Barriers and Facilitators to Early Physical Rehabilitation in ......understanding barriers and...

Barriers and Facilitators to Early Physical Rehabilitation in Mechanically Ventilated Patients

by

Shannon Lynn Goddard

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

Institute of Health Policy, Management and Evaluation University of Toronto

© Copyright by Shannon Lynn Goddard 2017

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Barriers and Facilitators to Early Physical Rehabilitation in

Mechanically Ventilated Patients

Shannon Lynn Goddard

Doctor of Philosophy

Institute of Health Policy, Management and Evaluation

University of Toronto

2017

Abstract

Background: Physical rehabilitation strategies, when initiated in critically ill patients, may

improve functional outcomes of survivors and may shorten duration of mechanical ventilation

and ICU length of stay, although evidence is conflicting. Despite some conflicting evidence, it

has been recommended in clinical practice guidelines, but not been consistently implemented

in critical care units. The implementation of complex interventions in healthcare is challenging,

but may be improved using theory to understand barriers and facilitators, and ultimately to

design interventions. The Theoretical Domains Framework (TDF) is a framework based on

health psychology that was designed to improve implementation of evidence based practice.

Methods: This dissertation describes a series of projects, based on the TDF, and aimed at

understanding barriers and facilitators to early physical rehabilitation in mechanically ventilated

patients. First, a systematic review of the literature, using the TDF to synthesize barriers and

facilitators was done. The following two research chapters describe a Delphi study of nurses,

physical and occupational therapists, respiratory therapists and physicians. The first round of

the Delphi consisted of semi-structured interviews. With the TDF, a theoretically driven topic

guide was developed and interviews analyzed using a theory-driven content analysis. The

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following rounds of the Delphi consisted of agree/disagree questions with a Likert scale, based

on Round 1 results that were reviewed and prioritized by the research group.

Results: The systematic review of the literature found that there was a general lack of theory in

assessing barriers and facilitators. Using the TDF to synthesize, we found a significant focus on

the domains of Behavioural Regulation, Environmental Context and Resources and Beliefs

about Consequences. The Dephi study confirmed these findings, although also found a focus

on the domains of Skills, Social and Professional Role, Beliefs about Capabilities, Social

Influences, Knowledge and Optimism.

Conclusion: A theoretically driven approach found a broader range of barriers and facilitators,

and provided a valuable tool for synthesis and organization. Further research should use these

findings to link to behaviour change techniques in designing interventions of early rehabilitation

in mechanically ventilated patients.

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Acknowledgments

I would first like to thank my thesis advisor, Dr. Brian Cuthbertson for his guidance and

availability in steering this work. I would also like to thank the rest of my thesis committee –

Professor Jill Francis, Dr. Eddy Fan and Dr. Gordon Rubenfeld for their valuable contributions

throughout this process.

I would also like to thank our collaborators on this work – Dr. Fabiana Lorencatto, Dr. Louise

Rose, Dr. Michelle Kho, Dr. Dale Needham and our research assistant, Ms. Ellen Koo. Dr.

Lorencatto, in particular, provided extensive and patient support to me in my initial

understanding of the Theoretical Domains Framework. Additional thanks to Dr. Andrea Patey,

who reviewed our topic guide.

We could not have done this work without the participants, who generously gave their time to

participate in the Delphi study.

This work was funded by an operating grant from the Canadian Institutes for Health Research

and support by the Canadian Critical Care Trials Group. Multiple organizations allowed us to

contact their members for participation in the Delphi – the Canadian Critical Care Trials Group,

the Canadian Association of Critical Care Nurses and the ICU Recovery Network.

Specific contributions are described in the body of the thesis, using initials (Shannon Goddard –

SG, Brian Cuthbertson – BH, Jill Francis – JF, Fabiana Lorencatto – FL, Ellen Koo – EK, Andrea

Patey – AP).

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Table of Contents

Contents

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

Chapter 1. Introduction to Thesis ............................................................................................................ 1

1.1. Burden of Critical Illness and Survivorship .................................................................................... 1

1.2. Rehabilitation in Critical Illness...................................................................................................... 1

1.2.1. ICU-Acquired Weakness ........................................................................................................ 1

1.2.2. Prevention and Management of ICU-Acquired Weakness .................................................... 2

1.2.3. The Evidence regarding Benefits and Risks of Early Rehabilitation ...................................... 3

1.3. Knowledge Translation Challenges and Early Rehabilitation ........................................................ 4

1.3.1. Knowledge Translation in Healthcare and Critical Care Medicine ........................................ 4

1.3.2. Complex Interventions in Healthcare – The Example of Early Rehabilitation....................... 5

1.3.3. Early Rehabilitation as an Exemplar Complex Intervention .................................................. 6

1.4. Studying Clinician Behaviour ......................................................................................................... 8

1.4.1. The Argument for a Theory Driven Approach ....................................................................... 8

1.4.2. The Theoretical Domains Framework.................................................................................... 8

Chapter 2. A Systematic Review and Theory-Driven Analysis of the Barriers and Facilitators to Early

Rehabilitation in Critically Ill Patients .......................................................................................................... 17

2.1. Background .................................................................................................................................. 17

2.1.1. Post-Intensive Care Syndrome ............................................................................................ 17

2.1.2. Early Rehabilitation in Critical Illness ................................................................................... 17

2.1.3. Barriers to Evidence-Based Practice .................................................................................... 18

2.1.4. Barriers to Early Physical Rehabilitation .............................................................................. 18

2.2. Methods ....................................................................................................................................... 19

2.2.1. Inclusion and Exclusion Criteria ........................................................................................... 19

2.2.2. Search Strategy .................................................................................................................... 19

2.2.3. Analysis ................................................................................................................................ 20

2.3. RESULTS ....................................................................................................................................... 21

2.4. DISCUSSION ................................................................................................................................. 23

Chapter 3. Barriers and Facilitators to Early Rehabilitation in the Intensive Care Unit – A Theory

Driven Interview Study ................................................................................................................................ 47

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3.1. Background .................................................................................................................................. 47

3.1.1. The Consequences of Critical Illness .................................................................................... 47

3.1.2. Knowledge Translation and Early Rehabilitation ................................................................. 48

3.1.3. The Theoretical Domains Framework and Complex Interventions ..................................... 48

3.1.4. Study Question .................................................................................................................... 49

3.2. Methods ....................................................................................................................................... 49

3.2.1. Study Design ........................................................................................................................ 49

3.2.2. Participants .......................................................................................................................... 49

3.2.3. Development of Topic Guide ............................................................................................... 50

3.2.4. Analysis ................................................................................................................................ 51

3.2.5. Ethical Considerations ......................................................................................................... 53

3.3. Results .......................................................................................................................................... 53

3.3.1. Participants .......................................................................................................................... 53

3.3.2. Inter-Rater Reliability ........................................................................................................... 53

3.3.3. Results by Domain ............................................................................................................... 53

3.3.4. Domains of Lower Importance ............................................................................................ 56

3.3.5. Differences Between Professional Groups .......................................................................... 56

3.4. Discussion .................................................................................................................................... 57

Chapter 4. Barriers and Facilitators to Early Rehabilitation in the Intensive Care Unit – A Theory

Driven Delphi Study ..................................................................................................................................... 79

4.1. Introduction ................................................................................................................................. 79

4.1.1. Introduction to Delphi Methodology................................................................................... 80

4.1.2. Study Aim ............................................................................................................................. 81

4.2. Methods ....................................................................................................................................... 81

4.2.1. Study Design ........................................................................................................................ 81

4.2.2. Sampling and Participants ................................................................................................... 82

4.2.3. Delphi Rounds ...................................................................................................................... 82

4.2.4. Item Development ............................................................................................................... 84

4.2.5. Analysis ................................................................................................................................ 84

4.2.6. Ethical Considerations ......................................................................................................... 85

4.3. Results .......................................................................................................................................... 85

4.3.1. Participants .......................................................................................................................... 85

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4.3.2. Delphi – Overall Results ....................................................................................................... 85

4.3.3. Participant Agreement – Round 2 and 3 ............................................................................. 86

4.3.4. Participant Rating of Importance – Rounds 2 and 3 ............................................................ 86

4.3.5. Agreement - Change from Round 2 to Round 3 .................................................................. 86

4.3.6. Importance – Change from Round 2 to Round 3................................................................. 87

4.4. Discussion .................................................................................................................................... 88

Chapter 5. Synthesis ............................................................................................................................ 107

5.1. Summary of Study Results by TDF Domain ............................................................................... 107

5.1.1. Systematic Review ............................................................................................................. 107

5.1.2. Delphi ................................................................................................................................. 107

5.2. Social Influences ........................................................................................................................ 108

5.3. The Use of Theory in Implementation Science .......................................................................... 109

5.4. Early Physical Rehabilitation. Are We Ready for Knowledge Translation? .............................. 110

5.5. Conclusions ................................................................................................................................ 113

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List of Tables

Table 1.1 - Features of Key Randomized Trials in Early Physical Rehabilitation in ICU Patients ................. 14

Table 2.1 - Sample Search Strategy (English language, 2000-2015)............................................................ 28

Table 2.2- Data Elements Extracted in Systematic Review (from Cochrane et al, 2007 74) ...................... 29

Table 2.3 -Characteristics of Included Studies ............................................................................................. 30

Table 2.4 - Barriers and Facilitators by Theoretical Domain ....................................................................... 42

Table 2.5- Domains of the TDF by Study Included in the Systematic Review ............................................. 44

Table 3.1-Domains of the Theoretical Domains Framework and example questions from Topic Guide ... 62

Table 3.2 - Topic Guide ................................................................................................................................ 63

Table 3.3 Participant Characteristics ........................................................................................................... 67

Table 3.4 - Beliefs classified into Domains of the Theoretical Domains Framework .................................. 68

Table 4.1 - Items Included in Rounds 2 and 3 of Delphi by Domain of the TDF .......................................... 91

Table 4.2 - Participants in the Delphi Study................................................................................................ 93

Table 4.3 - Round 3– Agreement for all Items in Order of Strength of Agreement .................................... 94

Table 4.4 - Items with High Agreement (Median Score >=7) and High Consensus (>=90% of Respondents

with Agreement>=7) by TDF Domain .......................................................................................................... 98

Table 4.5 - Round 2 to Round 3 Change in Agreement ............................................................................... 99

Table 4.6 - Round 2 to Round 3 - Change in Importance .......................................................................... 101

Table 5.1 - Overview of Results by Chapter - ............................................................................................ 114

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List of Figures

Figure 1.1 Overview of delphi process ........................................................................................................ 16

Figure 2.1 – Screening and included studies for systematic review............................................................ 46

Figure 3.1 - TDF domains important in systematic review .......................................................................... 76

Figure 3.2 - Overview and example of interview coding process................................................................ 77

Figure 3.3 - Frequency of beliefs by domain ............................................................................................... 78

Figure 4.1 -TDF domains important in the semi-structured interviews .................................................... 103

Figure 4.2 Screen shot of electronic survey interface .............................................................................. 104

Figure 4.3 Participant flow through delphi ................................................................................................ 105

Figure 4.4 -Agreement change scores by professional group across all items ......................................... 106

Figure 5.1 - TDF Domains identified as important in delphi - orange domains are new domains for

Rounds 2 & 3 of Delphi, crossed out domain was identified in interviews but not Rounds 2 & 3 ........... 115

1

Chapter 1. Introduction to Thesis

1.1. Burden of Critical Illness and Survivorship

Critical illness is a significant and growing health burden across the world. Globally, it is

estimated that there are between 13 and 20 million people who require mechanical ventilation

per year 1. As the population ages and general care of medical conditions is advanced, this

number is expected to rise2. Although large, these are likely underestimates of critical illness,

since they measure use of critical care services rather than critical illness per se, which is more

challenging to measure. For example, studies of critical illness may only count patients being

treated with mechanical ventilation, which many countries cannot provide. Therefore, in these

countries, critically ill patients remain un-counted or, at best, under-estimated.

Additionally, survival from critical illness is improving, as evidenced by cohorts of patients with

specific diagnoses such as sepsis 3 and acute respiratory distress syndrome (ARDS) 4. While

better survival is certainly a worthy accomplishment, it does come with burdens to those

survivors. Specifically, survivors suffer from impaired physical function 5, cognitive deficits 6,

mental health issues such as depression 7 and symptoms of post-traumatic stress disorder 8. All

of these issues culminate in impaired health-related quality of life (HRQOL) 9,10 and caregiver

burden 11.

1.2. Rehabilitation in Critical Illness

1.2.1. ICU-Acquired Weakness

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Traditionally, the focus in the intensive care unit (ICU) has been on the period of acute illness,

with resources and efforts directed at improving survival during that period. However, more

recently, observational data has compelled clinicians and patients to consider more carefully

the long-term outcomes of ICU survivors, which can persist for many years after the period of

illness.

ICU acquired weakness (ICUAW) is a well described phenomenon during and after critical

illness, although understanding of its pathophysiology is still in the early stages of research 12.

Although almost certainly multi-factorial, with a range of described risk factors, one of the

potentially modifiable factors is immobility during critical illness 13 leading to disuse atrophy.

1.2.2. Prevention and Management of ICU-Acquired Weakness

Traditionally the period of critical illness carried with it deep sedation and consequently bed

rest. The paradigm of care from acute illness to recovery was sequential; patients who survived

their critical illness then had initiation of rehabilitation after medical recovery was complete.

However, there has been a recent paradigm shift towards lighter sedation and sedation

interruptions 14,15, spontaneous breathing during mechanical ventilation 16 and earlier initiation

of rehabilitation strategies 17.

Rehabilitation in critically ill patients is highly variable in terms of timing of initiation, duration,

dose, modality and target. For example, it may be started on or shortly after admission, or at

the time of extubation. It may (and often does) focus on physical rehabilitation, but can also

include directed cognitive rehabilitation 18. Novel modalities, such as cycle ergometers 19 or

neuromuscular stimulation have been studied recently 20. However, most studies (and most

3

ICU practice) have focused on physical rehabilitation strategies, using functional rehabilitation

techniques with a focus on mobility. “Progressive mobility” has been used to describe a graded

rehabilitation strategy that progresses through a series of functional activities, such as sitting at

the edge of the bed, transferring from bed to chair and ambulation.

1.2.3. The Evidence regarding Benefits and Risks of Early Rehabilitation

Safety and feasibility of early rehabilitation in mechanically ventilated patients have been well

established by several observational and non-randomized interventional studies in a variety of

patient groups21,22.

Current randomized trial evidence for early rehabilitation, summarized in Table 1.1, is less

robust. As demonstrated in the table, both the populations and interventions are

heterogeneous, but in general, represent ICU patients who are mechanically ventilated and

study interventions focused on functional mobility (although sometimes with the addition of

strength training) at a relatively early stage of the ICU stay (although the interpretation of

“early” varies). An early randomized trial of progressive mobility showed promise, with

improved functional outcomes at hospital discharge, fewer days of delirium and shorter

duration of mechanical ventilation 17. A small randomized study of cycle ergometry in patients

who were in the ICU at least 5 days demonstrated improved ambulation distance at hospital

discharge, improved quadriceps force and a higher score on the physical function sub-scale of

the Short-Form 36 23. A recent trial of an early rehabilitation program in a surgical ICU

demonstrated improved mobility in the ICU, shorter ICU and hospital length of stay and

improved functional status at discharge from hospital. Other trials of rehabilitation initiated in

4

the ICU and continued after ICU or hospital discharge have not confirmed these findings 24,25. A

trial comparing intensive ICU based rehabilitation to usual rehabilitation also showed no effect

26. Similarly, rehabilitation strategies initiated post-ICU have not shown benefit in clinical trials

27-29.

Despite mixed evidence about its benefit, there has been continued support for early

rehabilitation in the ICU, which is reflected in current clinical practice guidelines. For example,

the Society for Critical Care Medicine has recommended early rehabilitation as part of a

strategy to reduce delirium in critically ill patients 30. Similarly, the European Society of

Intensive Care Medicine recommends early rehabilitation, while acknowledging the limits of the

evidence 31. Most recently, the American Thoracic Society has adopted early rehabilitation as

part of guidelines to facilitate liberation from mechanical ventilation 32.

1.3. Knowledge Translation Challenges and Early Rehabilitation

1.3.1. Knowledge Translation in Healthcare and Critical Care Medicine

Healthcare continues to face challenges in the implementation of evidence. Interventions to

improve uptake of evidence based practice have progressed beyond the traditional model of

didactic continuing medical education to include audit and feedback 33, educational outreach

visits 34 and inter-professional collaboration 35, but results have been of modest effect at best

36. In critical care in particular, one single-centre prevalence study of 10 commonly accepted

ICU best practices showed rates of eligible patients receiving the interventions ranged from

8.3% (sedation interruption) to 95% (VTE prophylaxis) 37. Interventions to improve uptake of

evidence based practice in critical care have been disappointing 38.

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1.3.2. Complex Interventions in Healthcare – The Example of Early Rehabilitation

1.3.2.1. Complex Interventions and Complex Patients

Complexity in healthcare interventions is an important challenge to implementation.

Complexity may come from multiple sources – the intervention itself, the targets for delivery,

the degree to which the intervention is fixed or may be tailored and the behaviours of those

delivering or receiving the intervention 39. There may also be an interaction between the

complexity of the intervention and that of the patient. Complex patients may be thought of as

those with multi-system illness, those with multiple interacting healthcare teams and those

with constant changes in clinical condition. There may be competing risks and competing goals

depending on which aspect of the patient is being treated.

The critically ill patient may be an exemplar of complexity in the inpatient setting. Like many

medically complex patients, they often have a baseline list of medical comorbidities and receive

highly complex interventions. In addition, severity of illness adds to this, both by increasing risk

of medical interventions and by increasing the sheer number of interventions. Even an example

of a patient with pneumonia leading to septic shock and respiratory failure has multiple

elements of complexity. The patient may need intravenous fluids to improve organ perfusion,

but fluids may worsen respiratory failure. The patient may be on multiple titratable drugs that

are adjusted hourly based on moving physiological targets. Among the consequences of

complexity is the need for personalized, adaptable and titratable interventions, which may be

difficult to implement in a standardized way.

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1.3.3. Early Rehabilitation as an Exemplar Complex Intervention

Early rehabilitation has been implemented with variable success. Single centres have shown

impressive rates of uptake using locally based quality improvement interventions 40,41.

However, more broadly, implementation has been disappointing. A recent survey of

physiotherapists in the United States found that 12% of ICU therapists had no training at all for

the ICU setting and that two thirds of institutions had no guidelines for physiotherapy

consultation in the ICU 42. In a one-day point prevalence study in Australia, no mechanically

ventilated patients performed any out-of bed activities, although some did do sitting at the

edge of the bed for postural training 43. Similarly, in a German point prevalence study, 92% of

patients who were endotracheally intubated remained in bed 44.

Complexity may be a key contributor to the challenge of implementing early rehabilitation in

the ICU setting. The intervention is complex. It can include multiple components – passive or

active range of motion, in-bed or out-of bed strength training, proprioceptive training,

cardiovascular training, cognitive or task training, electrical muscle stimulation and functional

mobility training, among other things 17-20. Furthermore, these elements of rehabilitation may

not be discrete from each other, making it challenging to design a protocolized pathway and to

understand which elements are most critical. For example, for a critically ill patient, significant

cognitive focus may be required to follow a therapist’s direction during gait training, so both

physical and cognitive rehabilitation may be happening. In addition, ICU-based rehabilitation is

only a part of the patient’s rehabilitation pathway, which may include further hospital based

rehabilitation, specialized inpatient rehabilitation or outpatient rehabilitation programs.

7

Rehabilitation is also highly customized to the patient’s type and severity of illness, baseline

functional status and goals. For example, some disease states (e.g. stroke, spinal cord injury)

have well established rehabilitation teams and pathways that begin while the patient is in

hospital 45,46, while others (e.g. general medical admissions) do not. Furthermore, it may

interact with other ICU interventions, such as sedation and delirium management in its impact

on outcomes. The goals of the intervention vary widely between patients and change over time

– for some, the goal is to return home to live independently and for others, the goal is more

short-term, to be liberated from mechanical ventilation.

Early rehabilitation also relies heavily on the availability, teamwork and skill of multiple

members of the healthcare team. An apparently simple task such as assisting a patient in

pivoting from bed to a chair may involve a physiotherapist, a registered nurse, a respiratory

therapist, a service assistant and/or a physiotherapy assistant. Furthermore, the patient must

also be a motivated member of the team. Even prior to the delivery of this intervention,

multiple team members must collaborate and agree on its safety and appropriateness, while

integrating different types of clinical information, such as level of consciousness, hemodynamic

stability, cardiorespiratory reserve, muscle strength and the presence of invasive medical

devices such as central venous catheters and endotracheal tubes.

Each team member described in the clinical scenario above has different skills, knowledge and

experience, and without the full engagement of any one of them, the intervention may not

happen. Minimal data exist on the views of these multiple team members in the delivery of

early rehabilitation, but there is suggestion of discordant views between professions. In a study

8

of bedside nurses and physiotherapists, nurses were more likely to identify hemodynamic

instability and renal replacement therapy as barriers to rehabilitation, while physiotherapists

were more likely to identify neurologic status 47.

1.4. Studying Clinician Behaviour

1.4.1. The Argument for a Theory Driven Approach

Given the disappointing impact of knowledge translation interventions to date, implementation

scientists have advocated for a theory-based knowledge translation approach instead of a

“common sense” or convenience approach. They have argued that the benefit of a theoretical

approach is to improve understanding of change mechanisms, by bringing a common language

to the description of barriers, developing rational knowledge translation interventions and

allowing for building a cumulative evidence base with stronger generalization to different

settings 36,48. Use of a theoretically driven approach may also encourage a broader view of

barriers and facilitators, leading researchers and clinicians beyond the commonly cited barriers

of knowledge, training and resources.

However, a theory-based approach to implementation is often not taken. In a review of 235

studies of guideline dissemination and implementation, a wide variety of techniques was used,

generally with only modest to moderate improvement in outcomes 36,48. Of note, there were

few studies that offered any theoretical basis or other rationale for their choice of intervention.

1.4.2. The Theoretical Domains Framework

9

Health psychologists have proposed many theories to explain behaviour, including the

behaviour of health professionals in a multi-disciplinary environment, to explain why

“knowledge users” may not act in a manner consistent with evidence-based practice.

Unfortunately, these theories are numerous and often unfamiliar to front-line clinicians, who

are frequently responsible for implementation of guidelines and evidence in individual

institutions. In an attempt to create a set of theoretical domains that would be accessible to

professionals without expertise in health psychology, Michie et al. used a consensus process to

review, evaluate and consolidate existing theories of behaviour and behaviour change 49. They

ultimately agreed upon 12 key domains that could be used to guide interventions, which has

since been validated and slightly elaborated to include 14 domains although the core

components of the framework remain the same 50. This “Theoretical Domains Framework”

(TDF) has been used previously to guide research on identifying barriers to implementation as

well as to design implementation interventions, both in the ICU and other healthcare settings

51-53.

Of note, a number of other KTE frameworks exist in the literature, including the Knowledge to

Action (KTA) Cycle 54, the Consolidated Framework for Implementation Research (CFIR) 55, and

the Promoting Action on Research Implementation in Health Services Framework (PARIHS) 56.

Given the knowledge translation frameworks that already exist in the literature, it is important

to explore the strengths of the TDF, in particular relative to other KTE frameworks.

The TDF is unique in its detailed perspective on the theoretical determinants of behaviour of

healthcare professionals. Largely through the lens of health psychology, the intention of the

10

TDF is to explain why people do or do not practice in accordance with guidelines and evidence,

and ultimately, to change that behaviour if necessary. Clearly, healthcare providers are human

beings, with broad and varied backgrounds, experience, motivations and personalities. They

may interact with the health care system and evidence based practice in complex ways. The

TDF and associated instruments provide a specific framework by which to study barriers and

facilitators to behaviour.

Importantly however, the TDF is not a longitudinal or iterative implementation framework.

Unlike, for example, the KTA cycle, it is not a process map for the entire knowledge translation

process. The KTA cycle does include the assessment of barriers to knowledge use as an

important step before developing tailored interventions. However, it provides no specific

methodology or framework by which to do so. The TDF then, could be used as a method to

conduct a detailed exploration of these barriers (and facilitators) and to develop targeted

interventions.

Like the KTA, the CFIR is a longitudinal and iterative implementation framework 55. However,

unlike the KTA, the CFIR does specifically reference individuals as a domain within the process

of knowledge translation. In addition to individuals, the CFIR consists of four other domains –

the intervention, the inner and outer settings and the process by which implementation is

accomplished. As such, while including the individuals as central, the CFIR takes a broader

approach to knowledge translation than the TDF. How then (if at all) can the TDF contribute?

First, we should examine the theoretical underpinnings of the “Characteristics of Individuals”

domain of the CFIR in order to contrast it with the TDF. Within the domain, there are then a

11

number of sub-domains, which overlap somewhat with the TDF – knowledge and beliefs, self-

efficacy, individual identification with organization and “other personal attributes”.

Conceptually in the original paper, the authors of the CFIR focus on the importance of the

relationship of individuals with organizations in determining behaviour. Although they refer to

key theories of individual behaviour change, such as self-efficacy and stage of change, there is a

larger focus on organizational theory as it pertains to individuals.

Like the KTA, the CFIR does not provide significant direction in terms of methods to measure or

change behaviour of individuals. This is not a criticism of either model, as both serve an

important role that the TDF cannot. First, as with the KTA, the models may be used together,

with the TDF being used to provide a detailed evaluation of the role of individuals. Secondly,

the models may be used for different problems. The CFIR may be most helpful in situations

where a practice is being implemented across different sub-units within an organization and

where organizational theory is most relevant. For example, a hospital may wish to implement

best practice guidelines around patient flow within a hospital to reduce time spent in the

emergency department or recovery room while waiting for an inpatient bed. Given the

complexities of patient flow across many levels of an organization, organizational theory may

be more relevant than theories of individual behaviour. Conversely, the TDF may be most

helpful where an intervention is highly dependent on individual behaviour and has a significant

volitional component. In our example of the implementation of early rehabilitation or mobility,

individual providers make frequent decisions daily about whether to, or how to provide

rehabilitation to a patient.

12

The PARIHS model 57, which has been explored in a number of other conceptual papers, is

based on three core elements – evidence, context and facilitation. In this model, individual

healthcare providers are not named as a core component, although it may be implied within

parts of the core elements. The PARIHS model has a weaker conceptual basis than either the

TDF or the CFIR, both of which are based on rigorous literature reviews and existing theory. In

contrast, the PARIHS model was originally developed on the basis of “experience within the

team, working with clinicians (mostly nurses) in helping them to improve the quality of their

care by setting clinical standards, introducing audit and quality improvement and in changing

patient services in several community hospitals in one health authority,” and illustrated using a

number of case examples 56. Although a number of further papers have attempted to improve

the conceptual basis of this framework, criticism continues that constructs between domains

are overlapping (e.g. culture and cultural boundaries) and lack conceptual clarity 58. Given the

already overlapping constructs within the PARIHS model, combining it with another approach

seems likely to create confusion.

To summarize, unlike the KTA and CFIR, the TDF does not provide a complete implementation

framework. In some cases, its role may be to provide a detailed evaluation of a component of

one of the steps of the KTA or domains of the CFIR. It does have a strong theoretical

background, based on rigorous literature review and validation exercises, a shortcoming of the

PARIHS model.

13

Given the importance of clinician behaviour in implementing evidence based practice, we have

chosen to use the TDF to study clinician behaviour in early rehabilitation. As stated by

Greenhalgh 59,

“People are not passive recipients of innovations. Rather… they seek innovations,

experiment with them, evaluate them, find (or fail to find) meaning in them, develop

feelings (positive or negative) about them, challenge them, worry about them, complain

about them, ‘work around’ them, gain experience with them, modify them to fit

particular tasks, and try to improve or redesign them – often through dialogue with

other users.”

With its health psychology lens focused on behaviour, the TDF is ideally suited to examine

clinician perspectives of barriers and facilitators and will form the theoretical basis of the

projects contained in this dissertation. The chapters consist of a systematic review (Chapter 2)

and a Delphi study consisting of a qualitative Round 1 (Chapter 3) and quantitative Rounds 2

and 3 (Chapter 4). The Delphi study is described in general in Figure 1.1 and specifically in

Chapter 4.

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Table 1.1 - Features of Key Randomized Trials in Early Physical Rehabilitation in ICU Patients

Study Population* Intervention Content Intervention Timing

Control Primary Outcome

Schweickert 17

Medical ICU patients, in ICU <72h, expected to be at least another 24h

OT/PT delivered progressive mobility protocol starting with passive ROM and progressing to ambulation

Start: ICU stay End: Hospital discharge

Usual care Number of patients returning to independent function at hospital discharge (defined as ability to perform 6 ADLs and walk independently)

Burtin 23 MICU or SICU patients, ICU stay ≥ 5d and ICU LOS anticipated to be ≥ 7 more days

Passive or active bed based cycling intervention 5 days per week

Start: in ICU (at least 5 d into stay) End:

Standard passive ROM and mobility program.

6MWT at hospital discharge.

Moss 26 ICU patients with ≥ 4d of MV

Progressive program of breathing, ROM, muscle strengthening, core mobility and strength, functional mobility training. 30 min/d PT sessions in ICU and 60 min/d on ward/outpatient setting, 7d/wk in inpatient setting.

Start: in ICU End: 28 days after randomization or until successful completion of program (could take place on ward or home as needed)

ROM and functional mobility retraining 3 d/ wk. Continued up to 28d or to hospital discharge

Physical function (using short form of the Continuous Scale Physical Functional Performance Test) at one month

Denehy 24

ICU stay ≥ 5d Individualized training program based on baseline using mix of functional and strength training and cardiovascular training (cycle ergometer). In ICU: 15 min/d while on MV, 15 min 2x/d off MV. On ward, 2x 30

Start: ICU End: 8 weeks after discharge home

Respiratory and mobility training according to “usual unit protocols”.

6MWT at 6 months

15

Study Population* Intervention Content Intervention Timing

Control Primary Outcome

min/d. Outpatient: 60 min 2x/wk x 8 wks.

Morris 25 P:F ratio <300 Intensive graded physical therapy regimen including PROM, PT and resistance training

Start: ICU End: Hospital discharge

Usual care Hospital length of stay

Schaller 60 SICU patients, MV < 48h and expected to need MV at least 24H from time of enrolment

Progressive mobility protocol starting with PROM and progressing to ambulation. Daily mobilization goal and closed-loop team communication

Start: ICU End: ICU discharge

Usual care Mean SOMS level patients achieved during their SICU stay

*Note that all studies have some mix of common exclusion criteria (moribund/not expected to survive, not functionally independent prior to

admission, etc.)

OT - occupational therapy, PT – physical therapy, PROM – passive range of motion, 6MWT – six minute walk test, PCP – primary care provider,

SICU – surgical ICU patients, SOMS – SICU optimal mobilization score

16

Figure 1.1 Overview of delphi process

Research Question

Selection of Experts

Delphi Round 1

Delphi Round 2

Delphi Round 3

Delphi Round 4

What are the important barriers to early

rehabilitation in patients on invasive

mechanical ventilation in the ICU?

ICU physicians

ICU nurses

ICU rehabilitation professionals

(physiotherapists and occupational

therapists)

ICU respiratory therapists

Item generation for future rounds –semi-

structured interviews based on theoretical

domains framework

Web-based questionnaire of items

generated from analysis of Round 1 data.

Each item phrased as two paired

statements: (1) agree/disagree statement,

(2) assessment of importance. Participants

will rate level of agreement with both

statements on 9-point Likert scale

Feedback of results of Round 2 to

participants in the form of summary

statistics (median and interquartile range)

for each item. Repeat of item rating in

Round 2

Evaluate responses for degree of agreement

and stability

17

Chapter 2. A Systematic Review and Theory-Driven

Analysis of the Barriers and Facilitators to Early

Rehabilitation in Critically Ill Patients

2.1. Background

2.1.1. Post-Intensive Care Syndrome

Survivors of critical illness suffer from “post-intensive care syndrome”61, a syndrome which

includes physical deficits 5,62, cognitive impairments 6, mental health challenges 63,64 and

reduced quality of life 10.

The physical impairments, which include intensive care unit-acquired weakness (ICUAW) and

impaired physical function, present significant challenges for patients, who have survived an

episode of life threatening illness, only to find themselves unable to perform physical tasks

without difficulty. These deficits are likely multifactorial, but are likely at least in part due to

immobility during the ICU stay. While some patients are likely too ill to be safely mobilized or

have injuries or medical conditions precluding many physical rehabilitation strategies, being

critically ill, or indeed mechanically ventilated, is not in and of itself a contraindication.

2.1.2. Early Rehabilitation in Critical Illness

18

Early rehabilitation in critically ill patients is a growing area of research. Early studies

demonstrate safety and feasibility 22,65,66, and two randomized trials have demonstrated

effectiveness in improving functional status17 and six-minute walk 23 at hospital discharge.

Furthermore, at least in the United States, there is some evidence of cost-effectiveness 67.

Interestingly, as discussed in the introductory chapter of this thesis, more recent studies24-26

have failed to show an effect, although in one trial, the investigators were unable to recruit to

their planned sample size 24. Although the field is still early in developing evidence, early

mobility has been adopted in evidence-based guidelines 30,32. Despite evidence and guidelines

supporting its use, several point prevalence studies have demonstrated low rates of

implementation of early physical rehabilitation in critically ill patients 42-44,68,69.

2.1.3. Barriers to Evidence-Based Practice

Understanding why clinicians adhere to guidelines and follow evidence-based practice is a

complex task. The assessment of barriers and facilitators is a critical first step to implementing

change and is embedded in commonly used frameworks for change and quality improvement

55,56,70. As discussed in the introductory chapter, the Theoretical Domains Framework (TDF) is a

framework based on multiple theories derived from health psychology intended for use in

implementation research 49,50. It has been used in the assessment of barriers and facilitators 51,

to develop interventions 71 and in systematic reviews 72.

2.1.4. Barriers to Early Physical Rehabilitation

19

There has been a growing interest in understanding barriers and facilitators to early

rehabilitation in the ICU setting, with clinicians and researchers working to improve

implementation locally and to produce high quality interventions for research studies. We

performed a systematic review using the TDF as a framework for synthesis, to examine the

barriers and facilitators of early physical rehabilitation strategies in mechanically ventilated

critically ill patients.

2.2. Methods

2.2.1. Inclusion and Exclusion Criteria

Eligible studies included any study reporting barriers or facilitators to early physical

rehabilitation in mechanically ventilated adult patients. For the purposes of this study, we

defined early physical rehabilitation as any intervention targeted at physical function, including

functional mobility training, cardiovascular training, strength training and range of motion. We

did not restrict based on provider profession, because in different healthcare settings, physical

rehabilitation strategies may be delivered by different providers. If both physical rehabilitation

and other strategies (e.g. cognitive rehabilitation) were part of the study, we included the

study. Because most ICUs include a mix of mechanically ventilated and non-mechanically

ventilated patients, studies could report on a mix of mechanically ventilated and non-ventilated

patients. Because of the expected heterogeneity in this area of research, studies were not

restricted on design or on level of analysis (e.g. healthcare provider, ICU or patient).

2.2.2. Search Strategy

20

The following databases covering literature relevant to multiple health professions were

searched: Medline, CINAHL, PEDRO, EMBASE, Cochrane Database of Systematic Reviews and

Cochrane Central. Two reviewers independently adjudicated application of the

inclusion/exclusion criteria. Any discrepancies were resolved by a third reviewer. In addition,

we reviewed reference lists of all included studies and review articles not included in the

systematic review. Review articles will be identified during the initial review of abstracts. A

general search strategy was developed and then adapted to the specific search terms of each

database. The strategy, along with the specific terms used in Medline is shown in Table 2.1.

Note that a term for “barriers” or “facilitators” was not included because in test searches,

known studies were missed.

2.2.3. Analysis

Data were extracted about study design, barrier methodology, conceptual framework and

study findings from each article using a tool previously described 73. The data elements are

shown in Table 2.2.

The articles were then reviewed in detail for barriers and facilitators. Barriers were defined as

any issue that interfered with rehabilitation practice in the ICU, regardless of whether the

authors specifically labelled them as barriers. Facilitators were any issues that promoted early

rehabilitation. Where studies reported successful quality improvement or implementation

strategies, elements of those strategies were reported as facilitators. Extracted barriers and

facilitators were then coded using content analysis according to domains of the TDF. Similar

items were grouped together within domains and used to inductively identify specific barriers

21

and facilitators. Where possible, similar themes were collapsed together to find similarities

between studies. For example, if a study identified “lack of high-wheeled walker” as a barrier,

this was coded under the domain of “Environmental Context and Resources”, with the specific

theme being “adequate or specialized equipment”. Because conceptually, the same item could

be either a facilitator or barrier if present or absent, both were included together.

Because the studies were anticipated to be of heterogeneous study designs, no specific

instrument was used to assess quality and quantitative meta-analyses were not done.

However, studies were evaluated for the use of a published theory or conceptual framework to

assess barriers and facilitators, which can be used to link barriers and facilitators to

implementation interventions 74.

2.3. RESULTS

In total, 38 articles met the inclusion criteria. Details of screening articles are shown in Figure

2.1. Study characteristics are shown in Table 2.3. As shown in Table 2.3, the studies used a

variety of study designs. Nine were cross-sectional studies, using survey methods, either

measuring institutional practice, clinician practice and perceptions or both 42,68,75-81. The rest of

the studies were either cohort/feasibility studies (eight) 47,77,82-87, point prevalence study (one)

43, focus group (one) 88 or semi-structured interviews (three) 89-91. Of note, four publications

described different aspects of two distinct quality improvement interventions 40,92-94. Sixteen of

the thirty-eight publications described a quality improvement study, 15 of which were single

22

centred 41,90,92,93,95-103 and two multi-centred 104,105. Most studies (27 of 38) did not report using

a guiding theory or conceptual framework.

Authors used a variety of methods to identify barriers and facilitators, including survey

42,68,75,76,78-81,92,96,100,105,106 or interview of healthcare providers (individually or in groups) 88-91

and prospective or retrospective patient level data collection from chart review or real-time

clinician report 43,47,77,83-85,87,97,107. Some studies, particularly quality improvement studies,

reported on barriers identified through a multi-modal method, using formal and informal

processes such as staff surveys 42,68,75,76,78-81,92,96,100,105,106, staff interviews 88-90,92,105 and inter-

professional team meetings 40,99. The degree of detail in description of these methods was

variable between studies. Some publications focused on the implementation process and its

results 40,41,82,86,98,101,103, providing less detail on the method by which barriers and facilitators

were identified.

Specific barriers and facilitators are shown in Table 2.4 by domain of the TDF. The domains of

Beliefs about Consequences, Environmental Context and Resources and Behavioural regulation

had the highest number of barriers and facilitators identified per domain. Certain specific

barriers and facilitators were identified in a large number of studies. Three specific items were

identified in at least 10 of the 38 publications. Eighteen studies identified “physiological

factors” (e.g. high oxygen needs or use of vasopressors) that impacted on the likelihood of

rehabilitation occurring (Beliefs about Consequences). A “culture of sedation” was also

identified in eighteen studies and a “need for adequate or specialized equipment” was noted in

13 studies (Environmental Context and Resources). The need for physician orders to allow

23

mobility were noted in eleven studies (Behavioural Regulation). Ten studies identified concern

for patient safety (Beliefs about Consequences).

Other barriers and facilitators reported in at least 5 of the 37 publications were staff education

(Knowledge), mobility champions (Social/Professional Role) and belief in general benefit of

mobility (Beliefs about Consequences). Under the domain of Environmental Context and

Resources, dedicated physiotherapy staff, adequate rehabilitation staff or time and a general

need for increased staffing or resources were identified in at least 5 publications. Both the

importance of leadership support and inter-professional collaboration were identified in the

domain of Social Influences. Behavioural Regulation strategies identified were the use of a

protocol and an “opt out philosophy” where an order is required NOT to have mobility rather

than the reverse.

Barriers and facilitators identified in the studies were from twelve of the fourteen domains of

the TDF. The only domains in which barriers and facilitators were not identified were Optimism

and Emotion. Domains represented in the included studies are shown in Table 2.5. Three

domains were identified in the majority of publications – Beliefs about Consequences,

Environmental Context and Resources and Behavioural Regulation.

2.4. DISCUSSION

This systematic review is the first to use a theoretical framework to analyze the barriers and

facilitators to early mobilization in the ICU in the published literature. Using the TDF, we found

that barriers and facilitators were commonly identified within the domains of Beliefs about

Consequences, Environmental Context and Resources and Behavioural Regulation and that no

24

identified barriers and facilitators were identified within the domains of Optimism or Emotion.

Specific barriers and facilitators were identified in a large proportion of studies. In particular,

patient safety (e.g. device removal) and concern about physiological deterioration were noted

very frequently. Additionally, we found that access to adequate resources (staff and

equipment) were reported very frequently, as was a culture of high sedation use. Issues

around patient safety or physiologic tolerance and resource limitations are in keeping with prior

literature 108.

Using the TDF has important advantages. First, barriers and facilitators can be complex, and

authors may not use consistent terminology. The TDF provides a way to synthesize results from

different study designs using common terminology and a framework by which to organize them

and group “like with like”. Second, and most importantly, it may provide a link between

barriers and behaviour change techniques, as demonstrated by Cane and colleagues 74,109. For

example, techniques aimed at education or information distribution may be most helpful where

Beliefs about Consequences are identified as barriers, particularly if specific incorrect beliefs

can be corrected. Conversely, educational interventions are unlikely to be helpful when

procedural issues, such as the requirement for a physician order to mobilize are barriers.

Early physical rehabilitation is a labour-intensive task for bedside clinicians, especially when the

patient is mechanically ventilated. It usually involves multiple team members, often for a

protracted amount of time, and requires rehabilitation equipment, so the frequent

identification of barriers within the domain of Environmental Context and Resources is not a

surprise. Additionally, despite evidence that adverse effects are very rare 110, clinicians still

25

have concerns about risk to the patient and most data about safety comes from expert centres.

Risks of physiological deterioration or risk of dislodgement of medical devices were commonly

cited barriers in the reviewed studies.

Interestingly, barriers and facilitators also fell commonly within the domain of Behavioural

Regulation. Behavioural Regulation is defined conceptually in the TDF literature as “Anything

aimed at managing or changing objectively observed or measured actions 49,50. The frequency

of identification of this domain may be because quality improvement studies often include the

creation of processes that aim to create situations where performing the behaviour is easier.

For example, a number of studies identified the use of a protocol guiding the rehabilitation

process as a facilitator (or barrier, when absent). They also identified one specific structural

process, the need for a physician order, as a common barrier to carrying out rehabilitation.

Very few of the studies in this review used any conceptual or theoretical model to guide their

evaluation or intervention. Similar to conventional medical sciences, where new pharmacologic

agents are based on sound theory and understanding of mechanism of action, interventions to

change behaviour should be based on theory, which may originate in psychology, sociology or

organizational theory 111 112.

This review contained a high proportion of quality improvement studies. Quality improvement

studies can provide very important granular data about barriers and facilitators that can be

helpful in understanding behaviour. They are, by nature, different from other published

research studies. First, they are customized to the local setting and so may suffer from a lack of

generalizability to other contexts. Unfortunately, adequate details about the study setting are

26

often not provided to allow the reader to understand generalizability. For example, in early

rehabilitation, it might be important to understand staffing models and staffing ratios, which

can vary widely between ICUs. Secondly, they are usually iterative in nature and may evolve

rapidly as a priority over documentation of methodology. As a result, published reports of

quality improvement projects may involve the best recollection of the writers rather than a

reporting of an a priori protocol that might be used in clinical research.

In addition, quality improvement research may be particularly subject to publication bias.

Publication bias in quality improvement work may have a number of root causes. Like other

areas of research, interventions that are not effective are less likely to be published than those

that were effective. Often, those who undertake local quality improvement work are front line

clinicians with little time to do the QI work. Perhaps most importantly, most quality

improvement work is done to improve local quality and academic publication was never

intended as part of its output.

In addition, quality improvement may suffer from biased or selective reporting. In this review,

some studies reported a narrative of their quality improvement process with information about

facilitative elements of the intervention, with before and after patient level data to

demonstrate increased uptake. Implied in developing the intervention is some evaluation of

barriers and perhaps selection of the barriers on which to focus, but in some cases, the process

was not described. Quality improvement studies can be of high quality and can provide

detailed information on barriers and the process by which they were identified. Published

guidelines are available to direct authors in reporting quality improvement research113.

27

In summary, there were a large number of studies using a variety of methods identified in this

systematic review. The studies rarely used a guiding theory or conceptual framework, which

may limit the ability to design effective interventions. Future research should focus on sound

assessment of barriers and facilitators using a guiding theory and development of interventions

that link to behaviour change techniques. Authors reporting quality improvement studies

should follow the SQUIRE guidelines in reporting quality projects for publication 113.

28

Table 2.1 - Sample Search Strategy (English language, 2000-2015)

Concept Synonyms MeSH Terms Free Text Search Terms

Critical illness Intensive care, intensive care

units, ICU, critical care,

critical care units, critical

illness, critically ill, critical

condition

“Intensive Care”,

“Intensive Care

Units, “Critical Care”,

“Critical Illness”

“Intensive care”, “ICU”,

“critical care”, “critical

illness”, critical

condition”

Rehabilitation Rehabilitation, mobility,

ambulation, physiotherapy,

physical therapy, physical

modalities, mobilization,

mobilization

“Rehabilitation”,

“Rehabilitation

Nursing”, “Physical

Therapy Specialty”,

“Physical Therapy

Modalities”

“rehabilitation”,

“physiotherapy”,

“physical therapy”,

“mobility”,

“mobilization”,

“mobilisation”,

“occupational therapy”

29

Table 2.2- Data Elements Extracted in Systematic Review (from Cochrane et al, 2007 74)

1. Overall Goal Larger purpose that motivates the study (develop an intervention,

test a theory, increase knowledge).

2. Clinical Problem The aspect of clinical practice being investigated (e.g., diabetes

management, hypertension). Answers the question, “Barriers to

improving practice related to what?”

3. Purpose of Study Stated purpose of the study.

4. Conceptual Framework The theories, models, and typologies used to inform the design of

the study. May be formal or informal, explicit or implicit

5. Hypotheses Formal or informal statements about what the researchers expected

to find.

6. Barrier Methodology General descriptions of methods and techniques used to identify the

barriers.

7. Instrument Characteristics Description of any instrument used to gather data about barriers.

Includes elements of instrument not specifically related to barriers.

May be a survey, list of questions used by interviewers, or

something else.

8. Instrument Development. Process by which the instrument for assessing barriers was

developed

9. Intervention If the barrier assessment was preliminary to an intervention, what

was the intervention?

10. Intervention Intervention planning process: What was the larger process (actual,

implied, assumed) of which barriers assessment-planning Process

was a part? How did the findings related to barriers get translated

into an intervention?

11. Sampling How the sample for the study was selected.

12. Subjects Description of the population of subjects for the study and who

participated.

13. Analysis The strategies and techniques used to analyze the data relating to

barriers.

14. Findings The results of the study.

30

Table 2.3 -Characteristics of Included Studies

Reference Study Design Study Purpose/Aim Conceptual Framework or Theoretical Basis

Method of Assessing Barriers and Facilitators

Sampling/Subjects

Abrams 82, United States

Single centre feasibility study

Single center study of early mobilization in ECMO patients

None stated Program level description of mechanisms to increase mobility

Consecutive patients who received physiotherapy Receiving ECMO as a bridge to recovery or transplant (N=35)

Appleton 75, Scotland

Multi-centre survey To identify the perceived barriers to the provision of rehabilitation within Scottish ICUs

None stated Telephone survey No data provided on instrument development

Lead physicians (n=22, response rate 98%) and lead physiotherapists (n=23, response rate 100%) from all ICUs in Scotland.

Bahadur 95, United Kingdom

Single centre quality improvement study

To facilitate local quality improvement in early rehabilitation in critical care

None stated Prospective recording by clinicians of reasons for non-delivery of mobilization

Consecutive patients with tracheostomy in single ICU during 4-month study period (n=30)

Bakhru et al. 76, United States

Multi centre survey/ “environmental scan”

To evaluate “environmental factors” that influence early mobility

None stated Telephone survey using self-report of local practices by nurse leaders

Random selection of US hospitals stratified by regional density of hospitals and hospital size. (N=500)

31



Sampling/Subjects

Balas et al. 92, United States

Single centre, multi-unit quality improvement project

To identify factors impacting on implementation of ABCDE bundle and to evaluate effectiveness of bundle implementation

Consolidated Framework for Implementation Research 55

Multiple - focus groups, online surveys, on-line evaluation of education

Complete sample of all staff members of inter-professional team from five adult ICUs (220 RNs, 70 RTs, 5 pharmacists, 2 PTs, 4 NPs, 1 PA, 17 attending MDs and 9 critical care fellows). Note that not all subjects participated in all methods of assessing barriers and facilitators.

Balas et al. 93, United States

Single centre, multi-unit cohort study (before/after)

To evaluate safety and effectiveness of ABCDE bundle and to identify “pitfalls” affecting implementation

Consolidated Framework for Implementation Research 55

Before after evaluation of implementation strategy

Consecutive patients before and after implementation of ABCDE bundle. Adult patients admitted to a medical or surgical ICU, including mechanically ventilated and non-mechanically ventilated patients. (N=146 pre and 150 post).

32



Sampling/Subjects

Barber 89, Australia

Single centre focus group study

To determine barriers and facilitators of early mobilization in the ICU

None stated Discipline specific focus groups, transcripts analyzed using content analysis approach

Physicians (12), nursing (6), physiotherapists (7)

Bassett 104, United States

Multi-centre quality improvement project

To introduce an evidence-based progressive mobility program while simultaneously addressing cultural change in the ICU

None stated Monthly “Coaching and Strategy” calls including discussion of potential barriers as well as solutions/elements of innovation (“facilitators”)

Representatives from 13 ICUs in 8 hospitals

Berney 83, Australia

Single centre cohort study (nested from intervention arm of RCT)

To report the safety and feasibility of providing exercise training for patients who survive critical illness

None stated Prospective recording on case report forms of reasons sessions not completed

All potential mobility patient-sessions in intervention arm of an RCT (n=74)

Berney 43, Australia and New Zealand

Multi-centre point prevalence study

To document current PT mobilization practices in ICU patients, with a focus on those requiring >48 h of MV

None stated Point prevalence study of patients based on mobility in last 24 hrs. Collected by chart review using 30-item CRF completed by a research nurse or physiotherapy.

All admitted adult patients in an ICU at a pre-specified time point. (N=514, from 38 ICUs)

33



Sampling/Subjects

Carrothers et al. 105, Unites States

Multi-centre quality improvement project

To identify barriers and facilitators to implementation of ABCDE bundle

Multiple (use of AHRQ and RAND Success Factors in survey)

Multiple - Gap analyses submitted by hospitals, site visits/interviews with staff, online staff survey, self-reported processes

Sampling not described specifically. Nurses, physicians, respiratory therapists, physical therapists, occupational therapists, QI/management team, physician assistants, nurse practitioners. (N=81 (from 4 hospitals))

Castro et al. 96, United States

Single centre quality improvement project

To assess and change mindset of staff towards mobilization

Plan, Do, Study, Act (PDSA)

Survey of staff pre-intervention, 6 months after implementation and 1 year after implementation, other barriers identified but methodology not specified.

Survey sent to all nurses in surgical intensive care unit (N=37, 34, 36; pre, 6 months post and 1 year post out of 56 nurses sent survey)

Dammeyer et al. 97, United States


To implement early mobility

Iowa Model of Evidence Based Practice 114

Multiple - review of charts in previous year, review of PT data for reasons PT not delivered if criteria met to participate previously, description of challenges and successes during implementation process

Not described

34



Sampling/Subjects

Drolet et al. 98, United States


To improve rates of mobilization to ICU and intermediate care unit patients

“Plan-Do-Check-Act”

Before after evaluation of implementation strategy

Consecutive patients for 3 months pre-implementation and for 6 months post-implementation with ICU stay >72 hrs, (N= pre and 784 post)

Eakin et al. 90, United States

Single centre qualitative interview study

To identify “sustaining” factors supporting a program of early mobilization at a single centre

CFIR Semi-structured interviews based on CFIR domains

Purposive sampling for clinician category, experience and other demographics; included rehabilitation professionals, physicians, nurses, respiratory therapy, coordinator and PA (N=20)

Engel et al. 99, United States


To establish a PT led early mobility program in the ICU and to achieve benefits described in the literature by physician-led programs

None stated Multiple – barriers identified during implementation through inter-professional meetings of team leading implementation. Also reported outcomes of implementation strategy at level of the patient (e.g. days to first physical therapy, distance walked)

All patients receiving PT, (N=179 (2009), N=294 patients (2010)). (Note that implementation outcomes measured in terms of patients but reported barriers include more informal assessment throughout implementation process)

35



Sampling/Subjects

Garzon-Serrano 47 United States

Single centre cohort study

To measure mobility and barriers

None stated Prospective recording by clinicians of barriers

Consecutive patients admitted to surgical ICU in one month (n=63)

Harris et al. 100, United States


To describe a local QI initiative in multiple ICUs within one hospital

None stated Discussion during meetings with RTs and nurse managers and physiotherapy, anonymous email survey to staff

Complete sample of critical care RT and nursing staff (for email survey). (N=32, response rate, characteristics of respondents not described)

Harrold 84 Australia and Scotland

Multi-centre observational cohort study

To identify barriers to mobilization in Australian and Scottish ICUs

None stated Prospective recording by treating physiotherapist for each patient day. Used pre-defined list of barriers and free-text. Local piloting of instrument

Mechanically ventilated patients in 10 ICUs in Australia (n=659) and 9 ICUs in Scotland (n=171)

Hildreth et al. 101, United States

Single centre local quality improvement study

To increase ordering of physical therapy and rates of mobilization using a protocol and computerized order entry in a surgical intensive care unit

None stated Before after evaluation of implementation strategy

Consecutive patients meeting eligibility criteria before and after intervention (N=50 pre and N=50 post; all surgical patients)

36



Sampling/Subjects

Hodgin et al. 68, United States

National survey To document current PT practice in ICU patients, and clinical factors predicting PT practice

None stated Paper mailed survey using clinical scenarios with varied admitting diagnoses to establish predictors of physiotherapy practice. Also asked questions re: demographics of hospital and PT staffing.

Mailed survey to all members of acute care section of American Physical Therapy Association (N=490 PTs (response rate 50%))

Holdsworth et al., Australia 91

Cross-sectional survey

To identify attitudinal, normative, and control beliefs toward mobilizing ventilated patients in the ICU

Theory of Planned Behaviour

Electronically administered 9-item elicitation questionnaire

Snowball sampling of inter-professional team in a single ICU (N=22). Questionnaire sent to inter-professional team but demographic data not collected to maintain confidentiality.

Jolley et al. 78, United States

Multi-centre cross sectional study

To document physical therapy practice and “process of care” factors associated with that practice

None stated Telephone survey of hospital/ICU level process factors and specific questions about sedation and staffing as barriers as well as a question about the "biggest barrier" faced

Single nurse manager from each medical ICU at each eligible hospital (Acute care non-children hospitals in Washington state) invited for participation. (N=47 out of 54 eligible)

37



Sampling/Subjects

Jolley et al. 77, United States

Single centre cohort study

To identify predictors of physical therapy in patients requiring mechanical ventilation for at least 14 days

None stated Retrospective chart review to identify demographics and cross sectional clinical variables (day 14) predicting mobilization

Consecutive patients meeting inclusion criteria (at least 18 yrs old, MV at least 14 d with no interruption of greater than 48 hrs). (N=175)

Jolley 106, United States

Single centre survey study

To investigate whether clinicians in MICU at one hospital are knowledgeable about barriers and to identify perceived barriers to delivery of mobility

None stated Survey – written or electronic. Used pre-populated list of potential barriers based on current known literature (different for physicians vs. nursing vs. PT) with open text option. Multiple professional inputs sought in development of instrument via focus groups.

Physicians (n=91), nurses (n=17), physiotherapists (n=12).

King 79, Canada

National survey To collect data on use of mobilization in intubated patients in ICUs in Canada

None stated Paper survey. Items developed from literature. Piloted with physiotherapists, nurses and physicians.

Survey sent to all hospitals in Canada with 10 or more ICU beds. Physiotherapists (n=81), nurses, (n=18), physicians (n=81)

38



Sampling/Subjects

Leditschke 107, Australia

Single centre practice audit

To assess frequency of early mobilization and identify barriers to early mobilization

None stated Prospective recording for each patient day by physiotherapist

Consecutive patient-days in the ICU during a 4-week audit period. Patients admitted to a mixed medical-surgical tertiary ICU (n=327 patient-days)

Malone et al. 42, United States

National survey To document current PT practice, demographics, staffing patterns, barriers to physical therapy in the ICU

None stated Paper mailed surveys consisting of demographic questions, questions about hospital staffing and training and hospital processes, questions about practice in hypothetical clinical scenarios

Mailed survey to all members of acute care section of American Physical Therapy Association (N=512, (667 surveys returned but not practicing in relevant area; response rate 29%)

McWilliams et al. 85, United Kingdom


To measure the impact of an early mobilization program on ICU length of stay and to identify barriers to mobilization

None stated Retrospective review of patient chart for patients not mobilized by day 5 of admission

Complete sample (excluding patients in ICU <48h) during a 3-month period (N=65 total; N=14 eligible but not mobilized; N=17 mobilized; N=34 not eligible to mobilize)

39



Sampling/Subjects

Miller et al. 80, United States

Multi-centre survey study

To describe implementation of components of ABCDE bundle and association with outcomes

None stated Written survey of self-reported compliance at hospital level with awakening, delirium assessment and early mobilization components of ABCDE bundle; included questions re: institutional processes regarding implementation of practices.

Convenience sample of 278 representatives of 51 hospitals attending annual meeting of QI collaborative. (N=212, 76% response rate)

Needham 40, United States


To improve physical medicine and rehabilitation service in medical ICU

Structured QI model from Pronovost 115

Small group meetings with local stakeholders and regular group meetings with multidisciplinary champions

Nurses (n=66), respiratory therapists (n=45), attending physicians (n=13), fellows (n=12), others (neurologists, physiatrists, occupational therapy/physical therapy)

Skinner 81, Australia

National survey To document prescription and measurement of exercise by physiotherapists in ICUs in Australia

None stated Survey – questions about factors affecting exercise prescription

Survey sent to one senior physiotherapist from each Australian adult ICU in the ANZICS database. N=111

40



Sampling/Subjects

Talley et al. 103, United States


To develop and implement an early mobility protocol for patients on continuous renal replacement therapy

None stated Program level narrative description of experiences while implementing program. Note that individual patients are described but not with respect to barriers.

N/A

Thomsen et al. 86, United States

Single centre cohort study (before/after with patients acting as their own controls)

To determine whether transfer of patients to a unit with a mobility protocol improved rates of ambulation

None stated Assessment of rates of ambulation before and after transfer to a unit with a mobility protocol

Consecutive patients who met criteria (respiratory failure requiring >4 d of MV, not terminally ill, not re-admitted, no neurologic disease precluding activity) (N=104)

Titsworth et al. 41, United States

Single centre cohort/QI study

To describe a mobility program for neuro ICU patients at a single centre

None stated Program level narrative description of elements felt to be important to implementation; before/after implementation data

Consecutive patients during two-week period before and after implementation (N=77 (pre) and N=93 (post))

41



Sampling/Subjects

Winkleman et al. 88, United ``States

Single centre interview study (clinicians) and patient cohort study

To examine nurse perceptions of barriers and facilitators to progressive mobility

Change framework 116

Semi-structured interviews conducted prior to any activity related to patient mobility. Topic guide constructed from pilot data from staff nurses, with content validation by content experts after guide was developed.

Convenience sample of patients from two closed ICUs involved in a larger study of mobility. Patient participants (n=49), nurse participants (n=33)

Winkleman et al. 87, United States

Cohort study single institution

Primary purpose was to measure effects of exercise, also measured reasons for delay/not doing mobility

None stated Prospective narrative recording of reasons given by bedside nursing staff if "no exercise" occurred

Consecutive patients meeting eligibility criteria (>48H of mechanical ventilated, anticipated to have at least 24 hrs more) N=75

42

Table 2.4 - Barriers and Facilitators by Theoretical Domain

Domain Specific Barrier/Facilitator

Knowledge Awareness of national/external guidelines75

Staff education as part of multimodal implementation strategy 41,90,92,98,104,105 Nursing staff education about role and skills of physiotherapist97,100

General knowledge around mobilization 81,96,105

Knowledge of ABCDE bundle92 Coaching or hands on teaching 104,105

Physiotherapist education about critical care issues42,100

Skills Inadequate “training” 42,89,91,96,105

Value of hands on “coaching” or support during mobilization 104,105 Social/Professional Role and Identity

Staff role in quality data collection 104

Creation of inter-professional teams / committees to advance early mobility41,90

Importance of a mobility “champion” 89,90,92,104,105

Explicit definition of roles for mobility (e.g. nurse responsibility, right MD for activity order) 89,96,97,103

Creation of “mobility team” with dedicated role 82,89

Role for family in goal setting 75 Difference in practice between professions in likelihood of mobility 47

Belief that mobility is outside of usual role47

Beliefs About Capabilities

Belief in own ability due to prior experience 92 Academic environment increases confidence42

Confidence improved with time/experience 92

Some patients more difficult to mobilize due to weight or high need for assistance 76,81,96

Staff empowered to modify physiologic support during mobility to maintain session without MD order 82

Beliefs About Consequences

Statement that mobility generally beneficial or non-beneficial or harmful 75,92,96,99,106

Mention of specific benefits of mobility 79,81,91,96,106

Concern re: patient safety (includes tubes/lines being pulled out) 40,77,79,81,91,94,96,100,104,106,107 Physiological factors impacting on likelihood of mobility (specific or general) 40,43,47,75,81-84,86-88,91,94-97,100,106

Diagnostic factors impacting on likelihood of mobility 42,68,79 Patient discomfort 47,81,96

Change in staff workload or increased staff stress 91,92,104,106

Risk of injury to staff 106 Belief that rest beneficial 97,104

Belief that mobility increases cost or is cost saving90,106

Reinforcement Lack of “accountability” of staff to make sure mobility happens 89,105

Using incentives to motivate staff 104 Lack of recognition for less visible parts of mobility process (e.g. preparation) 97

Intentions General expression of agreement with mobility or intention to mobilize77,81,100

Plan to mobilize patients87,88

43

Domain Specific Barrier/Facilitator Goals Explicit goal setting helpful 75,76

Collaborative team approach to goal setting (including MDs) 75,89,97

Memory, Attention and Decision Processes

Use of reminders or prompts or automatic processes to ensure evaluation by PT or to prompt progression of PTs 82,101,103,104 Staff have other priorities that compete for attention 76,96

Environmental Context and Resources

Culture generally supportive or not of mobility 75,76,90,100

Quality improvement culture 80,105 Culture of sedation of ICU patients 40,42,43,75,78,80,81,83-86,88-90,94,97,106

High staff turnover or high use of casual staff 105

Physiotherapy staff dedicated to ICU 76,90,97,99,100

Adequate funding 75 Adequate rehabilitation staff or time 42,68,75,76,81,85,89,99,104

Adequate nursing staff or time 77,104

Adequate respiratory therapy time 77

General need for increased resources or increased staffing 40,75,78,92,94,96,100,104,105

Adequate equipment or need for specialized equipment 40,75,81,82,88-

90,94,96,99,103,104,106

Characteristics of institutions – academic, size 42,78,80 Challenges in scheduling multiple staff members to be in unit and available at the same time or scheduling around patient procedure 84,100,105

General resource lack 76,84 Social Influences Importance of leadership support 40,89,92,94,105

Inter-professional collaboration and respect 41,75,91,97,100,104,105

Inter-professional communication 97,100,104 Patient refusal or engagement 75,83,87,97

Importance of physician support 92,104,105

Use of slogan to promote mobility41

Behavioural Regulation

Use of reminders or automatic processes (including by EHR) 41,82,97,105 Use of a protocol or structured program to guide mobility eligibility, progression, sedation 41,42,68,75,76,78,88,97,101

Structured inter-professional rounds 76,92,105

Need for MD order or referral to initiate mobility/ Presence of MD order restricting mobility47,88,96,97,99,104,107,40,68,81,94

Use of ABCDE approach80,97

Adopt “opt out” philosophy – where mobility is standard of care and order is required to stop (or reverse) 41,68,79,89,100

Collection and sharing of QI data with staff41,80,104

Purposeful QI intervention including inter-professional meetings 92,93,98-101,105 Rehearsing mobility 103

44

Table 2.5- Domains of the TDF by Study Included in the Systematic Review

Know-ledge

Skills Social /Professional Role and Identity

Beliefs about Capa-bilities

Beliefs about Consequences

Reinforce-ment

Intentions Goals Memory, Attention and Decision Processes

Environ-mental Context and Resources

Social Influences

Behav-ioural Regulation

Abrams et al. X X X X X

Appleton et al. X X X X X X X

Bahadur et al. X

Bakhru et al. X X X X X X

Balas et al., 2013 X X X X X X X

Balas et al. 2014

Barber et al. X X X X X X X X

Bassett et al. X X X X X X X X X

Berney et al., 2012 X X X

Berney et al., 2013 X X

Carrothers et al. X X X X X X X

Castro et al. x X X X X X X X

Dammeyer et al. X X X X X X X X

Drolet et al. X X

Eakin et al. X X X Engel et al. X X X

Garzon-Serrano et al. X X X

Harris et al. X X X X X X

Harrold et al. X X

Hildreth et al. X X X

Hodgin et al. X X X

Holdsworth et al. X X X X

Jolley et al. 2014 BMC Anesthesiol

X X X

Jolley et al. 2014 Dimens Crit Care

X X

Jolley et al., 2015 X X

King et al. X X

Leditschke et al. X X X

45

Know-ledge

Skills Social /Professional Role and Identity

Beliefs about Capa-bilities


Reinforce-ment

Intentions Goals Memory, Attention and Decision Processes

Environ-mental Context and Resources

Social Influences

Behav-ioural Regulation

Malone et al. X X X X X X

McWilliams et al. X X

Miller et al. X X

Needham et al. X X X X

Skinner et al. X X X X X X

Talley et al. X X X

Thomsen et al. X X

Titsworth et al. X X X X

Winkleman et al., 2010

X X X X

Winkleman et al., 2012

X X X X

Total studies identifying each domain

12 6 13 6 26 4 5 4 6 30 12 26

46

Figure 2.1 – Screening and included studies for systematic review

Records after duplicates removed =

1488

Records screened = 1488

Records excluded

(n = 1363)

Full-text articles assessed

for eligibility = 125

Full-text articles excluded

(n = 87)

Studies included in final

results = 38

47

Chapter 3. Barriers and Facilitators to Early Rehabilitation

in the Intensive Care Unit – A Theory Driven Interview Study

3.1. Summary of Previous Chapter

In the previous chapter, we demonstrated that the existing literature rarely includes the use of theory or

guiding frameworks. Using the TDF as a tool for synthesis, we found a heavy focus on three domains of

the TDF – Beliefs about Consequences, Environmental Context and Resources and Behavioural

Regulation, as shown in Figure 3.1. We therefore undertook a TDF-driven Delphi study to understand

whether using a theory-driven approach would identify different barriers and facilitators. Chapter 3

describes the first round of the Delphi, which consisted of semi-structured interviews with ICU clinicians.

3.2. Background

3.2.1. The Consequences of Critical Illness

Traditionally, critical illness involved a period of deep sedation and immobility. However, deep

sedation can be harmful 117,118, and critical illness is associated with significant muscle atrophy

and weakness 62,119, with survivors of critical illness frequently experiencing long lasting

physical, cognitive and psychological effects 5,6,9,10,120. Physical rehabilitation, initiated early in

the course of critical illness, is an active area of research within critical care. Observational

studies to date have demonstrated the safety and feasibility of early rehabilitation with

critically ill patients 22,24,65,110 and the successful implementation in single centres 40,94.

Furthermore, randomized trials, summarized in recent systematic reviews 121,122, as well as a

48

more recent single-centre study demonstrate improved patient-centred outcomes with early

rehabilitation strategies 123.

3.2.2. Knowledge Translation and Early Rehabilitation

Despite a small supportive evidence base and a significant push to implement such practices

31,32,124,125, uptake of early rehabilitation has been at best inconsistent. Point prevalence studies

have documented low levels of involvement of physical therapists in the intensive care unit

(ICU) and low rates of implementation of rehabilitation 42,44,68,126. Prior work studying barriers

to implementation of early rehabilitation strategies in the ICU has focused on resource issues

and concerns about patient tolerance and safety primarily from the perspective of physical

therapists and physicians, with minimal input from nurses and no input from respiratory

therapists.

3.2.3. The Theoretical Domains Framework and Complex Interventions

There is broader evidence that the translation of complex, evidence-based interventions into

clinical practice is often a slow and haphazard process 36,111. Early rehabilitation incorporates a

number of elements of complexity that may make it particularly challenging to implement – the

multiple steps involved, the involvement of multiple clinicians, the changing nature of ICU

patients and the need for real-time tailoring in the delivery of the therapy. It has been argued

that implementation and clinician behaviour change may be facilitated through the application

of theory to systematically identify the hypothesized causal mechanisms and factors influencing

clinical practice 74,127. The Theoretical Domains Framework (TDF) 49,50 of behaviour change

49

synthesizes constructs from 33 behaviour change theories into 14 ‘construct domains’, or

clusters of related constructs, that may explain practice change or, alternatively, the absence of

change (Table 3.1). It has been applied as a framework for developing questionnaires and

interview topic guides across a range of clinical contexts to systematically explore the barriers

and facilitators to clinician behaviour change 51,128. Each domain represents a range of related

constructs that may influence clinician behaviour. For example, the domain “Social influences”

encompasses overlapping constructs such as professional identity, boundaries, confidence,

leadership, and organizational culture/climate.

3.2.4. Study Question

This study explored clinician-reported barriers and facilitators to early physical rehabilitation in

critically ill patients receiving invasive mechanical ventilation. Additionally, the study assessed

relative importance of the identified barriers to the practice of early rehabilitation.

3.3. Methods

3.3.1. Study Design

This was a semi-structured interview study, based on the TDF, with a focus on ICU clinicians’

perceptions of barriers and facilitators to early rehabilitation.

3.3.2. Participants

Participants were purposively sampled from one of four clinician groups: critical care nurses,

critical care physicians, respiratory therapists and rehabilitation professionals (physical

therapists and occupational therapists) to achieve diversity in terms of years of experience,

50

academic vs. non-academic work environment, leadership position and ICU size. Eligible

participants had to be working as independent practitioners in their specialty and primarily

caring for adult patients. Because of the variation across units in staffing models, particularly

for rehabilitation professionals, participants did not have to work exclusively in an ICU to be

included in the study, but were required to identify critical care as a focus in their practice.

Clinicians from both Canada and the United States were invited to participate.

Given the inter-professional nature of the study sample, a variety of recruitment sources were

used to identify potential participants and adapted throughout the study to achieve the goals of

maximum variation sampling as described above 129. Initially, participants were recruited

through the “ICU Recovery Network” (IRN), an online interest group of clinicians interested in

critical care rehabilitation and recovery from critical illness. In addition, professionals were

recruited through professional associations and collaborative research groups in both Canada

and the United States.

3.3.3. Development of Topic Guide

A semi-structured interview topic guide was developed based on the TDF and expert knowledge

from the author group. To ensure we systematically and comprehensively applied the

framework to explore potential theoretical barriers/facilitators, at least one question for each

of the fourteen domains of the TDF was included. The interview guide was drafted by a subset

of investigators, including two critical care clinicians (SLG and BHC) and two health

psychologists with expertise in the TDF (JF and FL). Questions were revised and rephrased

following feedback from the wider investigator team to minimize duplication and enhance

51

clarity, clinical relevance and completeness. The interview guide was piloted with one clinician

from each of the four clinical stakeholder groups and question ordering and wording further

revised as needed.

To assess the extent to which the questions were likely to elicit responses related to each

domain, the questions were independently coded into theoretical domains by a health

psychologist with expertise in the TDF (AP). The reliability of this coding was assessed with

Cohen’s Kappa, with a Kappa value of 0.75 taken to represent high agreement 130.

Discrepancies were resolved through discussion, and if necessary, question phrasing further

revised. The final interview topic guide is shown in Table 3.2.

All interviews were conducted by a single member of the study team (EK) by telephone. All

interviews were audio-recorded, transcribed verbatim, checked for accuracy and anonymized.

3.3.4. Analysis

Using NVivo (Version 10), data were analyzed using a content analysis approach with the

following steps 131. Using the TDF as a coding framework, two investigators (SG, FL) first coded

transcripts from the 4 pilot interviews to practice the allocation of interview data to TDF

domains and establish coding heuristics as needed. The final pilot interview using the final

version of the topic guide was incorporated into the full study sample. All participant

utterances within each transcript were assigned to TDF domains by one investigator (SG). If a

response addressed more than one domain, it was allocated to all relevant domains. A sub-

sample of 10% of transcripts was independently coded by a second investigator (FL) to assess

52

inter-rater reliability using Cohen’s Kappa. Any discrepancies were resolved through discussion

or consultation with additional members of the investigator team (BC, JF).

Following initial coding, participants’ responses across transcripts were compared within each

domain. Responses that were thematically similar were grouped to inductively identify a ‘belief’

relevant to early rehabilitation. Additional detail on these methods is provided in Figure 3.2.

Frequency data were also generated to describe the total number of participants endorsing

each belief, both for the whole group and for each professional group. Analysis of interviews

was continued until saturation was achieved, with at least two additional interviews per group

analyzed beyond that point 132.

An expert consensus group comprising the wider investigator team met in person to review all

domain and belief coding for clinical and theoretical face validity, including a consideration of

how important each belief was to early rehabilitation. All disagreements about judgments

were resolved through group discussion. To establish importance, the group collectively

reviewed each belief with the following considered as evidence of importance: (1) high

frequency of belief (more than half the participants), (2) any participant expression of

importance (e.g. “it’s critical to educate the staff”, (3) discord among participants about belief

as a barrier or facilitator, (4) differences between clinician groups in frequency by at least 5

participants and (5) whether a belief was expressed spontaneously versus prompted by a direct

question. A similar approach to understanding importance has been used in prior TDF work

53,133. Beliefs were classified as “low importance” if zero or one of the five criteria was met and

53

of moderate importance if two criteria were met. All other beliefs were classified as high

importance.

3.3.5. Ethical Considerations

This study was reviewed and approved by the Research Ethics Board at Sunnybrook Health

Sciences Centre. Participation in the study was voluntary and all data was anonymized.

3.4. Results

3.4.1. Participants

Forty participants were included. Saturation was achieved for each of the four clinician groups

by a maximum of 8 interviews. The purposive sampling strategy was successful in achieving

diversity in the sample. Interviews lasted a mean of 46 minutes (range: 20-80 minutes).

Participant details are shown in Table 3.3.

3.4.2. Inter-Rater Reliability

Inter-rater reliability for blinded assignment of questions to TDF domains was 0.89. Inter-rater

reliability for duplicate coding of transcripts into TDF domains was 0.74.

3.4.3. Results by Domain

54

A total of 135 beliefs related to early rehabilitation were identified across the fourteen domains

of the TDF. Of these, 19 were classified as high importance, 40 of moderate importance and 76

of low importance as barriers or facilitators of early rehabilitation (Figure 3.3).

All beliefs classified as highly important fell within one of seven domains from the TDF: Skills,

Social/professional role and identity, Beliefs about capabilities, Beliefs about consequences,

Environmental context and resources, Social influences and Behavioural regulation. As shown

in Figure 3.3, domains with high importance beliefs also contained the highest number of

beliefs identified. Beliefs of high or moderate importance are shown in Table 3.4 with exemplar

quotations. High importance beliefs are elaborated in more detail below.

Skills

Participants reported that early rehabilitation was facilitated by working with experienced

colleagues, specifically through enhanced skill development.

Social/Professional Role and Identity

Underscoring the fact that early rehabilitation is a complex, team level behaviour, a large

number of specific roles were identified for a variety of team members. In particular, physician

roles as team leaders and as those who identify appropriate patients for rehabilitation were

identified as important, although most frequently by the physician group rather than by other

participant groups. However, the importance of a general “leadership role” for physicians was

emphasized by all professional groups.

Beliefs about Capabilities

55

Most participants reported that early rehabilitation was a difficult and complex therapy to

deliver (a potential barrier); however, some felt that it was fairly “easy” and fell within their skill

sets as ICU clinicians.


Participants reported a broad range of benefits of early rehabilitation. In particular, improved

strength or muscle mass, improved long term function, improved mental health and shorter

duration of mechanical ventilation were identified as important.

Environmental Context and Resources

Participants had conflicting views about resources. In particular, there was a range of views

about the adequacy of staffing for early rehabilitation; some reported severe under-staffing as

a barrier, while some felt staffing was adequate. There was similar diversity of views about

whether “specialized” equipment was a facilitator. However, there were similar views both

across and within professional groups that coordinating the various staff members and

equipment needed at a time that was optimal for a patient was a significant barrier. There was

also consistency in the belief that a staffing model for early rehabilitation that included

physiotherapists specifically assigned to the ICU, rather than a rotating model was a facilitator,

allowing staff to gain expertise and skills needed to work with critically ill patients.

Social Influences

There was a frequently held view that local “champions” facilitated early rehabilitation; this

view was held by more than half of the nurse and physician groups, but none of the

56

rehabilitation professional group and only one respiratory therapist. It was also reported by

6/10 nurses, 4/10 nurses and 4/10 physical therapists, and none of the respiratory therapists

that the support of ICU leadership was important. Family members were reported by all

professional groups to influence early rehabilitation, although sometimes as a facilitator and

sometimes as a barrier. All participants reported that discord or resistance from colleagues

could be an important barrier to early rehabilitation.


The importance of receiving feedback about early rehabilitation as a facilitator was noted by all

groups; however, there was a range of views about whether or not feedback was actually

received (a potential barrier). A unit protocol to guide early rehabilitation practice was

reported by all groups as a facilitator.

3.4.4. Domains of Lower Importance

Seven domains were identified as lower importance, on the basis of the number of unique

beliefs and the absence of direct expressions of importance beliefs: Knowledge, Optimism,

Reinforcement, Intention, Goals, Memory, Attention and Decision processes and Emotion.

3.4.5. Differences Between Professional Groups

Quantitative differences in stated beliefs about early rehabilitation were not common, when a

difference was defined as at least 5 between professional groups. Eighteen of the 59 beliefs

(31%) of at least moderate importance showed evidence of a difference in frequency between

57

groups. In most cases (13/18, 72%), physicians were one of the two groups who differed. Most

of the beliefs (13/18, 72%) fell under one of either Social/Professional role and identity, Skills or

Social Influences. With Social/professional roles, the differences were largely related to roles

participants assigned to their own professional group. For example, physicians frequently

reported that they were responsible for goal setting, whereas physiotherapists did not identify

this as a physician’s role.

Most physiotherapists reported the importance of practical experience for development of

skills (7 of 10) compared with only 2 of 10 in each of the other professional groups (skills

domain). Physicians and nurses reported the importance of “local champions” in early

rehabilitation but no members of the physiotherapy group and only 1 respiratory therapy group

thought this.

3.5. Discussion

This study used the TDF to study the beliefs of ICU clinicians regarding the barriers and

facilitators to early rehabilitation in mechanically ventilated patients. We identified seven

domains of the TDF which were most relevant to the behaviour of clinicians. Domains of high

importance were Skills, Social/professional role and identity, Beliefs about capabilities, Beliefs

about consequences, Environmental context and resources, Social influences and Behavioural

regulation. Differences between professional groups were uncommon. The importance and

level of elaboration of the domain Social / professional role and identity was noteworthy in this

study. TDF studies that investigate clinical behaviour most often report beliefs about

consequences (reflecting clinical thinking in terms of the balance between benefits and risks) as

58

the most populated domain (e.g. Duncan, 2012) 134. The importance of professional role in the

current study provides a clear indication that team-work and role clarity may be key to

achieving appropriate early rehabilitation practice.

This study also underscores that early rehabilitation is a highly complex intervention.

Complexity may have many different elements – the intervention may have multiple

components, involve multiple groups or targets, and may be tailored to the circumstance 135. In

addition, the causal links between the intervention and the desired (or undesired) outcomes

may also be complex through number of outcomes, mediators, feedback loops or synergy with

other interventions for example 135. In this study, we found the domain of Social/professional

role and identity to be highly elaborated, in part because of the many different professions

involved and because of the many different roles specific to the behaviour (e.g. goal setting,

identifying appropriate patients, carrying out rehabilitation). Not only does early rehabilitation

involve multiple types of clinicians, it also requires clinicians to interact and work together as a

team. To that point, we found that the domain of Social influences was particularly important,

underscoring that in addition to the specific roles team members play, the interactions

between those members can influence behaviour.

Using a theoretically driven strategy had several key advantages in our study. First, this

approach facilitated a broader view of barriers and facilitators than prior literature. Similar to

prior literature 75,79,88,89,108, we found that the domains of Beliefs about consequences and

Environmental context and resources, were highly elaborated in our data set, with a high

number of beliefs identified within these domains. However, this study also demonstrated

59

important factors not previously emphasized in the literature, in particular in the domains of

Social influences, a domain not commonly targeted in quality improvement interventions. The

domain of Social Influences includes constructs such as intergroup conflict, social norms and

power. Although themes of inter-professional collaboration and conflict have been explored in

the literature 136-138, these have been rarely applied by clinicians in implementation research.

A second advantage of using a theoretically driven strategy is the potential for linkage to

interventions for behaviour change. Michie et al. have identified behaviour change techniques

and mapped them to theoretical domains as a starting point for the development of

interventions 74. For example, leveraging local opinion leaders may be a useful intervention to

target the social influences domain 139, which was felt to be important by participants in our

study.

Our study also identified the domain of Behavioural Regulation as important to our

participants. Behavioural Regulation strategies might include protocols designed to provide

structure to the delivery of a complex intervention. They might also include a reliable time and

place to discuss delivery of early rehabilitation, such as inter-professional rounds, as reported in

our study. Such strategies are actually commonly reported in quality improvement literature,

although rarely labelled as Behavioural Regulation. A recent cross-sectional study of hospital

factors that influence early rehabilitation demonstrated that a formal protocol for early

rehabilitation was associated with increased uptake 77, a strategy which falls under the domain

of behavioural regulation. In a non-randomized interventional study, Hanekom et al.

demonstrated that the introduction of a protocol for early rehabilitation increased frequency of

60

rehabilitation sessions and reduced waiting time 140. Using a theoretical framework to label

these (labour-intensive) interventions allows implementation scientists to link back to

behaviour theory and apply them where they are likely to be most effective.

A third advantage is to identify those domains that are less important, so that efforts and

resources can be focused away from those areas. For example, the Knowledge domain was not

found to contain a high number of beliefs in this study, suggesting that educational

interventions may not be key to improving uptake of early rehabilitation, consistent with prior

knowledge translation research, which has shown only modest effects of educational

interventions on clinician behaviour 34,141.

This study has some limitations. First, participants were volunteers recruited from online

interest groups and professional organizations. Both by virtue of being volunteers and for some

participants, by being members of an interest group, there may be inherent selection bias. A

high number of participants reported determination to engage in early rehabilitation

(intentions domain). However, although they generally had a positive view of early

rehabilitation, they identified a range of barriers across most domains of the TDF. For example,

within the domain of Beliefs about consequences, participants endorsed a high number of

specific positive associations with early rehabilitation. While there is some evidence to support

the practice, some of the specific beliefs endorsed by participants are not supported in the

literature (e.g. mortality benefit). In addition, there was a commonly held belief that future

literature would demonstrate further benefit (Optimism domain). Participants may have

61

experienced the equivalent of a “halo effect” 142, where a generally positive view of early

rehabilitation creates a cognitive bias leading to other positive beliefs about early rehabilitation

which may not be supported by evidence.

A second limitation is in the methods by which we identified important beliefs and important

domains. Our interviews generated a large volume of data and it was necessary to try to

identify those domains that were most important, in particular with the view that targeted

interventions should be focused on those barriers and facilitators most likely to impact on early

rehabilitation. We used a variety of methods (e.g. frequency, assertions of importance) to

identify important domains based on work in prior literature 53, but it is not yet established that

this method will lead to more successful interventions.

Conclusions

Using a theoretically driven approach, this study identified important barriers and facilitators to

early rehabilitation in ICU patients. Differences between professional groups were uncommon,

but where they exist, highlight the importance of involving an inter-professional team in

implementation. Further work is required to validate our method for identifying importance

and to determine the frequency of barriers and facilitators in other stakeholder groups.

Domains identified as important should be targeted when designing interventions to increase

uptake of early rehabilitation going forward.

62

Table 3.1-Domains of the Theoretical Domains Framework and example questions from Topic Guide

Domain Description Example Question From Topic Guide Knowledge Knowledge/awareness of the scientific

rationale, evidence base and how to perform the behaviour

Are you aware of any hospital or unit guidelines or clinical protocols regarding early rehabilitation for ICU patients in your institution?

Skills Ability to perform the behaviour of interest, including safety, use of equipment. May include non-technical skills.

What skills are needed for you to undertake early rehabilitation with ICU patients?

Social/profes-sional role

Belief about one’s own role, as well as the role of others in the target behaviour.

To what extent does early rehabilitation fit with your professional role as a doctor/nurse/etc?

Beliefs about capabilities

The degree to which a clinician feels he/she/the team can perform the target behaviour

How confident are you in undertaking early rehabilitation with an ICU patient?

Optimism Belief that things will turn out for the best. In general, how important do you think early rehabilitation will be in the care of ICU patients in the future?

Beliefs about consequences

The influence of expected positive or negative outcomes of the behaviour. May include outcomes for others (e.g. patients) or for clinicians.

What do you see as the benefits of undertaking early rehabilitation?

Reinforcement Strategies to change likelihood of behaviour by making it contingent on reward or punishment.

Are you aware of any consequences for NOT undertaking early rehabilitation?

Intentions The degree to which the individual means to perform the behaviour.

How determined are you to engage in early rehabilitation with ICU patients?

Goals The end states that the behaviour is meant to achieve.

How are goals for early rehabilitation set? Are they explicitly stated?

Memory, attention and decision processes

The ability to pay attention to relevant information and make appropriate decisions.

How are decisions made in your unit about which ICU patients receive early rehabilitation?

Environmental context and resources

The influence of the environment on the individual’s performance of the behaviour – includes culture, human and other resources

What physical setup of the ICU is best for early rehabilitation? How close is your ICU to the ideal setup?

Social influences

The influence of others (health care providers, experts, patients, etc) on the behaviour.

To what extent do the views or practices of other team members influence how you undertake your role in early rehabilitation?

Emotion The role of both positive and negative emotions on performance of the behaviour.

To what extent does undertaking early rehabilitation affect you emotionally?

Behavioural regulation

Purposeful strategies to overcome obstacles to behaviour.

Are there strategies to improve early rehabilitation when goals are not met?

63

Table 3.2 - Topic Guide

1. How would you describe “early rehabilitation” for ICU patients?

• What does “rehabilitation” mean in this context? (synonyms, physiotherapy, mobilization, etc)

• What activities might qualify as early rehabilitation?

• What does “early” mean in this context? How long after ICU admission?

For the purposes of this interview, we will use the term “early rehabilitation” to refer to physical

rehabilitation activities that occur during the ICU stay, even while the patient is mechanically

ventilated.

2. In your view, what is the biological rationale for early rehabilitation?

• How consistent is the evidence base with the biological rationale?

3. What do you think is the evidence for early rehabilitation for ICU patients in the published

literature?

• Is there evidence for benefit?

• What about harm?

• How strong is that evidence?

• How credible is the evidence?

4. Are you aware of any hospital or unit guidelines or clinical protocols regarding early rehabilitation

for ICU patients in your institution?

• Is there a document?

• Have you read the document?

• Are you aware of what they say?

• How credible do you think these guidelines/policies are?

5. What specific roles do YOU play in undertaking early rehabilitation with ICU patients?

• To what extent does early rehabilitation fit with your professional role as a doctor/nurse/etc?

6. What specific roles do other clinicians play in early rehabilitation?

• Which clinicians should be involved? In what parts of early rehabilitation should they be involved?

• What roles do the leaders within the unit play in facilitating early rehabilitation?

7. How does undertaking early rehabilitation with ICU patients fit in with the other responsibilities of

your job?

• Are there other activities that require your attention that interfere with early rehabilitation?

• How do you balance early rehabilitation with those other activities?

64

8. How are decisions made in your unit about which ICU patients receive early rehabilitation?

• Who is involved?

• Is there a process or routine for this?

9. How determined are you to engage in early rehabilitation with ICU patients?

• Are there things that interfere with your intentions?

10. What skills are needed for YOU to undertake early rehabilitation with ICU patients?

• To what extent do you feel you have these skills?

• How can these skills be developed?

• What facilitates the development of these skills?

• What interferes with the development of these skills?

• Are there other “non-technical” skills that are needed?

• Do other types of clinicians need the same skills for early rehabilitation?

11. How confident are you in undertaking early rehabilitation with an ICU patient?

• What things would improve your confidence?

• What things would improve your team’s confidence?

• What things would decrease your confidence?

12. How easy or difficult do you find early rehabilitation with ICU patients?

13. What do you see as the most important goals in undertaking early rehabilitation with ICU

patients?

14. How are goals for early rehabilitation set?

• Who sets them?

• Are they explicitly stated?

• How are goals adapted in response to changes over time in the patient’s clinical status?

• How are goals adapted in response to events that occur during a physiotherapy session?

15. What do you see as the benefits of undertaking early rehabilitation?

• Are there short-term benefits (e.g. during the ICU stay)?

• Are there long-term benefits (e.g. after the ICU stay or after the hospital stay?)

• Do these benefits differ according to different types of patients?

• What types of physical benefits are there?

• What types of cognitive (e.g. thinking, mental processing) benefits are there?

• What types of mental, psychological or psychiatric benefits are there?

65

16. What do you see as the risks or adverse consequences that can occur as a result of undertaking

early rehabilitation?

• Are there patient safety concerns?

17. What resources are needed to undertake early rehabilitation?

• What equipment is needed?

• What physical setup of the ICU is best? (e.g. layout of the rooms, the unit)

• How close is your ICU to the ideal setup?

• To what extent do you feel your hospital already has the necessary levels of these resources?

• Are these resources consistently available and functioning when you need them?

• What staffing is required? Is your hospital staffing adequate?

18. To what extent do the views or practices of other team members influence how you undertake

your role in early rehabilitation?

• Who else might influence you?

19. To what extent do you feel the ICU culture encourages or discourages early rehabilitation?

20. To what extent do patients and their family members influence whether you undertake early

rehabilitation?

21. How do you prepare to undertake early rehabilitation?

• Do you follow any action-plans? (If-then statements; where/when/who/how plans)

22. How does your unit monitor your participation in early rehabilitation?

• Who monitors? Are there specific “metrics” that you know of? Does anyone audit early

rehabilitation?

• How often?

23. What kind of feedback is given when early rehabilitation does not occur?

• How is the feedback structured?

• Who gives the feedback?

• To whom is the feedback targeted? Individuals? Teams?

• What about when it occurs, but standards are not being met?

• Are teams or individuals held accountable when rehabilitation plans do not occur?

• How does this occur?

24. Are you aware of any ways in which undertaking early rehabilitation is encouraged or rewarded in

your unit?

• Is success celebrated or recognized?

66

25. Are you aware of any consequences for NOT undertaking early rehabilitation?

• What sorts of consequences are there?

26. Are there strategies to improve early rehabilitation when goals are not met?

27. To what extent does undertaking early rehabilitation affect you emotionally?

• Any feelings of stress, anxiety or depression?

• What about positive feelings?

28. How does this affect how you undertake early rehabilitation?

• Why? Why not?

29. In general, do you think your unit has the ability to improve the delivery of early rehabilitation?

• Why?

30. In general, how important do you think early rehabilitation will be in the care of ICU patients in

the future?

67

Table 3.3 Participant Characteristics

Frequency (N=40)

Professional Group Rehabilitation Professional1

Nurse Respiratory Therapist Physician

10 10 10 10

Professional Leadership Role

Yes No

18 22

Country of Employment Canada United States

23 17

Type of Institution Academic Health Sciences Centre Community Teaching Hospital Community Non-Teaching Hospital

25 10 5

Number of ICU Beds <10 10-20 21-50 >50

3 10 14 13

Years Since Graduation ≤5 6-10 >10

8 10 22

Years of ICU Experience ≤5 6-10 >10

10 11 19

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Table 3.4 - Beliefs classified into Domains of the Theoretical Domains Framework

Belief (Number of

participants endorsing

belief)

Excerpt from Interview Transcript

Knowledge domain

Knowledge of protocols

or guidelines impacts

performance of early

rehabilitation (22)

“So I know we have a protocol... and I follow it to some degree but honestly I don’t have it

memorized.” (RN)

Education and

knowledge facilitate

early rehabilitation (28)

“I think once education is out, then we understand what type of rehabilitation needs to be

done and why it’s important, then we can start to build on that and move forward, … it’s the

first priority.” (RT)

Gaps exist in literature

base. (15)

“There’s a lot of theory behind it and it makes probably intuitive sense but I still think it

needs to have the definitive study put into place.” (MD)

Skills domain

Skills for early

rehabilitation are

developed by working

with experienced

colleagues (12)

“I’d say what’s helped me a lot is mentorship, working with a more skilled ICU

therapist that’s been doing things for a little bit longer than me.” (PT)

Specialized skills are

(or are not) required for


“I feel like as ICU nurses we already have the knowledge and expertise, just what we do

every day to also engage in early rehabilitation with our patients.” (RN)

Practical training is

required to develop

skills for early

rehabilitation (13)

“… you bring them right into the ICU, with a mentor, and you just educate them and make

them review all the lines and the tubes and everything else and what the numbers mean, and

then actually just have them start to treat the patient with someone with good experience

there.” (PT)

On the job experience

develops skills needed

for early rehabilitation.

(14)

“I think the second is learning within your institution. … basically mobilizing the patients

over time and learning skills and the way things work are important.” (MD)

69

Belief (Number of


belief)


Interpersonal skills are

required for early

rehabilitation (11)

“You’ve got to have people skills. You’ve got to put your patients at ease. They’re probably

at one of their lowest, scariest points in their life and they’re trusting you that you’re going to

come in and get them up” (PT)

Communication skills

are needed for early

rehabilitation (11)

“Good communication, making sure that we’re, … communicating with the team effectively,

making sure everybody on the team’s on board, and being able to communicate the plan

effectively.” (RT)

Social and professional role/identity domain

Leadership has an

important role in early

rehabilitation. (22)

“… I work so closely with the nurses that if the nurses weren’t on board it would be

very difficult to do early mobility, so I would say that nursing leadership … makes sure

everybody’s educated and ready for that.” (PT)

Physicians have an

important role in

identifying

appropriate patients

for early


“… it’s through discussions with the other staff working with this patient that we all

agree it’s time, so when the doctors come in we all try to be there and try to suggest or

support rehabilitation, but in the end, again it ends up being a physician call when the

physios get involved.” (RT)

Physicians have an

overall leadership role

in early rehabilitation.

(7)

“And I like to talk to the doctors and have it spelled out to me what’s okay, what’s not

okay with that patient, if it’s not clear to me from looking at the chart..” (PT)

The physician’s role is

not in the actual

delivery of early

rehabilitation. (6)

“I think that my role personally in the actual act of early rehabilitation is somewhat limited

because … I’m not specifically trained in the physical activity of actually assisting patients

in this, and I think that’s more the role of the physiotherapist, or potentially nursing” (MD)

The physician has a role in goal setting.

“…the main keeper – of the goals does end up being the primary physician for the week.” (RN)

The physiotherapist has

a role in goal setting.

(21)

“As a PT I’m making my own individualized goals for that patient. I have the care plan in

mind but I’m thinking about what I think is realistic for that person.” (PT)

My other duties can

conflict with early

rehabilitation (11)

“…there are other things that I have to do. Documentation’s probably the number one thing.

… hygiene, giving meds, taking vital signs, talking with family. … there’s lots of stuff I

have to do that gets in the way …”

70

Belief (Number of


belief)


(RN)

Early rehabilitation is a

team responsibility (21)

“So it’s really about teamwork, working independently but also working in that big team,

and working what’s best with the nurse and working what’s best with the patient when

they’re clinically able to move, when it’s safest for them, and when it’s best for the team to

get that patient up.” (RT)

Nursing staff have an

important or central role

in early rehabilitation.

(7)

“…in terms of the ICU team you know the bedside nurse has a huge role to play because

essentially I think they’re the managers of the patient’s activities for the shift and really

facilitate and drive the plan in terms of the mobilization.” (MD)

Charge or lead nurses

have an important role

to play in early

rehabilitation. (8)

“I have worked in one [ICU] where the charge nurses did really promote it and go to each

patient so having an actual charge nurse role and having a charge nurse have time to go out

and assess each nurse and support them was always helpful.” (RN)

The respiratory

therapist has an

important role with

patients on mechanical

ventilation. (17)

“Respiratory therapy is a very huge, integral part of mobilization. They will often come in

and help us to walk a patient who’s on a ventilator. The hoses need to be switched over. .…

most of the time, they’ll require a larger amount of oxygen, a different rate. So the

respiratory therapist will be on board with that.” (PT)

Beliefs about capabilities domain

Early rehabilitation is

challenging. (22)

“I would describe it as very important but also very challenging, to get the people up at

such a … at a critical time as their care...” (PT)

The support of a team

improves confidence in


“I got oriented by another PT but ultimately it was the nurses that helped me develop the

bravery, I guess, in the beginning, and the attitude that … it could be done.” (PT)

Experience improves

confidence with early


“When we first instituted it and were training people it was obviously a problem, but now

that we have a long track record and experience and receive some extra staffing on the

intensive care unit we’re very, very confident.” (MD)

Lack of confidence

interferes with early


“I would say [I am] not confident. For those reasons, based on lack of understanding of how

to do it safely, both on my part and on the part of people that I work with.” (MD)

Optimism domain

71

Belief (Number of


belief)


I am optimistic research

will show more benefits

for early rehabilitation

in the future. (6)

“I think the evidence is there and I think the strength of the evidence will probably get bigger

with bigger studies, and I think in pushing the bar to mobilizing sicker patients we may start

to see a greater impact on that population from early mobilization.” (MD)

Early rehabilitation will

be part of ICU practice

in the future. (23)

“I think it’ll be... well, they say it’s going to be A, B, C, D, E, exercise. You know, we’re all

about airway, breathing, circulation, disability, and now E, I think it’s going to be just right

up there.” (RT)

Beliefs about consequences domain

Early rehabilitation

decreases muscle

atrophy or reduces

weakness (31)

“It limits or even reverses weakness and muscle wasting.” (PT)


affects long term

physical function (22)

“I would say the most important goal, ultimately, is to improve patient outcomes and

not only mortality outcomes but also functional outcomes in the long term.” (MD)


affects the mental

health of the patient

(27)

“Yes, it does, it gives them a huge sense of psychological and psychiatric benefits,

because I think laying in that bed, you know, day after day, it can put a tremendous

strain on these patients, and this allows them to … get out of the four walls of the

Critical Care”. (RT)


affects duration of

mechanical ventilation

(25)

“For me, ventilator days. If we’re seeing a … significant decrease in ventilator days in

our patient population I think that would … go a long way.” (RT)

Benefits outweigh the

harm for patients in early rehabilitation (32)

I’m not aware of any studies that support that getting a patient mobile early is going to do

more harm than good.” (PT)


affects delirium (20)

“Delirium does not set in if you start to see them 24 hours to 48 hours after. And that’s very

well documented in the literature, now.” (PT)


affects mortality (9)

“Everything that I've seen has suggested it's better from a mortality standpoint”. (RT)


affects ICU length of

stay (28)

“So I think there’s a growing body of evidence that supports that it’s helpful in shortening

the ICU and hospital length of stay.” (MD)

72

Belief (Number of


belief)


Early rehabilitation can

cause physiological

deterioration (21)

“I think another major concern is if the patient, from a physiologic perspective, does not

have the stamina or strength to engage in early mobilization and they’re pushed to do that

that could lead to physiologic consequences such as a drop in their blood pressure or

hypoxia”. (MD)


safe (32)

“Yes, well I think that goes along with if they lose any tubes and lines they have a high risk

of complications as well. I mean they would be at a higher risk for falling, just getting out of

the bed. But I think with the appropriate assessment and appropriate equipment and people,

it is a safe thing to do”. (RN)


personally rewarding to

healthcare providers.

(16)

“I find it satisfying … When you feel like you've done a good job with a patient, you feel

proud and positive about what you're doing.” (RN)

Reinforcement domain

There are [no]

consequences in my

unit for not

participating in early


“Not to my knowledge. I wish there were! Sometimes I’m like, “What did this nurse do all

day?” I’m sure they were busy, you know, but there are some nurses who I think they just...

they’re just not entirely on board.” (PT)

Intentions domain

I/we are determined to

engage in early


“Oh, I'm very determined. I'm very determined. We’ve been doing this, like I said, for a

year. I’ve been pushing and pushing and pushing.” (RN)

Goals domain

The goal is to improve

early rehabilitation

within our unit. (14)

“I see our goal as putting together a working group to devise the process for early

mobilization. I think that’s our short-term goal, is to actually put a process in place.” (RT)

Goals should be

explicitly stated and

reviewed. (23)

“The goals are not recorded to my knowledge. They might be stated on rounds but

inconsistently.” (MD)

Memory, attention and decision processes domain

Decisions about early

rehabilitation are made

as a team. (20)

“…it’s all a discussion between the whole team, the physicians, the physiotherapists and the

nurse sort of as to deciding on what the plan is.” (RN)

73

Belief (Number of


belief)


Environmental context and resources domain

We have adequate

staff to perform early

rehabilitation (35)

“Staffing is our main thing; that is a huge thing which interferes with… what we want

to do.” (PT)

ICU specialized

equipment is required

for early

rehabilitation (30)

“We really just need walkers. We don’t use anything special. I know people have fancy

stuff; we don’t.” (PT)


requires coordination

and scheduling

between staff and

team members (22)

“The problem is that it’s a multidisciplinary process so it does involve … all the RTs,

all the nurses, all the physios, the dieticians, so it involves everybody. To get everybody

to organize to do anything is always a challenge.” (RT)


requires therapy staff

specifically assigned to

the ICU. (16)

“I would definitely say that even amongst the physio personnel it would be better to

either maintain a smaller, more experienced group continually coming to the ICU

and/or doing more training amongst themselves of, you know, the importance and the

approaches necessary to facilitate it.” (RT)

ICU culture affects


“I’m really lucky because our culture is not just encouraging, it demands it, and I think... I

talk to other people and it seems like it can be quite a battle if the culture is one of … bed

rest.” (PT)

We have an adequate

physical layout to

perform early

rehabilitation (34)

“Horrible. We have tiny rooms that are very bed-centric, and our ICU is shaped as a triangle,

which is nice for visibility but when interdisciplinary rounds are occurring ….number of

bodies on the unit is challenging, and sometimes it’s the role of the nursing assistant to

encourage people to step aside during rounds.” (RN)

We have adequate equipment for

performing early

rehabilitation (28)

“Our beds are now 14 years old and often don’t function the way they’re supposed to and they don’t go down low enough.” (PT)

Social influences domain

Local champions

influence early

rehabilitation practice

(12)

“Our lead physical therapist recently left and she was a huge advocate of mobilizing

patients and it quickly became apparent how person-specific our mobility culture was,

that she was driving a lot of it.” (MD)

74

Belief (Number of


belief)


ICU leadership

facilitates early

rehabilitation practice

(14)

“So the role is really a huge one because if they’re not making the policies and telling

the nurses that mobility is okay and it’s actually … not mandatory but important then

it’s not going to happen. It wouldn’t happen without the leaders of the ICU, the lead

nurses and the nurse educators.” (PT)

Discord between team

members affects

delivery of early

rehabilitation (30)

“…we go in there and they [say], don’t touch them, they are finally settled. Don’t touch

them … they’re sleeping. Don’t touch them; they have a line in them. And I’m like,

yeah so what? So, it can definitely influence things.” (PT)

Family members

affect delivery of early

rehabilitation (33)

“I think for the most part we’re probably undershooting the goals, so we’re actually

doing less in order to not … freak out the family.” (RT)

Comparison with other

team members practice

impacts my

rehabilitation practice.

(16)

“Like, maybe there’s a level of sickness that I wouldn’t mobilize someone that a colleague

would, and I think just understanding and seeing examples of that being done safely would

help improve my confidence in achieving that.” (MD)

Physicians influence

early rehabilitation

practice. (15)

“If you have even one or two physicians that are against that it can surprisingly go awry.”

(RN)

Behavioural regulation domain

Feedback affects early

rehabilitation

practice. (33)

“I think talking about the successes and failures and how we could make it better

would be more important. I don't think we get as much feedback on that as I think

would be beneficial to say, hey, this is working and this is where we fell short and we

need to step up to do a better job. So, I think more feedback would be a great thing.”

(RT)

Having a unit protocol

facilitates early

rehabilitation (27)

“ It would be nice to have a standard of care with regard to at least a consideration of

mobilization and maybe realize that everybody will need to make their own decisions,

but we’re asking a question; has the patient mobilized and if not, what sort of barriers

or what sort of thought processes getting in the way of that happening should be

undertaken?” (PT)

We discuss early

rehabilitation plans

“So, after you talk about all of the systems, talking about mobilization I think is important

for every patient, and in some units they actually have a physiotherapist that rounds with the

team. However, that’s not the case with all of the units and I think perhaps if there was the

75

Belief (Number of


belief)


every day on rounds.

(21)

presence of the physiotherapist that may, from an optics standpoint, help remind the team

about addressing the question of mobilization of that patient.” (MD)

RN = nurse; MD = physician; RT = respiratory therapist; PT = physiotherapist; OT = occupational therapist

(Beliefs classified as “high importance” are in bold.)

76

Figure 3.1 - TDF domains important in systematic review

Behaviour

Intentions

Goals

Memory, attention

and decision

processes

Environ-mental

context and resources

Social influences

Emotion

Behav-ioural

regulationKnowledge

Skills

Social/ professional

role

Beliefs about capa-

bilities

Optimism

Beliefs about conse-

quences

Reinforce-ment

77

Figure 3.1 – Overview and Example of Interview Coding Process

“I’ve found that when the

physicians are really on board,

everyone else will follow suit and

get excited about mobility.”

Social Influences

TDF Domain Belief

When physicians

engage in early

rehabilitation, they

influence the rest

of the healthcare

team.

Hypothetical Excerpts

“Some doctors are very good about

bringing up rehab goals on rounds

but others ignore it. If they bring it

up, it makes the nurses, physios

and everyone else realize it’s just as

important as all the medical details

they’re managing.”

Figure 3.2 - Overview and example of interview coding process

78

Figure 3.3 - Frequency of beliefs by domain

0

5

10

15

20

25

30

35

40

45

50

Nu

mb

er o

f U

niq

ue

Bel

iefs

Id

enti

fied

Low

Mod

High

79

Chapter 4. Barriers and Facilitators to Early Rehabilitation

in the Intensive Care Unit – A Theory Driven Delphi Study

4.1. Summary of Previous Chapter

In the previous chapter, using semi-structured interviews designed and analyzed according to the TDF,

we found a similar focus on the three domains of the TDF found in the systematic review (Beliefs about

Consequences, Environmental Context and Resources, and Behavioural Regulation, shown in Figure 3.1).

However, using multiple measures of importance, our participants also identified the domains of Beliefs

about Capabilities, Social and Professional Role, Skills and Socials Influences (Figure 4.1).

4.2. Introduction

Early physical rehabilitation is a relatively new intervention in critical care, with some early

supportive evidence 17,23,60,143 and increasing incorporation in clinical practice guidelines 30,32,125

However, multiple surveys and point prevalence studies document low rates of active

mobilization of critically ill patients and low use of physical therapists in general and

mechanically ventilated patients in particular 42,44,68,81.

In Chapter 3 of this thesis, theory-driven semi-structured interviews were used to identify

barriers and facilitators to early physical rehabilitation in mechanically ventilated patients, the

results of which formed the basis for the next phase of the research and of this chapter of the

thesis. In order to understand the strength of these views more quantitatively, a Delphi survey

80

was undertaken, with the interviews as described previously forming Round 1 of the Delphi.

Further rounds of the Delphi are described in this chapter.

4.2.1. Introduction to Delphi Methodology

Human and organizational factors that influence the conduct of tasks in complex environments

are difficult to study. A Delphi design, including qualitative (Round 1) and quantitative (Rounds

2 and 3) elements, allows for exploration of the complex nature of clinician behaviour and of

factors (such as emergent themes) not identified using traditional quantitative methods. The

qualitative component (as described in Chapter 3 of this thesis) applied an inductive process to

ensure that a wide range of views are considered and the quantitative component (reported in

the current chapter) assessed the stability and importance of the views of the participants.

The Delphi method was originally developed to establish consensus (or stable lack of

consensus) among experts where evidence did not exist or was uncertain 144. It relies on an

iterative process where “experts” respond anonymously to questions via a series of “rounds”,

complemented by anonymous feedback of the group’s previous responses, to establish a group

view on a topic. Since its development, it has been used in the ICU setting to develop practice

guidelines 145, set educational goals 146 and to develop disease definitions 147. More recently in

ICU and other areas within health care, it is being used to identify and understand opinions

among health care providers of different backgrounds about barriers and facilitators in

translating evidence to health care practice 51,148-152.

In our use of the Delphi method, consensus was not necessarily the goal or endpoint of the

study. Rather, the usefulness of the iterative process is its ability to detect stability of

81

participant responses when feedback on group responses is provided and to assess the level of

consensus (if any) that describes participants’ views. The intention is not to prove that some

items are barriers and others are not. However, assessing stability and agreement does provide

important information about how strongly held a belief may be, and thus helps to prioritize

perceived facilitators and barriers.

The Delphi method has a number of features that would strengthen the validity of our findings.

First, feedback is anonymous and so participants with different clinical backgrounds and levels

of expertise can participate equally without the imposition of a hierarchy. This is an important

advantage, where stakeholders from four different professional groups will be included.

Secondly, research has shown that using a structured consensus technique (such as the Delphi)

in idea generation increases number of ideas generated and satisfaction with the process when

compared with an informal group 153.

4.2.2. Study Aim

This study aimed to identify barriers and facilitators to early rehabilitation in mechanically

ventilated patients, as perceived by key ICU clinicians.

4.3. Methods

4.3.1. Study Design

A Delphi study, consisting of an initial qualitative round and subsequent survey rounds was

conducted among four clinician groups to gather clinician opinion on the barriers and

82

facilitators to early rehabilitation in the intensive care unit (ICU) for mechanically ventilated

patients.

4.3.2. Sampling and Participants

The study recruited healthcare providers who work mainly in the ICU setting: nurses,

rehabilitation professionals (physical therapists and occupational therapists), respiratory

therapists and physicians. To be eligible, clinicians had to identify ICU as a primary focus of

their clinical practice and had to be independently licensed practitioners (i.e. non-trainees) in

either Canada or the United States. While other healthcare providers may participate in early

rehabilitation in the ICU, these clinicians were identified as those most likely to be involved in

either decision making around or delivery of early physician rehabilitation.

Because of the variety of clinicians involved in the study, multiple methods of recruitment were

used: an online interest group (the ICU Recovery Network), professional groups (for respiratory

therapists and nurses), and a research interest group (the Canadian Critical Care Trials Group).

We used purposive sampling to maximize variability in participants around profession, years of

experience, type and size of ICU.

4.3.3. Delphi Rounds

An overview of the Delphi process is shown in Figure 1.1. The first round of the Delphi

consisted of a semi-structured interview, the results of which are presented in Chapter 2.

Through analysis of these interviews, an extensive list of potential barriers and facilitators to

early rehabilitation were identified using content analysis with the TDF as a guide (See Table 3.4

83

from previous chapter of this thesis). These barriers and facilitators were then used for item

development for subsequent rounds of the Delphi.

The second and subsequent rounds consisted of agree/disagree statements of beliefs about

barriers and facilitators to early rehabilitation, with a 9-point Likert response scale, where 9

represented high agreement and 1 represented high disagreement with the statement. Details

of item development are described below. These rounds were administered electronically,

using a custom-programmed web based interface. Participants received an individual email link

to the questionnaire. For each round, participants received two reminders if they had not yet

responded, two and four weeks after the initial invitation.

In Round 2, participants received only the questionnaire. In Round 3, each participant was

presented with the same questions as Round 2, along with individualized feedback about their

response on Round 2 as well as a graphical representation of group responses. A sample

screenshot of a question with feedback, as used in Round 3 is provided in Figure 4.2.

The optimal number of rounds in a Delphi study is not well established; in general, the total

number of rounds is usually 3 or 4. In most studies using this method, studies are stopped when

consensus occurs. Because our primary goal was not necessarily consensus, we had an a priori

agreement that the study would be stopped when either consensus on 70% of items was

achieved or there was no change in participant scores between two consecutive rounds,

defined as a mean change across all participants of less than an absolute value of 1 (on the 9-

point scale) for any individual item 51,148. We also limited the number of total rounds to a

maximum total of 4 to minimize participant burden.

84

4.3.4. Item Development

Working from the complete list of potential barriers and facilitators identified in the first round

(Chapter 2), the investigator group held an in-person meeting to select items to include for the

rest of the Delphi. Because a large number of items were identified and there were concerns

that including all of these items could lead to participant fatigue and attrition, the team used a

list of criteria to identify those barriers and facilitators felt to be most important, which are

described in detail in Chapter 2 of this thesis. In order to include as many beliefs as possible,

we also occasionally merged items that could be considered examples of a more general

concept. For example, the item “It is facilitated by education and knowledge” was originally

coded from the interviews as “It is facilitated by education” and “it is facilitated by knowledge”.

From this list, items were reframed as statements with which participants could agree or

disagree, on a 9-point Likert scale. Items were worded in a direction consistent with the

findings in the interviews. For example, participants in the qualitative interviews reported a

belief in the positive impact of early rehabilitation on long term physical function, so the item

was worded, “it improves long term physical function”. In general, our participants tended to

endorse facilitative factors rather than barriers, so more items were worded as facilitators than

barriers. For each item, there was also an accompanying statement asking the participant to

rate the importance of the item to implementation of early rehabilitation. Items were piloted

with clinicians from each of the groups and adjustments for clarity and sensibility made prior to

use in the study. The full list of items can be found in Table 4.1.

4.3.5. Analysis

85

Responses to items were summarized using medians and interquartile ranges (IQR) for each

item in the Delphi. As in previous Delphi studies 51,148, change scores were calculated at the

level of the individual participant, by subtracting each participant’s Round 2 rating from Round

3 for each item. Mean and median change scores were then reported for both agreement and

importance.

4.3.6. Ethical Considerations

This study was approved by the Sunnybrook Research Ethics Board. Participants provided

informed consent to participate in the study. Participation was voluntary and all results were

anonymized.

4.4. Results

4.4.1. Participants

In total, 74 clinicians consented to participate in the study. Through our purposive sampling

strategy, participant recruitment included a range of participants in terms of profession,

country of origin, years of experience and type and size of intensive care unit. Because of

attrition during the rounds of the Delphi, there is complete data for 50 of the 74 participants

(final response rate 67%), as shown in Figure 4.3. Participant characteristics are shown in Table

4.2. There was no difference between those who completed the full Delphi and those who did

not.

4.4.2. Delphi – Overall Results

86

A total of 3 rounds (one qualitative, two quantitative) were completed. The study was stopped

after the third round, as per our pre-specified stopping rules because the mean change score

for all items was <1, although consensus was not reached.

4.4.3. Participant Agreement – Round 2 and 3

In general, agreement with Delphi survey items was high in both rounds. Median (IQR)

agreement scores for the final round are shown in Table 4.3. In Rounds 2 and 3 respectively, 53

and 55 of the 68 items had a median agreement of 7 or more. To further understand this high

agreement, we identified items within this set that also had high consensus (i.e. where at least

90% of responses fell within a high (7,8,9) three-point band.) In Round 2, 18 of these items fell

within this range. In Round 3, the same 18 items also had high consensus, with an additional 7,

for a total of 25. These items are shown in Table 4.4 by domain of the TDF. Of note, not all

domains of the TDF were represented in these high agreement, high consensus items and some

were disproportionately represented. For example, 10 of the 14 items for Beliefs about

Consequences had high agreement and these items were all worded as facilitators of early

rehabilitation (or positive consequences). Conversely, none of the 5 items for Behavioural

Regulation had high agreement and high consensus.

4.4.4. Participant Rating of Importance – Rounds 2 and 3

Similar to agreement, participants tended to rank the importance of the Delphi items as very

high. In Round 3, no items had a median importance of less than 7.

4.4.5. Agreement - Change from Round 2 to Round 3

87

On average, individual agreement scores changed very little from Round 2 to Round 3 of the

Delphi. The median change score for every item was 0. Mean change scores ranged from -0.52

to 0.68. There was no overall difference in change scores between professions (Figure 4.4).

However, at the individual level, there were outliers; there was a range of change scores,

between -8 and +8. To identify items where a change in score was common, items were

identified where at least 5 individuals (10% of the sample) changed their agreement scores by

at least 2 points in either direction. There were two items where this occurred in the negative

direction, both of which were under the domain of Environmental Context and Resources, and

fifteen items where this occurred in the positive direction (i.e. agreement scores increased). As

seen in Table 4.5, this was common in some domains of the TDF and not others. For example,

there was a high degree of positive change of five of the seven items under the domain of

Social Influences.

4.4.6. Importance – Change from Round 2 to Round 3

Similar to agreement, importance ratings showed little change on average, with a median

change score of 0 for all items and mean change scores ranging from -0.12 to 0.7. Again, at the

individual level, the highest and lowest change scores were -8 and +8. However, when looking

at how frequently these change scores occurred, only one item had at least five individuals

whose score decreased by at least 2. Conversely, importance ratings overall tended to increase

from Round 2 to Round 3. There were 32 items where at least 5 individuals increased their

rating by at least 2. Items with change scores of at least 2 that occurred with a frequency of at

least 5 are shown in Table 4.6.

88

4.5. Discussion

In this Delphi study of ICU clinicians using the TDF as a guiding framework, we identified a large

number of barriers and facilitators to early physical rehabilitation in critically ill patients across

a range of domains of the TDF.

Study participants tended to have high agreement and high consensus regarding items under

eight of the 14 domains of the TDF. In particular, there was high agreement and high

consensus in most of the items under the domain of Beliefs about Consequences and both of

the items under the domain of Optimism. The items in Beliefs about Consequences were

largely about the positive effects of early rehabilitation for patients, reflecting the generally

positive view the study participants had about early rehabilitation. This may, in part, reflect the

fact that some of the domains without high agreement and high consensus did not have a large

number of items in them. However, one domain (Behavioural Regulation) had five items and

none of those items were found to have high agreement/high consensus. These items tended

to reflect an individual clinician’s or unit’s practice and so the lack of consensus likely reflects

the real-world variability in practice between clinicians or units.

This study has a number of strengths. First, it is the broadest study of barriers and facilitators

with respect to the range of clinician groups included. While other studies have examined the

views of these professional groups individually or in combination 75,89,96,100, few studies have

included all four of these professional groups and numbers have been smaller 90 or lacked clear

sampling strategy 105. This is important to understanding the implementation of early

89

rehabilitation because all of the professionals in this study have a different and essential role,

and thus may have a unique viewpoint.

The second strength is the use of the Delphi method to investigate stability of responses. By

providing feedback on prior responses and the responses of the group, individuals are given an

opportunity to reflect on and to change their response if they choose. This process helps to

establish how stable a person’s response is over time and reflects how often they will change

their viewpoint. Interestingly, we found that while on average there was very little change in

response, there were outliers in individual change scores. In general, they were more likely to

increase the strength of their agreement with the items and to increase their assigned

importance of items, even when there was generally already high agreement.

One potential criticism of the study is selection bias. While we used maximum variation

sampling to increase the diversity of our sample in terms of profession, type and size of

institution and experience, recruitment was voluntary. As such, our participants may not

represent the views of all professionals. More specifically, we hypothesized that they were

likely to be advocates for early rehabilitation. Indeed, our participants endorsed high levels of

agreement with, for example, two items under the Optimism domain. In particular, they

endorsed a belief that future evidence would show increasing evidence of benefit.

Furthermore, participants agreed with a number of items within the Beliefs about

Consequences which have little or no evidence to support them in randomized trials. For

example, the median level of agreement with the statement “Early rehabilitation reduces

90

mortality” had a median agreement of 8 on the 9-point Likert scale, a statement for which we

are unaware of any supporting evidence.

There are a number of possible explanations for this discrepancy between beliefs and the

published evidence. First, there may be a lack of knowledge about the published literature,

combined with a generally positive view of early rehabilitation. Secondly, participants may be

answering based on their personal experience rather than the published literature, which may

also be subject to optimism bias.

Another potential source of bias is in attrition from Round 2 to Round 3. Although we found no

difference in demographic features of participants who completed the Delphi and those who

did not, it is possible that there are unmeasured differences that may impact on results.

However, given the low change scores between rounds, this is unlikely to affect the overall

study results.

In summary, this Delphi identified beliefs about early rehabilitation across a variety of domains

of the TDF that may impact on provider behaviour. In our sample, clinicians held generally

positive beliefs about early rehabilitation, some of which are not presently supported in the

current body of evidence.

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Table 4.1 - Items Included in Rounds 2 and 3 of Delphi by Domain of the TDF

Domain Item stem

Knowledge (2 items)

It is facilitated by education and knowledge

Gaps exist in the evidence base

Skills (8 items)

I have the required skills It requires interpersonal skills

Relevant skills are developed by working with experienced colleagues

It requires leadership skills

It requires on the job experience

It requires specialized skills

Skills in biomechanics are required

It requires practical training (outside of the work environment) Social/Professional Role (11 items)

It is a team responsibility

It is part of my role

My role is to encourage and advocate I have a leadership role in its implementation

My role is to set individual patient goals

Charge/senior nurses play a leadership role

My role is to carry it out

My role is to provide education

My role is to screen and identify appropriate patients

My role is to coordinate it around other patient care activities It can conflict with my other duties

Beliefs about Capabilities (4 items)

Interprofessional team support facilitates staff confidence

We (in our unit) are generally confident in its performance

It is challenging Adverse events decrease confidence

Optimism (2 items)

It will be commonplace in ICU practice in the future

Future research will show more evidence of its benefits Beliefs about Consequences (14 items)

It reduces delirium

It improves long term physical function

It reduces ICU length of stay

It increases muscle mass and strength (or decreases atrophy and weakness)

It positively affects patient mental health

It reduces hospital length of stay

Seeing patient progress due to early physical rehabilitation is personally rewarding

It improves long term cognition It reduces use of sedating agents

The benefits outweigh the harms

It reduces mortality

It reduces nosocomial complications

It improves family perceptions of ICU care

It increases costs

92

Domain Item stem

Reinforcement (1 item)

There is positive feedback in my unit for participation in its delivery

Intentions (no items)

N/A

Goals (2 items)

One of our unit’s goals is to improve its delivery Our unit has a process for setting goals for individual patients

Memory, Attention, Decision (2 items)

Our interprofessional team makes decisions for individual patients

Our unit has no standard process for making decisions for individual patients

Environmental Context and Resources (9 items)

Its delivery is affected by ICU culture

We have adequate staff to deliver it

Its delivery is affected by sedation practices It requires coordination and scheduling between the interprofessional team.

We have an adequate physical layout to deliver it We have adequate funding for its delivery

We have adequate equipment to deliver it

It requires rehabilitation staff that are specifically assigned to the ICU

It requires ICU specialized equipment

Social Influences (7 items)

Its delivery is influenced by ICU leadership

Its delivery is influenced by local champions

My practice is influenced by exposure to experts in the field My practice is influenced by practices of other team members

My practice is influenced by learning what works well at other institutions

Its delivery is negatively influenced by discord between professions

Its delivery is influenced by patients and family members

Emotion (1 item)

Clinician fear affects participation

Behavioural Regulation (5 items)

A plan is discussed everyday on rounds

It is facilitated by a unit protocol

We discuss barriers and ways to improve outside of clinical rounds. We receive feedback on its delivery in my unit

My practice is facilitated by formulation of a personal action plan

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Table 4.2 - Participants in the Delphi Study

Characteristic Participants who Completed Delphi N (%)

Participants Not Completing Delphi N (%)

p value (chi-square)

Profession MD PT/OT RN RT

10 (20) 18 (36) 15 (30) 7 (14)

5 (21) 6 (25) 4 (17) 9 (37)

0.12

Years Since Graduation <1 1-5 5-10 >10

0 (0) 10 (20) 12 (24) 28 (56)

0 (0) 6 (25) 5 (21) 13 (54)

0.87

Years of ICU Experience <1 1-5 5-10 >10

1 (2) 13 (26) 13 (26) 23 (46)

0 (0) 6 (25) 6 (25) 12 (50)

0.91

Type of Institution Academic Health Sciences Centre Academic/Teaching Community Hospital Non-teaching Community Hospital

25 (50) 15 (30) 10 (20)

14 (58) 8 (34) 2 (8)

0.44

Country of Residence Canada United States

29 (58) 21 (42)

11 (46) 13 (54)

0.33

Number of ICU Beds <10 10-20 21-50 >50

6 (12) 16 (32) 18 (36) 10 (20)

1 (4) 6 (25) 9 (38) 8 (34)

0.47

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Table 4.3 - Round 3– Agreement for all Items in Order of Strength of Agreement

TDF Domain Item stem Round 3 MEDIAN

Round 3 1st Quartile

Round 3 3rd Quartile

Beliefs about Capabilities Interprofessional team support facilitates staff confidence

9 8 9


The benefits outweigh the harms 9 8 9



9 8 9


It improves long term physical function

9 8 9


It positively affects patient mental health

9 8 9


It reduces ICU length of stay 9 8 9


It reduces hospital length of stay 9 8 9



9 9 9


It reduces delirium 9 8 9


It improves long term cognition 9 8 9

Environmental Context & Resources

Its delivery is affected by ICU culture

9 9 9


Its delivery is affected by sedation practices

9 9 9


It requires coordination and scheduling between the interprofessional team.

9 8 9

Optimism It will be commonplace in ICU practice in the future

9 9 9

Optimism Future research will show more evidence of its benefits

9 8 9

Skills It requires interpersonal skills 9 8 9

Skills Relevant skills are developed by working with experienced colleagues

9 8 9

Social Influences Its delivery is influenced by ICU leadership

9 8 9

Social Influences Its delivery is influenced by local champions

9 8 9

95




Social Professional Role/Identity

It is part of my role 9 8 9


It is a team responsibility 9 9 9


My role is to encourage and advocate

9 8 9


I have a leadership role in its implementation

9 7 9

Knowledge It is facilitated by education and knowledge

8.5 8 9

Skills It requires “on the job” experience

8.5 8 9


My role is to carry it out 8.5 6 9


It reduces use of sedating agents 8 8 9


It reduces mortality 8 7 9


It reduces nosocomial complications

8 7 9


It improves family perceptions of ICU care

8 7 9

Emotion Clinician fear affects participation 8 7 9



8 7 9

Goals One of our unit’s goals is to improve its delivery

8 7 9

Skills It requires leadership skills 8 8 9

Social Influences My practice is influenced by exposure to experts in the field

8 7 9

Social Influences My practice is influenced by practices of other team members

8 7 9

Social Influences My practice is influenced by learning what works well at other institutions

8 7 9

Social Influences Its delivery is negatively influenced by discord between professions

8 5 9


Charge/senior nurses play a leadership role

8 7 9



8 6 9

96





My role is to set individual patient goals

8 7 9


My role is to provide education 8 7 9


My role is to coordinate it around other patient care activities.

8 5 9

Behavioural Regulation It is facilitated by a unit protocol 7 5 8

Beliefs about Capabilities It is challenging 7 6 9

Beliefs about Capabilities We (in our unit) are generally confident in its performance

7 5 8

Beliefs about Capabilities Adverse events decrease confidence

7 5 8


We have an adequate physical layout to deliver it

7 4 8



7 5 8

Goals Our unit has a process for setting goals for individual patients

7 4 8

Memory Attention Decision Making

Our interprofessional team makes decisions for individual patients

7 5 8

Reinforcement There is positive feedback in my unit for participation in its delivery

7 6 9

Skills It requires specialized skills 7 6 9

Skills I have the required skills 7 7 8

Skills Skills in biomechanics are required

7 6 8

Behavioural Regulation My practice is facilitated by formulation of a personal action plan

6 5 8

Behavioural Regulation We discuss barriers and ways to improve outside of clinical rounds.

6 3 8

Knowledge Gaps exist in the evidence base 6 4 8

Skills It requires practical training (outside of the work environment)

6 4 8

Social Influences Its delivery is influenced by patients and family members

6 5 8


It can conflict with my other duties

6 3 7

97





It requires ICU specialized equipment

5 5 7


We have adequate funding for its delivery

4.5 2 6

Behavioural Regulation A plan is discussed everyday on rounds

4 2 7



4 2 6

Memory Attention Decision Making

Our unit has no standard process for making decisions for individual patients

4 1 7

Behavioural Regulation We receive feedback on its delivery in my unit

3 2 6


It increases costs 2.5 1 5

98

Table 4.4 - Items with High Agreement (Median Score >=7) and High Consensus (>=90% of Respondents with Agreement>=7) by TDF Domain

TDF Domain Item Rounds with High Consensus

Knowledge It is facilitated by education and knowledge 2 and 3

Skills

Relevant skills are developed by working with experienced colleagues

2 and 3

It requires on the job experience 3

It requires interpersonal skills 3

It requires leadership skills 3


It is part of my role 2 and 3

It is a team responsibility 2 and 3

My role is to encourage and advocate 2 and 3



2 and 3

Optimism

It will be commonplace in ICU practice in the future

2 and 3

Future research will show more evidence of its benefits

2 and 3



2 and 3

It positively affects patient mental health 2 and 3

It reduces ICU length of stay 2 and 3

It reduces hospital length of stay 2 and 3


2 and 3

It reduces delirium 2 and 3

It improves long term physical function 3

It reduces use of sedating agents 3

It improves family perceptions of ICU care 3

It improves long term cognition 3


Its delivery is affected by ICU culture 2 and 3

Its delivery is affected by sedation practices 2 and 3

It requires coordination and scheduling between the interprofessional team.

2 and 3

Social Influences Its delivery is influenced by ICU leadership 2 and 3

99

Table 4.5 - Round 2 to Round 3 Change in Agreement

Domain of the TDF Item Number of Individuals with an Absolute Change Score of ≥ 2 (N=50)

Round 2 Median Agreement Score (N=50)

Skills

It requires on the job experience

8 8

It requires interpersonal skills

5 9


My role is to coordinate it around other patient care activities.

5 7

I have a leadership role in its implementation

5 8


7 8



8 7


6 6

Its delivery is affected by sedation practices

5 9

We have adequate funding for its delivery

8#

5


5# 4.5

Social Influences


8 7


8 6

Its delivery is influenced by local champions

6 8.5

My practice is influenced by exposure to experts in the field

6 8

100

# - negative change score

My practice is influenced by practices of other team members

6 7.5

Emotion Clinician fear affects participation

7 8

Behavioural Regulation My practice is facilitated by formulation of a personal action plan

7 6

101

Table 4.6 - Round 2 to Round 3 - Change in Importance

TDF Domain Item stem Number of Individuals with an Absolute Change Score of ≥ 2 (N=50)

Round 2 Median Importance Score

Skills

It requires interpersonal skills 9 9

It requires “on the job” experience 7 8

It requires leadership skills 6 8



7 7.5

My role is to carry it out 5 8

Charge/senior nurses play a leadership role 5 8

It can conflict with my other duties 6# 6.5



5 9

Optimism Future research will show more evidence of its benefits

5 8


The benefits outweigh the harms 6 8.5

It improves family perceptions of ICU care 6 8

It reduces use of sedating agents 5 9


5 9

Reinforcement There is positive feedback in my unit for participation in its delivery

6 8


5 9

Our unit has a process for setting goals for individual patients

5 8



7 8

102

# - negative change score

Its delivery is affected by sedation practices 6 9

Its delivery is affected by ICU culture 6 9

We have adequate funding for its delivery 5 8

Social Influences

My practice is influenced by learning what works well at other institutions

7 7

Its delivery is influenced by local champions 7 8

My practice is influenced by practices of other team members

6 7


6 7

Its delivery is influenced by ICU leadership 5 9

My practice is influenced by exposure to experts in the field

5 7


5 7

Emotion Clinician fear affects participation 7 7


We receive feedback on its delivery in my unit 7 8

My practice is facilitated by formulation of a personal action plan

6 6

It is facilitated by a unit protocol 5 8

We discuss barriers and ways to improve outside of clinical rounds.

5 8

103

Figure 4.1 -TDF domains important in the semi-structured interviews

Behaviour

Intentions

Goals

Memory, attention

and decision

processesEnviron-mental context

and resources

Social influences

Emotion

Behav-ioural

regulationKnow-ledge

Skills

Social/

professional role

Beliefs about capa-

bilities

Optimism


quences

Reinforce-ment

104

Figure 4.2 Screen shot of electronic survey interface

105

Figure 4.3 Participant flow through delphi

Round 3 Participants



74

63 complete data for Round 2

50 complete data (1 missing data for 1

question - have assumed no change

from Round 2)

7 non-respondents

5 extensive missing data

9 non-respondents (7 of these went on to complete Round 3)

2 extensive missing data

106

Figure 4.4 -Agreement change scores by professional group across all items

107

Chapter 5. Synthesis

5.1. Summary of Study Results by TDF Domain

5.1.1. Systematic Review

An analysis of barriers and facilitators is a key component of implementation science research

and of local quality improvement. In this series of studies, using the TDF as a framework, we

identified barriers and facilitators to early physical rehabilitation in ICU patients, with a focus on

mechanically ventilated patients (Table 5.1). As anticipated, in the systematic review of the

literature, we found a focus on the domains of Environmental Context and Resources, and

Beliefs about Consequences (Figure 3.1). However, we also commonly identified the domain of

Behavioural Regulation. Behavioural Regulation, as defined in the TDF literature, is “anything

aimed at managing or changing objectively observed or measured actions” 49,50. For example,

we found that many papers reported changing from an “opt-in” to “opt-out” approach, where

mobility became the default and a reason had to be given not to mobilize. Given the finding

that a large proportion of studies we identified were reporting implementation or quality

improvement interventions, Behavioural Regulation is often embedded in these interventions

through protocols or other practice structures such as inter-professional rounds, although was

never specifically labelled as such.

5.1.2. Delphi

Compared to the systematic review, the semi-structured interviews (Delphi Round 1) with

clinicians identified barriers and facilitators across a wide range of domains of the TDF. In fact,

108

seven of the fourteen domains of the TDF were identified as being of high importance (Figure

4.1). The same three domains as identified in the systematic review (Beliefs about

Consequences, Environmental Context and Resources, Behavioural regulation) were all

identified among the seven. However, four other domains were also identified by this method

– Skills, Social and Professional Role, Beliefs about Capabilities and Social Influences.

As items in Rounds 2 and 3 of the Delphi were based on the analysis of Round 1 and were

conducted with the same participants, concordance was expected. In Rounds 2 and 3 of the

Delphi, two additional domains of the TDF – Knowledge and Optimism - were identified as

important (Figure 5.1). As described in the relevant chapters, in Round 1 (the semi-structured

interviews), importance was determined by multiple factors (frequency of mention, participant

expression of importance, discord, difference between clinician groups and spontaneous

expression). However, in Rounds 2 and 3, importance was determined by virtue of having high

consensus among participants and high agreement on a Likert scale.

5.2. Social Influences

One of the domains identified in the semi-structured interviews that was also endorsed by

participants in subsequent Delphi rounds was Social Influences. Relative to domains which

were clearly dominant (Environmental Context and Resources, Beliefs about Consequences and

Behavioural Regulation), Social Influences was less commonly identified in the systematic

review of existing literature, although other qualitative work has identified team resistance as a

barrier 108. Specific beliefs were identified across the chapters, including issues around

interprofessional conflict, collaboration, and leadership.

109

Interprofessional collaboration and conflict in healthcare have been studied extensively in the

literature in general and to some extent in the ICU 136-138. Supportive literature for

interprofessional collaboration suggests it may be helpful, at least between physicians and

nurses, although barriers clearly exist 154. Variability in training, differing time pressures and

hierarchy in the culture of healthcare all contribute to challenges to meaningful

interprofessional collaboration. Our data suggest unique challenges when multiple professions

are involved in early physical rehabilitation for ICU patients.

5.3. The Use of Theory in Implementation Science

Recently, authors have advocated for the use of theory in implementation science 36,111.

However, in our systematic review, we found that studies rarely used any guiding theory or

framework for in assessing barriers and facilitators, or in the design of interventions. There

may be multiple reasons for this gap. First, researchers and quality improvers may lack the

expertise to incorporate theoretical frameworks into research questions. The newest version of

the TDF contains 14 domains, each based on a set of theories of behaviour rooted in psychology

and each including multiple constructs 50. It may be impractical for clinicians or researchers

who are clinical content experts to also become adequately trained in health psychology to

integrate complex theoretical frameworks into already complex implementation projects. If

theory-driven assessment of barriers (and subsequent design of interventions) improves

success, it may make more sense to routinely integrate those with implementation science

expertise into our research teams.

110

Secondly, theory-driven interventions are labour intensive. Even with adequate expertise, they

require time to assess barriers and facilitators and then develop interventions that are

theoretically sound, practical to deliver and in keeping with the clinical evidence base.

However, while interventions that lack a theoretical basis may be easier and quicker to design

and deploy, there is still significant time spent, which may be wasted if the intervention is

unsound.

The third reason for the lack of integration of theory may be that evidence of its efficacy is still

lacking. While it seems intuitive that interventions based on sound scientific principles

grounded in theory will work better that those that are not, there is, at this stage a lack of

strong evidence that this is the case. Most early TDF studies examined barriers and facilitators,

but had not yet reached the point of intervention 52,128,155,156. A few early trials have shown

promise 157,158, and other trials for which protocols have been published will hopefully provide a

fuller understanding of the role of theory driven interventions 159-161. The field of

implementation science requires more robust evidence that theoretically driven interventions

are better than those based on common sense.

5.4. Early Physical Rehabilitation. Are We Ready for Knowledge Translation?

Early physical rehabilitation, often called “early mobility” in the ICU literature, has enjoyed

growing interest among the ICU community. This has been driven by increased attention by

intensivists to the morbidity of ICU survivors 61,162, a body of early supportive literature

17,22,23,65,66 and by a general move away from a culture of bedrest. However, more recent trials

have been disappointing. An underpowered Australian trial showed no effect on six-minute

111

walk distance at six months of an individualized intervention starting in the ICU and continuing

to the post-hospital discharge period 24. Further trials 25,26 of similar interventions, including

one of an increased intensity intervention 26 also showed no effect on the primary outcome.

Somewhat hopefully, a recent trial of early mobility in surgical ICU patients showed

improvement in three co-primary outcomes: mobility during ICU stay, ICU length of stay and

functional status at hospital discharge 60. Importantly, ICU length of stay and hospital length of

stay (secondary outcome) were 3.0 and 6.5 days shorter in the treatment arm.

It is challenging to interpret this body of work and to know how to act on it, for those engaged

in implementation science, those designing future research and for clinicians. Except for two

trials conducted at five centres 26,60, all other studies are either single or two-centre trials.

Trials have been modest in size, with the largest trial of 300 patients powered on an optimistic

30% improvement in hospital length of stay. In contrast, a recent trial of early rehabilitation in

acute stroke (A Very Early Rehabilitation Trial - AVERT) randomized over 2000 patients in 56

centres, and showed harm of early mobility. While direct comparisons between this and the

ICU literature are inappropriate when outcomes and populations are different, the AVERT trial

has three important lessons. First, achieving adequate statistical power to detect differences

between treatment groups, especially in outcomes many months after the intervention, may

require very large sample sizes. This leads to concern that trials of early mobility in critically ill

patients have used overly optimistic effect sizes in sample size calculations, so called delta

inflation 163. One trial anticipated a 30 percent reduction in hospital length of stay 25, although

the authors’ own data from prior published quality improvement work showed a reduction of

only 23% 66.

112

Secondly, early positive results from small trials in any field may be spurious and should be

interpreted with caution. Like the evidence in critical care, early small trials of early mobility in

acute stroke were suggestive of benefit, although inconclusive 164-167. The potential for small,

early trials to over-estimate treatment effects is well established from empirical research,

particularly with non-fatal outcomes 168. It may be secondary to treatment heterogeneity 169,

methodologic issues 170 and to publication bias 171. An analysis of the impact of sample size on

effect size in 317 trials published in 27 meta-analyses in critical care specifically found when

comparing small (<100 participants) to large trials effect sizes were significantly larger 172.

Thirdly, while challenging, this trial demonstrates that it is feasible to conduct large scale multi-

centred trials of complex interventions. Critical care researchers need to leverage existing

clinical trial networks to carry out trials across settings to ensure adequate statistical power and

generalizability.

The question remains whether it is appropriate to engage in wide scale implementation of early

mobility at this time. The optimal timing of knowledge translation interventions for new

interventions generally is unknown. Interventions adopted too early may be based on flawed

evidence and may either be useless or potentially harmful and, in either case, divert resources

from effective therapies in healthcare. Once adopted, interventions are often difficult to “de-

adopt” 173. A recent study showed little reduction of the use of rescue therapies for acute

respiratory distress syndrome after “high impact” publications not supporting their use 174.

Conversely, clinicians are often slow to adopt evidence based therapies, and implementation

can take years, especially as complexity of the intervention increases.

113

Key factors impacting on timing of implementation include the strength of the evidence (ideally

evaluated using an agreed-upon tool, such as GRADE 175), risks of the intervention, financial and

other costs of the intervention, the degree of change from usual practice and effects on other

interventions (often called “balancing measures” in quality improvement literature). In the

case of early physical rehabilitation, although early literature was promising, the strength of the

evidence at present is low. Furthermore, although there is recently robust safety data

regarding accidental tube dislodgment and acute cardiorespiratory deterioration 110, there are

concerning (although not statistically significant) point estimates for increased mortality in

some studies 60. On the other hand, if physiotherapists are already engaged in ICUs, the

financial cost to changing workload from, for example, chest physiotherapy, to mobilization

may be reasonably low. Ultimately, given important new and concerning data about mortality

60, large scale implementation work in early rehabilitation in the ICU may be premature.

However, this type of theory driven work may have important implications for integrated

knowledge translation in future trials in this area.

5.5. Conclusions

This is the first comprehensive, theoretically driven series of studies examining barriers and

facilitators to early physical rehabilitation in critically ill patients. Using the TDF as a tool for

synthesis, a systematic review found little to no use of theory in the previously published

literature on this subject. Using the TDF, we found barriers and facilitators not previously

identified , in particular in the domain of Social Influences. The data from this work should be

used in future implementation work, in designing integrated KT and in implementation trials.

114

Table 5.1 - Overview of Results by Chapter -

Domain Systematic Review

Delphi Round 1 (Semi-Structured Interviews)

Delphi Rounds 2 and 3 (Questionnaire)

Knowledge ✓

Skills ✓ ✓ Social or Professional Role and Identity ✓ ✓

Beliefs about Capabilities ✓ ✓

Optimism ✓ Beliefs about Consequences ✓ ✓ ✓

Reinforcement

Intentions Goals

Memory, Attention and Decision Processes

Environmental Context and Resources ✓ ✓ ✓

Social Influences ✓ ✓ Emotion

Behavioural Regulation ✓ ✓

Shaded domains were not identified as important by any methodology.

115

Figure 5.1 - TDF Domains identified as important in delphi - orange domains are new domains for Rounds 2 & 3 of Delphi, crossed out domain was identified in interviews but not Rounds 2 & 3

Behaviour

Intentions

Goals

Memory, attention

and decision

processesEnviron-mental context

and resources

Social influences

Emotion

Behav-ioural

regulationKnow-ledge

Skills

Social/ professional

role

Beliefs about capa-

bilities

Optimism


quences

Reinforce-ment

116

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