 Propanolol (nonselective β1, β2)

3837 26% (p < 0.005)

23% (p < 0.01)

Excluded severe HF

NTT (1981) 17 Timolol (nonselective β1, β2)

1884 39% (p = 0.0003)

28% (p = 0.006)

Excluded uncontrolled HF

CAPRICORN (2001)

15 Carvedilol (nonselective β1, β2)

1959 23% (p = 0.031)

40% (p = .01)

Included acute LVD and CHF

Note. Adapted from ―β-Blockers for the post-myocardial infarction patient: current clinical evidence and practical considerations‖, by G.C. Fonarow, 2006, Reviews in Cardiovascular

Medicine, 7(1), p. 4. CHF = congestive heart failure; LVD = left ventricular dysfunction.

The earlier studies, BHAT and NTT, excluded patients with severe or uncontrolled heart

failure (HF), whereas the CAPRICORN trial specifically enrolled only patients with

documented LVD in the current era of thrombolysis, angioplasty and ACE inhibitor therapy

(Beta-Blocker Heart Attack Trial Research Group, 1982; CAPRICORN Investigators, 2001;

Norwegian Multicenter Study Group, 1981). Trials of β-blockers now include broader groups

of patients such as those at high risk of HF or with a diagnosis of HF, which enables the

benefits to be extended to such patients (Freemantle, Young, Mason, & Harrison, 1999).

A meta-analysis of 82 RCTs comparing β-blockers with placebo or other therapies in patients

with MI further highlights the long-term benefit of β-blocker use after MI. This review

showed a 23% reduction in mortality for all β-blockers combined (OR 0.77, CI 0.69 to 0.85).

Drugs with cardio-selectivity showed no reduction in mortality (OR 1.10, CI 0.89 to 1.39)

(Freemantle et al., 1999). This review supports the clinical trial evidence that the clinical

benefits of β-blockers after MI are not a class effect, and therefore evidence-based,

nonselective β-blockers should be used (Fonarow, 2006).

All of these studies support the ACC/AHA/CCS guideline recommendation that β-blockers

be prescribed and continued indefinitely in all patients post MI unless there is an absolute

30

contraindication, with a gradual titration scheme for those with moderate or severe HF

(Antman et al., 2008).

In summary, the effectiveness of individual secondary prevention strategies has been

demonstrated. However, individuals with AMI most often have more than one modifiable

risk factor and in many cases multiple risk factors. Accordingly, secondary prevention should

consist of a combination of strategies to address the risk factors with which patients present.

A description of the nature and effectiveness of multi-component programmes which consist

of multiple secondary prevention strategies follows.

Multi-Component Secondary Prevention Strategies

Secondary prevention multi-component programmes have been proposed as a way to

improve the delivery and implementation of the treatment strategies described above, with

the objective of improving the quality of care and outcomes for patients with CHD (Cohen,

2001; Williams et al., 2002; Antman et al., 2008). This type of programme delivery typically

focuses on patient education and counselling, health care provider use of clinical practice

guidelines, and consultations with appropriate support services for a particular set of

problems. This type of approach has been described as a structured systems response to

delivering health care, within which the patient becomes the pivot around which health care

is organized (Hunter, 2000). The rationale for this type of delivery in secondary prevention

care is based on a growing literature base which has examined disease management

programmes as a means of bridging the gap between our knowledge of the benefits of

treatment for CHD and clinical reality. A review of this literature follows, with the objective

of determining the state of knowledge on what constitutes effective multi-component

secondary prevention care/programmes. Evidence from meta-analyses will be presented first,

followed by a synthesis of evidence from relevant clinical trials.

31

Meta-analyses.

Within the last decade, two meta-analyses have been completed to determine whether

secondary prevention programmes improve processes of care and outcomes in patients with

established CHD (McAlister, Lawson et al., 2001; Clark et al., 2005). An earlier study

conducted by McAlister et al. (2001) examined 12 non-exercise based studies (9803 patients)

that reported the impact of secondary prevention programmes on death, myocardial

infarction, and rates of admission to hospital in patients with CHD. The impact of

programmes on cardiovascular risk factors and use of drugs proven to be efficacious

(processes of care), as well as quality of life, functional status and cost savings outcomes

were included in the meta-analysis when these variables were reported in the primary studies.

This review excluded any study which was not randomized, evaluated single modality

interventions (such as exercise alone) or enrolled fewer than 50 patients. The mean duration

of follow-up was 12 months. Of the 12 studies included in this review, four incorporated a

structured exercise component in their programmes.

The authors concluded that patients randomized to secondary prevention programmes were

more likely to be prescribed efficacious lipid lowering drugs (RR 2.14, 95% CI, 1.92 to

2.38), β-blockers (RR 1.19, 95% CI, 1.07 to 1.32), and antiplatelet agents (RR 1.07, 95% CI,

1.03 to 1.11). Significant improvements in risk factors (i.e., reduction in cholesterol

concentration, rates of smoking cessation, and reduction of blood pressure) were observed in

patients assigned to the programme as compared to usual care. The effect sizes were of a

moderate magnitude. In addition, the results of this meta-analysis showed that participants

who received the programme had a reduction in re-admission rates to hospital (RR 0.84, 95%

CI, 0.76 to 0.94). However, there were no significant differences in all cause mortality (RR

0.91, 95% CI, 0.79 to 1.04) or recurrent MI (RR 0.94, 95% CI, 0.80 to 1.10) (McAlister,

Lawson et al., 2001). Only three out of eight studies reporting quality of life or functional

capacity demonstrated significant improvements in these outcomes in the intervention group

compared to usual care (DeBusk et al., 1994; Naylor et al., 1994; Naylor et al., 1999).

This meta-analysis expanded our knowledge of the impact of secondary prevention

programmes by examining programmes which were not limited to exercise. With the small

number of eligible trials (12), short mean duration of follow-up of 12 months (range 1-48

32

months), and low event rates in both groups, it is difficult however to draw definitive

conclusions about the mortality or morbidity benefits of secondary prevention programmes

on the basis of these meta-analysis results. The likelihood of detecting a beneficial effect on

mortality is significantly reduced when event rates are low (Mant, 1995).

The differences in process of care indicators that were examined in this meta-analysis are

clinically relevant, as this information points to aspects of care that contribute to

demonstrated long-term morbidity and mortality benefits. For example, in the seven trials

that evaluated the impact of secondary prevention programmes on cardiac risk factors (i.e.,

smoking, weight, BP, lipid levels) and/or use of drugs shown to decrease risk, there were

greater improvements in risk factors and increased prescriptions for lipid-lowering drugs, β-

blockers and anti-platelet agents in the intervention groups compared to usual care

(Campbell, Thain, Deans, Rawles, & Squair, 1998; Cupples & McKnight, 1994; DeBusk et

al., 1994; Dorossiev, 1983; Haskell et al., 1994; Vermeulen, Lie, & Durrer, 1983). This

review highlights the fact that process of care measurements such as risk factor reduction and

drug use are more sensitive than mortality in the short-term evaluation of programme

performance (Mant, 1995).

The more recent meta-analysis by Clark et al. (2005) builds on the review by McAlister,

Lawson et al. (2001) by comparing the effectiveness of secondary prevention programmes

with and without exercise programmes. The selection criteria for studies included in this

review were RCTs reporting the effect of secondary prevention programmes on mortality,

MI, or hospitalization rates in patients with CAD. These criteria were the same as the

previous review, with the exception of single modality exercise programmes, which were

selected for review. Also, when reported in the primary studies, similar processes of care

were included in the analysis (management of cardiovascular risk factors and use of drugs

proven to be efficacious), as well as the outcomes of quality of life, functional status and cost

savings. A total of 63 studies were selected for this meta-analysis including those reviewed

by McAlister, Lawson et al. (2001). The authors categorized the 63 studies according to the

type of programme evaluated. The three groups were: 1) programmes that were solely

exercise-based; 2) programmes that included risk factor education and counselling only; and,

3) programmes with risk factor education and counselling and an exercise component.

33

All programmes, except those restricted to exercise alone, included risk factor education or

counselling. The most frequent features of the 23 programmes without exercise included:

nurses leading or managing the programme (19), individual counselling and education (19),

and frequent telephone follow-up (7). The features of 24 programmes with exercise were:

nurses leading or managing the programme (6), relaxation or stress management (6), and

individual counselling (4).

By pooling the results of these 63 studies, it was determined that the summary risk ratio was

0.85 (95% CI. 0.77 to 0.94) for all-cause mortality. This ratio differed over time, with a RR

of 0.97 (CI 0.82 to 1.14) at 12 months and 0.53 (CI, 0.35 to 0.81) at 24 months, with a

sustained benefit after 5 years. A reduction in risk of recurrent MI was also seen, with a

summary risk ratio of 0.83 (CI, 0.74 to 0.94) over a median follow-up of 12 months. Of the

63 studies included in this review, only 3 identified statistically significant benefits on their

own (Campbell et al., 1998; Dugmore et al., 1999; Fridlund, Hogstedt, Lidell & Larsson,

1991). Although the authors concluded that the effects were similar among the 3 types of

programmes studied, the evidence (Table 4) they presented shows that these benefits differ

slightly with programme type (Clark et al., 2005). These summary risk ratios demonstrate

statistically significant improvements in mortality with two programmes: programmes with

education and counselling only, and exercise only programmes; and a reduction in rates of

reinfarction in the programme including education and counselling and an exercise

component. Tests for heterogeneity were not significant within groups and between groups,

and a random-effects model was used for this analysis. The results do not change using a

fixed-effects model (personal communication, Eady, March 6, 2006).

Table 4

Summary of Clark et al. (2005) Programme Outcome Results

Programme type Mortality (RR) Reinfarction (RR) Solely exercise-based RR, 0.72 (CI, 0.54 to 0.95) RR, 0.76 (CI, 0.57 to 1.01) Education and counselling without exercise component

RR, 0.87 (CI, 0.76 to 0.99) RR, 0.86 (CI, 0.72 to 1.03)

Education and counselling with an exercise component

RR, 0.88 (CI, 0.74 to 1.04) RR, 0.62 (CI, 0.44 to 0.87)

34

With respect to quality of life and functional status, 24 of the 42 trials reporting these

endpoints demonstrated statistically significant differences favouring patients exposed to the

intervention programmes compared to usual care. The effect sizes were reported as small.

In most studies included in this meta-analysis the programme was led by nurses, highlighting

the pivotal role that nurses have in managing and delivering secondary prevention care.

Most of the studies in this review however do not describe the nursing role in enough detail

to be easily reproducible in other settings, or describe the level of training or education of the

nurses delivering the interventions, which would also be necessary to further understand the

ideal mix of skills, knowledge and expertise needed for delivering secondary prevention care.

For example, in the programmes with education and counselling and an exercise component

(n = 19), 16 studies indicated that the components were delivered by a "nurse", while in

three studies other terms were used to describe the nursing role: "nurse counsellor" (1), "specially

trained nurse" (1) and "nurse specialized in cardiac rehabilitation" (1). In the

programmes without an exercise component (n = 23), 19 were described as nurse-led, while 7

were limited to the description of "nurse".

The following terms were used to describe nurses leading the programme: "experienced

cardiac nurse‖ (3), "specialist cardiac liaison nurse" (2), "nurse case manager" (1) "case

manager" (does not specify if this is a nurse) (1) "nurse rehabilitator" (1), "experienced

intensive care nurse" (1), "trained nurse" (1), "advanced practice nurse" (APN) (1), "clinical

nurse specialist" (CNS) (2), and "nurse practitioner" (NP) (1). In this latter group, three

programmes were led by providers other than nurses, including a team consisting of a

physician, psychiatrist and nutritionist (P.RE.COR. Group, 1991); and a dietician with

experience in cardiac disease (Vale et al., 2003). Ornish and colleagues (1998) did not

identify who delivered the intervention.

The results of this meta-analysis provide strong evidence that programmes consisting of risk

factor education and counselling, with and without exercise, improve outcomes for patients

with CAD. Which specific programme components are necessary to achieve these

improvements is unclear. Education and counselling, delivered by nurses, is the most

common component in the programmes investigated in studies included in this review. The

Patti

Typewritten Text

35

other features of programmes varied too widely to draw any conclusions as to the optimal

mix, intensity or duration of programme.

Another meta-analysis which is particularly relevant to this study tested the hypothesis that

success on proximal targets (e.g., risk factors including BP, exercise, emotional distress and

smoking behaviour) in secondary prevention programmes contributes to the reduction of

cardiac mortality and cardiac event rates (Dusseldorp et al.,1999). This meta-analysis

included 37 studies (28 RCTs) examining the effects of psycho-educational programmes on

the outcomes of cardiac death and reinfarction in patients with coronary heart disease. In

most primary studies, the psycho-educational programmes consisted of a health education

and stress management programme. Four studies also included an exercise training

programme, but this was also offered to the control group. Studies included were published

in the time period between 1974-1997, with the duration of interventions averaging 28

weeks. Quasi-experimental trials were included only if samples were stratified or matched

pair-wise, or if patients from the same hospital were allocated by time periods.

The combined results suggest that psycho-educational programmes were associated with a

34% reduction in cardiac mortality over the long-term (>2 years) (6 studies) and a 29%

reduction in recurrent MI at 2 – 10 years (7 studies). Significant improvements were also

seen in risk factor profiles and related behaviours: blood pressure (8 studies), cholesterol (7

studies), body weight (8 studies), smoking behaviour (21 studies), physical exercise (8

studies) and eating habits (6 studies) (p < 0.025). No effects of psycho-educational

programmes were found on rates of coronary artery bypass surgery (9 studies), anxiety (10

studies), or depression (13 studies).

Additionally, success on proximal targets (risk factors) was found to be an important

mediator of success on distal outcomes (cardiac death and reinfarction). For example, the

reduction in cardiac mortality in studies with success or partial success on proximal target

risk factors was 31% compared to an increase of 14% for studies with no success. The

reduction in recurrence of MI in the psycho-educational programmes with success on

proximal targets was 36% compared to 2% in studies without or with only partial success on

proximal targets (Dusseldorp et al., 1999). As is the case in the meta-analyses by Clark et al.

36

(2005) and McAlister, Lawson et al. (2001), most programmes included in this review are

described vaguely, without empirical evidence to support a causal relationship between

specific programme components and the positive effects on outcome or the short term

indicators of success.

Overall, the systematic reviews were of good quality and have made an important

contribution in clarifying the collective benefits of secondary prevention programmes, all of

which highlight the need for further research to determine the incremental benefit of

individual programme components, their required intensity, and the resources (setting and

providers) required to maximize improvements to patient outcomes.

These meta-analyses also make evident the fact that few individual randomized clinical trials

have demonstrated improvements in mortality and reinfarction rates with these types of

programmes. This is thought to be related to the small sample sizes of individual trials, and

follow-up periods which may be too short to capture long term mortality and morbidity

benefits. A description of four clinical trials examining specific secondary prevention

interventions follows to help illustrate what is known about how programmes are delivered.

The studies selected have all demonstrated improvements in patient outcomes with their

programme delivery.

Individual clinical trials.

The study by Campbell et al. (1998) is one of the few large RCTs which have long-term

outcome data (1343 patients; mean follow-up 4.7 years) after a 12 month secondary

prevention intervention (Murchie et al., 2003; Murchie, Campbell, Ritchie, Deans, & Thain,

2004). Participants in the intervention group attended a nurse-led secondary prevention clinic

within their general practitioner‘s office. The nurse intervention included: assessment of

symptoms and lifestyle factors; a review of drug treatment and the promotion of aspirin use;

assessment of blood pressure and lipid management with reference to hypertension and local

lipid management guidelines (if drug treatment was indicated, participants were referred to a

general practitioner); and assessment of behavioural risk factors and negotiation of

behavioural change, as appropriate. Patients were offered regular follow-up (every two to six

months) as needed. The initial clinic visit took approximately 45 minutes, with follow-up

37

visits averaging 20 minutes. Each clinic contact was described as concluding with feedback,

goal setting and an agreed upon action plan which was outlined on a take home form. Details

on how individual components of the intervention were delivered compared to what was

intended were not described. Study findings included significant improvements in functional

status and general health perceptions in the intervention group (p < 0.05), with fewer patients

in the intervention group having worsening chest pain (p = 0.025) and fewer requiring

hospitalization (p = 0.003) (Campbell et al., 1998).

The subsequent follow-up study (Murchie et al., 2003) was undertaken to determine if

improvements in processes of care translate into reduced coronary events and mortality.

Follow-up of the 1343 CAD patients from the previous trial was completed by postal

questionnaire, review of case notes and national datasets. The outcome measures included

components of secondary prevention (aspirin use, blood pressure management, lipid

management, healthy diet, exercise, smoking status), total mortality and coronary events

(non-fatal MI and coronary deaths). Patients in the intervention group showed sustained

improvement in all components of secondary prevention at 4 years, except for exercise. In

the longer follow-up period (mean 4.7 years), there were no longer significant differences

between the intervention and control groups with respect to components of secondary

prevention. This is attributed to the use of secondary prevention clinics by the control group

after the initial year (Murchie et al., 2003).

Adjusting for age, general practice, sex, and baseline secondary prevention, the reduced

mortality and coronary event rates seen in the intervention group at one year of follow-up

were sustained at 4.7 years (proportional hazard ratio for total mortality was 0.75, 95% CI

0.58 to 0.98, p = 0.036; for coronary events the proportional hazard ratio was 0.76, 95% CI,

0.58 to 1.00, p = 0.049). In a supplementary adjusted analysis, longer exposure to clinics was

associated with improvements in aspirin use, blood pressure and lipid management, and

exercise. This suggests that longer participation in the clinics yielded the best outcomes with

respect to reaching treatment goals for these individual secondary prevention treatment

strategies (Murchie et al., 2003). The main limitation of this trial is the crossover of

participants from control to intervention and vice versa which could account for the non-

significant between-group difference at long-term (4.7 years) follow-up. In spite of these

38

limitations, and the recognition that this trial was conducted in a primary care setting, the

study demonstrates that improvements in secondary prevention provided in nurse led clinics

are maintained in the long-term. Additionally, this study also establishes a relationship

between secondary prevention processes of care and the long-term outcomes of mortality and

coronary event rates.

Another long-term trial examining the effectiveness of health promotion in reducing risk

factors in CHD patients shows conflicting results compared to the Campbell et al. (1998) and

Murchie et al. (2003) studies. In this trial (Cupples & McKnight, 1994), patients with angina

were randomized to receive personal health promotion by a "trained" nurse or usual care.

The intervention group received "practical advice" regarding relevant cardiovascular risk

factors and health education every four months for two years. Specific details about the

content of the health education or how it was delivered were not included. At two years there

were no significant effects on objective cardiovascular risk factors (BP, cholesterol levels,

BMI, smoking, Nottingham health profile questionnaire score). Self- reported activity

restrictions related to angina, exercise frequency, and healthy diet eating were, however, all

significantly improved in the intervention group compared to usual care. Patients who

completed the two year study were invited to a five year follow-up interview to determine if

differences in lifestyle and risk factors between the two groups persisted 5 years later. At the

end of five years the benefits reported in exercise were evident but smaller in magnitude than

those obtained at post-test, while the angina and healthy diet eating benefits were no longer

present. There was no significant difference in total mortality at five years (Cupples &

McKnight, 1999). The sample size in this trial was significantly smaller (688 versus 1343)

than that of Murchie et al. (2003) which limits this study‘s ability to detect a significant

mortality benefit. This study‘s report also did not describe the intervention beyond personal

health promotion education, limiting the ability to draw comparisons with other programmes

or link processes of care to outcomes.

Another large randomized controlled trial assessed the effectiveness of three different ways

of promoting secondary prevention implementation by healthcare providers to patients with

CHD: audit, GP recall, and nurse recall (Moher et al., 2001). All three groups received an

audit summary of the number of patients with MI, angina and revascularization, and

39

feedback on the proportion of patients with "adequate assessment‖ and treatment with

antiplatelet drugs, blood pressure drugs, and lipid lowering drugs. Anonymous data from

other practices in the study were given for comparison purposes. The audit group received

only the audit summary. The GP recall group received a review of the guidelines for

secondary prevention, and assistance and ongoing support with setting up a register and

recall system for regular review of their patients with heart disease. The nurse recall group

intervention included the same information as the GP recall group, as well as education on a

clinic protocol on implementation of secondary prevention guidelines (Moher et al., 2001).

The main outcome measures for this study were "adequate assessment‖ of three risk factors

(blood pressure, cholesterol and smoking status); prescription of hypotensive drugs, lipid

lowering and antiplatelet drugs; and evaluation of blood pressure, serum cholesterol level,

and plasma cotinine levels. At 18 months follow-up, adequate assessment of all three risk

factors was markedly improved in all three groups. At baseline approximately 30% of

patients were adequately assessed overall. Adequate assessment was more common in the

nurse and GP recall groups (85% and 76% respectively) compared to the audit group (52%).

After adjustment for baseline differences, the absolute increase in the proportion of patients

adequately assessed overall, compared with the audit group was 33% in the nurse recall

group (95% CI, 19% to 46%, p < 0.001) and 23% in the GP recall group (95% CI, 10% to

36%, p < 0.002). Although adequate assessment was higher in the nurse recall group than the

GP recall group, this difference was not statistically significant. (Moher et al., 2001). The

results indicate that setting up a disease register and a recall system increases rates of follow-

up and assessments which are deemed adequate in patients with CHD. This study also shows

that follow-up by nurses is as effective as, and possibly more effective than, follow-up by

GPs in primary care.

Summary of the Evidence for Secondary Prevention Programmes

Based on meta-analyses and multiple large randomized controlled trials, there is substantial

evidence that secondary prevention programmes are effective in improving the

implementation of components of secondary prevention (aspirin use, blood pressure

management, lipid management, healthy diet, exercise, smoking cessation), reducing total

mortality and coronary events (non-fatal MI and coronary deaths) and improving quality of

40

life in patients with established CHD (Campbell et al., 1998; Carllson et al., 1998; Clark et

al., 2005; Cupples & McKnight, 1994; Jolly et al., 1999; McAlister, Lawson et al., 2001;

McHugh et al., 2001; Murchie et al., 2003). The key strength of this evidence is that all trials

included random assignment with control groups receiving usual care. The most common

limitations are inadequate double blinding with this type of intervention and inadequate or

unclear concealment of allocation (e.g., 76% of the studies in the meta-analysis conducted by

Clarke et al. were reported to have unclear or inadequate allocation concealment), which can

inflate treatment effects and should be considered when interpreting results. Additionally, a

large portion of the clinical trials lack detailed descriptions of the intervention, making it

difficult to delineate which components of the interventions influenced the outcomes.

Although the majority of clinical trials examining secondary prevention care have used

nurses to carry out the intervention activities, there is no clarity on the specific activities

included or the type of nurse training or experience that would be most appropriate to

implement the secondary prevention strategy and best meet the complex needs of the

patients. This is reflected in the combined Canadian and American clinical practice

guidelines for the management of patients after myocardial infarction, which includes the

recommendation for cardiac rehabilitation or secondary prevention programmes in post MI

care (Antman et al., 2008), but does not specify how these programmes should be delivered

or by whom.

The following section presents a review of studies which have used nurses with advanced

education or training to deliver components of secondary prevention. The objective is to

determine if there is research evidence to support the hypothesis that nurse practitioners have

a unique skill set that if implemented in a secondary prevention setting has the potential for

improving outcomes in patients with CHD.

Nurse Practitioner Delivered Secondary Prevention

Ten studies evaluated the impact of a nurse practitioner or advanced practice nurse (APN)

role on process and outcome aspects of secondary prevention in patients with CHD. They

will be discussed according to the type of nursing intervention evaluated: nursing case

management to increase guideline adherence; screening and counselling; and transitional

care.

41

Nursing case management to increase guideline adherence.

Six studies evaluated nursing case management interventions aimed at improving provider

and patient adherence to specific secondary prevention guideline recommendations (Allen et

al., 2002; Ansari et al., 2003; Brown & Cofer, 2000; DeBusk et al., 1994; Goessens,

Visseren, Sol, de Man-van Ginkel, van der Graaf, 2006; Khunti et al., 2007). Three studies

examined the impact of the nursing case management on a single risk factor (Allen et al.,

2002; Ansari et al., 2003; Brown & Cofer, 2000). Allen and colleagues (2002) conducted an

RCT which examined the effectiveness of nursing case management on hyperlipidemia in

patients who recently had coronary revascularization. The comparison group in this trial

received usual care enhanced with feedback on lipids profiles and recommendations for goal

levels sent to their primary care physician and/or cardiologists at 4 weeks, 6 and 12 months

after discharge. The 12 month nurse practitioner intervention included: an outpatient visit 4

to 6 weeks after discharge for lifestyle modification counselling (nutritional counselling,

physical activity recommendations, referral to an exercise programme, and smoking

cessation); prescription or adjustment of lipid-lowering medications; and follow-up telephone

calls to reinforce counselling and adjustments in medications based on the results of blood

tests. Significantly more patients assigned to the NP group achieved target LDL-C levels (p =

0.0001), accompanied by significant improvements in dietary and exercise patterns. Being

assigned to the NP group and being on a lipid lowering drug were significant independent

predictors of LDL-C levels (Allen et al., 2002). However, only 69% of participants

completed the one year follow-up. This clinical trial provides a detailed description of the

nurse practitioner activities, which include prescribing and monitoring lipid-lowering

therapy.

Ansari et al. (2003) evaluated the impact of a nurse facilitator (NP) on the improvement of

guideline adherence (by provider and patient) to β-blocker therapy in patients with

congestive heart failure compared to two other interventions (provider education, and

provider and patient notification). The description of nurse practitioner activities in this study

is limited to the explanation that the NP assumed responsibility for initiating, titrating and

stabilizing appropriate CHF patients on β-blockers after obtaining approval from the primary

physician provider. There was a significant improvement in the proportion of patients who

42

were initiated or uptitrated and maintained on β-blockers in the NP group (67%) compared to

the provider education group (27%) and the provider and patient notification groups (16%) (p

< 0.001). The percentage of patients on target doses at a mean follow-up of 12 months was

highest in the NP group (43%) compared with provider education group (10%) and provider

and patient notification groups (2%). However, the enrolment rate was significantly less than

intended, resulting in less power to detect differences between interventions. This study

demonstrated that NPs can be successful in achieving target goals for β-blocker therapy, one

of the recommended secondary prevention treatment goals post MI.

Brown and Cofer (2000) evaluated the impact of a nurse-managed lipid clinic (physician

directed) on achievement of target cholesterol levels in patients with CHD compared to the

rates collected in 140 medical practices in a national quality assurance programme. This was

a retrospective descriptive study. This trial used a registered nurse who worked

autonomously in scheduling laboratory tests and changing doses of lipid medications

according to a written protocol. Abnormalities in laboratory tests which were not cardiology

related were referred to the patient‘s primary care physician. The RN worked in an expanded

role similar to that of a nurse practitioner (ordering diagnostic laboratory testing and

adjusting lipid medications). The improvements seen with this nurse-led intervention are

consistent with the other two NP single intervention studies by Allen et al. (2002) and Ansari

et al. (2003). These studies demonstrate the positive potential impact of NP care on

adherence to guideline recommendations when medication adjustment and monitoring

response to treatment on achieving treatment goals are included as nursing responsibilities.

A much earlier study by DeBusk and colleagues (1994) evaluated a nurse-managed, home-

based case management system (also physician-directed) for coronary risk factor

modification. This randomized controlled study used specially trained nurses to deliver

interventions for smoking cessation, exercise training, and diet-drug therapy for

hyperlipidemia in patients following myocardial infarction. The nursing interventions in this

study were described in detail, including the amount of time the programme nurses spent

with each participant over the course of the one year intervention and how that time was

spent. For example, approximately 9 hours was spent delivering the nursing intervention over

the year in the following areas of practice: smoking cessation, 2 hours; dietary management,

43

1.5 hours; lipid-lowering drug therapy, 2.5 hours; exercise training, 1 hour; communicating

with primary care physician and other hospital personnel, 1 hour; and consultation with

hospital-based senior nurse coordinator, 1 hour. Compared to usual care, the intervention

group had significantly better smoking cessation rates (70% vs. 53%, p = 0.03) and LDL

cholesterol levels (2.77 +/- 0.69 vs. 3.41 +/- 0.90, p = 0.001) at one year, and improvements

in functional capacities (9.3 METS vs. 8.4 METS, p = 0.001) six months after the infarction.

This study by DeBusk and colleagues expands the scope of nursing case management to

include concurrent management of multiple risk factors by a single nurse case manager. With

the use of standardized management algorithms, a physician lipid specialist and a senior

nurse coordinator who provided telephone consultation to the case managers, the nurses in

this study were able to provide a broad range of treatment strategies to the study population.

This approach is similar to the type of care which is within the scope of practice for nurse

practitioners, particularly with the initiation and titration of specific drug therapy. As the

nurses in this study were not nurse practitioners, the case managers telephoned the primary

care physician when the addition of a new drug was indicated.

A much more recent randomized controlled trial completed by Goessens and colleagues

(2006) evaluated the impact of a nurse practitioner intervention on cardiovascular risk factor

profiles in patients with symptomatic vascular disease (transient ischemic attack, stroke,

aortic abdominal aneurysm or peripheral artery disease) who had two or more modifiable

vascular risk factors. A history of CHD was reported in 24% of those in the intervention

group and 18% in the control group, but these percentages did not differ significantly

between groups. Patients were randomized to receive treatment by a nurse practitioner plus

usual care or usual care alone. Usual care in this setting included a vascular screening and

prevention programme, offered by a multidisciplinary team of specialists who assessed and

made treatment recommendations for the management of individual risk factors or vascular

disorders which were communicated in writing to the general practitioner and treating

vascular specialist. Vascular screening results were considered baseline measurements for the

NP intervention study.

44

The NP intervention was an extension of the vascular prevention programme delivered at a

tertiary academic medical centre. The NP intervention included formulation of a risk factor

action plan, in cooperation with the patient, to address smoking cessation, regular exercise,

healthy diets, and medications to reduce risk. Changes to medications were made by study

physicians, as NPs were not allowed to do this in the country where this study was

conducted. Nurse practitioner activities were well described with a recording of number of

visits, length of visit and time spent on each risk factor. The relationship between these

variables and achievement of treatment goals was not presented.

The primary endpoints in this study were the rate of achievement of treatment goals for blood

pressure, lipid, blood sugar and homocysteine levels, body mass index and smoking one year

after randomization. Medication use and quality of life (as measured by SF-36) were assessed

and reported at one year. The proportion of patients who achieved treatment goals was

significantly higher in the NP intervention group than in the control group for systolic blood

pressure, total cholesterol, LDL-cholesterol and BMI. Medication use was increased in both

groups at one year, with more patients in the intervention group than in the control group

using lipid lowering drugs (89% versus 73%) and ACE-inhibitors (76% versus 53%). Quality

of life scores were not significantly different between groups at baseline or at follow-up. The

rates of smoking at one year increased in both groups (Goessens et al., 2006).

In considering extrapolating these results outside of this type of setting, the rates of

improvement in treatment goals with the nurse practitioner intervention should be interpreted

cautiously for several reasons. Baseline rates of achievement of treatment goals in both

groups would be potentially higher than would be expected in settings without a vascular

prevention programme as part of usual care. Considering that the usual care group was

receiving close to optimal care already, the treatment effect of the nurse practitioner

intervention may be underestimated. Additionally, a significant number of patients withdrew

their consent before the study started (n= 61, Zelen design), and were not included in the

analysis. Without adequate information and comparison on baseline characteristics between

those who withdrew and those who completed the study, selection bias is possible. This study

however further demonstrates how a comprehensive approach to secondary prevention

45

including pharmacological and non-pharmacological management of multiple risk factors

improves patient outcomes.

The effectiveness of a disease management programme for secondary prevention of CHD

and heart failure in primary care was evaluated in the United Kingdom (Khunti et al., 2007).

In this randomised controlled trial, nurse-specialists travelled to ten primary care practices

where they held weekly clinics. All patients were followed for 12 months. The primary

outcomes were proportion of patients with a history of myocardial infarction receiving a

beta-blocker, a recorded serum cholesterol less than 5 mmol/L in the previous year, and the

proportion of patients with left ventricular systolic dysfunction being treated with an ACE

inhibitor. Secondary outcomes included BMI, level of blood pressure control, confirmation

or rejection of left ventricular dysfunction and quality of life measurements.

Comparisons between the treatment and control groups showed significant improvement in

patients with CHD in the treatment group, compared to the control group, on beta-blockers

use, adequate management of their blood pressure and cholesterol level within target range.

In patients with unconfirmed diagnosis of congestive heart failure, significantly more patients

in the treatment group had a diagnosis of left ventricular dysfunction confirmed or excluded

when compared to the control group. There were also significant improvements in the

treatment group compared to the control group in quality of life measurements in patients

with CHD. No between-group differences were found in quality of life for those with a

confirmed diagnosis of left ventricular dysfunction (Khunti et al., 2007).

Although this study describes components of a successful intervention as having regular

contact with patients, education and optimisation of treatment, the description of the

intervention is limited to assessment, confirmation of diagnosis by investigations, medication

management and titration, home visits and a facility to refer patients for assessment in a

secondary care cardiology clinic. The control group also had open access to the secondary

care cardiology clinic.

46

Screening and counselling.

The role that nurse practitioners have in providing specific types of health counselling during

clinic visits in hospital ambulatory care settings has been examined using data obtained from

a national sample survey conducted by the National Center for Health Statistics in the United

States. In a secondary analysis of this survey, the National Hospital Ambulatory Medical

Care Survey, rates of health counselling provided at hospital outpatient department visits

involving an NP were compared to those without an NP (Lin, Gebbie, Fullilove, & Arons,

2004). This study included outpatient department (OPD) visits made to three types of clinics

(general medicine, pediatrics and OB-GYN), which accounted for 78% of all the sampled

OPD visits between 1997 and 2000. An NP was involved in 6.8% of the OPD visits that were

made to general medicine, pediatric and OB-GYN clinics during that period of time. Of the

6,062 OPD visits with an NP, 45.5% were made by patients with acute problems, 26.3%

were for non-illness care, and 24.9% were made for chronic conditions.

In OPD visits for chronic problems (which included patients with established CHD),

counselling for healthy diet, exercise and tobacco use were much more likely to be provided

when patients were seen by an NP only or by an NP in addition to other health care providers

(diet, adjusted OR 2.5, 95% CI 1.6 to 3.8; exercise, OR 2.8, CI 1.6 to 5.1; tobacco use, OR

1.8, CI 1.1 to 3.0). Provision of health counselling at OPD visits for non-illness care was also

consistently higher for visits involving an NP than those visits not involving an NP (diet,

adjusted OR 1.7, CI 1.2 to 2.5; exercise, 1.8, CI 1.2 to 2.8; tobacco use, OR 1.7, CI 1.2 to

2.5). OPD visits for acute problems showed a significant increase in health counselling by

NPs in diet only (OR 1.8, CI 1.2 to 2.7). This study controlled for the following potential

confounding variables in the analyses: patient age, gender, clinic type, metropolitan status,

geographic location of the hospital and number of providers seen. This study by Lin and

colleagues demonstrates that nurse practitioners can improve preventive services in

outpatient hospital departments.

Carroll and Rankin (2006) examined the impact of an APN intervention in improving self-

efficacy in older unpartnered adults post myocardial infarction. This study compared the

effects of two self-efficacy interventions, delivered by an APN or a peer advisor, to a control

group that received standard care after MI. The premise of this study was that unpartnered

47

older patients are especially vulnerable to problems related to recovery after heart attack

compared to patients with significant others, because they do not have the same social

support or access to someone who can monitor complications or encourage adherence to

treatment recommendations. The hypothesis was that two self-efficacy interventions,

delivered by a peer advisor or APN, would enhance recovery and improve health outcomes

in this patient population. Patients in the peer advisor group received a telephone call from

the peer advisor once a week for 12 weeks after discharge from hospital. The peer advisor

was encouraged to share personal experiences and information relating to their own recovery.

The APN intervention included individualized patient education, and a review of strategies to

manage physiological arousal that could contribute to symptoms and negative emotions.

Outcome measurements included self-efficacy for performing recovery behaviours, and

actual performance of recovery behaviours (Jenkins Self-Efficacy Scales and the Duke

Activity Status Index Self-Efficacy Scale), as well as physical and mental status (Medical

Outcomes Survey, SF-36). Outcomes were measured at baseline, 3 weeks, 6 weeks and 3, 6

and 12 months after the intervention period.

The results were reported for comparisons between baseline and 12 week posttest. Results

revealed no significant differences in health outcomes between the 3 groups. This may be

due to a high attrition rate (24%), which makes this study underpowered to detect true

differences between the groups at the 0.05 level. This study was also limited by significant

differences in the frequency of diabetes and hypertension between groups at baseline. These

baseline characteristics may influence how participants responded to self efficacy and

performance of activity results because they are both chronic disease conditions that are

known to require self monitoring beyond that required for the target condition (post AMI),

and therefore are related to the outcomes measured. An imbalance in these characteristics

between groups threatens internal validity. Results were not reported with adjustments in

baseline differences. An adjusted test would yield a P value that would provide the reader

with the probability of the results had these characteristics been the same at baseline

(DiCenso, Guyatt, Ciliska, 2005).

Although the issue of APN and peer advisor ―dose‖ was addressed in this study, and

operationalized with length and frequency of contacts during the intervention, these results

48

were not reported. A description of how measuring intervention dose was carried out, and

results on the intensity of the intervention for each group would have been helpful in

understanding the findings. Reporting on the intervention dosage and quantification of the

amount delivered in the statistical analysis would have made it possible to examine the

effects of dose on the outcomes, which may have affected study results (Sidani, 1998).

Another study examined screening and counselling practices of nurse practitioners compared

to physicians within three practice settings (Hopkins, Lenz, Pontes, Lin, Mundinger, 2005).

The practice settings included a primary health care centre staffed by nurse practitioners, four

primary health care centres staffed by physicians, and a private practice staffed only by nurse

practitioners. By retrospective chart review, the percentage of patients who received

preventive screening and counselling behaviours during the first patient encounter and any

encounter in the subsequent 6 weeks were compared across the three provider groups.

Comparisons of primary health care centre NPs to primary health care MDs, revealed that

NPs were significantly more likely than MDs to counsel about nutrition, diet and exercise (p

< 0.0001), and screen for depression (p < 0.05). Primary care centre MDs were found to

assess and/or counsel about tobacco more often than primary care centre NPs (p < 0.0001).

Private practice NPs‘ performance was more consistent with U.S. preventive practice

guidelines overall compared to both NP and MD primary care centre providers. Private

practice NPs were most likely to assess history of and provide counselling for all categories

examined, including nutrition and diet, tobacco use, exercise (p <0.0001) and alcohol use (p

< 0.05).

Taking into account the important differences in the practice settings, most notably private

NPs not constrained by productivity requirements and a patient population with more

resources (private insurance and higher education), this study highlights the importance of

context of provider care. Although NPs in the primary care centre performed better than their

MD colleagues in similar settings on most screening and counselling activities, they were

consistently outperformed by the private practice NPs, in spite of the fact that NP training

was similar in both NP groups. This study‘s results suggest that NP screening and

counselling activities in a practice setting not constrained by productivity requirements and

49

limited insurance (for example, a salaried NP paid for within the context of a universal health

insurance plan), could expect significant improvements in secondary prevention care

compared to usual MD delivered primary care or specialist care in Ontario, both of which are

constrained by productivity requirements in a fee-for-service payment environment. These

results are limited by data obtained by chart review (i.e., potential discrepancies in measuring

what was recorded versus what was done).

Transitional care (discharge planning and home follow-up).

Naylor and colleagues have conducted two randomized controlled trials examining the

effectiveness of a transitional care intervention delivered by advanced practice nurses in

improving patient outcomes and reducing healthcare costs compared to usual care (Naylor et

al., 1999; Naylor et al., 2004). In the earlier study, participants were elderly (mean age 75

years) and hospitalized for one of several medical or surgical reasons (79% had an admitting

diagnosis from a cardiovascular cause). APN transitional care began within two days of

admission and included discharge planning and home follow-up for a period of 4 weeks after

discharge. Usual care consisted of discharge planning by RNs, social workers and discharge

planners and a visiting nurse (VN) during the first 4 weeks after index hospital admission.

The APNs in this study were master‘s prepared gerontological clinical nurse specialists with

a mean of 6.5 years of post-degree experience. The intervention group received a

standardized comprehensive discharge planning and home follow-up protocol implemented

within 48 hours of hospital admission. APN care, based on individual needs, focused on

medications, symptom management, diet, activity, sleep, medical follow-up, and the

emotional status of patients and caregivers. The APN collaborated with physicians if

adjustments to medications or referral for additional services were needed. Outcomes

included readmissions to hospital (total hospital days and mean length of stay), time to first

admission, acute care visits after discharge, estimated cost of health services after discharge,

patient functional status, depression and satisfaction.

At 24 weeks, patients in the APN group were less likely to be readmitted at least once, had

fewer multiple admissions, had fewer hospital days per patient and had lower costs. The time

to first readmission was increased in the APN group (p <0.001). The groups did not

significantly differ in post-discharge acute care visits, functional status, depression or patient

50

satisfaction. This study by Naylor and colleagues demonstrates that discharge planning and

follow-up care by APNs can reduce hospital service utilization and health care costs in

elderly patients at risk for hospitalization. No additional costs were attached to the APN

intervention compared to usual care while patients were still in hospital because the APN

substituted care delivered by RNs, social workers and discharge planners (Naylor et al.,

1999).

A more recent study by Naylor and colleagues (2004) examined similar outcomes in an

APN-directed discharge planning and home follow-up protocol in elderly patients with heart

failure. This study also utilized master‘s prepared nurses, with general expertise in the

management of conditions common in older adults. The APN intervention in this study was

more intense than the previous study during both hospitalization and follow-up. The intense

APN intervention consisted of daily visits by the APN during index hospitalization, weekly

visits for the first month post-discharge and bimonthly visits during the second and third

month follow-up visits. Also different from the previous study, the APN intervention was

delivered in addition to routine pre-discharge care provided by RNs and discharge planners.

The APNs‘ involvement in the transitional period between hospitalization and follow-up was

collaborative, providing input to nursing staff regarding discharge needs, and working

closely with discharge planners and physicians to coordinate services and prevent duplication

of services. Like the previous study the APNs collaborated with the patient‘s physician

regarding medication adjustments and other therapies.

Outcome measurements for this study were time to first hospitalization or death, number of

hospitalizations, quality of life, functional status, costs, and satisfaction with care. The

intervention period for this study was 3 months, with a follow-up period of one year. One

year after the index hospitalization, the APN intervention group patients had fewer

readmissions (p = 0.047) and lower mean total costs (US$7636 vs. US$12,481, p = 0.002)

than the comparison group. Time to first readmission or death was longer in the APN

intervention group patients (p = 0.026) and short-term improvements were seen in overall

quality of life (12 weeks, p < .05) and patient satisfaction (assessed at 2 and 6 weeks, p

<0.001). This study also demonstrated reductions in hospitalizations caused by co-morbid

conditions (p = 0.013).

51

The results of this study clearly support the claim that APN care given in the transitional

period between hospitalization and 3 months of follow-up improves outcomes in patients at

high risk for rehospitalization. Although the multidimensional approach of the APN

intervention is well described, conclusions on which components were the most effective are

unknown.

Summary of NP Evidence in Secondary Prevention

Studies which utilized nurses in advanced practice roles in delivering secondary prevention

care (or components thereof) have shown improvements in a wide range of patient outcomes

in addition to improvements in adherence to AMI guideline recommendations when

compared to usual care. This is particularly the case with nurses with an expanded scope of

practice such as nurse practitioners. Improvements have been seen in achievement of LDL-C

cholesterol levels (Allen et al., 2002; Brown & Cofer, 2000; DeBusk et al., 1994; Goessens et

al, 2006); β-blocker use in CHF patients (Ansari et al., 2003); dietary and exercise patterns

(Allen et al., 2002); smoking cessation rates (DeBusk et al., 1994); functional capacity

(DeBusk et al., 1994); achievement of blood pressure treatment goals and BMI (Goessens et

al., 2006; Khunti et al., 2007); health counselling in outpatient ambulatory care (Lin et al.,

2004); health counselling on nutrition, diet and exercise in primary care (Hopkins et al.,

2005); and reductions in readmissions to hospital and lower costs (Naylor et al., 1999; Naylor

et al., 2004).

The key strengths of these studies include randomized controlled study designs (Allen et al.,

2002; Ansari et al., 2003; DeBusk et al., 1994; Goessens et al., 2006; Khunti et al., 2007);

however, small sample sizes, high drop-out rates and confounding co-interventions are

limitations contributing to inconclusive inferences on the causal effects of the interventions

(Goessens et al., 2006; Allen et al., 2002; Khunti et al., 2007).

Although most of the studies included in this review did not describe the nursing role

functions and practice patterns in enough detail to easily replicate in other settings,

identifying the commonalities in the nursing interventions which have demonstrated

improvements in patient outcomes improves our understanding of which advanced practice

nursing activities are related to desired outcomes. Once the common role functions and

52

practice patterns are identified, research studies can be designed to test the relationship

between specific nurse activities and the achievement of patient health care goals and

outcomes.

Similar to the most common components seen in secondary prevention programmes included

in the meta-analysis by Clark and colleagues (2005), counselling and education by the nurses

were reported in all of the studies reviewed. Seven of the eleven studies also included the

titration of secondary prevention drugs, as well as monitoring response to drug treatment

with laboratory testing, among the activities for which the nurse was responsible. The degree

of autonomy with these activities varied across studies, according to the nurses‘ training and

whether or not written protocols were used to extend prescriptive authority to nurses who

were not nurse practitioners.

The major shortcoming of the evidence supporting the utilization of nurse practitioners in

delivering secondary prevention is the paucity of studies evaluating NPs who have been

formally educated in the role. Although few studies have utilized NPs to deliver particular

components of secondary prevention (Allen et al., 2002; Ansari et al., 2003; Goessens et al.,

2006; Hopkins et al., 2004; Lin et al., 2004), other studies describe the secondary prevention

interventions as being delivered by nurses with expanded role functions that were not clearly

defined and beyond the scope of practice of an RN. For example, in the study conducted by

Brown & Cofer (2000) the RN worked in an expanded role, working autonomously ordering

laboratory tests and changing medications with use of a protocol or consulting with the

primary care physician. DeBusk and colleagues (1994) described a ―specially trained‖ RN

case manager, who communicated with physicians for medication changes, and worked with

both a physician lipid specialist and senior nurse coordinator to deliver the intervention. In

the case of the study conducted by Khunti and colleagues (2007) in the UK, ―nurse

specialists‖ rather than NPs, were used to deliver the intervention, including medication

management and adjustment.

This interchanging of nurses with different levels of training (those with formal education in

the NP role and those working in expanded nursing roles with mechanisms in place to extend

authority to perform NP scope of practice such as medical directives, protocols and

53

collaboration agreements with physicians), calls for a clarification of which role functions are

utilized and necessary to achieve the desired outcomes in patients receiving secondary

prevention post AMI. Based on the literature reviewed, an NP appears ideally suited to

deliver the secondary prevention strategies recommended in the secondary prevention

guidelines. An RN does not have the advanced educational preparation required to diagnose,

order and interpret diagnostic tests or prescribe and adjust medications without the immediate

availability of a physician. Secondary prevention programmes that do not have a provider

with the authority to titrate medications to target levels, order diagnostic tests to monitor

progress and response to treatment, order smoking cessation aids, or make referrals to CR,

will miss the opportunity for delivering comprehensive secondary prevention in one setting.

An NP has the skills required to deliver this type of comprehensive care in almost any

practice setting without additional physician or CR resources provided structures are in place

for consultation with other healthcare providers as needed.

Although an NP is suited to work within a multidisciplinary team (Humbert et al., 2007;

Jones & Way, 2004; Watts et al., 2009), the NP in this study delivered the secondary

prevention intervention without the immediate assistance of other healthcare team members.

This context allowed for an evaluation of the feasibility and acceptability of an NP working

alone in the delivery of secondary prevention care, which may be desired or necessary if this

type of intervention were to be utilized in community or rural settings where physicians are

not readily available.

Research Question

The research evidence presented here supports the hypothesis that nurse practitioners have a

unique skill set that enables them to implement secondary prevention recommendations and

contributes to improvement of outcomes in patients with CHD. The current study addressed

the question, ―Does a secondary prevention intervention delivered by a nurse practitioner to

patients post AMI improve the implementation of evidence-based secondary prevention

strategies and patient achievement of evidence-based secondary prevention target goals‖?

This was addressed by examining the processes (i.e., intervention activities) and outcomes of

the NP delivered intervention within the context of secondary prevention. Specifically, the

study identified NP activities and the dose (frequency and duration) of implementing those

54

activities within the context of secondary prevention intervention, and explored their

relationship to outcome achievement. The study was guided by a conceptual framework

derived from relevant literature.

Conceptual Framework

The conceptual framework that guided the study was adapted from the framework developed

by Sidani and Irvine (1999). These authors identified several factors that influence the NPs‘

delivery of care and subsequent patient outcomes. They organized the factors into structure,

process, and outcomes, and delineated a system of interrelationships among them. Structure

entails the characteristics of patients receiving NP care, the characteristics of NPs providing

care, and the characteristics of the organization in which NP care is delivered. Process

involves the independent and interdependent functions of the NP role, that is, the

interventions NPs implement to assist patients manage their conditions, and the strategies

NPs use to collaborate with other health care professionals in coordinating patient care.

Outcomes consist of changes in patients‘ clinical status and functioning expected as a result

of NP care.

The adaptation of the framework involved identifying structure, process, and outcome

variables that are most relevant to the evaluation of the NP secondary prevention intervention

(Figure 1). Of the structure variables listed in Figure 1, only patient characteristics were

assessed and controlled for statistically in this study. The NP and organizational variables

were excluded because the secondary prevention NP intervention was delivered by one NP in

one setting. The processes of care were operationalized with the activities in which the NP

engaged in to deliver the secondary prevention intervention. The NP activities formed the

intervention and reflected four practice categories (assessment, health teaching, guidance and

counselling, case management and medication adjustment) implemented in relation to each

individual secondary prevention strategy. That is, the practice categories intersected with the

secondary prevention strategies recommended by the American College of Cardiology,

American Heart Association and the Canadian Cardiovascular Society (Antman et al., 2008;

Smith et al., 2006). These practice categories were derived from the responsibilities of the

NP and used as a means to describe and communicate what the NP actually performed when

delivering the secondary prevention intervention. The NP recorded which practice activities

55

were utilized during each contact with each participant as well as the amount of time spent on

each.

The secondary prevention strategies included: delivery of or referral to smoking cessation

counselling; initiation or titration of BP medications if BP not at target goal; initiation or

titration of lipid lowering therapy if lipid levels not at target goals; delivery of physical

activity counselling or referral to cardiac rehabilitation programme; measurement of weight,

BMI, waist circumference, and dietary counselling; measurement of blood glucose and

diabetes risk factor counselling for diabetic patients; initiation of ASA if not contraindicated,

and clopidogrel or warfarin if clinically indicated; initiation or titration of ACE inhibitor

towards treatment goals unless contraindicated; and, initiation or titration of β-blockers

towards treatment goal unless contraindicated.

The outcome variables represented the treatment goals achieved by the patient and expected

as a result of the secondary prevention intervention implemented by the NP. The outcomes

were: complete smoking cessation; BP at target goal; lipid levels at target goals; completion

of physical activity 30 minutes 5 to 7 days a week; attendance at cardiac rehabilitation

programme; reductions in weight for BMI > 25 kg/m 2, reduction in BMI and waist

circumference if outside of target range at baseline; HbA1C < 7%; current use of ASA, β-

blocker and ACE inhibitor as recommended. The major components of the framework can be

found in Figure 1.

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Structure

Patient Variables

Demographics Clinical variables NP Variables

Education– Master‘s Degree, cardiology experience Scope of practice– NP licensure, legally accountable for practice Organizational Variables

Practice setting– inpatient and outpatient, access to outpatient laboratory, access to emergency services Practice model– individualized patient centered care Role authority– autonomous decision-making with collaborative relationships with other health team members: physicians, nurses, cardiac rehabilitation coordinator, nutritionist

Process

NP intervention

Practice Patterns

Assessment Health teaching, guidance and

counselling Case management

Medication adjustments

Secondary Prevention Strategies

Smoking cessation BP management

Lipid management Physical activity

Cardiac rehabilitation BMI and waist measurements

Diabetes management ASA use

Clopidogrel or Coumadin use Lipid lowering medication use

Β-blocker use ACE inhibitor use

NP Intervention Scheduled Contacts

Time 1: pre-discharge (30-60 min) Time 2: 1 week post discharge telephone assessment and teaching (15min) Time 3: 2 weeks post hospital discharge (30-60 min) Time 4: 6 weeks (30-60 min) Time 5: 3 months (30– 60 min)

Outcome

Clinical outcomes

Measured by research assistant 3

months post discharge in all patients

Smoking status

SBP DBP

LDL-C HDL-C

Triglyceride Physical activity 30 minutes 5 days a

week Physical activity > 5 days a week

CR attendance BMI and waist measurements

HbA1C (diabetes) Current use of:

ASA Lipid lowering drug

Β-blocker ACE or ARB

Usual care Time 1: pre-discharge assessment by study NP (15 min); discharge teaching by staff RN, time variable. Most patients given appointment with family physician for 1-2 weeks and cardiologist 6-8 weeks after discharge from hospital. Time 5: outcome assessment clinic visit with research assistant in outpatient facility. Note. LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol; SBP = systolic blood pressure; DBP = diastolic blood pressure; CR = cardiac rehabilitation; BMI = body mass index; B-blocker = beta-antagonistic blocking agent; ACE = angiotensin converting enzyme inhibitor; ARB = angiotensin receptor blocker.

Figure 1.

Conceptual Framework for Evaluating NP Care in Delivering Secondary Prevention

Post AMI

Chapter 3

Methodology

Design

The research design selected for this pilot study was a prospective cohort design to examine

the activities in which the NP engaged when delivering a secondary prevention intervention,

and the effects of this intervention on the rates of implementation of secondary prevention

strategies and the rates of patients‘ achievement of treatment goals. The cohort design is

appropriate in this pilot study; it permits evaluation of intervention feasibility and fidelity of

implementation, as well as preliminary effects. An assessment of the feasibility is important

to determine the applicability of the intervention in day-to-day practice; and of

implementation (i.e., the degree to which the intervention was delivered as intended) which is

essential in understanding the actual processes that underlie the observed outcomes

(Bruckenthal & Broderick, 2007). A cohort design yields comparative evidence that can then

be used to make estimations on the effects of the NP intervention on rates of provider and

patient achievement of secondary prevention target goals.

Using this design, a group of eligible AMI patients exposed to NP care was compared to a

group of AMI patients not exposed to NP care. All AMI patients admitted to the coronary

care unit (CCU) over a six month time period at the selected setting were screened for

eligibility. In the study setting patients admitted with AMI on weekdays were cared for by a

team comprised of cardiologists who were part of the hospital‘s cardiology service and an

NP. Patients admitted on the weekend were cared for by cardiologists without an NP. Both

groups of patients were invited to participate in the study. Patients cared for by cardiologists

and an NP while in hospital were assigned to the NP care group (intervention group). Patients

cared for by cardiologists on the weekend without NP care while in hospital were assigned to

the usual care group (control group). All interventions by cardiologists were similar between

groups. All patients were screened for study entry according to the same inclusion and

exclusion criteria.

Patti

Typewritten Text

Patti

Typewritten Text

57

58

The researcher (who is an NP with expertise in cardiac secondary prevention) delivered the

NP component of care to the intervention group, which included comprehensive

cardiovascular assessments and education, counselling and treatment recommendations

related to heart attack recovery and secondary prevention care. The intervention was

delivered at the following time intervals: time 1 (T1), prior to discharge from hospital; (T2),

1 week following hospital discharge; (T3), 2 weeks after discharge from hospital; (T4), 6

weeks after discharge, and (T5), 3 months after hospital discharge. Pertinent data were

collected at these points in time. Control group patients received care provided by their

cardiologist (excluding any NP care), and had data collected at two points in time: baseline

(T1) and T5. Figure 2 presents an overview of the study design.

Figure 2. Overview of study design

Patients with cardiologist and no NP care while in hospital

Control group (usual care)

Intervention group (NP secondary prevention)

Patients with cardiologist and an NP while in hospital

All AMIs screened in CCU

T2: 1 week post discharge telephone contact with NP

T3: 2 week post discharge outpatient clinic visit with NP

T4: 6 week post discharge outpatient clinic visit with NP

T5: 3 month post MI outpatient visit with NP process and outcome data collection by research assistant

T5: 3 months post MI process and outcome data collection by research assistant

Exclude patients with AMI who underwent CABG or were admitted for procedures only

Control group (usual care) (

Intervention group

T1: Baseline data collection prior to discharge from hospital for all consenting patients

T1, NP group: pre-discharge assessment and teaching

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The NP intervention was given to patients assigned to the intervention group in addition to

usual care, which includes services by a team of cardiologists and NPs in the hospital. The

control group received usual care provided by cardiologists in the hospital. For the purposes

of this study usual care was not withheld for ethical considerations. There is no evidence that

the two cohorts of patients differ on characteristics that could influence outcomes. However,

an examination of baseline equivalence of the two cohorts was completed, and any

confounding variable (reflecting variables with significant baseline differences) controlled

for statistically. By using this design and controlling for significant baseline differences, the

validity of the results related to the effects of NP care on outcomes were enhanced.

Examining the delivery of the NP intervention in a natural setting improves external validity

and minimizes logistical issues related to current practice and flow of care in this setting.

Setting

The pilot study was conducted in a large tertiary care community hospital with full cardiac

services (coronary angiography, coronary artery bypass surgery, cardiac exercise

rehabilitation programme). The hospital is within a multicultural community with a

population of 500,000. The number of AMI patients admitted to the CCU each year is

approximately 700 (A. Linnett, personal communication, May 18, 2006).

The NP intervention consisted of inpatient and outpatient components. The inpatient

component of the intervention was delivered on one of three medical wards that routinely

admit patients discharged from the CCU following AMI, as well as patients with a range of

cardiac and general medical diagnoses. Services available for all AMI patients while on the

medical ward include nutritional counselling and access to a psychologist/social worker/or

home care (with referral).

The outpatient clinic component of the intervention was delivered in a private clinic room in

the hospital‘s cardiac rehabilitation outpatient facility. Laboratory, electrocardiography and

radiology services are available within the same building. A cardiac rehabilitation physician

was in the clinic 3 days per week; the physician had agreed to be available for consultation

with the NP, as needed, when present. An emergency room and cardiac arrest team were

within the same facility.

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Sample

The target population consisted of patients who live in south central Ontario admitted to the

study site CCU for the medical management of AMI. The eligibility criteria included:

confirmation of AMI (2 out of 3 criteria: presence of troponin/CK MB; chest pain > 30

minutes; ECG changes consistent with MI), and scheduled for discharge from CCU. Patients

with a previous MI were included and pertinent data recorded. Exclusion criteria included:

AMI patients with coronary artery bypass graft (CABG) surgery on target admission or those

transferred from another hospital for the purpose of coronary procedures (coronary

angiogram or angioplasty); significant co-morbidity which was expected to effect one year

survival (i.e., metastatic cancer, end stage heart or renal disease) as reported in the patients‘

health record; language barrier or dementia or cognitive impairment which would affect

ability to understand instructions or ability to read and sign consent; and

geographic/transportation obstacles which would prohibit follow-up appointments. The staff

nurse caring for the patient prior to discharge from the CCU was asked to identify eligible

participants based on health record data with respect to significant co-morbidity and

cognitive ability (assessed in terms of ability to read and sign a consent form). To confirm

cognitive ability, the researcher administered the mini mental state examination (MMSE)

following patient consent when indicated. The MMSE is an instrument for assessing

cognitive function that has demonstrated validity and reliability in psychiatric, neurologic,

geriatric and medical populations (Holsinger & Williams, 2007; Folstein, Folstein &

McHugh, 1975).

Sample Size

A sample size of 60 patients (30 in intervention group and 30 in control group) was estimated

to be adequate to detect moderate to large effect sizes for the intended outcomes at β = .80

and α = .05 (Cohen, 1992). Moderate to large effect sizes have been reported in studies which

have investigated relevant components of the NP intervention, such as guideline-based care

and nurse case management on lipids, diet and exercise (Allen et al., 2002; Ansari et al.,

2003; DeBusk et al., 1994; Goessens et al., 2006; Murchie et al., 2003). This sample size was

also selected based on admission rates for AMI in the study setting, with the objective of

attaining a balanced group size within a 6 month period. The 6 month time period for

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recruitment minimized disruption to clinical practice routines and reduced use of

administrative resources. Based on data from the period January 2005 through January 2006,

with an average of 60 AMI (50 in NP group; 10 in control group) patients per month

(excluding CABG), and a conservative estimate of a 50% recruitment rate for each group

(20% exclusion criteria and 30% decline participation), recruitment was estimated to take

approximately 2 months for the NP intervention group and 3 months for the control group.

To account for an anticipated 10% attrition rate (as reported by Goessens et al., 2006), 6

additional participants (3 in each group) were recruited, for a total of 66 (33 in each group).

Measures

Data were collected on the following variables:

1. Patient characteristics: Data on patient age, gender, marital status, employment status,

living arrangements (alone, family, spouse), complications of AMI (heart failure, unstable

angina), medical history (diabetes, hypertension, hyperlipidemia, prior AMI, CHF, previous

CABG, PTCA, and stroke), and smoking status were obtained from their medical records.

2. Processes of NP delivered intervention: Two types of processes, reflecting those in which

the NP engaged when delivering the intervention, were recorded: practice activities of the NP

and implementation of secondary prevention strategies. These were assessed with a clinical

log completed by the NP during each contact with each patient (Appendix A).

Practice activities: Four broad categories were used to describe the NP practice activities: 1)

assessment; 2) health teaching, guidance and counselling; 3) case management/coordination

of care; and 4) medication adjustments. These categories were adapted from work done by

Martin and Scheet (1992) in the Intervention Scheme of the Omaha Classification System,

which was designed to provide a means for health care practitioners to describe and

communicate their practice patterns. Brooten and colleagues (2003) later used this system to

identify and classify advanced practice nurse (APN) interventions in response to five

different categories of patient problems. APNs used clinical logs to record the type of

intervention delivered, type of contact (telephone, in-person), and dose (amount of APN time

spent in each contact, including start and stop times). Validity and reliability of the Omaha

system has been supported by earlier studies which have reported an intercoder reliability of

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≥ 80% for the intervention categories and activities (Martin & Scheet, 1992; Brooten,

Youngblut, Deatrick, Naylor & York, 2003; Hays, 1995). A description of each category and

examples of interventions within each category follows.

Assessment refers to activities performed for the purpose of identifying the patient‘s status in

relation to their recovery from AMI and implementation of secondary prevention strategies.

Examples include inquiry regarding signs and symptoms, history and physical examination,

24 hour diet recall, and ordering laboratory tests (cholesterol measurement). Health teaching,

guidance and counselling refers to activities designed to provide information and materials

which encourage the patient to take action and responsibility for self-care and coping, and to

assist the patient and family to make decisions and solve problems. Examples include

nutritional counselling, smoking cessation counselling, review of medication benefits and

potential side effects and instructions on signs and symptoms to report. Case management

refers to activities that improve communication among health and service providers and

guide the patient and family toward the use of appropriate resources. Examples include

communication with the patient‘s family physician and/or most responsible physician,

referral for home care services, and referral for cardiac rehabilitation. Medication adjustment

refers to activities which involve medication prescriptions that are designed to prevent or

decrease risk or alleviate signs and symptoms of the patient. Examples include adjusting lipid

lowering medication dose to target levels according to cholesterol levels, and adjusting blood

pressure medication dose to achieve target levels according to BP measurements, in

consultation with the patient‘s most responsible physician.

The NP recorded the time each contact started and the time it ended. For each secondary

prevention strategy the NP documented on the log whether or not the strategy was addressed

and the length of time spent on each activity. Total time spent with the NP at each contact

was calculated for each category of practice pattern, within and across secondary prevention

strategies.

Secondary prevention strategies: The NP‘s implementation of the following strategies was

assessed: delivery of or referral to smoking cessation counselling; initiation or titration of BP

medications if BP not at target goal; initiation or titration of lipid lowering therapy if lipid

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levels not at target goals; delivery of physical activity counselling or referral to cardiac

rehabilitation programme; measurement of weight, BMI, waist circumference, and dietary

counselling; measurement of blood glucose and diabetes risk factor counselling for diabetic

patients; initiation of ASA if not contraindicated, and clopidogrel or warfarin if clinically

indicated; initiation or titration of ACE inhibitor towards treatment goals unless

contraindicated; initiation or titration of β-blockers towards treatment goal unless

contraindicated.

3. Outcomes: The outcome variables included treatment goals achieved by the patient

(Appendix B). These include: smoking status; systolic BP (mmHg), diastolic BP (mmHg);

LDL cholesterol (mmol/L), HDL cholesterol (mmol/L), triglycerides (mmol/L); involvement

in physical activity; attendance at cardiac rehabilitation programme; BMI and waist

circumference (cm); HbA1C; and current use of ASA, β-blocker and ACE inhibitor as

recommended. The instrument to assess/monitor these outcomes has been adapted from the

AHA/ACC/CCS secondary prevention for patients with coronary disease clinical practice

guidelines table and the CCORT/CCS AMI process of care quality indicators table (Antman

et al., 2008; Smith et al., 2006; Tu et al., 2005). The instrument includes all of the AHA/ACC

secondary prevention guideline goals. For each patient contact, the tool was used to record if

the target goal was achieved based on data available in his/her medical record for each

secondary prevention strategy, identified as yes or no. For example, has the patient smoked

since the previous contact?; or, is the last recorded LDL-C level at the target level?

NP Secondary Prevention Intervention

The NP delivering the intervention was a Master‘s prepared NP with experience in inpatient

and ambulatory care of patients recovering from heart attack. Additionally, the NP has an

extended class license with the scope of practice and authority to order diagnostic tests (e.g.,

lipid levels and electrocardiograms), renew prescriptions and make adjustments in

medications recommended in the secondary prevention clinical guidelines. Addition of new

medications recommended in the guidelines is not within the scope of practice of the NP. The

NP contacted the most responsible physician (MRP) when medication adjustments were

indicated.

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The NP activities comprising the intervention included both pharmacologic and

nonpharmacologic care components recommended by the AHA/ACC/CCS guidelines for

preventing heart attack and death in patients with atherosclerotic cardiovascular disease

(which includes AMI) (Antman et al., 2008; Smith et al., 2006). All guideline

recommendations were integrated into the NP intervention, with the exception of

thrombolytic and PCI treatments, which are beyond the scope of NP practice.

As previously described, the NP intervention included four components of care: 1)

assessment; 2) health teaching, guidance and counselling; 3) case management/coordination

of care; and 4) medication recommendations and adjustments. These role functions were

used to categorize and describe the specific activities in which the NP engaged to deliver the

secondary prevention strategies.

The intervention was provided in five sessions at the following points in time: face-to-face

contact prior to discharge from hospital; a telephone call to patient one week following

discharge from hospital; and outpatient clinic appointments with the NP at 2 weeks, 6 weeks

and 3 months after discharge from hospital. Although optimal timing of secondary

prevention interventions has not been established, the time intervals were selected to

maximize the potential of reaching secondary prevention goals during the period of time in

which the patient is at highest risk for reinfarction and death (Anderson et al., 2007;

Kornowski et al., 1993). The risk of progression of disease in those with non ST elevation MI

is highest in this period (Anderson et al., 2007). Additionally, patients are seen by a

cardiologist on average 8-10 weeks after discharge from hospital, and entry into cardiac

rehabilitation begins on average between 2 and 3 months after discharge. Timing the

intervention in the early discharge period provides care to patients who are most vulnerable

for reinfarction, have a heightened awareness of their health and future risk, and are

potentially receptive to strategies to decrease future risk. Lastly, early interventions which

can address individual barriers to entry into cardiac rehabilitation programmes, given before

discharge from hospital and soon after discharge have demonstrated to be the most effective

in improving enrolment in these programmes (Grace et al., 2011; Gravely-Witt et al., 2010).

65

The number of contacts and the amount of time allotted for each contact were flexible, based

on individual patient needs, which is a fundamental characteristic of patient-centered care

(Robinson, Callister, Berry, & Dearing, 2008). One hour was allocated for the time spent

with each participant before discharge from hospital, while 30-60 minutes was allocated for

the outpatient contacts. These times were selected based on an estimation of the time

required to complete a health history and focused cardiovascular examination, and to discuss

and individualize all secondary prevention strategies. The number of contacts was similar to

those reported in other studies (Goessens et al., 2006; Redfern et al., 2008). This provided for

repeated contacts to assist patients in applying the secondary prevention recommendations

and to address potential barriers.

The content of the health teaching, guidance and counselling components of care was based

on the ACC/AHA/CCS guidelines for the management of patients with ST-elevation

myocardial infarction, which includes specific recommendations for patient education before

discharge from hospital as well as long-term management and follow-up recommendations

(Antman et al., 2004; 2008). Examples of specific topics within these recommendations

include education about acute cardiac symptoms and appropriate responses, lifestyle change

and drug therapy that are important for secondary prevention, and encouraging a diet low in

saturated fat with an increased consumption of fruits, vegetables and soluble fibre.

Education about recognizing acute cardiac symptoms and appropriate actions is included to

expedite early evaluation and treatment (by physicians as appropriate) and self-management

(by patients) should symptoms recur. A description of specific activities for each contact

follows. The protocol for the NP intervention can be found in Appendix C.

Contact 1, NP secondary prevention care prior to discharge from hospital (T1) included: a

clinical history and focused cardiovascular assessment and a review of individualized

secondary prevention target goals. Topics reviewed included smoking, BP, lipids, physical

activity, weight, diabetes, anti-platelet therapy, β-blocker therapy and ACE inhibitor therapy.

Contact telephone numbers for the NP were given to patients and families, and contact

numbers were requested from the patient for the purpose of communication about

appointments and questions that the patient or family had about secondary prevention

between scheduled contacts.

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Contact 2, one week following discharge from hospital (T2); the NP telephoned the patient to

review progress with heart attack recovery (i.e., symptoms, activity and medications),

reinforce secondary prevention recommendations made before discharge, and answer

questions. The timing of this contact was also to identify and help those who had difficulty

filling their prescriptions early. Thirty minutes was allowed for this contact.

Contact 3, two weeks following discharge (T3); patients were seen in an outpatient clinic by

the NP. This visit included: a health history and focused cardiovascular assessment

(including weight and BP); a detailed review of medications and individualized secondary

prevention target goals; and health teaching. Topics reviewed included smoking, BP, lipids,

physical activity, weight, diabetes, anti-platelet therapy, β-blocker therapy and ACE inhibitor

therapy. Referral to cardiac rehabilitation was discussed and arranged, and referral to a

smoking cessation programme if currently smoking and/or patient would like supplemental

support. The timing of this contact was to reinforce principles of self management and

behaviour change as they related to individual needs and goals, and to identify those who

needed assistance or reassurance on symptom management and how to safely return to

normal activities. The scheduled time for this visit was 45 minutes to one hour.

Contact 4, six weeks post MI (T4), a follow-up appointment at the outpatient clinic included:

a health history and focused cardiovascular assessment; a detailed review on medication and

individualized secondary prevention target goals; and health teaching. Topics reviewed

included smoking, BP, lipids, physical activity, weight, diabetes, anti-platelet therapy, β-

blocker therapy and ACE inhibitor therapy. The timing of this contact coincides with the

recommended timing for measuring response to treatments (lipid levels, liver function and

renal function tests if on drug treatment). The scheduled time for this visit was 30 to 45

minutes.

Contact 5, three months post MI, the outpatient follow-up included: health history and

focused cardiovascular assessment; a detailed review of medication and individualized

secondary prevention target goals; and health teaching. Topics included smoking, BP, lipids,

physical activity, weight, diabetes, anti-platelet therapy, β-blocker therapy and ACE inhibitor

therapy. Cardiac rehabilitation progress/candidacy was reviewed and arrangements made for

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remeasurement of lipid levels (and liver function tests if on drug treatment). The timing of

this contact was to further reinforce principles of self-management and behaviour change,

and to assess patients‘ short-term achievement of secondary prevention target goals. The

scheduled time for this visit was 30 to 45 minutes.

Control Group

The comparison group received usual care, which included discharge teaching by staff RNs

and access to an outpatient group teaching session on heart attack recovery. Post discharge

follow-up appointment timing and content were determined by the most responsible

physician (MRP) and/or a family physician if the patient had a family physician.

Procedure for Data Collection

Following ethics review board approval, the principal investigator oriented the nursing and

medical staff to the study objectives, inclusion and exclusion criteria, and the NP

intervention. This was accomplished by scheduled presentations for each shift in the three

medical clinical units that most frequently admitted patients who were discharged from the

CCU. Nursing staff were requested to identify patients who were eligible for the study based

on inclusion and exclusion criteria, and to inquire if there was interest in the study. The script

used by staff is in Appendix D. The researcher recorded in a log book those patients who

were eligible for the study, and reasons for exclusion. The researcher met with interested

patients and provided a detailed description of the study. A detailed description of the

intervention and total number of contacts (outpatient visits and phone contact) were reviewed

with each potential participant. The researcher also reviewed with each patient their rights as

research participants before consent was obtained.

Consecutive consenting patients in each of the intervention and control groups had baseline

data collected by the researcher prior to discharge from hospital. Baseline data that were

abstracted from the health record after obtaining consent included: demographic information

(age, gender, race, marital status, primary language), date of admission, date of MI (with

documentation of confirmation according to troponin/CK MB levels, ECG changes and chest

pain characteristics), past medical history, complications while in hospital, and medications

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on admission to CCU and at time of enrolment in the study. The baseline data collection

form is in Appendix E.

At T1, an NP clinical log was started for the intervention group, to record implementation of

secondary prevention strategies and practice activities. The NP recorded the activities

performed at each contact in the clinical log (Appendix A).

Patients in the intervention group also had rates of achievement of secondary prevention

goals determined by assessment and medical record data abstraction completed by a research

assistant at the three month follow-up appointment. Data collected included: BP

measurement, lipid levels, lipid treatment, weight, BMI, waist circumference, ASA or other

antiplatelet use, β-blocker dose, and ACE inhibitor dose. Participants were asked to indicate

whether they were currently smoking, had received smoking cessation counselling, were

engaged in physical activity, and had been referred to cardiac rehabilitation. The research

assistant was trained to interview patients the same for both groups to minimize interviewer

or expectation bias. The outpatient clinic data collection form can be found in Appendix F.

After participants in the control (usual care) group signed their consent, the researcher

obtained telephone numbers to contact them 3 months post AMI. The patients were asked to

attend one outpatient visit at the cardiac rehabilitation site, conducted by a research assistant,

3 months post AMI. The purpose of this visit was to assess for rates of achievement of

secondary prevention goals, utilizing the same form used with the intervention group

(Appendix B). Data collected included: BP measurement, lipid levels, lipid treatment,

weight, BMI, waist circumference, ASA or other antiplatelet use, β-blocker dose, and ACE

inhibitor dose. Participants were asked to indicate whether they were currently smoking, had

received smoking cessation counselling, were engaged in physical activity, and had been

referred to cardiac rehabilitation. The patient‘s record was reviewed by the research assistant

to determine achievement of secondary prevention goals at the three month follow-up period

for those patients who were unable to attend or who did not attend this scheduled

appointment. Patients in the control group were not contacted after discharge from hospital

until T5 to avoid influencing their health care seeking behaviour, which could result in

contamination or dissemination of the intervention. For example, inquiring about cardiac

69

rehabilitation, smoking cessation counselling and medications could encourage patients to

seek referrals when they might not otherwise.

As the research assistant used the NP outpatient record for a portion of the 3 month follow-up

data (blood test results), and therefore was not blinded to treatment groups, a second research

assistant was hired to audit five randomly selected charts from each group, to determine the

accuracy of data extraction of the 3 month follow-up visit.

Plan for Data Analysis

Data were analyzed in the following four steps:

Step 1. Descriptive statistics (frequency distributions, measures of central tendency and

dispersion) were used to describe the baseline characteristics of the sample, NP practice

activities performed when delivering the secondary prevention intervention, outcomes

measured at each time point, and to test for the assumptions of normal distribution of data

underlying the planned statistical tests used for data analysis. Independent-samples t-tests

(for continuous variables) and chi-square tests (for dichotomous variables) were conducted to

examine the comparability of the intervention (i.e., received NP care) and the control (i.e.,

received usual care) groups on all baseline variables. The Levene‘s test examined the

equality of variance assumption, and if not met, the appropriate formula for the t-test was

reported.

Step 2. NP practice activities and rates of NP implementation of evidence-based secondary

prevention goals were analyzed using descriptive statistics to describe frequency of activities

performed and percentage of participants who achieved treatment goals.

Step 3. Analysis of covariance was conducted to compare the intervention and control groups

on post-test outcomes while controlling for confounding variables. The covariates included

variables showing significant between-group differences at baseline and correlation with the

post-test outcomes, as recommended by Norman and Streiner (2008).

Step 4. A multiple regression or logistic regression analysis, based on the level of

measurement of the dependent variable, was used to examine the relationship between

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practice patterns and outcomes, controlling for the same confounding variables included in

the analysis of covariance.

Baseline characteristics.

Descriptive statistics were used to characterize the sample on all variables measured at

baseline. Differences between the intervention and usual care groups in baseline

demographic, clinical and risk factor characteristics were examined with t tests for

continuous variables and x2 tests for categorical variables. Continuous variables were

reported as means with standard deviations and categorical variables as frequency and

percentages. For example, for the continuous variable LDL-C at baseline, group means for

the intervention and control groups were compared using an independent samples t-test. For

the categorical variable, current smoker, a chi-square test was done to report the percentage

of current smokers in the intervention group compared to the percentage of those in the usual

care group. T-test and chi-square were also used to compare baseline characteristics for

participants who completed the study with those who were lost to follow-up for any reason.

Variables showing significant baseline differences between the control and intervention

group were adjusted in subsequent analyses if they demonstrated significant correlation with

the posttest outcomes (Norman & Streiner, 2008). Subsequent analyses are described in

relation to the study objectives.

NP practice activities.

Descriptive statistics were utilized to summarize the type of activity, frequency and amount

of time spent on the secondary prevention strategies implemented by the NP during clinical

contacts. The practice patterns were quantified as the percentage of activities performed

within each category of practice (i.e., assessment; health teaching, guidance and counseling;

case management/coordination of care; and medication adjustments) and the time spent in

each category of practice.

NP implementation of secondary prevention.

Descriptive statistics were utilized to summarize the frequency of NP implementation of

evidence-based secondary prevention strategies in the intervention group only. The variables

included in this analysis were dichotomous (yes or no): delivery of or referral to smoking

71

cessation counselling; initiation or titration of BP medications if BP not at target goal;

initiation or titration of lipid lowering therapy if lipid levels not at target goals; delivery of

physical activity counselling or referral to cardiac rehabilitation programme; measurement of

weight, BMI, waist circumference, and dietary counselling; measurement of HbA1C and

diabetes risk factor counselling for diabetic patients; initiation of ASA if not contraindicated,

and clopidogrel or warfarin if clinically indicated; initiation or titration of ACE inhibitor

towards treatment goals unless contraindicated; initiation or titration of β-blockers towards

treatment goal unless contraindicated.

Patient achievement of secondary prevention goals.

For each secondary prevention goal, the mean value within and between groups was

calculated and reported. Chi-square tests and t-tests were used to compare outcome

achievement between groups (independent sample t-test) and within groups (paired t-test).

The association between the rate of outcome achievement, group membership and NP

practice activities was examined using logistic regression for categorical dependent variables

or multiple linear regression for continuous dependent variables, with hierarchical entry to

control for baseline differences. Variables entered into the model to predict outcome

achievement were: variables showing significant between-group differences at baseline and

correlation with posttest outcomes, provider variables, NP practice activities by practice

activity category and group membership. The number of clinical visits in the three month

intervention period and the total number of minutes spent with the NP were also examined as

independent predictors of success in achieving outcome goals.

Data for all patients lost to follow-up or those who dropped out of the NP care group were

analyzed in the groups to which they were originally assigned.

Ethical Considerations

Participants were informed of the purposes of the research study, the expected duration of

participation, and a description of what participant involvement entailed. A description of

any foreseeable risks and benefits to the participants, as well as a statement describing how

confidentiality would be maintained was also included. Consent by participants was obtained

in writing. A copy of the consent form can be found in Appendix G.

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Patients eligible for participation were approached by a staff nurse who informed them of the

study. The investigator met with patients expressing interest in participating in the study for

an in-depth description of the study. All potential participants were told that refusal to

participate would involve no penalty or loss of benefits to which they were entitled, and that

they could discontinue participation at any time without penalty or loss of benefit.

Several strategies were used to ensure the confidentiality and privacy of participants who

were screened and entered into the study. Data collection forms were kept in a locked storage

box in the outpatient clinic office. Participant names or identifying information were not

included on data collection forms and analysis reports. Participants were identified by a study

identification number. Participant names and corresponding study identification numbers

were stored separately. Information about specific individuals was not available to anyone

except the researchers.

Risks.

The NP intervention which included assessment, health teaching, guidance and counselling,

and case management poses no known risks to participants. All participants had access to all

standard cardiac, emergency, and medical care services. Outpatient clinical appointments for

the study were in addition to usual care.

Medication adjustments were limited to those related to secondary prevention (antiplatelets,

lipid lowering agents, β-blockers, and ACE-inhibitors) and were made in collaboration with

the most responsible physician.

If post AMI patients reported or experienced symptoms such as chest pain or shortness of

breath during their outpatient visit with the NP, the following actions were taken:

1) A thorough history and focused cardiovascular physical examination were

completed to aid in determining the cause of symptoms;

2) The NP contacted the participant‘s most responsible physician (with the

patient‘s permission) if symptoms warranted further investigation or medication

adjustment(s);

3) In the event of symptomatic distress, the NP escorted the participant to the

73

hospital emergency department, or activated the in-hospital emergency protocol if the

patient was unstable.

This study required participants to travel to the cardiac rehabilitation programme outpatient

facility for three follow-up appointments. This travel was not expected to be stressful or

burdensome as patients typically travel for routine follow-up appointments. Patients were

offered reimbursement for parking while attending appointments for the study.

Benefits.

There were no direct benefits to patients in the study. However, it was proposed that results

would help identify the extent to which the NP intervention contributes to the achievement of

secondary prevention goals.

Ethical approval.

Ethical approval for conducting clinical research was obtained from the Research Ethics

Board at the University of Toronto and participating hospital on 12 May, 2008, and was

renewed as needed.

Chapter 4

Results

In this chapter, results are presented in relation to participation and attrition rates, the sample

characteristics, and each study objective. The objectives related to the description of NP

practice patterns within the context of secondary prevention, and to the evaluation of the

preliminary effects of the NP intervention.

Participation Rates

During the recruitment period of June 8, 2008 to February 8, 2009, 562 patients with the

primary diagnosis of AMI were admitted to the participating CCU. The number of patients

who did not meet the study eligibility criteria was 487 (86.6% of total patients admitted).

Reasons for ineligibility are in Table 5. The most common reasons for ineligibility were

admissions limited to interventional procedures (such as coronary angiography and

percutaneous angioplasty), admission and discharge timing restricting NP participation on

the healthcare team, surgical intervention (such as coronary artery bypass surgery or valve

replacement), being too ill (ascertained with a Charlson Comorbidity Index score greater than

2, as documented in the patient‘s chart) (Charlson, Pompei, Ales, & MacKenzie 1987; Hall,

Jani, Ryu, Narayan, & Vijayakumar, 2005) and having dementia (i.e., unable to sign

consent). Of the 75 (13.4% of total patients admitted) eligible patients who were approached

about study participation, 10 declined. Most (n = 6) patients did not provide a reason for

declining enrolment in the study; for the remaining patients (n = 4), time commitment for the

study was an issue that prevented their participation. The study sample consisted of 65

patients who were admitted to hospital with the diagnosis of AMI, representing an 87%

participation rate and 13% refusal rate for those eligible. Participants were allocated to the

intervention (n = 32) or the control (n = 33) group.

Patti

Typewritten Text

Patti

Typewritten Text

74

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Table 5

Summary of Reasons for Non-eligibility (n=487)

Reason for Non-eligibility n (%)

Admission for interventional procedure 178 (36.5)

Staff NP not available 96 (19.7)

CABG or valve surgery 71 (14.6)

Too illa/ dementiab 42 (8.6)

Language (non-English speaking) 28 (5.7)

Missed (not approached due to timing of

discharge)

17 (3.5)

Discharged home from CCU 16 (3.3)

Expired 16 (3.3)

Geographic (not living in the region) 11 (2.2)

Participating in another study 8 (1.6)

Transportation (no transportation for clinic

appointments)

4 (0.8)

Note. CABG = coronary artery bypass grafting; CCU = coronary care unit. a defined using Charlson Comorbidity Index (CCI) score >2 (Hall et al., 2005; Charlson et al., 1987). bunable to independently sign consent.

Attrition

Of the total number (n = 65) of participants who consented, 4 dropped out, yielding an

attrition rate of 6.1%. Of the 4 dropouts, 3 were assigned to the control group (9% attrition

rate for this group) and 1 was assigned to the intervention group (3% attrition rate for this

group). All withdrawals occurred before the outpatient intervention was provided. The

reasons for dropouts are unknown; all telephone and written correspondence to participants

who dropped out were unanswered.

Due to the small number of dropouts, statistical comparison between dropouts and

completers was not meaningful. However, the measures of central tendency for baseline

characteristics of those who dropped out (n = 4) and completers (n = 61) are presented in

Table 6. Overall, compared to completers, dropouts were men, younger, married, lived with

76

their family and/or spouse and were employed. The mean number of days in hospital was

shorter in those who dropped out of the study (3 days versus 4.8 days). A larger percentage

of patients who dropped out had a history of diabetes (75% versus 21%) and prior AMI (25%

versus 11%).

Table 6

Baseline Characteristics of Those who Dropped Out of the Study and Those who

Completed the Study

Characteristic Dropped out ( n = 4) Completers (n = 61)

Demographic

Age, mean years (SD) 49.8 (2.87) 58.9 (9.9)

Male, n (%) 4 (100) 50 (82)

Married, n (%) 4 (100) 45 (73.8)

Employed, n (%) 4 (100) 36 (59)

Days in hospital, mean (SD) 3 (0.81) 4.8 (4.05)

Risk factors, n (%)

Current smoker 2 (50) 25 (41)

Hypertension 2 (50) 32 (52.5)

Hyperlipidemia 2 (50) 35 (57.4)

Diabetes 3 (75) 13 (21.3)

Family history of cardiac disease 2 (50) 33 (54.1)

Clinical

Prior MI, n (%) 1 (25) 7 (11.5)

LDL-C, mean (SD), n 2.55 (1.89), 3 2.44 (1.38), 58

PTCA, n (%) 4 (100) 54 (88.5)

Stent, n (%) 4 (100) 54 (88.5)

DES 3 (75) 21 (34)

Troponin, mean (SD) 39.89 (39.19) 17.27 (10.75)

Blood glucose in hospital, mean (SD) 10.07 (8.32) 5.9 (1.22)*

SBP prior to discharge, mean (SD) 116 (8.85) 117 (13.90)*

DBP prior to discharge, mean (SD) 70 (11.13) 68 (9.8)*

77

Characteristic Dropped out ( n = 4) Completers (n = 61)

Complication CHF, n (%) 0 1 ( 3.3)

Referral to cardiac rehabilitation at discharge, (%)

3 (75%) 61 (100)

Note. MI = myocardial infarction; LDL-C = low density lipoprotein cholesterol; PTCA = percutaneous transluminal coronary angioplasty; DES = drug eluting stent; SBP = systolic blood pressure; DBP = diastolic blood pressure; CHF = congestive heart failure. *n = 60 for these variables.

Characteristics of Participants

This section reports on study participants‘ demographic and clinical characteristics measured

at baseline. Also, results of comparisons between the intervention and control groups on

these variables are presented in the respective subsections.

Demographic.

The mean age of participants was 58.3 years (SD 9.87, range 39 to 89). The majority of

participants were men (83%), married (75%), employed (61%), with high school education

or above (65%). Demographic characteristics for the total sample and the intervention (NP)

and control groups are in Table 7. The intervention and control groups were similar in

gender, employment and education. The mean age of participants in the intervention group

was significantly higher, t(54.62) = -3.002, p = .004, than the control group. More

participants in the control group were married x2(1) = 5.83, p = .02, whereas more

participants in the intervention group were widowed (0 vs. 9.4%, p = .000). Therefore, age

and marital status were controlled for in the analyses addressing the study objectives.

Correlation coefficients between baseline variables and post-test outcomes can be found in

Appendix H.

78

Table 7

Demographic Characteristics

Characteristic Total Sample

(n = 65)

NP Group

(n = 32)

Control Group

(n = 33)

P-value

Mean Age (SD) 58.3 (9.87) 61.87 (10.88) 54.9 (7.44) .004

Male, n (%) 54 (83.1) 25 (78.1) 29 (87.9) .29

Married, n (%) 49 (75) 20 (62.5) 29 (87.9) .02

Employed, n (%) 40 (61.5) 17 (53.1) 23 (69.7) .20

Education, n (%) high

school

16 (24.6) 8 (25) 8 (24.2) .17

Education, n (%) post

secondary

26 (40) 11 (34) 15 (45.45) .17

Clinical characteristics.

In the total sample, the mean number of days in hospital was 4.7. Smoking at the time of

admission to hospital was reported by 42% of participants. A significant proportion of

participants had a history of hypertension (52.3%), hyperlipidemia (56.9%), diabetes (24.6%)

and family history of cardiovascular disease (60%). Most had percutaneous transluminal

coronary angioplasty (PTCA) and stent, with just over one-third (37%) receiving drug-

eluting stent (DES). Only two participants experienced complications. Baseline clinical

characteristics of the total sample and the intervention and control groups are in Table 8.

There were no baseline differences between the intervention and control groups for the risk

factors of hypertension, hyperlipidemia, diabetes or family history. The groups differed in the

rates of prior MI (15.6% versus 9.1), but this difference did not reach statistical significance.

The groups were similar for troponin levels and the complications of congestive heart failure

and unstable angina.

The rates of interventional treatment of percutaneous angioplasty (PTCA) and use of stents

were different between groups. More participants in the control group received PTCA (97%

vs. 81.3%, p = .03), stents (97% vs. 81.3%, p = .03), and drug eluting stents (51.5% vs.

21.9%, p = .01). The variable stent was significantly correlated with age and not known to

79

have clinical significance in the measured outcome variables; therefore it was not controlled

for in subsequent analyses.

Table 8

Clinical Characteristics

Characteristic Total Sample

(n = 65)

NP Group

(n = 32)

Control

Group

(n = 33)

P-value

Days in hospital, Mean (SD) 4.7 (3.96) 5.0 (5.47) 4.48 (1.46) .60

Risk factors, n (%)

Smoker 27 (41.5) 13 (40.6) 14 (42.4) .12

Former smoker 14 (21.5) 10 (31.3) 4 (12.1)

Never smoked 24 (36.9) 9 (28.1) 15 (45.5)

Hypertension 34 (52.3) 18 (56.3) 16 (48.5) .53

Lipids 37 (56.9) 17 (53.1) 20 (60.6) .54

Diabetes 16 (24.6) 8 (25.0) 8 (24.2) .94

Family history 35 (60) 16 (50) 19 (57.6) .54

Prior MI, n (%) 8 (12.3) 5 (15.6) 3 (9.1) .42

PTCA, n (%) 58 (89.2) 26 (81.3) 32 (97) .03

Stent, n (%) 58 (89.2) 26 (81.3) 32 (97) .03

DES, n (%) 24 (36.9) 7 (21.9) 17 (51.5) .01

Troponin, mean (SD) 38.50 (38.42) 33.37 (39.52) 43.46

(37.23)

.29

Complications, n (%)

CHF 2 (3.1) 1 (3.1) 1 (3.0) .98

Unstable angina 2 (3.1) 1 (3.1) 1 (3.0) .98

Note. MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty;

DES = drug eluting stent; CHF = congestive heart failure.

80

Outcome Variables at Baseline

Measures of central tendency for the outcome variables assessed at baseline are presented in

Table 9 for the intervention and control groups. Medications participants reported taking at

the time of admission were ASA (27.7%), plavix (6.2%), statin (35.4%), beta-blocker

(16.9%), ACE-inhibitor (23.1%), and ARB (7.7%). The mean fasting LDL-C and HDL-C

were 2.44mg/dl (SD 1.39) and .94mg/dl (SD .27) respectively. Fasting triglyceride mean was

1.75mg/dl (SD 1.10), and fasting glucose mean was 6.19mg/dl (SD 2.39). Mean systolic and

diastolic blood pressure measurements (last recorded prior to discharge from hospital) were

116mm/Hg (SD 13.59) and 68.30mm/Hg (SD 9.71) respectively. Mean BMI was 27.86 (SD

4.5), and mean waist measurement was 40.56 (SD 4.27). Mean waist measurement for men

was 40.92 (SD 3.54), and for women 36.83 (SD 9.45).

Differences between the intervention and control groups in outcomes measured at baseline

were examined to determine their initial comparability. Chi-square tests were used for

dichotomous variables and independent-samples t-tests were used for continuous variables.

There were no significant baseline differences in LDL-C, HDL-C and triglyceride levels

(measured fasting within 24 hours of admission), fasting blood glucose, systolic and diastolic

blood pressure (last recorded BP prior to discharge from hospital), BMI, and waist

measurement. Medications reported at the time of admission were also similar. However,

some differences between groups were moderate to large, though not statistically significant,

in the variables ASA, plavix, statin, β-blocker use and blood glucose, triglyceride levels and

BMI.

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Table 9

Outcome Variables at Baseline

Variable Total sample

(n = 65)

NP Group

(n = 32)

Control

Group

(n = 33)

P-value

Medications on

admission, n (%)

ASA 18 (27.7) 7 (21.9) 11 (33.3) .30

Plavix 4 (6.2) 3 (9.4) 1 (3.0) .35

Statin 23 (35.4) 14 (43.8) 9 (27.3) .16

β-blocker 11 (16.9) 8 (25.0) 3 (9.1) .08

ACE inhibitor 15 (23.1) 8 (25.0) 7 (21.2) .71

ARB 5 (7.7) 4 (12.5) 1 (3) .18

LDL-C on admission,

mean (SD)a

2.44 (1.39) 2.46 (1.76) 2.42 (.88) .91

HDL-C, mean (SD)a .94 (.27) .98 (.31) .89 (.21 .18

Triglycerides, mean (SD)a 1.75 (1.10) 1.50 (.77) 1.99 (1.33) .08

Blood glucose in hospital,

mean (SD) b

6.19 (2.39) 5.8 (1.25) 6.59 (3.11) .18

SBP prior to discharge,

mean (SD)c

116 (13.59)

115.96 (14.52)

114.96

(11.51)

.78

DBP prior to discharge,

mean (SD)c

68.30 (9.71) 66.76 (8.92) 68.11 (9.07) .59

BMI, mean (SD)d 27.86 (4.5) 26.4 (4.95) 29.0 (3.85) .07

Waist, mean (SD)d 40.56 (4.27) 39.78 (4.23) 41.05 (4.32) .41

Note. LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol; SBP = systolic blood pressure; DBP = diastolic blood pressure; BMI = body mass index. a Measured within 24 hours of admission (fasting). b Measured at least 24 hours after admission. c Last recorded BP prior to discharge, some unavailable (NP group, n = 5; Control group n = 6). d Baseline BMI unavailable on 12 in NP group, 8 in control group; waist unavailable on 19 in NP group, 13 in control group.

82

Health Care Provider Variables

The number of self-reported family physician visits, cardiologist visits, nutritionist and

diabetic clinic visits (health care provider visits) since discharge from hospital was recorded

for each participant at the 3 month follow-up visit. Confirmation was obtained from

providers by telephone if the participant was not sure of the information given. Table 10

presents health care provider visits for the total sample and by intervention and control

group.

The mean number of family physician visits during the time period between discharge from

hospital and the three month follow-up study visit was 2.51 for the total sample. The

percentage of patients visiting a nutritionist or diabetic clinic was 21% and 10% respectively.

There were a total of 13 patients visiting a nutritionist, whereas a total of 6 patients were seen

in a diabetic clinic. The mean number of visits to a cardiologist for the total sample was one

visit (range = 0 to 2). Participants in the control group (mean = 1.14) visited a cardiologist

more frequently than participants in the intervention group (mean = .81), p .003. There were

no significant differences between the two groups on the number of family physician,

nutritionist or diabetic clinic visits.

Table 10

Mean Number of Health Care Provider Visits (SD)

Health care

provider

Total sample

N=59

Intervention

group

Control group P- Value

Family MD 2.51 (1.66) 2.58 (1.94) 2.42 (1.31) .73

Cardiologist .97 (.45) .81 (.48) 1.14 (.35) .003

Nutritionist .21 (.41) .23 (.42) .20 (.41) .81

Diabetic clinic .10 (.30) .16 (.37) .03 (.18) .09

NP Practice Activities

The practice activities were assessed with a clinical log completed by the NP at each clinical

contact with patients assigned to the intervention group. The clinical log included the total

number of minutes for each contact and the number of minutes spent in each category of

practice (assessment, teaching, case management/coordination of care, and medication

83

adjustments) for each secondary prevention strategy. These practice pattern variables were

assessed in the intervention group only.

The NP intervention included a minimum of 5 clinical contacts. The total number of

visits/contacts made by the NP ranged from five to 11, with a mean of 6.06 (SD 1.46) (Table

11).

Table 11

Distribution of NP Clinical Visits

Number of NP

Clinical Visits (n = 31)

Frequency Percentage

5 15 48.4

6 8 25.8

7 3 9.7

8 3 9.7

9 1 3.2

11 1 3.2

The mean number of minutes the NP spent with each participant across all visits was 218.22

(3.64 hours) (SD 31.00 minutes), with a range of 160 to 285 minutes (2.67 to 4.75 hours). In

Table 12, the mean, standard deviations and range for the total number of contacts and the

time spent by the NP across all visits in each practice category are presented. On average, the

NP had a larger (> 4) number of contacts related to lipids, physical activity, and medications,

and the most time (> 17 minutes) was spent on lipids, physical activity, and blood pressure.

Smoking assessment was done with all intervention participants, including those reported as

non-smokers at baseline, to eliminate missing those who were not accurately reported at

baseline or those who had been non-smokers and relapsed or those at risk of relapse.

84

Table 12

Mean, Standard Deviations and Range for Total Number of Contacts and Total Number of

Minutes with NP in each Secondary Prevention Strategy

Secondary prevention

strategy

Total # of contacts

Total # minutes

Smoking cessation 3.71 (2.04)

Range 1-8

15.55 (15.33)

Range 1-48

Blood pressure 3.9 (.65)

Range 2-5

17.74 (7.04)

6-38

Lipids 4.35 (1.17)

Range 2-9

30.61 (15.84)

13-68

Physical activity 5.45 (.92)

Range 4-9

45.26 (15.42)

24-93

Weight 3.45 (.67)

Range 2-5

13.48 (5.77)

6-29

Diabetes 2.90 (.94)

Range 2-5

6.90 (6.12)

2-27

Antiplatelets 5.03 (.75)

Range 4-8

16.77 (9.41)

10-62

ACE inhibitor 5.03 (.84)

Range 4-8

16.22 (4.72)

11-30

β-blocker 4.90 (.70)

4-7

14.64 (3.16)

9-24

Total time 218.22

The mean, standard deviations and range for time the NP spent in each practice category per

patient are presented in Table 13. The NP spent the majority of time doing health teaching,

guidance and counselling activities (60%), followed by assessment (36%). Case management

and medication adjustments comprised less than 5% of the NP activities combined. These

percentages were calculated by dividing the total minutes in each category by the total

number of NP minutes. The NP spent a mean of 41 minutes per participant across all visits

on miscellaneous topics or issues.

85

Table 13

Mean, Standard Deviations and Range for NP Time Spent in Each Practice Category Per

Patient (N = 31)

Secondary

prevention strategy

Assessment Teaching Case mgmt Meds

Smoking cessation 6.29 (5.77)

Range 1-23

8.81 (9.27)

Range 0-29

.22 (1.26)

Range 0-7

.22 (.96)

Range 0-5

Blood pressure 6.22 (1.92)

2-11

10.55 (3.80)

4-20

.64 (1.94)

0-10

.32 (1.08)

0-5

Lipids 12.26 (6.60)

5-27

16.03 (7.30)

7-40

.84 (2.30)

0-9

1.51 (5.30)

0-23

Physical activity 14.45 (6.00)

8-34

29.97 (9.65)

15-57

.68 (1.51)

0-5

.16 (.90)

0-5

Weight 4.97 (1.45)

3-9

8.52 (4.97)

3-22

0 0

Diabetes 3.26 (2.60)

1-13

3.55 (3.45)

1-14

.19 (.65)

0-3

0

Antiplatelets 6.06 (4.06)

4-26

10.10 (3.33)

6-20

.61 (2.91)

0-16

0

ACE inhibitor 5.61 (1.80)

4-13

9.26 (2.43)

5-16

1.22 (2.65)

0-10

.45 (1.41)

0-5

β-blocker 5.12 (1.23)

4-11

9.09 (2.36)

3-15

.3 5 (.85)

0-3

.06 (.35)

0-2

Total time NP spent

in each practice

category

(percentage)

64.24 (29) 105.88 (48) 4.75 (3) 2.72 (1.5)

86

NP Implementation of Secondary Prevention

Data to examine NP implementation of evidence-based secondary prevention strategies were

obtained from the intervention group only due to inaccessibility of primary care provider

health records for the control group. Descriptive results for the intervention group are shown

in Table 14.

Smoking cessation counselling was provided to 92% of the intervention group participants

who were current smokers at baseline (n = 12). Referral and attendance to a smoking

cessation clinic occurred in 25% (n = 3) of smokers in the intervention group. All participants

in the intervention group who were smokers were offered smoking cessation clinic referral

before discharge from hospital. Those not attending declined the referral and the reasons

cited included ―can do it on my own‖ (n = 6), ―not ready‖ (n = 2), and no reason offered (n =

1).

Rates of referral to cardiac rehabilitation were 81% in the intervention group; those declining

referral reported reasons such as schedule/work conflict (n= 2), transportation (n = 3), and

not interested (n = 1). One participant reported not wanting to attend because of not having

suitable clothing or shoes.

Physical activity counselling and measurement of weight and BMI calculation were done for

100% of participants. Diabetic teaching was completed with all participants, and 100% of

participants with diabetes had an HbA1C measured.

87

Table 14

NP Implementation of Secondary Prevention Guideline Activities for the Intervention

Group

Secondary prevention

strategy

N Percentage of provider

implementation

Smoking cessation

counselling

11 (12) 92%

Referral and attendance to

smoking cessation clinic

3 (12) 25%

Delivery of physical

activity counselling

31 (31) 100%

Referral to cardiac

rehabilitation

25 (31) 81%

Measurement of weight and

BMI

30 (31) 97%

Delivery of dietary

counselling

31 (31) 100%

Delivery of diabetes

teaching

31 (31) 100%

Measurement of HbA1C 7 (7) 100%

Post-Test Outcomes

The intervention and control groups were compared to examine differences in outcome

achievements for each secondary prevention goal at the three month follow-up visit. Analysis

of covariance was used for these comparisons to control for baseline differences in age and

marital status. Because the two confounding variables - age and stent - were moderately and

negatively correlated (r =-.37, p < .01), stent was excluded from this analysis whereas age

and marital status were considered as covariates in the analysis of covariance because of their

correlation with several outcomes. A chi-square test was used to compare goal achievement

on dichotomous outcomes. Fisher‘s exact test is reported when cell sizes are less than 5.

Results for continuous and dichotomous outcomes are presented separately. In addition,

88

paired t-tests were used to examine within group changes in the continuous outcomes from

pre-test to post-test.

Continuous outcome variables.

In Table 15, the results of the comparative analyses for the continuous outcome variables of

blood pressure, lipid levels, BMI and waist measurements, and number of weeks to cardiac

rehabilitation attendance controlling for baseline differences in age and marital status are

presented.

Table 15

Achievement of Secondary Prevention Goals at 3-Month Follow-up, Continuous

Variables, Controlling for Covariates (adjusted means/SE)

Variable Total

(n = 65)

NP Group

(n = 32)

Control Group

(n = 33)

F(df) P-

value

SBP 60 114.11 (2.31) 116.50 (2.40) .47 (56) .50

DBP 60 68.12 (1.52) 70.28 (1.58) 0.86 (56) .35

LDL-C 59 1.70 (0.10) 1.52 (0.10) 1.34 (55) .25

HDL-C 60 0.98 (0.06) 1.08 (0.06) 1.15 (56) .29

Triglycerides 58 1.07 (0.14) 1.61 (0.16) 5.48 (54) .02

BMI 55 27.47 (0.89) 28.57 (0.95) 0.64 (51) .42

Waist 55 39.67 (0.87) 41.91 (0.92) 2.84 (51) .10

Weeks to CR 41 8.15 (0.71) 10.50 (0.86) 3.83 (37) .05

Note. SBP = systolic blood pressure; DBP = diastolic blood pressure; LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol; BMI = body mass index; CR = cardiac rehabilitation.

There were no significant differences between the intervention and control groups on systolic

blood pressure, diastolic blood pressure, LDL-C or HDL-C blood levels measured at post-

test. BMI and waist measurements were also similar in both groups. However, the two

groups differed significantly on triglyceride level, F(1,54) = 5.48, p = .02 and on weeks to

cardiac rehabilitation, F(1,37) = 3.83, p = .05. The intervention group had lower triglyceride

levels and had a shorter number of weeks from hospital discharge to cardiac rehabilitation

intake than the control group.

89

Dichotomous outcome variables.

In Table 16, the percentages of achievement for the dichotomous outcome variables of

smoking cessation, BP targets, physical activity, cardiac rehabilitation, diabetes management,

and the use of statin, antiplatelet, β-blocker and ACE inhibitor medications are presented. For

the post-test secondary prevention goal related to smoking cessation, 58% of the intervention

group participants who were current smokers achieved complete smoking cessation,

compared to 23% of the control group, x2 (1) = 3.30, Fisher‘s exact test, p = .11, Phi .36.

Attendance at a smoking cessation clinic occurred in 25% of participants who were current

smokers at baseline in the intervention group, compared to no attendance in the control

group, x2 (1) = 4.85, Fisher‘s exact test, p =.09, Phi .38.

The percentage of participants with a target BP less than 140/90 was similar in both groups,

x2 (1) = .17, Fisher‘s exact test, p = .73. The percentage of participants with BP less than

130/80 was also similar, x2 (1) = .1.31, Fisher‘s exact test, p = .30. The percentage of

participants with diabetes achieving the target BP less than 130/80 in the intervention group

was higher than the control group, 71% versus 50%, but did not reach the preset level of

statistical significance, x2 (1) = .630, Fisher‘s exact test, p = .59. The number of patients in

each group with chronic kidney disease or diabetes (factors which lower the target levels for

SBP and DBP from 140/90 to 130/80) was comparable (intervention group n = 9, control

group n = 7, p = .51).

The percentage of participants who achieved LDL-C less than 2.6 mmoL/L was similar in the

intervention and control groups, x2 (1) = .07, p = .79. The percentage of patients who

achieved an LDL-C less than 1.79 mmol/L did not differ between groups, x2 (1) = .07, p =

.78.

The physical activity goal of at least 30 minutes on more than 5 days per week was achieved

by a significantly higher percentage of participants in the intervention group, compared to the

control group, x2 (1) = 20.02, p = < .001. Engagement in physical activity for a minimum of

5 days per week was also higher in the intervention group, 74% versus 60%, but did not

reach the preset level of statistical significance, x2 (1) = 1.4, p = .24.

90

Participant attendance at cardiac rehabilitation (confirmed by cardiac rehabilitation

attendance logs) was higher in the NP group compared to the control group, but the

difference was not statistically significant, x2 (1) = 2.22, p = .14. Return to work within the

first 3 months after hospital discharge was higher for participants in the control group

compared to those in the intervention group, but this also did not reach the preset level of

statistical significance, x2 (1) = 2.54, p = .11.

A goal in diabetes management is a blood level measurement HbA1C of less than 7%. This

was achieved in 100% of participants who had diabetes in the intervention group, and in 33%

in the control group, x2 (1) = 8.41, Fisher‘s exact test p = .02.

The percentage of participants on statins at discharge from hospital was similar in both

groups, x2 (1) = .32, Fisher‘s exact test p = 1.0. At three months, the percentage receiving

statins was higher in the intervention group compared to the control group, x2 (1) = 5.97,

Fisher‘s exact test, p = 0.05. Rates of achievement of the recommended medications ASA,

clopidogrel, B-blockers and ACE inhibitors were not statistically different between groups at

discharge from hospital and three-month follow-up (all p‘s > .05). Ten per cent of patients

under the age of 65 in the intervention group reported not being able to afford medications

prescribed at the time of discharge from hospital. This information was not obtained from the

control group.

91

Table 16

Achievement of Secondary Prevention Goals, Dichotomous Variables

Variable N by group

intervention/

control

Intervention

group,

n (%)

Control

group,

n (%)

Likelihood

Ratio

P-

value

Smoking cessation 12/ 13* 7 (58) 3 (23) 3.30 .11

Attended smoking

cessation clinic

12/ 13* 3 (25) 0 4.85 .09

BP < 140/90 31/ 30 4 (12.9) 5 (16.7) .17 .73

BP < 130/80 31/ 30 28 (90) 24 (80) 1.31 .30

BP < 130/80

(diabetes)

7/ 6 5 (71.4) 3 (50) .63 .59

LDL-C < 2.6 31/ 28 9 (29) 9 (32.1) .07 .79

LDL-C < 1.79 31/ 28 20 (64.5) 19 (67.9) .07 .78

Physical activity

>5 days per week

31/ 30 21 (67.7) 4 (13.3) 20.02 <0.0

Physical activity 5

days per week

31/30 23 (74.2) 18 (60.0) 1.4 .24

Attended cardiac

rehabilitation

32/ 33 24 (75) 19 (57.6) 2.22 .14

Return to work at 3

month follow-up

16/ 20 7 (43.8) 14 (70) 2.54 .11

Diabetic

management

(HbA1C < 7 for

diabetics)

7/ 6

7 (100)

2 (33.3) 8.41 .02

ASA at discharge 32/ 33 32 (100) 31 (93.9) 2.77 .49

ASA at 3 month

follow-up

31/ 30 30 (96.8) 29 (96.7) .001 1.00

Clopidogrel at

discharge

32/ 33 31 (96.9) 32 (97) .00 1.00

Clopidogrel at 31/ 30 28 (90.3) 27(90.0) .002 1.0

92

Variable N by group

intervention/

control

Intervention

group,

n (%)

Control

group,

n (%)

Likelihood

Ratio

P-

value

follow-up

Statin at discharge 32/ 33 31 (96.9) 31 (93.9) .324 1.0

Statin at 3 month

follow-up

31/ 30 31 (100) 26 (86.7) 5.97 .05

B-blocker at

discharge

32/ 31 28 (87.5) 28 (84.8) .10 1.0

B-blocker at

follow-up

31/ 30 27 (87.1) 25 (83.3) .17 .73

ACE inhibitor at

discharge

32/ 33 27 (84.4) 28 (84.8) .003 1.0

ACE inhibitor at

follow-up

31/30 28 (90.3) 25 (83.3) .66 .47

Note. BP = blood pressure; LDL-C = low density lipoprotein cholesterol; HbA1C = glycosylated haemoglobin; ASA = aspirin; β-blocker = beta blocker; ACE inhibitor = angiotensin- converting enzyme inhibitor. *current smokers at baseline n = 27 (data on 2 participant drop outs missing).

Overall, the results indicate that after 3 months, a significantly higher percentage of

participants in the intervention group engaged in 30 minutes of physical activity more than 5

days a week, and more participants were on statins, when compared to the usual care group.

In addition, a significantly higher proportion of people with diabetes in the intervention

group achieved a blood level measurement of HbA1C less than 7% compared to those

receiving usual care.

Paired t-tests: within group changes.

Within group differences in continuous outcome variables from baseline to 3 month follow-

up were examined using paired-samples t-tests. Table 17 presents the results of the paired t-

tests for the intervention and control groups. Both groups experienced significant reductions

in LDL-C, intervention group t(29) = 2.88, p < .01, control group t(24) = 6.35, p < .01.

Comparisons on C-HDL revealed significant improvements from baseline to 3-month follow-

93

up in the intervention group only, t(29) = -2.65, p < .05. Triglyceride levels were also

significantly improved in the intervention group only, t(30) = 3.27, p <.01. For the variables

SBP, DBP, BMI and waist circumference, there were no significant changes from baseline to

3-month follow-up in both groups, all p‘s > .05.

Table 17

Within Group Changes between Baseline and 3 Months for Continuous Secondary

Prevention Outcome Variables

Variable Mean difference (SD)

T(df) P value

Intervention Group

SBP

.64 (14.52)

.24 (30)

.80

DBP -.52 (8.10) - .35 (30) .72

LDL-C .84 (1.59) 2.88 (29) .007

HDL-C -.13 (.28) -2.64 (29) .01

Triglycerides .38 (.65) 3.27 (30) .003

BMI -.06 (1.99) -.13 (17) .90

Waist .34 (2.8) .38 (9) .71

Control group

SBP 2.82 (16.14) .92 (27) .36

DBP -1.61 (12.18) -.70 (27) .49

LDL-C .86 (.68) 6.35 (24) .00

HDL-C -.04 (.16) -1.4 (27) .17

Triglycerides .44 (1.41) 1.59 (25) .12

BMI .10 (1.79) .26 (18) .80

Waist -.83 (2.22) -1.44 (14) .17

Note. SBP = systolic blood pressure; DBP = diastolic blood pressure; LDL-C = low density

lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol; BMI = body mass

index.

94

Predictors of Outcome Achievement: Multiple Regression Results

Multiple regression analysis was used to examine the relationship between healthcare

provider variables and group membership, and continuous outcomes measured at post-test,

controlling for baseline differences. In Tables 18 to 21, the results of regression analyses are

presented. A separate regression model was completed for each outcome measured at post-

test. The B, SEB, β, and t-test are presented for the predictors included in the regression

analyses. The entry of predictors controlled for potential confounding variables. For each

dependent variable, the first set of predictors included the demographic and clinical variables

showing baseline differences between groups (age and marital status). The second set

consisted of the health care provider variables, that is, number of family physician visits

since discharge from hospital, the number of cardiologist visits since discharge, and

attendance at a cardiac rehabilitation programme. The provider variables were included to

control for their potential influence on outcomes before examining the effects of group

membership. The third set of predictors was the group to which participants were assigned

(intervention or control).

In Table 18, systolic blood pressure (SBP) and diastolic blood pressure results are presented.

SBP level measured at post-test was weakly related to age only (β = .28), which accounted

for 8% of variance in SBP among participants. The relationship was positive, indicating that

older patients tended to have higher SBP. None of the remaining variables showed a

significant relationship with SBP when entered into the equation. DBP measured at post-test

was not significantly related to any of the predictor variables.

Table 19 presents LDL-C, HDL-C and triglyceride levels results. LDL-C measured at post-

test was not significantly related to any of the predictor variables. The family physician visit

variable was moderately and negatively related to HDL-C (β = -.29), accounting for 15% the

variance, indicating that a high number of family physician visits is associated with a

decrease in HDL-C. Triglyceride levels were related to group membership (β = -.30) and

accounted for 6% of variance, implying that belonging to the intervention group is associated

with lower triglyceride levels; however, the magnitude was small and did not reach the pre-

set level of statistical significance (p = .057).

95

BMI and waist measurements are presented in Table 20. BMI correlated with age only,

indicating that the older the person the higher the BMI (R2 = .11). Waist measurement was

not significantly related to any of the predictor variables.

Time from hospital discharge to intake into cardiac rehabilitation and attendance at cardiac

rehabilitation results are presented in Table 21. These variables did not vary across

participants. Therefore, the outcomes were not significantly correlated with the hypothesized

predictors.

In this analysis, a different set of predictors influenced the outcomes but the magnitude of the

relationship was small as reflected in the low values of the β coefficients. They also

accounted for a small percentage of the variance in the outcome.

96

Table 18

Relationships between Provider Variables, Group Membership and Outcomes for Blood

Pressure

Variable

Systolic BP

B SEB Β T 95% CI

Low High

Age .35 .18 .28 1.9 -.02 .71

Marital 2.46 4.16 .09 .59 -.59 10.80

Family MD .78 1.02 .10 .76 -1.27 2.83

Cardiologist -4.33 4.22 -.16 -1.03 -12.81 4.14

CR attendance 2.10 3.73 .08 .56 -5.38 9.58

Group -4.89 4.04 -.20 -1.2 -13.00 3.22

Note. R2 = .08 for Set 1, ∆R

2 =.01 for Set 2, ∆R

2 for Set 3 = .02, (p= n.s.)

Variable

Diastolic BP

B SEB Β T 95% CI

Low High

Age -.14 .12 -.17 -1.16 -.37 .10

Marital 2.26 2.71 .12 .83 -3.18 7.70

Family MD .16 .67 .03 .24 -1.17 1.50

Cardiologist -2.05 2.75 -.12 -.74 -7.57 3.48

CR attendance -2.52 2.43 -.15 -1.04 -7.40 2.35

Group -1.87 2.71 -.12 -.69 -7.40 3.17


2 =.04 for Set 2, ∆R

2 for Set 3 = .01 (p= n.s.)

Table 19

Relationships between Provider Variables, Group Membership and Outcomes for LDL-C,

HDL-C, and Triglyceride Blood Measurements

Variable

LDL-C

B SEB Β T 95% CI

Low High

Age -.01 .01 -.23 -1.49 -.03 .004

Marital -.01 .17 .01 .10 -.33 .35

97

Variable

LDL-C

B SEB Β T 95% CI

Low High

Family MD -.04 .04 -.14 -1.01 -.13 .04

Cardiologist -.04 .18 -.03 -.22 -.39 .31

CR attendance .13 .16 .12 .80 -.19 .45

Group .17 .17 .16 .98 -.18 .51


2 =.05 for Set 2, ∆R

2 for Set 3 = .02 (p= n.s.)

Variable

HDL-C

B SEB Β t 95% CI

Low High

Age .004 .004 .11 .81 -.005 .013

Marital -.09 .10 -.13 -.92 -.03 .11

Family MD -.06 .02 -.29 -2.25* -.11 -.01

Cardiologist -.10 .10 -.14 -.97 -.31 .11

CR attendance .14 .09 .20 1.52 -.04 .33

Group .05 .10 .08 .54 -.15 .25


2 =.15 for Set 2, ∆R

2 for Set 3 = .01 *p <.05

Variable

Triglyceride

B SEB Β t 95% CI

Low High

Age -.00 .01 -.05 -.37 -.02 .03

Marital .33 .27 .17 1.22 -.21 .87

Family MD .05 .07 .09 .69 -.09 .18

Cardiologist .06 .27 .03 .23 -.49 .61

CR attendance -.29 .25 -.16 -1.18 -.79 .20

Group -.52 .27 -.30 -1.94* -1.05 .02


2 =.08 for Set 2, ∆R

2 for Set 3 = .06 *p = .057

98

Table 20

Relationships between Provider Variables, Group Membership and Outcomes for BMI and

Waist Circumference

Variable

BMI

B SEB Β t 95% CI

Low High

Age -.16 .07 -.34 -2.35* -.31 -.02

Marital -.70 1.63 -.06 -.43 -.04 2.58

Family MD .38 .38 .14 .99 .39 1.14

Cardiologist -2.69 1.55 -.27 -1.73 -5.81 .43

CR attendance 1.19 1.41 .12 .84 -1.65 4.03

Group -2.60 1.57 -.28 -1.66 -5.75 .56


2 =.03 for Set 2, ∆R

2 for Set 3 = .05 * p < .05.

Variable

Waist

Circumference

B SEB Β t 95% CI

Low High

Age -.10 .07 -.20 -1.39 -.24 .04

Marital 1.16 1.64 .11 .71 -2.14 4.45

Family MD .23 .38 .08 .60 -.54 .99

Cardiologist -1.47 1.56 -.15 -.94 -4.60 1.67

CR attendance -.59 1.42 -.06 -.42 -3.45 2.26

Group -2.63 1.57 -.28 -1.67 -5.80 .54


2 =.03 for Set 2, ∆R

2 for Set 3 = .05 (p= n.s.)

Table 21

Relationships between Provider Variables, Group Membership and Weeks to Cardiac

Rehabilitation

Variable Weeks to

Cardiac Rehabilitation

B SEB β t 95% CI

Low High

Age .10 .06 .38 1.84 -.01 .22

Marital .28 1.21 .04 .23 -2.18 2.74

99

Variable Weeks to

Cardiac Rehabilitation

B SEB β t 95% CI

Low High

Family MD -.04 .26 -.03 -.17 -.58 -.49

Cardiologist -.09 1.23 -.01 -.07 -2.59 2.41

Group -1.78 1.17 -.30 -1.51 -4.17 .62


2 =.003 for Set 2, ∆R

2 for Set 3 = .06 p = n.s..

A logistic regression analysis was conducted to examine achievement of secondary

prevention goals, which were operationalized as dichotomous dependent variables. This

analysis was conducted to examine the relationship between healthcare provider variables

and group membership, and outcomes measured at post-test, controlling for possible

covariates. The order of predictor entry was the same as the one followed in linear

regression. For each dependent variable, the first set of predictors included age and marital

status. The second set consisted of the health care provider variables, that is, number of

family physician visits since discharge from hospital, the number of cardiologist visits since

discharge, and attendance at a cardiac rehabilitation programme. The third set of predictors

included the group variable (intervention or control). Tables 22 through 28 present the results

of the logistic regression analyses, done for each outcome measured at post-test. The B, SEB,

Wald Statistic, Odds Ratio and significance are presented for the predictors included in the

analyses.

Rates of smoking cessation measured at post-test did not reveal any statistically significant

relationship with the second set (provider visits and cardiac rehabilitation attendance) of

predictors. Group membership and marital status were significant predictors (p = .05 and .04

respectively). Odds ratio values indicate that when participants are currently married, the

odds of smoking cessation is 8 times higher than if not married, and that participants in the

intervention group are 5 times more likely to quit smoking.

In the analysis pertaining to the dependent variable of attendance at smoking cessation clinic,

large standard errors were observed in the group predictor set. The large value of the standard

100

errors reflects low variability in the dependent variable, with all attendees (n = 3) belonging

to the intervention group.

Rates of achievement of LDL-C to target goals of less than 2.6 mmol/L or less than 1.79

mmol/L at post-test were not significantly associated with any of the predictors.

Achievement of BP less than 140/90 (i.e., greater than 130/80) was significantly related to

age, p < .05, and of borderline significance with attendance at cardiac rehabilitation, p =

.056. The odds ratio for group membership in achieving a BP less than 130/80 was 15,

suggesting that participants in the intervention group were 15 times more likely to attain this

BP goal.

Rates of achievement of BP less than 130/80 in participants with diabetes or kidney disease

were significantly related to the number of visits to a cardiologist, p < .05.

Achieving the goal of engaging in physical activity more often than 5 days per week was

significantly associated with group membership, p = <.001. Participants in the intervention

group were 34 times more likely than those in the control group to engage in physical activity

more than 5 days a week. Similarly, participants in the intervention group were 17 times

more likely to achieve the minimum goal of engaging in activity on 5 days a week than those

in the control group.

Attendance at cardiac rehabilitation was not significantly related to age and marital status,

family physician, or cardiologist visits. However, group membership was associated with

attendance at cardiac rehabilitation, p = .01. Participants in the intervention group were 7

times more likely to attend cardiac rehabilitation than those in the control group.

Return to work within the first three months post AMI was not significantly related to any of

the variables (age, marital status, provider visits, attendance at cardiac rehabilitation, or

group membership).

The likelihood of achievement of the goal of HbA1C less than 7% in participants with

diabetes at post-test was significantly predicted by group membership, p = <.01. Intervention

101

group participants were 10 times more likely to achieve an HbA1C less than 7% than those in

the control group.

The secondary prevention goals of the continued use of ASA and statin at 3 months were not

associated with any predictor. Large standard errors were found in these analyses due to low

variability in the dependent variables.

Continued use of plavix at 3 months was related to marital status, p <.05. Compared to those

non-married, participants who were currently married were 18 times more likely to take this

medication at 3 months follow-up.

Continued use of β-blocker and ACE inhibitor medications showed no significant

relationship with any predictor.

Consultation with a nutritionist, or attendance at a diabetes clinic, showed no significant

relationship with baseline characteristics (age or marital status), provider visits (family

physician and cardiologist), attendance at cardiac rehabilitation, or group membership.

Table 22

Relationships between Provider Variables, Group Membership and Smoking Outcomes

Variable

Smoking

cessation

B SEB Wald Exp(B)

Odds Ratio

95% CI for

Odds Ratio

Low High

Age -.04 .04 1.60 .96 .89 1.02

Marital 2.04 .98 4.31* 7.70 1.12 52.88

Family MD -.01 .18 .00 .99 .69 1.42

Cardiologist -.86 .88 .95 .42 .07 2.38

Cardiac

rehabilitation

-.32 .77 .17 .73 .16 3.30

Group 1.58 .81 3.74* 4.84 .98 23.88

*p = < .05

102

Variable

Smoking cessation

clinic attendance

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.15 .12 1.45 .86 .67 1.10

Marital 1.06 1.95 .29 2.89 .06 132.70

Family MD -.13 .55 .06 .87 .30 2.55

Cardiologist 1.72 1.80 .91 5.6 .16 193.29

Cardiac

rehabilitation

-1.44 1.88 .59 .23 .01 9.39

Group 20.76 7097.03 0 1.03E9 .00

Table 23

Relationships between Provider Variables, Group Membership and LDL-C Outcome Goals

Variable

LDL-C <2.6

mmol/L

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.03 .04 .89 .97 .90 1.04

Marital -1.13 .77 2.15 .32 .07 1.47

Family MD .12 .19 .41 1.13 .78 1.62

Cardiologist .21 .80 .07 1.23 .26 5.90

Cardiac

rehabilitation

.94 .78 1.46 2.56 .56 11.71

Group .04 .77 .003 1.04 .23 4.71

Variable

LDL-C < 1.79

mmol/L

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .06 .04 2.58 1.06 .99 1.14

Marital 1.18 .79 2.26 3.27 .70 15.28

Family MD -.06 .19 .09 .94 .65 1.37

Cardiologist -.30 .78 .15 .74 .16 3.38

Cardiac -1.13 .79 2.04 .32 .07 1.53

103

Variable

LDL-C < 1.79

mmol/L

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

rehabilitation

Group -.55 .76 .51 .58 .13 2.63

Table 24

Relationships between Provider Variables, Group Membership and Outcomes for Blood

Pressure

Variable

BP < 140/90

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .13 .06 4.37* 1.14 1.01 1.28

Marital -1.21 1.14 1.13 .30 .03 2.78

Family MD .17 .20 .70 1.19 .79 1.77

Cardiologist 1.63 1.10 2.17 5.09 .58 44.37

Cardiac

rehabilitation

2.72 1.43 3.65* 15.28 .93 250.69

Group -2.03 1.18 2.96 .13 .01 1.33

* p = .056

Variable

BP < 130/80

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.13 .06 4.20* .88 .78 .99

Marital 1.28 1.17 1.20 3.59 .36 35.48

Family MD -.29 .21 1.90 .75 .50 1.13

Cardiologist -1.31 1.09 1.45 .27 .03 2.28

Cardiac

rehabilitation

-1.79 1.12 2.56 .17 .02 1.50

Group 2.70 1.28 4.39* 14.78 1.19 183.50

*p = < .05

104

Variable

Diabetes & BP

<130/80

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .80 .04 3.28 1.08 .99 1.18

Marital -1.34 .91 2.16 .26 .04 1.57

Family MD .44 .26 2.91 1.55 .94 2.58

Cardiologist 2.39 .99 5.87* 10.92 1.58 75.58

Cardiac

rehabilitation

-.56 .80 .50 .57 .12 2.73

Group .34 .90 .14 1.40 .24 8.17

*p = < .05

Table 25

Relationships between Provider Variables, Group Membership and Continuous Outcomes

for Physical Activity, Attendance to Cardiac Rehabilitation and Return to Work

Variable

Physical activity >

5 days a week

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.02 .04 .46 .97 .91 1.05

Marital 1.28 .85 2.25 3.60 .67 19.17

Family MD -.05 .20 .07 .95 .64 1.41

Cardiologist .90 .80 1.25 2.45 .51 11.85

Cardiac

rehabilitation

.31 .76 .16 1.36 .31 6.02

Group 3.54 .93 14.34*** 34.33 5.51 213.97

***p = <.001

Variable

Physical activity 5

days a week

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.07 .04 3.00 .93 .85 1.01

Marital 3.38 1.14 8.83** 29.24 3.15 271.18

Family MD -.33 .20 2.78 .72 .49 1.06

105

Variable

Physical activity 5

days a week

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Cardiologist .36 .94 .14 1.43 .23 9.08

Cardiac

rehabilitation

.41 .69 .36 1.51 .39 5.86

Group 2.84 1.14 6.17* 17.05 1.82 159.68

*p = < .05 **p = < .01

Variable

Attendance in

cardiac

rehabilitation

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.02 .03 .43 .98 .92 1.04

Marital .92 .78 1.39 2.51 .54 11.62

Family MD -.11 .18 .36 .89 .62 1.28

Cardiologist 1.08 .81 1.78 2.93 .60 14.25

Group 2.00 .78 6.62** 7.43 1.61 34.22

**p = .01

Variable

Return to work

within 3 months

post AMI

B SEB

Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.05 .04 2.09 .95 .88 1.02

Marital .06 .77 .01 .94 .21 4.30

Family MD -.13 .21 .37 .88 .58 1.33

Cardiologist 1.24 .88 2.01 3.47 .62 19.35

Cardiac

rehabilitation

-.30 .66 .20 .74 .20 2.72

Group -.72 .70 1.07 .49 .12 1.91

106

Table 26

Relationships between Provider Variables, Group Membership and Diabetes Management

Variable

HbA1C < 7%

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .07 .04 3.26 1.07 .99 1.15

Marital .50 .80 .40 1.65 .35 7.87

Family MD .29 .26 1.21 1.34 .78 2.25

Cardiologist .58 .81 .51 1.79 .36 8.77

Cardiac

rehabilitation

-.20 .76 .07 .81 .18 3.65

Group 2.26 .84 7.18** 9.63 1.83 50.47

**p = < .01

Table 27

Relationships between Baseline Characteristics, Provider Variables, Group Membership

and Outcomes for Medications

Variable

ASA at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.08 .07 1.09 .92 .80 1.07

Marital 1.21 1.56 .61 3.37 .16 71.90

Group 1.11 1.73 .41 3.05 .10 91.37

Variable

Statin at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.08 .08 1.03 .92 .78 1.08

Marital 1.50 1.78 .71 4.48 .14 146.30

Family MD .18 .56 .11 1.20 .40 3.58

Cardiologist 16.41 5924.87 0 1.35E7 0

Cardiac

rehabilitation

.95 1.43 .44 2.59 .16 4.53

107

Variable

Statin at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Group 36.36 8305.42 0 6.21E15 0

Variable

Plavix at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .08 .06 1.73 1.08 .96 1.22

Marital 2.90 1.41 4.19* 18.09 1.13 289.88

Family MD .23 .53 .19 1.26 .45 3.53

Cardiologist -1.66 1.44 1.32 .19 .01 3.23

Cardiac

rehabilitation

2.48 1.31 3.57 11.99 .91 157.76

Group .29 1.32 .05 1.34 .10 17.91

*p = <.05

Variable

ßeta-blocker at 3

month follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .06 .05 1.52 1.06 .96 1.17

Marital .96 .96 .98 2.60 .39 17.25

Family MD -.23 .22 1.14 .79 .52 1.21

Cardiologist -.86 .99 .74 .42 .06 2.98

Cardiac

rehabilitation

.14 .84 .03 1.16 .22 6.06

Group .14 .92 .02 1.14 .18 7.04

Variable

ACE at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age .005 .05 .01 1.00 .92 1.10

Marital -1.15 1.25 .84 .32 .03 3.70

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Variable

ACE at 3 month

follow-up

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Family MD .72 .45 2.56 2.06 .85 4.97

Cardiologist -.09 1.05 .01 .91 .12 7.17

Cardiac

rehabilitation

.31 .92 .11 1.36 .22 8.30

Group .30 1.05 .08 1.34 .17 10.44

Table 28

Relationships between Provider Variables, Group Membership and Outcomes for

Nutrition Consultation and Diabetes Clinic Attendance

Variable

Nutritionist

consultation

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.03 .04 .69 .97 .89 1.05

Marital .01 .87 0 1.01 .18 5.57

Family MD .02 .20 .01 1.02 .69 1.50

Cardiologist .38 .87 .19 1.46 .27 7.97

Cardiac

rehabilitation

2.07 1.11 3.45* 7.92 .89 70.37

Group .07 .80 .01 1.07 .22 5.14

*p = .06

Variable

Diabetes clinic

attendance

B SEB Wald Exp(B)

Odds

Ratio

95% CI for

Odds Ratio

Age -.01 .06 .03 .99 .89 1.11

Marital -.93 1.14 .66 .39 .04 3.69

Family MD .59 .33 3.31 1.81 .95 3.43

Cardiologist .43 1.31 .11 1.53 .12 20.05

Cardiac

rehabilitation

.82 1.26 .43 2.28 .19 26.91

Group 1.43 1.3 1.21 4.18 .38 53.34

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Summary of regression analyses.

Results of the multiple regression analysis showed that group membership did not

significantly predict outcomes measured at the continuous level. Findings of the logistic

regression indicated that intervention group membership was a significant predictor of

smoking cessation, achievement of BP less than 130/80mmHg, engagement in physical

activity more often than 5 days a week and in 5 days a week, attendance at cardiac

rehabilitation, and achievement of an HbA1C level less than 7% in patients with diabetes.

NP Practice Activities as Predictors of Outcome Achievement

The relationship between NP practice activities and outcome achievement was examined in

the intervention group to evaluate which NP practice activities were related to successful

outcome achievement. This analysis was conducted using multiple regression analysis. In

Table 29, the results (B, SEB, β, and t-test) for continuous outcomes that showed significant

association with predictors are presented. For the dichotomous variables, B, SEB, Wald and

Exp(B) are presented in Table 30. The entry of predictors aimed at controlling for potential

confounding, with the first two sets including baseline characteristics of age and marital

status and healthcare provider variables (i.e., provider visits and attendance at cardiac

rehabilitation). Next, the variables measuring time spent in each NP practice activity

(assessment, health guidance and teaching, case management, and medication adjustment)

for each secondary prevention strategy were entered.

Table 29

NP Practice Activities as Predictors of Outcome Achievement, Continuous Variables

Variable

Triglycerides

B SEB β t 95% CI

Age .01 .01 .21 .92 -.01 .03

Marital .11 .16 .13 .69 -.22 .03

Family MD .04 .04 .18 .95 -.05 .12

Cardiologist .03 .19 .03 .15 -.36 .42

CR attendance -.06 .19 -.07 -.33 -.46 .34

Lipid assessment -.03 .01 -.45 -1.92 -.06 .00

Lipid teaching .04 .01 .70 2.68* .01 .07

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Variable

Triglycerides

B SEB β t 95% CI

Lipid case

management

-.04 .05 -.23 -.73 -.15 .07

Lipid medication 0 .02 .03 .10 -.05 .05


2 for Set 2 =.08, ∆R2 for Set 3 = .01, ∆R

2 for Set 4 =.19, ∆R2 for

Set 5 = .04, ∆R2 for Step 6 = 0, *p = < .05.

Variable

Weeks to CR

B SEB β t 95% CI

Age .12 .06 .42 2.04 -.01 .24

Marital -.59 1.30 -.09 -.46 -3.34 2.15

Family MD -.30 .29 -.21 -1.02 -.93 .32

Cardiologist 1.56 1.43 .24 1.09 -1.48 4.59

Physical activity

assessment

-.41 .14 -.89 -2.96** -.71 -.12

Physical activity

teaching

.18 .08 .65 2.12* .00 .36

Physical activity

case management

-.44 .42 -.22 -1.04 -1.34 .46


2 for Set 2 =.004, ∆R2 for Set 3 = .17, ∆R

2 for Step 4 =.11, ∆R2

for Step 5 = .03, *p = .05, **p < .01.

As shown in Table 29, the achievement of the triglyceride blood level goal was significantly

related to the NP practice activity of lipid teaching (which includes guidance and

counselling). NP‘s implementation of this practice activity was associated with low blood

levels of triglyceride (R2 = .19).

The weeks to cardiac rehabilitation attendance variable was significantly associated with the

NP practice activity of physical activity assessment (R2 = .17), and physical activity teaching

(R2 = .11). This finding supports the contribution of these NP practice activities to patients‘

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engagement in physical activity, accounting for a small-moderate amount of variance in the

achievement of this goal.

The same regression model, utilizing the four practice categories for each individual

secondary prevention strategy and order of entry, was used to predict the successful

achievement of the dichotomous outcome variables of BP less than 130/80, physical activity

greater than 30 minutes 5 days a week, physical activity at least 30 minutes 5 days a week,

and achievement of a HbA1C less than 7 in participants with diabetes. The results of the

logistic regression analyses (Table 30) indicated that the predictors were not associated with

achievement of these goals. Odds ratio results are inflated in multiple analyses due to low

variability in the predictors‘ marital status and cardiac rehabilitation: 77% of those married

attended cardiac rehabilitation, while 23% not married attended.

For the predictor smoking case management there was only one case with values on this

variable, so the test statistic is reported as zero.

The analysis of the BP less than 130/80 revealed no significant predictors due to

multicollinearity across multiple variables, resulting in large standard errors on the predictor

variables. The multicollinearity resulted in extremely high OR values for some variables as

reported in Table 30.

Table 30

NP Practice Activities as Predictors of Outcome Achievement, Dichotomous Variables

Variable

Smoking cessation

B SEB Wald Exp(B) 95% CI for

Odds Ratio

Age .14 .09 1.36 1.11 .93 1.32

Marital 13.60 8.70 2.44 802590.54 .03 2.05E13

Family MD -.55 .75 .53 .58 .13 2.52

Cardiologist -1.9 2.39 .64 .15 .00 16.13

Cardiac

rehabilitation

10.90 7.39 2.17 54178.78 .03 1.06E11

Smoking

assessment

-3.52 2.21 2.53 .03 0 2.26

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Variable

Smoking cessation


Odds Ratio

Smoking teaching 2.73 1.72 2.54 .11 .53 445.63

Smoking case

management

-3.15 5741.85 0 .04 0

Smoking

medication

20.57 7226.61 0 8.58E8 0

Variable

BP < 130/80


Odds Ratio

Age .15 2011.03 0 1.17 0

Marital -2.60 23620.15 0 .07 0

Family MD 1.26 11715.98 0 3.51 0

Cardiologist -11.19 31188.90 0 0 0

Cardiac

rehabilitation

-30.97 49191.13 0 1.0 0

BP assessment 1.83 14967.96 0 6.23 0

BP teaching .19 8267.70 0 1.22 0

BP case

management

-19.84 9949.22 0 .00 0

BP medication 11.78 119745.1

7

0 130994.8

0

0

Variable

Physical activity >

30 minutes 5 days

a week


Odds Ratio

Age -.14 .08 3.46 .87 .75 1.01

Marital 3.05 2.17 1.97 21.12 .30 1500.16

Family MD .03 .44 0 1.03 .44 2.42

Cardiologist 1.11 1.18 .88 3.03 .30 30.52

Cardiac 2.69 1.58 2.89 14.67 .66 325.10

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Variable

Physical activity >

30 minutes 5 days

a week


Odds Ratio

rehabilitation

Activity assessment .02 .17 .01 1.02 .73 1.42

Activity teaching .12 .15 .65 1.13 .84 1.50

Activity case

management

-1.49 .79 3.57* .23 .05 1.06

*p = .06

Variable

Physical activity

30 minutes 5 days

a week

B SEB Wald Exp(B) 95% CI for Odds

Ratio

Age -.70 .68 1.06 .50 .13 1.88

Marital 5.79 4.60 1.58 326.83 .04 2687375.42

Family MD .06 .83 0 1.06 .21 5.41

Cardiologist -6.05 6.38 .90 .002 .00 634.44

Cardiac

rehabilitation

15.49 15.42 1.01 5334748. .00 7.193E19

Activity assessment -.35 .32 1.19 2.70 .37 1.33

Activity teaching .81 .71 1.27 2.24 .55 9.11

Activity case

management

-1.68 1.61 1.09 .19 .01 4.35

Variable

Diabetes

management


Odds Ratio

Age .10 .06 3.06 1.10 .99 1.23

Marital 1.62 1.10 2.18 5.07 .59 43.69

Family MD .43 .54 .63 1.54 .53 4.47

Cardiologist -.61 1.18 .27 .54 .05 5.44

Cardiac -1.43 1.37 1.09 .24 .02 3.52

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Variable

Diabetes

management


Odds Ratio

rehabilitation

Diabetes

assessment

-.33 .53 .39 .72 .25 2.03

Diabetes teaching .80 .49 2.69 2.23 .85 5.80

Diabetes case

management

2.24 2.82 .63 9.40 .04 2383.55

Summary of Results

Analysis of baseline characteristics revealed statistically significant differences in age and

marital status. Although not statistically significant, differences were noted on triglyceride

and blood glucose levels at baseline, and statin use on admission.

The majority of participants in the intervention group (74%) were seen by the NP five or six

times in follow-up. The mean number of hours the NP spent with each participant across all

visits was 3.64 hours. The NP spent most of this time doing health teaching, guidance and

counselling, and assessment.

NP implementation of recommended secondary prevention strategies exceeded 90%

(assessed by a research assistant 3 months AMI) for: smoking cessation counselling, physical

activity counselling, measurement of weight and BMI, dietary counselling, diabetic teaching,

measurement of HbA1c in patients with diabetes, and medication prescribed at discharge and

three month follow-up.

Comparisons between groups on the continuous outcome variables with adjustment for

covariates revealed that the two groups differed significantly on triglyceride levels, weeks to

cardiac rehabilitation, and statin use. These findings indicate that participants in the

intervention group had lower triglyceride levels, shorter number of weeks to cardiac

rehabilitation entry and a higher rate of statin use at the three month follow-up visit.

Regression analysis examining provider visits and group as predictors for the outcome

variables, controlling for the baseline differences of age and marital status, showed that

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membership in the intervention group was associated with increased odds of smoking

cessation (OR 5), achieving a BP less than 130/80 (OR 15), attending cardiac rehabilitation

(OR 7), achieving the minimum physical activity goal of 5 days a week (OR 17), engaging in

physical activity more than 5 days a week (OR 34), and achieving a HbA1C less than 7% in

those with diabetes (OR 10).

Examination of NP practice activities as predictors of successful outcome achievement

revealed that successful achievement of recommended triglyceride levels was associated with

the NP practice activity of lipid teaching, and shorter weeks to cardiac rehabilitation was

related to NP practice activity of physical activity assessment.

Chapter 5

Discussion

Guided by a process-outcome framework, this pilot study evaluated the NP practices relative

to the secondary prevention strategies and the outcomes achieved by patients post AMI. In

this chapter, the acceptability and feasibility of implementing secondary prevention by the

NP and the representativeness of the sample are discussed. The findings pertaining to each

study objective are discussed. The strengths and limitations of the study and the implications

of the findings for future research are identified.

Acceptability and Feasibility of Secondary Prevention Delivered by an NP

Acceptability and feasibility of NP implementation of secondary prevention post AMI were

inferred based on examination of participants‘ enrolment and attrition rates.

Enrolment.

An unanticipated delay in recruiting eligible participants occurred because a large number of

AMI patients (87%) did not meet the study eligibility criteria. The most frequent reason for

non-eligibility was patient admissions from other hospitals for interventional procedures post

AMI. This group of patients was transferred back to referring hospitals the day after the

procedure and geographically not accessible for follow-up. Another common reason for

ineligibility related to the physician rotation schedule. An entry criterion for the study was

that all potential candidates for the intervention group had a staff NP on their healthcare

team. This criterion was included to minimize selection bias and maintain consistency in NP

exposure between groups at baseline. Owing to administrative guidelines (related to the

number of NPs employed in this setting), NPs were members of the healthcare team Monday

to Friday only and, therefore, patients admitted with AMI on weekends were not eligible for

enrolment (20% of AMIs). Although patients admitted during week-days and week-ends are

not known to differ in socio-demographic and clinical profile, the administrative guidelines

raise some concerns about the feasibility of having an NP available to reinforce secondary

prevention strategies to all patients with AMI post-discharge.

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The recruitment rate for eligible patients was high (87%). Time constraint was the only

reported reason for refusals in the NP study (only 4 of 10 provided a reason). Similar studies

evaluating interventions targeting risk factor reduction have reported rates of recruitment in

the range of 48% to 90%. Lower rates of recruitment were reported in studies targeting

participants who were completing cardiac rehabilitation (Carlsson, Lindberg, Westin, &

Israelsson, 1997; Lear et al., 2003) and higher rates in those offering comprehensive lifestyle

interventions delivered by nurses and/or dieticians (Vale et al., 2003; Vesthold Heartcare

Study Group, 2003). Two other comparable nurse-led secondary prevention studies have

reported recruitment rates in the 70% range (Campbell et al., 1998; Goessens et al., 2006).

The high enrolment rate in this study suggests that the NP secondary prevention intervention

is a desired option, acceptable to patients with AMI; however, time constraints are a potential

barrier for patient engagement in the intervention activities, particularly in the post-discharge

period. Future studies could explore distance (e.g., phone) contacts made with the NP post-

discharge.

Attrition.

The attrition rate was 9% in the control group and 3% in the intervention group. Attrition

rates of 10% - 18% (Campbell et al., 1998; Carlsson et al., 1997; Goessens et al., 2006;

Lichtman et al., 2004; Masley, Phillips & Copeland, 2001; Vesthold Heartcare Study Group,

2003) are common in secondary prevention studies, with few reporting less than 10% (Lear

et al., 2003; Redfern et al., 2009). However, most of those reviewed for this study included

interventions with follow-up periods of one to two years. For the NP study, all dropouts

occurred before the outpatient intervention was provided, with reasons for withdrawal being

unknown. The very low attrition rate in the NP study intervention group suggests high

acceptability of the intervention. The high acceptability may be related to the frequent

contacts, discussion of individual barriers to secondary prevention implementation, and the

therapeutic alliance developed between the NP and patients, which played a role in

minimizing dropouts. The low attrition rate could also be related to the short follow-up

period. This is consistent with findings of a systematic review examining predictors of

referral, entry and long term behaviour change related to cardiac rehabilitation. Factors that

influenced each phase of cardiac rehabilitation differed, indicating that tailoring

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rehabilitation interventions to individual patients‘ preferences and needs would maximize

adherence (Jackson, Leclerc, Erskine, & Linden., 2005).

Based on the low attrition rate in the intervention group, it can be inferred that the NP

intervention was acceptable to patients with AMI.

Characteristics of Participants

The majority of study participants were married men, employed, with at least high school

education and a mean age of 58 years. The mean age of all AMI survivors at the participating

site was 58 years during the recruitment period. The mean age of AMI in Canada is 71 years

and 35% are women (Canadian Institute for Health Information [CIHI], 2010). The study

sample is younger, with a higher percentage of males. This difference is likely related to the

inclusion of all AMIs in the CIHI data, not just survivors and those meeting eligibility

requirements. The study characteristics are comparable to those reported for patients with

AMI in two systematic reviews examining the benefits of cardiac secondary prevention

programmes. The results of the reviews described participants as mid-aged, with the majority

(74-79%) of the sample comprised of men (McAlister, Lawson et al., 2001; Clark et al.,

2005). The similarity of participants‘ characteristics across studies supports the

representativeness of this study sample of the target population defined as AMI survivors.

Therefore the study findings are applicable to middle age men with AMI.

Although assignment to the NP intervention and the comparison (usual care) groups was non

random, comparability of the two groups was maintained on most baseline characteristics,

due to the effective cohort selection resulting from consistent application of well defined

eligibility criteria. However differences in the groups‘ means were observed in some baseline

characteristics, as anticipated in a small sample. These differences may not be replicated in

large samples. Baseline variables demonstrating significant between-group differences and

correlation with outcomes measured at posttest were controlled for in the analyses addressing

the study objectives, as recommended by Norman and Streiner (2008).

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NP Practice Patterns

How the NP role is enacted varies across care settings or clinical programmes and

institutions. Differences in how the role is enacted, and differences in how NP activities are

implemented, can lead to variability in outcome achievement (Sidani & Irvine, 1999). The

description of NP practice activities in this secondary prevention study aids in linking

specific NP activities with outcomes achieved by patients, those contributing to outcomes

reflect the essential ingredients of NP delivered secondary prevention interventions. The

descriptions also help in differentiating this role from that of physicians and registered

nurses. The implementation of these activities is discussed next.

Practice activities.

The NP practice categories assessed in this study were adapted from those described by

Brooten and colleagues who have reported on advanced practice nurses‘ interactions with

patients in a broad spectrum of care settings including cardiology. Analysis of 333 APN

interaction logs from five randomized controlled trials evaluating APN interventions revealed

that the intervention most frequently implemented was surveillance, followed by health

teaching, guidance and counselling, case management and treatments and procedures

(Brooten et al., 2003). Surveillance is defined as the activities of detecting, measuring,

critically analyzing and monitoring with the intention to identify the individual‘s status in

relation to a given condition (Martin & Scheet, 1992). In the current study focusing on NP

delivery of secondary prevention, surveillance was labelled as assessment; medication

adjustment was substituted with treatment and procedure; health teaching, guidance and

counselling, and case management were retained. Contact with other health care providers

(made through communication with either the family physician or cardiologist) was logged

under case management. Medication adjustments were logged separately. All these practice

categories are applicable to the secondary prevention intervention, and are essential

components of NP practice examined in this study.

The study results indicated that the NP implemented the practice categories to various extents

when providing secondary prevention to patients with AMI. Specifically, the NP spent the

majority of time doing activities in the health teaching, guidance and counselling practice

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category, followed by assessment, and a small amount of time (less than 5%) in case

management and medication adjustment.

The findings by Brooten and colleagues (2003) differ from the current study in that health

teaching, guidance and counselling were the predominant interventions logged in the NP

secondary prevention study, followed by assessment and case management as compared to

surveillance or assessment that was most frequently reported by Brooten and colleagues. This

difference in practices is likely related to three factors. First is the relative stability of the

AMI patients compared to patient populations studied by Brooten et al., including infants,

patients with recent surgery and elders with cardiac diseases. Second is the focus on

secondary prevention, which encompasses discussion of healthy lifestyle with AMI patients,

compared to management of patient conditions requiring continuous assessment reported by

Brooten and colleagues. As such, patients with stable conditions may not require excessive

monitoring but may be in need of guidance in self-management. Third is the type of APN

with different role responsibilities involved in the studies. Brooten et al. studied the clinical

nurse specialist (CNS) whereas the current study included an NP. While both CNSs and NPs

are types of APNs, NPs have more autonomy in practice and can initiate treatment without

supervision, whereas CNSs are expected to coordinate and manage patient care in

collaboration with other members of the healthcare team (CNA, 2008), particularly as it

relates to pharmacological treatments.

The NP in this study spent a large percentage of time in health teaching pertaining to

secondary prevention. This finding is consistent with the intervention objective of improving

uptake and adherence to proven treatment recommendations and health related behaviours,

which was the focus of the individualized health teaching, guidance and counselling provided

by the NP to AMI patients. Previous studies have consistently found that patient education

enhanced compliance with health recommendations (Fahey, Schroeder & Ebrahim, 2006;

Haynes et al., 2006; Petrilla, Lattanzio, Demeray, Varalio, & Blore, 2005). Patients‘

knowledge of and implementation of recommended lifestyle changes have been found to be

directly related to the amount of time the healthcare professionals spend discussing relevant

topics during the visit (Kravitz et al., 1993; Wilson & Childs, 2002). The NP intervention of

secondary prevention was designed to allow adequate time for health teaching, guidance and

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counselling to address individual barriers to lowering cardiovascular risks. Accordingly, the

high percentage of time spent in health teaching, guidance and counselling supports fidelity

of treatment implementation, that is, the NP intervention was delivered as intended.

The NP reported small numbers of contacts and minutes spent in case management and

medication adjustment categories, implying that the NP worked autonomously with

participants on most secondary prevention strategies. These findings also indicate that the NP

was functioning to full scope of practice. Scope of practice refers to the activities that

members of a profession are educated and authorized to perform (Davies & Fox-Young

2002; Oelke et al. 2008). Restriction on scope of practice would have been reflected in

lengthy log times in case management and medication categories, as a result of waiting for a

physician to assess, make a diagnosis, or make a treatment recommendation. Full scope NP

practice was illustrated with the following situation: if a participant was found to have an

abnormality or new finding on physical examination, the NP had the authority to order a

diagnostic test (e.g., ECG), which could be done while in the outpatient clinic, the results

discussed with the most responsible physician on the telephone if appropriate, and the

participant sent home or referred for further evaluation as appropriate. Alternatively, if a

participant presented with signs or symptoms beyond the scope of practice of an NP (e.g.,

heart failure), the NP took the participant to the emergency room by wheelchair to be

assessed and further managed by a physician. These practice patterns are consistent with the

core competencies of NPs described by the Canadian Nurses Association (CNA, 2010). The

autonomy of this nursing role may also be a contributing factor in the acceptability of the

provider as it minimizes inconvenience in waiting times for physician consultations (Sidani

& Irvine, 1999).

The design of the NP intervention emphasized the individualization of secondary prevention

care. Individualized care is a core element of patient-centered care which is considered and

was found to be effective in achieving the intended behavioural outcomes (e.g., Lauver et al.,

2002; Suhonen, Valimaki & Leino-Kilpi, 2008)

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Contact time with NP.

The mean time the NP spent with each participant at each of the five visits was 36 minutes.

All participants had the targeted five contacts with the NP, indicating that the intervention

was implemented as planned and was feasible and acceptable to participants. All secondary

prevention categories had at least 15 minutes of time logged for each strategy over the total

number of contacts with the NP, with the exception of diabetes and weight management,

which were not applicable to all participants.

Although there are no known direct comparisons between NP and physician contact times in

a secondary prevention setting, a systematic review examining the relationship between

physicians‘ average contact length (time), and process measures and outcomes is relevant

(Wilson & Childs, 2002). In this systematic review, primary care physicians‘ length of

consultations (US, UK, Netherlands and Sweden) were compared to objectively measured

processes or outcomes. The most consistent finding was that physicians who had longer

average consultation times prescribed less and were more likely to include lifestyle advice

and preventive activities. Longer consultation times were associated with the implementation

of preventive activities (Wilson & Childs, 2002). These findings were consistent across

countries with marked differences in healthcare systems, and in studies using a variety of

designs and methods. Physicians who spent less time (i.e., those with an average consultation

time of less than seven minutes) were less likely than those who spent more time (average

nine minutes or more) to recognize and deal with long-term problems. In addition, physicians

who spent more time were more likely to offer preventative care than those who spent less

time, even after controlling for individual consultation length. The most common barrier to

effective implementation of guideline recommendations identified in a physician survey was

lack of time (Erhardt, 2005).

In a related study which examined the relationship between average consultation length and

control of chronic disease in general practice, a booking interval of ten minutes (compared to

five minutes) was the most powerful predictor of quality of chronic disease management

(Campbell et al., 2001). One coauthor of a recent 9 year survey of outpatients with

cardiovascular disease or risk factors (EUROACTION), which identified suboptimal

achievements in treatment goals, states ―one of the major problems is the contact time

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allowed between doctor and patient. In many countries, this is around eight to 10 minutes,

and it is impossible in this time frame to get any serious message across or have a serious

discussion‖ (Nainggolan, 2008, p. 3). This is in contrast to an analysis of nurse-led secondary

prevention clinics in primary care, which were associated with improvements in multiple

outcomes, including cost-effectiveness. These nurse-led secondary prevention programmes

included an initial visit ranging from 30-60 minutes and subsequent visits from 10-30

minutes, which is consistent with the times for consultation predicting quality of chronic

disease management (Campbell et al., 1998).

In the context of the current study, the NP spent a longer (mean 36 minutes) time with the

patient at each visit as compared to the time spent by physicians reported in the literature and

observed in clinical practice. Accordingly, the NP had ample opportunity to provide, clarify,

and reinforce information about secondary prevention. This finding supports the use of

appointment times that exceed the 10-minutes usually allotted for each patient, for delivering

the NP secondary prevention intervention with fidelity.

NP Implementation of Secondary Prevention Strategies

The NP‘s implementation of guideline-based secondary prevention strategies exceeded 90%

(assessed by a research assistant 3 months post AMI) for: smoking cessation counselling,

physical activity counselling, measurement of weight and BMI, dietary counselling, diabetic

teaching, measurement of HbA1c in patients with diabetes, and medication prescribed at

discharge and three month follow-up. Only two secondary prevention strategy categories

were below the ideal target: cardiac rehabilitation referral (81%) and ACE inhibitor

prescribed at discharge (87%, including 3% contraindicated). In the case of the cardiac

rehabilitation referral rate, 100% of patients were offered referral, whereas 19% declined.

The percentage of those on ACE inhibitor at discharge was slightly under the ideal target,

which in the absence of contraindications could be related to the NP having less influence in

an inpatient environment with multiple providers, as the 3 month follow-up exceeded 90%.

There is evidence that improvements in implementation and adherence to clinical practice

guidelines by healthcare professionals caring for patients with AMI population are associated

with lower mortality rates. Quality indicators have been developed for these professionals to

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measure adherence to key clinical practice guidelines (Tu, Khalid, Donovan, & Ko, 2008).

These quality indicators serve as a benchmark and a means for quality improvement. In this

study of NP delivered intervention, quality indicators were measured as applicable at pre-

discharge and 3 months- following the intervention. These included smoking cessation

counselling during hospital stay, referral to cardiac rehabilitation, and the following

medications prescribed at discharge and at 3 months after discharge: ASA, β- blocker, ACE

inhibitor, statin. The target benchmark for these quality indicators is 90% in ideal patients,

that is, patients without contraindications to treatment recommendation (e.g., allergy to ASA)

(Tu et al., 2008). Additionally, ACC/AHA guideline recommendations for the management

of patients with coronary and other atherosclerotic vascular disease were captured to assess

NP performance and adherence to guidelines. The specific recommendations related to

physical activity counselling, measurement of BMI and weight, dietary counselling, diabetic

teaching, and measurement of HbA1C (Smith et al., 2006).

The observed high NP performance on these quality indicators may be reflective of the

dedicated focus of the intervention on secondary prevention, the timing of the intervention

within the patient‘s recovery, the adequacy of the time the NP spent implementing prevention

activities, the discharge and follow-up checklists used by the NP, and the awareness that

implementation rates would be recorded and examined in relation to a comparison group.

This is consistent with what is already known about a variety of methods for increasing

adherence to guidelines; for example, the Get With The Guidelines (GWTG) programme, the

largest hospital-based national performance initiative for CAD (USA), has been successful in

improving guideline adherence in a large number of hospitals. This programme‘s stated

focus is to improve adherence to prevention guidelines (Lewis et al., 2008). Key features of

this programme include using a patient management tool for data collection, clinical decision

support and feedback, as was done in the NP secondary prevention study.

The timing of the NP secondary prevention intervention, spanning the period before

discharge and continuing for 3 months, could have contributed to the high implementation

rates for the secondary prevention strategies. It has been reported that patients are more

motivated to begin and maintain interventions that lower risks while they are still in hospital

(Fonarow & Ballantyne, 2001). This is likely due to a heightened awareness of their current

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health, and strengthened perception of the link between treatments and the importance of

decreasing future risks (Fonarow & Ballantyne, 2001). In addition to the NP intervention

beginning in hospital, the intervention was designed to allow adequate time to address

multiple secondary prevention strategies at each visit, which will be further discussed in the

section addressing time for delivering the intervention.

Multiple studies have reported improvements in guideline adherence with the use of care

maps, standard orders or discharge checklists (Eagle et al., 2005; Mehta et al., 2002). Eagle

et al. (2005) reported higher adherence to guidelines in centres that routinely used patient

care algorithms and discharge checklists. Feedback on performance is also known to improve

adherence to guidelines (Fonarow et al., 2001). This is thought to be related to the gap

between what providers perceive they are implementing in practice and what actually takes

place in practice, the checklist serving as a reminder for implementation (Erhardt, 2005).

Knowledge that performance will be measured heightens vigilance and provides a method to

maintain improvements.

The type of healthcare provider has been identified as a factor in how recommended

secondary prevention medications are utilized by patients with AMI. A study that examined

factors associated with use of β-blockers, angiotensin-modifying drugs and statins post AMI,

found that patients who received care from non-cardiologists had lower rates of prescription

for evidence-based drug use after discharge from hospital (Austin, Tu, Ko, & Alter, 2008). It

is possible that the increased adherence to appropriate medications (and other treatment

strategies) in this study is related to the dedicated secondary prevention focus and

cardiovascular experience of the provider, rather than cardiologist designation.

In summary, the results indicate that a comprehensive individualized secondary prevention

intervention delivered by an NP is highly successful in achieving provider implementation

targets, which likely translates into improved outcomes for patients with AMI. This is based

on the premise that consistent use of evidence-based care processes leads to improved patient

outcomes (Peterson et al., 2006).

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Achievement of Treatment Goals

Overall effectiveness.

This prospective cohort study found that after three months, AMI patients who received an

individualized secondary prevention intervention delivered by an NP demonstrated

significant improvements in multiple treatment goals when compared to patients who

received usual care. Improvements in treatment goals were inferred from the analyses that

compared treatment goals between the NP intervention and the control groups, and that

examined the relationships between process and outcome variables. The improvements

included an increased odds of participants who received the NP intervention achieving

smoking cessation (OR 5), achieving a BP < 130/80 (OR 15), attending cardiac rehabilitation

(OR 7), achieving the minimum physical activity goal of 5 days a week (OR 17), engaging in

30 minutes of physical activity more than five days a week (OR 34), and achieving an

HbA1C blood measurements <7% in those with diabetes (OR 10). A higher proportion of

those in the NP intervention group achieved lower triglyceride levels, had shorter number of

weeks from hospital discharge to cardiac rehabilitation intake, and remained on statin

medications three months after discharge from hospital.

The wide confidence intervals (CI) found for most outcomes are related to the sample size

obtained for this pilot study. The most likely absolute difference between groups is the value

reported, however, the true difference may be as low as the lower CI or as high as the highest

CI. Interpretation of these findings should consider the lower CI in determining clinically

important differences. The significant differences in the improvement of secondary

prevention goals between groups are of clinical relevance because of the known association

between treatment goals and improved outcomes in patients with AMI. The NP‘s

implementation of the evidence-based secondary prevention treatment strategies with high

fidelity may have contributed to the clinically relevant improvements in treatment goals.

These results are consistent with evidence that short-term secondary prevention programmes

can be effective in improving multiple cardiovascular risk factors and uptake of guideline

based recommendations for patients with established CVD (Clark et al., 2005). The CHOICE

(Choice of Health Options In prevention of Cardiovascular Events) randomized controlled

trial evaluated over a 12-month follow-up period, a 3 month secondary prevention

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intervention for acute coronary syndrome survivors who were not accessing cardiac

rehabilitation. The intervention group had significant improvements in the risk factor levels

for total cholesterol, BP, physical activity, smoking cessation and statin use at 3 months.

These results are similar to those observed in the NP secondary prevention study. However,

the CHOICE study did not specify who delivered the intervention; rather, the intervention

was described as an individualized, structured case management approach overseen by

treating physicians (Redfern et al., 2009), which was comparable to the approach the NP

followed in delivering the secondary prevention strategies.

In addition, the CHOICE study made comparisons with a reference group beginning standard

cardiac rehabilitation. No significant differences between the reference group and the

intervention group at one year were reported for mean risk factor levels (cholesterol levels,

BP, BMI, physical activity, depression score and smoking status) or proportion taking statins.

With respect to physical activity, the mean level for the cardiac rehabilitation group peaked

at 3 months, whereas the CHOICE group continued to improve for one year. These results

are similar to those of the NP study and demonstrate that an individualized short-term

approach to secondary prevention, which does not include a structured exercise component,

may have comparable results to standard cardiac rehabilitation.

The CHOICE study findings also highlight what is well known about cardiac rehabilitation,

that the majority of eligible patients do not access these programmes, and that those who opt

out may have greater need for risk factor modification and support (e.g., more risk factors,

higher mean levels of LDL, more depression and lower physical activity in those opting out)

(Redfern et al., 2009). The high rate of consent in the CHOICE study (40%) among those

patients not accessing rehabilitation compared to the attendance rate for cardiac rehabilitation

internationally (15% - 20%), as well as the high enrolment rate in the NP study may

represent evidence that alternative secondary prevention programmes with multicomponent

interventions including risk factor modification and support are acceptable to acute coronary

syndrome survivors (CCN, 2002; Gravely-Witte et al., 2005).

Giallauria and colleagues (2009) compared participants in the control group who engaged in

a structured cardiac rehabilitation programme for the first 3 months post AMI and

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participants in the intervention group who received additional monthly visits beginning prior

to discharge from the hospital. The comparisons were made on cardiopulmonary parameters

(maximal oxygen consumption and maximal workload) and cardiovascular risk profiles (BP,

BMI and lipids) over two years post AMI. Participants did not show any significant

differences in the outcomes at 3 months. Participants in both groups showed significant

improvements in functional capacity and risk profiles at 3 months, with significant

differences favouring the treatment group not seen until the 12th month. This finding suggests

the need for additional support provided during the visits to initiate and maintain patients‘

engagement in cardiac rehabilitation, as was done in the current NP study.

The lack of significant differences between groups at 3 months may be related to the timing

of entry into cardiac rehabilitation (immediate entry upon discharge from hospital) and

intensity of the cardiac rehabilitation programme (three times per week). This indicates that

attending cardiac rehabilitation early with or without additional interventions is associated

with significant improvements in secondary prevention goals when measured at 3 months.

However, this benefit progressively deteriorates after the cardiac rehabilitation programme is

completed.

In the NP study, the mean length of time from hospital discharge to cardiac rehabilitation

programme participation was 9 weeks (SD 3.30), with the NP secondary prevention

intervention beginning before discharge from hospital. This highlights again that secondary

prevention programmes, with and without exercise components, are effective in improving

risk factor profiles in patients with AMI and established CVD (Clark et al., 2005; McAlister,

Lawson et al., 2001), with timing of the start of a programme as an additional factor to be

considered. Given that the majority of eligible patients do not attend structured cardiac

rehabilitation programmes, and those who do, start in the range of 6-12 weeks after the event,

secondary prevention programmes outside of traditional cardiac rehabilitation, beginning as

early as possible, such as done in the NP study, appears to be a feasible and effective

alternative. Secondary prevention programmes may be a desired option for patients who do

not have immediate access to a cardiac rehabilitation programme and may serve to motivate

patients and/or facilitate their engagement in cardiac rehabilitation programmes.

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Individual secondary prevention strategies and NP practice patterns.

Smoking.

Over half the smokers in the NP intervention group (58%) stopped smoking within three

months post AMI compared to 23% in the control group, a clinically important (although not

statistically significant) finding. The odds of achieving this goal were five times higher if the

participant received the NP intervention. Examination of NP practice activities revealed that

all current and former smokers received smoking cessation counselling delivered by the NP

prior to discharge from hospital and in follow-up contacts. Rates of smoking cessation

reported in secondary prevention studies vary widely. For example, in the primary care

nurse-led secondary prevention clinic study conducted by Campbell and colleagues (1998),

there was no effect on smoking cessation. In the CHOICE study, initiated after an acute

coronary event, there was a significant decrease in the number of smokers in the intervention

group (40%), compared to a slight increase in the number of smokers in the control group

(Redfern et al., 2009). A meta-analysis examining the effects of nurse-delivered smoking

cessation interventions reported that nursing interventions with inpatients with cardiovascular

disease were the most effective (OR 2.14) (Rice, 2006; Rice & Stead, 2008). This suggests

that beginning the NP intervention in hospital may have had a beneficial effect on this

treatment goal. The benefits of this timing are likely related to participants‘ heightened

awareness of their risk while they are in hospital, and therefore greater motivation to initiate

and maintain health behaviours that lower risk (Fonarow & Ballantyne, 2001). Physical

activity may also have been a factor in the success of this goal. Although a systematic review

in the Cochrane Library (Ussher, Taylor, & Faulkner, 2008) concluded that there is

insufficient evidence to establish a favourable impact of exercise on smoking cessation,

largely due to methodological limitations, there is some clinical trial evidence of a beneficial

effect on smoking cessation rates when regular exercise sessions are added to behavioural

modification programmes (Marcus et al., 1999).

Blood pressure.

The observed improvements in the achievement of the target BP < 130/80 were not predicted

by any of the measured NP practice activities. However, blood pressure was ranked as third

in the amount of time logged by the NP in an individual secondary prevention strategy.

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Based on the amount of time reported in the case management and medication adjustment

categories (range 0-10 minutes), a small number of participants required consultation with a

physician and/or titration of medication for abnormal BPs during their visits with the NP.

Improvements in this treatment goal may be indirectly related to physical activity, a

mechanism that was not evaluated in this study but is worth examining in future studies. A

systematic review of the literature has concluded that exercise and physical activity can

reduce systemic blood pressure and should remain a cornerstone in the treatment of

hypertension (Fagard & Cornelissen, 2007). This is consistent with the Canadian Education

Program recommendation of 30-60 minutes of moderate, dynamic exercise 4-7 times a week

as an adjunct to anti-hypertensive therapy (Khan, Hemmelgarn, & Herman, 2009).

Physical activity.

One of the most evident benefits of the NP intervention is its impact on the secondary

prevention goal of physical activity and attendance at cardiac rehabilitation. Adherence to

regular physical activity has been described as the most difficult achievement in secondary

prevention care (Oldridge et al., 1991). Physical activity counselling was provided to all

participants in the intervention group at each contact. The physical activity teaching and

counselling included encouragement to be as physically active as possible given individual

ability and limitations, with the goal of achieving the equivalent of a brisk walk for at least

30 minutes daily. Physical activity was the most frequently applied secondary prevention

strategy logged by the NP, which includes a mean of 45 minutes discussing physical activity

per participant across all visits. There was 50% more time spent on this strategy compared to

the next most frequently applied secondary prevention strategy (lipid management).

Ample time was allotted to discuss physical activity recommendations prior to discharge as

well as in follow-up contacts one week following discharge. The time allotted to this

recommendation as well as the individualized approach to care followed by the NP allows

patients to present individual concerns about or barriers to physical activity recommendations

to a healthcare provider at a time when they are most vulnerable and often lacking in

confidence. Most patients see their family physician one to two weeks after discharge from

hospital, their cardiologist nine weeks after discharge, and for those who attend cardiac

rehabilitation, this begins on average nine weeks after discharge from hospital. Physical

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activity goals individually tailored, prior to discharge and reinforced in the early follow-up

period (at every contact with the NP), when they have a heightened awareness of their

current health and are motivated, appears to improve the acceptability of, engagement in, and

adherence to, physical activity recommendations. Individually tailored nursing interventions

have been shown to be superior to non-individualized interventions, particularly in areas such

as patient education and counselling and adherence to recommended care (Suhonen et al.,

2008). Similarly, improvements seen in attendance at cardiac rehabilitation and time (in

weeks) to attend cardiac rehabilitation may also be related to these factors. In the analysis

examining NP practice activities and individual treatment goals, the ‗weeks to cardiac

rehabilitation attendance‘ variable was significantly associated with NP physical activity

assessment and physical activity teaching, which may indicate that one-to-one time spent

between NP and participant may have contributed to the improvement in this outcome

compared to usual care.

These results are consistent with meta-analytic evidence on interventions to increase physical

activity among cardiac patients, which identified the most successful interventions as

including face to face encounters, with ample contact time (Conn, Hafdahl, Moore, Nielsen,

& Brown, 2009). Individual face-to-face encounters and ample contact time are key

characteristics of the NP intervention. The relationship between physical activity and

cardiovascular health in secondary prevention has been extensively documented, with clear

evidence that regular aerobic physical activity significantly reduces cardiovascular risk

(Giannuzzi et al., 2003; Taylor et al., 2004). Both self-reported physical activity level and

objectively measured cardiorespiratory fitness are inversely associated with the risk of

cardiovascular diseases and all-cause mortality (Aadahl, Kjaer, Kristensen, Mollerup &

Jorgensen, 2007). In a study comparing self-reported physical activity and objectively

assessed maximum oxygen uptake, a linear relationship was found between these parameters

in adult men and women (Aadahl et al., 2007). These findings support the claim that the self-

reported physical activity in the NP secondary prevention study may represent reductions in

cardiovascular risk for those achieving the secondary prevention physical activity target

goals. An earlier study examining the relationship between physical activity, types of

activity, changes in physical activity and all-cause mortality in men with established CVD,

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found that light or moderate activity was associated with a significant reduction in risk of all-

cause and cardiovascular mortality (Wannamethee, Shaper, & Walker, 2000). In the recent

Ontario-specific epidemiological study examining the association between decline in CHD

mortality and medical treatments and risk factors, reductions in physical inactivity were

found to be associated with fewer CHD deaths (Wijeysundera et al., 2010). These studies

highlight the potential impact of achieving physical activity targets, such as demonstrated in

the NP intervention group.

Diabetes management.

HbA1C was measured on all participants with diabetes who represented a small subgroup (n

= 8) of patients in the NP intervention group. Improvements observed in HbA1C in patients

with diabetes were not predicted by any of the measured NP practice activities. This may be

related to high fidelity in intervention implementation and therefore low variability in this

activity. Based on the amount of time reported in the case management (range 0-3 minutes)

and medication adjustment (0 minutes) categories, a small number of participants required

consultation with a physician for issues related to diabetes during their visits with the NP.

Improvements in this treatment goal may also be indirectly related to physical activity. Low

to moderate intensity exercise lowers plasma glucose both during and after the activity. A

study following patients with diabetes over a 14 year period demonstrated fewer

cardiovascular events and deaths in patients with the highest total physical activity compared

to the lowest (Tanasescu, Leitzmann, Rimm, & Hu, 2003).

Statin use post-discharge.

Adherence to statins three months after discharge from hospital was 100% in the NP

intervention group. All participants in the intervention group received pre-discharge teaching

about lipids and statin use, as well as follow-up lipid testing approximately 6-8 weeks after

discharge from hospital. The NP activities of case management and medication adjustment

were among the highest in the lipid secondary prevention category, indicating that

communication with a physician occurred most often in relation to lipid management. Ten

percent of participants in the NP intervention group told the NP they were unable to afford

the medications prescribed at discharge from hospital. This accounted for a majority of the

case management time spent in this category. The lipid management category was the second

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most frequent category for total time NP spent with each participant, and time spent teaching.

This suggests that the NP worked with both the participant and a physician to facilitate

optimal lipid management, and that pre-discharge and follow-up teaching and lipid testing

may have contributed to the success of participants in achieving this treatment goal.

The improvement seen in adherence to statins at follow-up in the NP intervention group

compared to the usual care group is clinically and statistically significant (100% vs. 86.7%; p

= .05). Improved secondary prevention with statin therapy represented the most important

advance in treatment in a recent eleven year period (1994-2005) in Ontario (Wijeysundera et

al., 2010). In the study conducted in Ontario examining the relationship between adherence

to evidence-based pharmacotherapy and mortality after myocardial infarction among statin

users, the risk of mortality was greatest for low adherers (Rasmussen, Chong & Alter, 2007).

It has been reported that only 74% of patients fill all of their prescriptions by 120 days post

myocardial infarction, with 10% not filling their statin prescription at 30 days post MI in

Ontario (Jackevicius et al., 2008). In this Ontario study, documentation of discharge

medication counselling was associated with reduced one year mortality rates. Additionally,

patients who have follow-up and lipid testing in the first 3 months have been reported as 45%

more likely to be adherent with lipid-lowering medication (Benner et al., 2004). Discharge

medication counselling, follow-up and lipid testing within the first 3 months were provided

to all participants in the NP intervention group, likely contributing to the successful

achievement of this goal.

Secondary prevention strategies: Outcomes with no difference between

groups.

The absence of significant improvements in participants in the NP intervention group

compared to those in the usual care group in the outcomes LDL-C, HDL-C, BMI, waist

circumference and current use of ASA, B-blocker and ACE inhibitor are most likely related

to three factors: 1) a 'ceiling effect', whereby interventions have a diminishing beneficial

effect once certain levels of risk factor management are reached (Buckley, Byrne, & Smith,

2010); 2) small sample size; and 3) short follow-up. Both the intervention and usual care

groups experienced similar improvements in LDL-C levels when comparing baseline levels

to those at three months. Participants in the two groups achieved the adjusted mean target

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goal, making small incremental improvements less likely to detect. The exact mechanism

responsible for this finding is not clear but should be elucidated in future research.

Nonetheless, this finding is encouraging, supporting the adequacy of usual care in achieving

these outcomes. The sample size for this study was powered to detect differences between

groups in the moderate to large range; therefore, smaller differences between groups would

go undetected, even if clinically important. Differences between groups in measurements

such as BMI and waist circumference would be expected to be small over the brief 3-month

follow-up period because of the gradual nature of weight loss. Again, small differences

would go undetected.

Relationship between NP Practice Activities and Outcome Achievement

Examination of NP practice activities as a predictor of successful outcome achievement

revealed that successful triglyceride levels were related to the NP practice activity of lipid

teaching, and shorter weeks to cardiac rehabilitation were related to NP practice activity of

physical activity assessment. The magnitudes of these effects were considered moderate. It is

inferred from the high rates of implementation of guideline based secondary prevention

strategies by the NP, and adequate time for preventative care at each clinical visit, that these

factors facilitated the implementation of NP activities and consequently successful outcome

achievement.

The relationships between activities in which NPs engage to provide care, and outcomes

achieved by patients have been examined by Sidani and Doran (2010). They found a positive

association between NP activities and improvements in outcomes. Specifically, patients who

reported receiving a high level of counselling showed improvement in physical function and

patients who reported receiving high levels of education showed improvement in social

function. The effectiveness of psychoeducational interventions is supported by evidence

obtained from meta-analyses, whose authors posit that the robust effect of education on

functional status and medication use may be attributable to the fact that many of the

educational programmes included instructions on medication usage and self care activities

(Devine, 1996; Devine & Reifschneider, 1995). These findings are consistent with the

association between NP lipid teaching and physical activity assessment activities reported in

this study.

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The description of the NP practice activities helps to explain some of the potential

mechanisms underlying the outcomes achieved by patients receiving secondary prevention

care. In particular, having adequate time (mean 36 minutes per visit) to assess and discuss

multiple risk factors, and potential strategies to address them, increases the health providers‘

and patients‘ understanding of personal risk. Such an understanding guides healthcare

providers‘ prescription of appropriate management strategies and patients‘ engagement in

self-care, respectively, and subsequently improvement in functional status. Adequate time to

address patients‘ concerns likely contributes to increases in satisfaction with care received, a

consistent finding in studies examining the effectiveness of NPs (Horrocks et al., 2002), and

is a potentially significant factor in the high acceptability of this type of intervention.

The amount of time nurses spend with patients has been described as nurse ―dose‖. Brooten

and colleagues (2002), who developed and tested a quality cost model of advanced practice

nursing (APN) transitional care (comprehensive discharge planning and home follow-up)

made observations about APN ―dose‖. APN is a broad term, used to describe nurses with

advanced education and training, which includes the NP. Although the number of APN

contacts and amount of time at each contact (described as ―dose effect‖) varied by patient

groups, patient groups with greater mean APN time and contacts per patient have been

reported as having greater improvement in outcomes (including functional status, affect and

satisfaction with care) and greater healthcare cost savings. In another example of dose effect,

Naylor and colleagues (1994; 1999) conducted two studies examining APN care, with

differences in APN dose. The first examined APN care with elderly cardiac medical and

surgical patients, for the period extending from hospital discharge to 2 weeks after discharge

(phone follow-up), while the second study added home visits to the model of care, to

‗strengthen the APN dose‘. The first study showed reduced rehospitalizations in the APN

compared to control group from discharge to 6 weeks with these differences disappearing by

12 weeks. The second study reported improvement in outcomes in those with the additional

APN home visits (significantly fewer readmissions and total hospital days) when compared

to the control group six months after hospitalization (Naylor et al., 1994; Naylor et al., 1999;

Brooten et al., 2002). In contrast to these findings on nurse dose, analysis of the amount of

time or number of contacts the NP spent with patients in this study did not significantly

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predict successful achievement of measured outcomes. This may be related to both the type

of outcomes measured and the difference between the concept of adequate time to

individualize care and a more quantifiable " dose". For example, satisfaction with care is

known to be associated with the amount of time spent with providers, while re-

hospitalizations have been shown to be prevented with more frequent follow-up (contacts)

because of early detection and treatment of complications before hospitalization is required.

It would appear that the absence of a significant relationship between total time and total

contacts with the NP in the secondary prevention study indicates that rather than quantity

(i.e., dose), it is the content of the intervention that has made an impact on the achievement

of treatment goals. This claim requires further investigation in future studies of NP

effectiveness.

In summary, examination of the relationship between NP practice activities while delivering

the secondary prevention intervention and the treatment goals achieved by patients provided

preliminary evidence supporting the direct contribution of the NP practices to patient

outcome achievement. Successful outcome achievements in this study were likely related to:

the high acceptability of the NP secondary prevention intervention, consistent and high

fidelity in implementation of guideline recommendations by the NP, adequate time with the

patient to address individual secondary prevention strategies, and beginning the NP

secondary prevention intervention before discharge with early follow-up intervals while the

patient was motivated with a heightened awareness of the link between treatments and

decreasing future risk. The utility of the conceptual framework that guided the design of the

intervention and the study related to the specification of the NP role components and

operationalizing specific activities. A comprehensive list of NP activities facilitated

assessment of fidelity in intervention implementation as well as examination of the

relationships between the intervention activities and outcomes. These relationships begin to

identify the essential ingredients that differentiate the intervention and that are responsible

for producing the desired outcomes.

Strengths and Limitations

The strengths of this pilot study are related to its design and implementation, which were

guided by a clear conceptual framework. The use of a prospective cohort design with the

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application of the same eligibility criteria for selecting consecutive AMI patients contributed

to comparability between groups on most baseline characteristics. Variables showing

differences at baseline and significant correlation with posttest outcomes were controlled for

statistically. The NP intervention was carefully designed to integrate clearly defined NP

activities, derived from the NP scope of practice and previous research, relative to the most

recent and effective secondary prevention strategies. The intervention activities were

operationalized in a log that guided its appropriate delivery and accurate documentation of

the activities carried out with each participant. This resulted in high fidelity and

standardization of the intervention implementation and contributed to the achievement of

intended outcomes. The intervention was delivered by one interventionist to a small sample,

in one setting. Single centre studies, as well as a limited number of interventionists provide

less heterogeneity in the delivery of the intervention and less chance of undetected co-

interventions (e.g., multiple hospitals would have varying discharge or cardiac follow-up

practices). Homogeneity in treatment delivery and patient characteristics limits external

validity or applicability of the findings to other contexts. The intervention was implemented

by one NP. The NP may have professional qualities and an interactional style that may not be

reflective of those characterizing other NPs.

This study involved a small number of patients, characterized as middle-aged, married,

employed men. Although representative of the patient population served in the setting and of

the AMI population taking part in research studies, it may not be representative of two

subgroups of cardiac patients that is, women and older adults.

The sample size in both groups was powered to detect moderate to large differences between

groups, a conservative target for the purposes of examining the feasibility and acceptability

of the intervention. However, small but clinically significant differences in outcomes

between the intervention and comparison groups likely have gone undetected. Taking into

consideration that the sample size required to detect a large (Cohen‘s d of .7) and medium

effect size (Cohen‘s d of .5) for a two-tailed t test comparison is 34 and 64 per group

respectively, with the accrued study sample (n = 65) smaller effect sizes would go

undetected. Multiple regression analyses with six predictors require at least 60 participants to

detect a large effect size.

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Smoking behaviour, engagement in physical activity, and medication use were self-reported

as is commonly done in secondary prevention studies (Goessens et al., 2006; Peterson et al.,

2006; Giallauria et al., 2009; McAlister et al., 2009). Self-report may have introduced bias

related to social desirability and expectation bias. Assessment of objective indicators of these

outcomes would strengthen the results; however, this was not feasible within the constraints

of this pilot study, but should be considered in future research. As previously discussed, self-

report on physical activity has been reported as correlating well with objective measurement

of physical activity markers (Aadahl et al., 2007).

Participant evaluation bias was minimized by employing a research assistant to collect

posttest outcome data in the intervention and comparison groups, and to enter the obtained

data on variables into the database. However, experimenter expectancy bias is likely in this

study. The researcher knew participants‘ assignment to study groups, delivered the

intervention, and conducted the data analysis (for learning purposes). This has the potential

of inflating results in favour of the intervention group.

This study may not have identified all the relevant activities in the NP practice which may

have had an impact on the outcomes measured. The amount of time spent with each

participant was recorded by the NP at each visit, with just over 40 minutes logged as

miscellaneous activities across all visits. Additional activity categories, addressing issues

such as symptom management and psychosocial or financial aspects of care may have better

delineated potentially important activities performed by the NP and contributing to

improvement in outcomes. The use of direct observation techniques in recording the NP

activities would have improved the accuracy of findings, however, this would have also

introduced a source of bias known as the Hawthorne effect (DiCenso et al., 2005).

Implications

The implications of this pilot study focus on features of future research aimed at

evaluating the efficacy of NP secondary prevention interventions. Suggestions for practice

are also presented.

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Research implications.

Guided by a clear conceptual framework linking specific NP practice activities and desired

outcomes achieved by patients, the study findings provide preliminary evidence supporting

the acceptability and feasibility of the NP secondary prevention intervention, as well as the

contribution of NP activities to the achievement of secondary prevention treatment goals post

AMI. The results of this pilot study are encouraging and support future research, using a

randomized controlled trial to evaluate the efficacy of the NP secondary prevention

intervention. With the small sample size, it is recognized that the study may have over- or

underestimated the effects of the intervention. A larger sample size would increase the ability

to detect statistically and clinically significant improvements in outcomes. Broader inclusion

criteria (e.g., including patients admitted for interventional procedures or having CABG)

would increase the generalizability of the findings and their applicability to patients admitted

to inpatient units for the management of cardiac disease. Blind outcome assessment would be

used to address expectancy bias. In addition to the 3 month follow-up, assessment of

outcomes at 6 months and 12 months post AMI would be required to detect long-term

effectiveness and sustainability of the NP delivered intervention on outcomes, as well as

potential benefits of the NP intervention on additional outcomes including mortality or

reducing risk of recurrent vascular events.

The pilot study findings support the ability of the NP to deliver secondary prevention

interventions within the full scope of practice. Future research needs to include different NPs

in different contexts to determine the extent to which the NP and setting characteristics

influence implementation of the intervention and achievement of outcomes, as proposed by

the conceptual framework that guided the study. In settings where NP care is being delivered

in hospital as usual care, consideration should be given for comparing three groups in a

future study: usual inpatient NP care and outpatient usual care (which does not include an

NP), inpatient NP intervention care and NP intervention outpatient care, and inpatient care

and outpatient care which does not include an NP. This would make it possible to make

comparisons on the effects of inpatient and outpatient NP care on outcomes separately, which

would help further delineate the influence of setting on fidelity of intervention

implementation and on the measured outcomes.

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Examination of the NP practice activities as conducted in the pilot study is recommended in a

future study to further delineate the NP practice activities that contribute to outcomes and

assess the fidelity of intervention implementation. However, some modification in the

practice categories is warranted based on experience using the clinical log and the finding

that approximately 40 minutes per participant (across all contacts) was not accounted for in

the measured practice categories. The modification involves adding the practice categories of

symptom management and psychosocial support such as reassurance. Outcomes related to

these intervention activities include symptom control and comfort level, which have also

been identified as sensitive to APN care (Sidani & Irvine, 1999).

The cost-effectiveness of this type of NP secondary prevention intervention should be

investigated in future research. In addition to replicating this research with a larger sample, a

programme of research will be sought to include: an examination of the impact of financial

factors limiting secondary prevention medication use and entry into cardiac rehabilitation

programmes; a qualitative study to explore professional qualities and interactional style of

NPs that may have affected the implementation of the intervention and patients‘ engagement

in and adherence to treatment recommendations; and a descriptive study to examine patients‘

perception of factors within the context of the visit that contribute to their satisfaction with

care, and the impact this has on application of secondary prevention recommendations.

Suggestions for practice.

This study demonstrates that the NP secondary prevention intervention potentially has broad

appeal for AMI patients in this type of practice setting. The high enrolment and low attrition

rates may represent a desire for cardiac follow-up in the time period extending from hospital

stay to three months post AMI. This study highlights the potential advantages of providing

care that spans the inpatient and outpatient settings, with frequent follow-ups at a time when

patients‘ motivation for change is heightened. Secondary prevention programmes that

incorporate pre- and post-discharge secondary prevention teaching, and early outpatient

follow-up could serve as a bridge to entry into cardiac rehabilitation.

Additionally, secondary prevention programmes such as the one piloted here may appeal to

patients who desire an alternative to traditional cardiac rehabilitation, or to those who could

141

benefit from assistance in overcoming barriers to cardiac rehabilitation. This could also

potentially translate into reaching those who have been shown to attend cardiac rehabilitation

the least (women and the elderly). Further research is needed on programme preferences,

especially for those less likely to attend traditional cardiac rehabilitation. Providers delivering

secondary prevention should build time in their practices to allow adequate time for health

teaching, discussing treatment options, and the opportunity for individual barriers and

concerns to be expressed.

Conclusion

In summary, the results of this study demonstrate that a comprehensive secondary prevention

intervention can be safely and effectively delivered by an NP. This preliminary evidence

helps to delineate the activities in which the NP engages when delivering secondary

prevention care in this type of practice setting and which activities to incorporate in future

applications of the intervention. This study found that an NP delivered secondary prevention

intervention, beginning prior to discharge and continuing for three months post myocardial

infarction, is well received by patients and significantly improves the implementation of

guideline based secondary prevention treatments and risk factor reduction strategies. Every

percentage increase in guideline adherence has the potential of an equivalent decrease in

death (Peterson et al., 2006). In addition to improvements in most secondary prevention

treatment goals, the NP secondary prevention intervention was strongly associated with

improvements in risk factors that have been particularly challenging to improve in other

secondary prevention programmes: physical activity and diabetes. Diabetes and obesity have

recently been identified as the last two risk factors cutting into the survival gains made from

declines in smoking, hyperlipidemia and hypertension (Wijeysundera et al., 2010).

Interventions such as this, which successfully address those risk factors, and multiple others,

warrant replication.

142

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SECONDARY PREVENTION STRATEGY

NP IMPLEMENTATION GOAL

VISIT 1 Predischarge Date: Time Spent:

VISIT 21 week post discharge Date: Time Spent:

VISIT 3 2 weeks post dischargeDate: Time Spent:

VISIT 46 weeks post dischargeDate: Time Spent:

VISIT 53 months post dischargeDate: Time Spent:

Smoking cessation

c Assessment mins.c Teaching mins.c Case mgnt. mins.c Medication mins.





GOAL: delivery of or referral to smoking cessation counselling c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A

BP control






GOAL: initiation or titration of BP medications if BP not at target goal c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A

Lipid management






GOAL: initiation or titration of lipid lowering therapy if lipid levels are not at target goals

c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A

Physical activity






GOAL: delivery of physical activity counselling or referral to cardiac rehabilitation programme


Appendix A. NP Clinical Log

Patient ID#

171

Weight management






GOAL: measurement of weight, BMI, waist circumference, and dietary counselling c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A c Yes c No c N/A

Diabetes management






GOAL: measurement of blood glucose and diabetes risk factor counselling for diabetic patients


Antiplatelet/anticoagulant






GOAL: initiation of ASA if not contraindicated, and clopidogrel or warfarin if clinically indicated


ACE inhibitor






GOAL: initiation or titration of ACE inhibitor towards treatment goals unlesscontraindicated


B-blocker






GOAL: initiation or titration of β-blockers towards treatment goal unless contraindicated.


Adapted from: American College of Cardiology and the American Heart Association, Inc. (2001). Guidelines for preventing heart attack and death in patients with Atherosclerotic cardiovascular disease: 2001 update Available: www.acc.org/clinical/guidelines/atherosclerosis_pdf.pd, and

Adapted from: Brooten, D., Youngblut, J.M., Deatrick, J., Naylor, M., York, R. (2003). Patient problems, advanced practice nurse (APN) interventions, time and contracts among five patient groups. Journal of Nursing Scholorship, 35(1), 73-79.

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SECONDARY PREVENTION GOALS Achievement rate:VISIT 1

Achievement rate:VISIT 2




SMOKING: complete cessation Assessment and counselling at each contact

BP CONTROL: <140/90 mm/Hg or <130/80 mm/Hg if diabetes or renal insufficiency

LIPID MANAGEMENT : LDL < 100mg/dL or < 2.6 (mmoL/L)further reduction of <70 mg/dL or < 1.79 mmoL/L is reasonableStatin prescribed at dischargeStatin at follow up

PHYSICAL ACTIVITY: 30 minutes, 5 days per week (or greater than 5 days a week) Referral to cardiac rehab

WEIGHT MANAGEMENT: Goal: calculate BMI and measure waist circumference as part of assessment

DIABETES MANAGEMENT: Goal HbA1c < 7%

ANTIPLATELET AGENTS : ASA prescribed at discharge ASA at follow upcontraindication

B-BLOCKER: B-blocker prescribed at discharge B-blocker at follow upcontraindication

ACE INHIBITORS: ACE prescribed at discharge ACE at follow upcontraindication

Appendix B. Rates of Achievement of Secondary Prevention Treatment Goals 173

Adapted from: Smith et al. (2006). AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 Update. Available at www.circulationaha.org and

Tu, J.V., Donovan, L.R., Austin, P.C., Ko, D.T., Newman, A.M., Wang, J., Fang, J. (2005). Quality of cardiac care in Ontario- Phase 1. Report 2. Toronto: Institute for Clinical Evaluative Sciences.

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SECONDARY PREVENTION GOALS Achievement rate:VISIT 1





SMOKING: complete cessation Assessment and counselling at each contact

BP CONTROL: <140/90 mm/Hg or <130/80 mm/Hg if diabetes or renal insufficiency

LIPID MANAGEMENT : LDL < 100mg/dL or < 2.6 (mmoL/L)further reduction of <70 mg/dL or < 1.79 mmoL/L is reasonableStatin prescribed at dischargeStatin at follow up

PHYSICAL ACTIVITY: 30 minutes, 5 days per week (or greater than 5 days a week) Referral to cardiac rehab

WEIGHT MANAGEMENT: Goal: calculate BMI and measure waist circumference as part of assessment

DIABETES MANAGEMENT: Goal HbA1c < 7%

ANTIPLATELET AGENTS : ASA prescribed at discharge ASA at follow upcontraindication

B-BLOCKER: B-blocker prescribed at discharge B-blocker at follow upcontraindication

ACE INHIBITORS: ACE prescribed at discharge ACE at follow upcontraindication

Appendix B. Rates of Achievement of Secondary Prevention Treatment Goals 174

Adapted from: Smith et al. (2006). AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 Update. Available at www.circulationaha.org and

Tu, J.V., Donovan, L.R., Austin, P.C., Ko, D.T., Newman, A.M., Wang, J., Fang, J. (2005). Quality of cardiac care in Ontario- Phase 1. Report 2. Toronto: Institute for Clinical Evaluative Sciences.

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NURSE PRACTITIONER SECONDARY

PREVENTION PROTOCOL

T1: predischarge

Date:

T2: telephone contact one week post dischargeDate:

T3: outpatient clinic visit two weeks post discharge Date:

T4: outpatient clinic visit six weeks post dischargeDate:

T5: outpatient clinic visit three months post dischargeDate:

Clinical history

Focused CV assessment

Counseling and guidance on CV risk factors: Smoking BP Lipids Physical activity Weight Diabetes Antiplatelet rx B-blocker rx ACE-inhibitor rx

Reinforce predischarge counseling and education

Review of signs and symptoms to report (incl nitroglycerin use review)

Antiplatelet B-blocker ACE-inhibitor adjustment(s) to target goal (in consultation with most responsible physician)

Lipid measurement BP measurement HbA1c Weight/BMI calculation Waist circumferenceLiver function and renal function tests (for monitoring lipid rx and/or ACE rx)

Obtain baseline measurements from health record or arrange with most responsible physician

Referral to cardiac rehabilitation Check on enrollment Check on enrollment

Referral for smoking cessation Check on enrollment Check on enrollment

Referral for dietary counseling

Schedule outpatient clinic appointments and obtain 2 telephone contact numbers

Appendix C. NP Intervention ProtocolPatient ID#

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Appendix D. Script for Recruitment

Script for recruitment

Mr/Mrs/Ms ______________ , you are eligible for a research study which is being conducted at this medical centre. You are eligible because you have had a recent heart attack. The study is about the recommendations and goals for care following heart attack. The purpose of the study is to examine how nurse practitioners and doctors provide care to patients after a heart attack. This study will also examine how well patients achieve goals for decreasing their risk of a heart attack in the future. The doctor responsible for your care has referred you to a nurse practitioner to deliver care while you are in the hospital. Because you will be cared for by a nurse practitioner as part of your team while in hospital, you are eligible to have an additional nurse practitioner join in your care who is conducting the research study. Patients who agree to participate in the study will have information about their health history collected from their hospital record, and will be asked to spend approximately one hour with the study nurse practitioner discussing topics related to heart attack recovery and risk factors before they go home from hospital. Patients participating in the study will also be asked return to the hospital for 3 outpatient visits with the study nurse practitioner at the following times: 2 weeks, 6 weeks and 3 months after discharge from hospital. At each of these visits the NP will ask questions about your health history and how you are feeling. You will have a physical examination and have your blood pressure and weight taken in addition to having the opportunity to discuss topics related to your health and heart attack recovery. Participation in a research study is entirely voluntary. You are free to refuse to take part in the study or withdraw at any time without affecting or jeopardizing your care in any way. Participation in this research study will not involve additional costs to you or your health care insurer. If you are interested in hearing more about this study I will contact the nurse practitioner conducting the study and ask that she come by and discuss the study with you in more detail.

PATIENT INFORMATION

Patient Name: Patient Id # Age: Admission Date: / / Transfer Date: / / Discharge Date: / / Patient Contact Numbers: home work cell Attending MD: Family MD: Gender: £ male £ female Marital Status: £ single £ married £ divorced £ widowed Education: £ grade 8 £ grade 12 £ high school £ university or college £ graduate school £ other Employment Status: £ employed £ unemployed £ retired profession Living Arrangements: £ alone £ family £ spouse £ other

MEDICAL HISTORY

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Appendix E. Baseline Data Collection FormDate:

HPI: Coronary angiogram:

Type of MI: £ ST elevation £ non ST elevation location Complications of MI: £ heart failure £ unstable anginaPrior: £ AMI £ CHF £ CABG £ PTCA £ stroke

History of: £ diabetes £ hypertension £ hyperlipidemia £ family history £ other Smoking status: £ non-smoker £ smoker £ former smoker cigarettes per day number of years

Troponin date obtained

CK date obtained

total cholesterol (mmol/L) date obtained

HDL cholesterol (mmol/L) date obtained

LDL cholesterol (mmol/L) date obtained

triglycerides (mmol/L) date obtained

Cholesterol HDL ratio date obtained

height weight date obtained

waist circumference (cm) date obtained

hip circumference (cm) date obtained

ETOH: amount times per week date obtained

body mass index (kg/m2) date obtained

systolic BP (mmHg) date obtained

diastolic BP (mmHg) date obtained

glucose date obtained

urea date obtained

creat date obtained

K date obtained

Na date obtained

HbgA1C date obtained

CURRENT MEDICATIONS

On admission CCU On discharge

RISK FACTORS

£ Smoking £ Blood pressure £ Hyperlipidemia £ Diabetes £ Physical activity £ Weight/ waist circumference

PLAN

NOTES

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MEDICAL HISTORY AND PHYSICAL EXAMINATION

CURRENT SYMPTOMS:

General well being & energy:

CP/ ntg use:

SOB/Orthopnea/PND:

Depression:

Interim visits:

Other:

RISK FACTOR GOALS

Smoking

BP control

Lipid management

Physical activity

Weight management

Diabetes management

Antiplatelet agents

B-blocker

ACE inhibitors

LABORATORY

Cholesterol levels Glucose

Liver function tests Renal function tests

Patient Name: Patient Id # Age:

Appendix F. Outpatient Clinic Data Form Date:

CURRENT MEDICATIONS:

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Activity/exercise

Diet

Smoking status

Cardiac rehabilitation

BP

Heart rate

Chest

Heart

Edema

Weight

Waist circumference

PLAN:

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Appendix G. Consent Form

PARTICIPANT INFORMATION AND CONSENT Title: The nurse practitioners’ role in secondary prevention after heart attack Investigator: Patricia Harbman RN(EC), NP, (PhD Student) Supervisor: Dr. Souraya Sidani (supervisor), University of Toronto, Faculty of Nursing I am inviting you to participate in a research study. In order to decide whether or not you want to be a part of this research study, you should understand what is involved and the potential risks and benefits. This form gives detailed information about the research study, which will be discussed with you. Once you understand the study, you will be asked to sign this form if you wish to participate. Please take your time to make your decision. Feel free to discuss it with your friends and family, or your family physician. Background and Purpose You are being invited to participate because you have had a recent heart attack. This study is about the recommendations and goals for care following heart attack. The purpose of this study is to examine how nurse practitioners and doctors provide care to patients after a heart attack. This study will also examine how well patients achieve goals for decreasing their risk of a heart attack in the future. What will you be asked to do? If you agree to participate in this study, the following things will happen: 1) If the doctor responsible for your care does not refer you to a nurse practitioner to deliver care while you are in hospital, you will be asked to continue under his/her care. You will be asked questions about your health and health history at two points in time: while in the hospital and three months later. While in the hospital and after obtaining permission, the researcher or her assistant will collect information about your health history from your medical chart. Three months later, you will also be asked to return for one clinic visit. During this visit, the researcher or her assistant will ask you questions about your health and health history. You will be weighed and your blood pressure taken. You will be asked to have a blood test to measure your cholesterol levels and/or response to cholesterol medication, if this has not already been done by your doctor. The blood tests will require 1-2 small tubes of blood taken from your arm. You can decline these blood tests if you wish to do so, and this will not affect your care or participation in the study. If your blood has already been tested, the researcher or her assistant will telephone your doctor for those results. This visit will take less than 30 minutes. 2) If the doctor responsible for your care refers you to a nurse practitioner to deliver care while you are in the hospital, you will also be seen by the nurse practitioner delivering the study intervention (Patricia Harbman) at different points in time: before you are discharged from hospital, and two weeks, 6 weeks, and 3 months after discharge from

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hospital. During the first visit in the hospital, the nurse practitioner conducting the study will collect information on your health history from your medical chart, and will spend approximately one hour with you discussing topics related to heart attack recovery and risk factors. The nurse practitioner will also telephone you one week after discharge from hospital to discuss how you are recovering. This telephone call will take up to 30 minutes. 3) If you are being cared for by a physician and nurse practitioner, you will be asked to return for clinic visits at the following times: 2 weeks, 6 weeks and 3 months after discharge. At each of these visits the nurse practitioner will ask you questions about your health history and how you are feeling. You will have a physical examination (including blood pressure and weight) and you will have the opportunity to discuss topics related to your health and heart attack recovery. If you have not had blood tests to measure your cholesterol levels and/or your response to your medication, you will be asked to have these blood tests. The blood tests will require 1-2 small tubes of blood taken from your arm. You can decline these blood tests if you wish to do so, and this will not affect your care or participation in the study. If your blood has already been tested, the researcher or her assistant will telephone your doctor for those results. Any recommendations on changes to your medications (if applicable) will be made with your physician’s approval. The researcher or her assistant will collect information about your health and health history from your medical chart for each clinic visit. The clinic visits with the nurse practitioner will be in addition to the care that your doctor provides. How many people will be in this study? About 66 persons who have had a heart attack will be asked to volunteer in this study. Potential Benefits You may not benefit directly from your participation in this study. However, the results of this study will provide us with information about the type of care that is provided to patients and that may contribute to decreasing the risk for future heart attacks. Potential risks The care provided by the nurse practitioner and doctors to patients taking part in this study follows standard recommendations and poses no known risks. You will have access to all usual cardiac, emergency, and medical care services as needed. The clinic visits for the study will be in addition to the care you are entitled to. All visits will be documented and information about your health will be given to your doctor if you request it. Any changes in your medications will be made in consultation with your doctor. Cost Your participation in this research project will not involve additional costs to you or your health care insurer. Financial compensation If you agree to take part, you will be reimbursed for your parking expenses for the clinic visits which are parts of this study.

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Confidentiality Information will not be shared with anyone except the researcher. To ensure privacy, all personal information such as your name, address, phone number, OHIP number, and family doctor’s name will be removed from your study records and will be replaced with a number. A list linking the number with your name will be kept in a secure place, separate from your file. All information about you will be securely stored in a locked office. All information obtained in this study will be used for research purposes only. If you wish, the researcher will send you a copy of the results of the study when completed. If the results of the study are published, your name will not be used and no information about your identity will be released or published without your specific consent. Contact If you have any questions about the study, you can contact Patricia Harbman (Faculty of Nursing, room 308, 416-978-6969) or Dr. Souraya Sidani (416-978-2856). If you have any concerns about your treatment and rights as a research participant, you can call Nicole Pageau, Chair-Research Review Team Trillium Health Centre at telephone 905-848-7580 or by email: [email protected]; or Jill Parsons, Health Sciences Ethics Review Officer, Ethics Review Office, University of Toronto, at telephone 416-946-5806 or by email: [email protected]. Right to Refuse or Withdraw Your participation in this study is entirely voluntary and you are free to refuse to take part in the study or to withdraw at any time without affecting or jeopardizing your care. Consent Your signature on this form indicates that you understand the information regarding your participation in the research project and agree to participate. In no way does this waive your legal rights nor release the investigators, or involved institutions from their legal and professional responsibilities. You, __________________________________, the undersigned, agree to participate in the research study described. Any questions have been answered and you understand what is involved in the study. You realize that participation is voluntary and that you will not benefit directly from your involvement. You acknowledge that a copy of this form has been offered to you. Name of Participant ____________________________________ ____________________________________ ________________ Signature of Participant Date You would like to receive a copy of the study findings ______Yes _______ No

mailto:[email protected]

mailto:[email protected]

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To be signed by the Investigator To the best of my ability I have fully explained to the participant the nature of this research study. I have invited questions and provided answers. I believe that this individual fully understands the implications and voluntary nature of the study. I have been given a copy of this consent form. _____________________________________ _______________ Signature of Investigator Date

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Appendix H. Correlation Coefficients Representing Relationship Between Baseline and Post-Test Outcome Variables

AGE GENDER MARTIAL STATUS

ANGIO PTCA STENT EDUCATION PRIOR MI

TRIG ADM

BS ADMIN

STATIN ADM

AGE 1 .14 -.07 -.38** -.43** -.45** -.12 .12 -.26* -.11 -.47* GENDER .14 1 -.31* .08 .02 .02 -.01 -.17 .11 -.03 .34 MARITAL STATUS

.07 .31* 1 -.10 .03 .03 .22 -.003 .13 .14 .32

Note. ANGIO = angiogram; PTCA = percutaneous transluminal coronary angioplasty; MI = myocardial infarction; TRIG ADM = triglyceride blood level during admission; BS ADM = blood glucose during admission; STATIN ADM = statin use on admission. * p < .05, ** p < .01



TRIG ADM

BS ADMIN

STATIN ADM

OUTCOME VARIABLES

SBP .26* .14 .14 -.15 .14 .14 .20 -.03 .10 .24 .11 DBP -.19 .03 .16 .04 .12 .12 .30* -.03 .21 .17 .54** LDL-C -.16 .15 -.05 .12 .20 .20 .16 -.17 -.17 -.19 .26 HDL-C .16 .57** -.23 .03 -.03 -.03 .15 -.27* -.09 -.05 .38 TRIGLYCERIDES -.02 -.15 .28* -.36** -.14 -.14 -.00 .27* .43** .10 -.27 BMI -.30* -.20 .03 .13 .15 .16 -.07 -.09 .16 .35* -.31 WEEKS TO CR .19 -.13 .09 -.09 -.11 -.11 -.20 .03 -.13 .08 -.27 SMOKING CESSATION

-.02 ..20 .19 .11 .11 .10 .30* -.10 -.08 .03 .35

ATTEND SC CLINIC

-.10 -.11 -.04 .04 .08 .08 .17 -.08 -.10 -.20 .33

BP < 140 .16 .17 .04 .08 .15 .15 .19 -.15 -.11 .22 .06 BP < 130 -.14 -.17 -.04 -.08 -.15 -.15 -.19 .15 .01 -.24 -.06 LIPIDS < 2.6 -.17 .19 -.17 .09 .22 .22 .26 -.22 .06 -.10 .15 LIPIDS < 1.79 .23 -.15 .21 -.09 -.24 -.24 -.24 .24 -.01 .12 -.15

Note. Systolic blood pressure; DBP = diastolic blood pressure; LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol ; BMI = body mass index ; CR = cardiac rehabilitation; HbA1C = glycosylated haemoglobin; ASA = aspirin; DC = discharge; F/U = follow-up; BB DC = beta blocker use at discharge; BB F/U = beta- blocker use at follow-up; ACE D/C = angiotensin- converting enzyme inhibitor use at discharge; ACE F/U= angiotensin- converting enzyme inhibitor use at follow-up; ANGIO = angiogram; PTCA = percutaneous transluminal coronary angioplasty;. MI = myocardial infarction; TRIG ADM = triglyceride blood level during admission; BS ADM = blood glucose during admission; STATIN ADM = statin use on admission. * p < .05, ** p < .01

Appendix H. Correlation Coefficients Representing Relationship Between Baseline and Outcome Variables



TRIG ADM

BS ADMIN

STATIN ADM

OUTCOME VARIABLES PA > 5 days

.10 -.04 .04 -.03 -.12 -.12 -.04 .12 -.11 .03 .15

PA = 5 days -.11 -.13 .29* .07 .08 .08 .12 .03 -.12 .04 .02 ATTEND CR -.01 .15 .04 .06 .07 .07 .14 -.33** -.01 .24 .11 RETURN TO WORK

-.27* -.12 .10 .15 .18 .18 .19 .13 -.13 .01 .22

HBAIC .36** .09 -.02 -.24 -.16 -.16 -.01 .05 -.16 .20 .16 ASA DC -.06 .08 -.10 .48** .22 .22 -.25 -.20 -.09 .02 .14 ASA F/U -.13 .09 .10 .48** .51** .51** .05 -.51** .03 -.02 .16 STATIN DC .02 -.10 -.13 -.04 -.08 -.08 .07 .08 -.24 -.30* -.14 STATIN F/U -.07 -.22 -.01 .32* .11 .11 .09 -.11 .02 -.07 .14 BB D/C -.01 -.17 .08 .19 .00 .00 -.05 -.12 -.19 .01 .25 BB F/U .17 -.17 .07 -.08 -.15 -.15 .12 .15 -.13 -.06 .20 ACE D/C -.03 -.15 -.05 .17 .26* .26* -.19 -.1 -.08 .10 .14 ACE F/U -.13 -.07 -.12 .20 .32 .32 -.03 -.01 .06 .03 .02

Note. PA = physical activity; CR = cardiac rehabilitation; HbA1C = glycosylated haemoglobin; ASA = aspirin; DC = discharge; F/U = follow-up; BB DC = beta- blocker use at discharge; BB F/U = beta- blocker use at follow-up; ACE D/C = angiotensin- converting enzyme inhibitor use at discharge; ACE F/U= angiotensin- converting enzyme inhibitor use at follow-up; ANGIO = angiogram; PTCA = percutaneous transluminal coronary angioplasty;. MI = myocardial infarction; TRIG ADM = triglyceride blood level during admission; BS ADM = blood glucose during admission; STATIN ADM = statin use on admission. * p < .05, ** p < .01

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Development and Testing of a Nurse Practitioner …...Patients with acute myocardial infarction...

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