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Clinical and Diagnostic Testing Services at the Point of Care in Pharmacies across Greater Manchester Evaluation of a Department of Health sponsored High Street Testing Pilot

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Clinical and Diagnostic Testing Services at the Point of Care in Pharmacies across Greater Manchester

Evaluation of a Department of Health sponsored High Street Testing Pilot

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Document control sheet

Client The Association of Greater Manchester Primary Care Trusts

Document Title Evaluation of the High Street Testing Pilot

Version 07

Status Final

Reference

Author Nadine Fry

Date 7th January 2008

Further copies from email: [email protected] quoting reference and author

Quality assurance by: Heather Heathfield

Document history

Version Date Author Comments

06 and 07 18th February 2008 Heather Heathfield Final release

05 12th February 2008 Heather Heathfield Updated after comments from client

04 7th January 2008 Nadine Fry 1st Issue Version

04 27th December 2007 Heather Heathfield Final QA

03 16th December 2007 Nadine Fry 1st Draft for internal QA

Contact details

Main point of contact

Telephone number

Email address Postal address

Dr Heather Heathfield

0161 902 1100 [email protected] Tribal ConsultingParkway House Palatine Road Northenden Manchester M22 4DB

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Contents 1 Introduction ...................................................................................................................1 1.1 The High Street Testing Pilot ..............................................................................1 1.2 Aims and Objectives............................................................................................1 1.3 Evaluation............................................................................................................2 1.4 Evaluation Questions ..........................................................................................2 1.5 About this document............................................................................................2

2 Background to the Pilot .................................................................................................4 2.1 Drivers for ‘High Street Testing’ models of care..................................................4 2.2 Alignment with DH Priorities................................................................................5 2.3 Funding................................................................................................................6 2.4 Pilot Implementation............................................................................................7 2.5 Participants..........................................................................................................9 2.6 Governance.........................................................................................................9 2.7 Timescales ........................................................................................................10

3 Methodology................................................................................................................11 3.1 Overview............................................................................................................11 3.2 Evaluation Questions ........................................................................................11 3.3 Stakeholders .....................................................................................................11 3.4 Data Sources.....................................................................................................11 3.5 Evaluation Framework.......................................................................................13 3.6 Operational Data ...............................................................................................14 3.7 External Quality Assessment ............................................................................14 3.8 Patient Involvement...........................................................................................14 3.9 Staff Involvement...............................................................................................14 3.10 Financial Data ...................................................................................................15 3.11 Ethical Considerations.......................................................................................15 3.12 Confidentiality....................................................................................................15

4 Operational Data .........................................................................................................16 4.1 Introduction........................................................................................................16 4.2 The findings.......................................................................................................19 4.3 Pharmacy attrition .............................................................................................19 4.4 Patient attrition ..................................................................................................20 4.5 Pharmacy data overview...................................................................................26 4.6 Patient consultation ...........................................................................................27 4.7 Clinical data.......................................................................................................34 4.8 Pharmacy scheduling ........................................................................................34 4.9 Summary ...........................................................................................................40

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5 External Quality Assessment Data .............................................................................41 5.1 Introduction........................................................................................................41 5.2 External Quality Assessment ............................................................................41 5.3 Pharmacists’ competence .................................................................................41

6 Patient Experiences ....................................................................................................42 6.1 Introduction........................................................................................................42 6.2 Questionnaires ..................................................................................................42 6.3 Patient Interviews ..............................................................................................45 6.4 Summary ...........................................................................................................48

7 Staff Experiences ........................................................................................................49 7.1 Introduction........................................................................................................49 7.2 Results...............................................................................................................49 7.3 Participation.......................................................................................................50 7.4 Current Status ...................................................................................................53 7.5 Experiences.......................................................................................................54 7.6 Overall ...............................................................................................................61 7.7 Summary ...........................................................................................................65

8 Financial Considerations.............................................................................................66 8.1 Introduction........................................................................................................66 8.2 Financial model .................................................................................................66 8.3 Financial principles applied ...............................................................................66 8.4 Costs in the system...........................................................................................68 8.5 Comparison of pharmacy approach to conventional process ...........................69 8.6 The pharmacy perspective................................................................................71 8.7 Summary ...........................................................................................................72

9 Discussion...................................................................................................................73 9.1 Introduction........................................................................................................73 9.2 Overview of the Findings...................................................................................73 9.3 Caveats .............................................................................................................76 9.4 Barriers and Incentives......................................................................................77 9.5 Fit with NHS Strategy ........................................................................................78 9.6 Conclusions and recommended further work....................................................80 9.7 Summary ...........................................................................................................81

Appendix A1 – Conventional Process......................................................................................82 Appendix A2 – HST Process....................................................................................................83 Appendix A3 – Quality outcome framework targets.................................................................87 Appendix A4 – Consultation questions and responses ...........................................................92 Appendix A5 – Tests conducted ..............................................................................................98

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Appendix A6 – Clinical data .....................................................................................................99 Appendix B1 – Performance Monitor Report .........................................................................104 Appendix C – Patient Questionnaire......................................................................................112 Appendix D – Staff Questionnaire..........................................................................................116 Appendix E – Staff Interview Schema....................................................................................122 Appendix F – List of participating staff ...................................................................................126 Appendix G – Financial model ...............................................................................................129

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Executive summary

Background

1. The aim of the High Street Testing (HST) pilot is to offer patients with diabetes and/or cardiovascular disease the choice of attending a pharmacy for a clinical consultation and diagnostic blood tests, instead of visiting their GP. The strategic objectives of the pilot are to1:

■ Provide opportunities under the new pharmacy contract for pharmacists to manage patients.

■ Assess whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions.

■ Inform the Department of Health (DH) as to the likely valuation of the new pharmacy contract.

■ Inform DH as to the contribution of Point of Care Testing (POCT) to the development of primary care facing laboratory medicine services.

■ To increase patients’ choice of access to more conveniently sited services.

2. The benefits are expected to be enhanced clinical, financial and organisational outcomes, increased patient choice, transferable clinical care pathways, electronic patient records in pharmacies and integration of pharmacy into the healthcare community.

3. The Greater Manchester High Street Testing pilot began offering clinical consultations and POCT for the management of diabetes and (secondary prevention) cardiovascular disease for up to 1200 people in nine pharmacies across four Greater Manchester PCTs in August 2006.

4. The pilot sought to provide choice for patients to attend two episodes of care over one year that includes HbA1C, lipid profile (cholesterol, HDL-cholesterol, triglycerides), weight and height measurement.

5. The evaluation of the High Street Testing pilot took place between August 2006 and November 2007 and focuses upon assessing whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions.

Findings

Overview

■ Of 22 pharmacies selected in August 2005, 13 withdrew before service commencement in August 2006 due to:

Reluctance of GPs to refer patients.

Relationship breakdown between pharmacies and GP practices.

Pharmacist resignation and/or relocation.

One pharmacy not selected as the service provider for a new GP (LIFT) centre.

1 High Street Testing: Full Business Case, Version 1.5, May 2006.

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■ 34% of 603 patients took up choice to receive a pharmacy-led consultation and point of care blood tests for management of their diabetes and/or coronary heart disease.

■ 86% and 14% of patients, respectively, reported high and moderate levels of satisfaction with their pharmacy-led consultation. No dissatisfaction was expressed.

■ 47% of patients reported their care to be better than that received at their GP practice, 50% reported this to be as good as their GP practice consultation.

■ External quality assessment reports indicate that pharmacists are able to deliver point of care diagnostic testing to standards equivalent to those of central laboratories.

■ There is insufficient data for patients having second visits to the pharmacy (22) to draw any conclusions with regard to clinical management. However, for those patients with two visits, test results were generally similar or better for the second set of tests.

■ The calculations show that HST can be a commercially viable service for both commissioners and providers of services. However, this is based upon assumptions about the cost of a GP practice appointment and that a visit to the pharmacy removes the need for the patient to visit their GP in relation to the management of their CHD or diabetes.

Key benefits

■ For patients - Improved choice of access to more conveniently sited services, opportunity for increased exchange of information and discussion, self empowerment and encouraged self management through immediate feedback of results from POCT.

■ For pharmacists - Improved service to patients, expanded job role and greater job satisfaction, opportunities to support the new pharmacy contract and public health agenda and increased payment to the pharmacy,

■ For general practice staff - Reduce workload allowing concentration on other areas, potential reduction in costs of managing patients, support for the choice agenda and requirement for alternative service delivery.

Key barriers

■ Lack of GP and practice staff engagement and confidence in the service.

■ Concerns over additional patient journeys being generated due to the limited repertoire of diabetes/CHD management services offered by the pilot. Notably, phlebotomy was cited.

■ Small numbers of patients seen by pharmacists, so lack of practice and confidence in ability to undertake POCT.

■ Lack of IT infrastructure between high street pharmacies and GP practices. A PC-based solution that supported protocol-driven care and electronic communication between providers was developed but delayed pilot implementation between August 2005 and August 2006.

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Meeting the strategic objectives of the pilot

Provision of opportunities under the new pharmacy contract

6. In line with opportunities under the new pharmacy contract, HST offers pharmacists an extended job role and increased satisfaction. The new contract will underpin the new contractual framework for community pharmacy agreed for England and Wales, drawing on community pharmacy’s assets to support the diverse needs of patients and communities and patients who wish to care for themselves, help deliver the National Service Frameworks, be a source of innovation in the delivery of services and help tackle health inequalities.

7. In particular, HST fits into the category of enhanced services, commissioned and funded locally by Primary Care Trusts, for example, anticoagulant monitoring, medicines assessment and compliance support and medication review.

HST as a Suitable Setting to Deliver Care for Long Term Conditions

8. The pilot has demonstrated that HST is a suitable environment to deliver care for diabetes and CHD, and potentially a larger range of long term conditions.

9. Patients stated they were satisfied with all aspects of their HST appointments, including booking the appointment, choice of time and date, surroundings, and any advice given to them by the pharmacist. The majority of patients stated that they were ‘very satisfied’ with the service and wished their High Street pharmacy to continue to manage their condition.

10. There is insufficient data to make any inferences about how well HST manages patients. However, the analysis shows for the small number of patients who visited the pharmacy twice, second test results showed an improvement over the first.

11. The level of remuneration offered to pharmacies in the pilot were agreed with key stakeholders beforehand and may serve as a baseline from which future services may be valued. Further work on tariff setting is required, particularly in relation to remuneration for achieving Quality Outcomes Framework (QOF) targets. Key outcomes data reported here on average length of a pharmacy consultation (28 minutes), days and times of the week (incl. Saturdays and Sundays) on which services are provided and the types of staff involved in service provision may provide evidence to develop appropriate models

The contribution of POCT to the development of primary care facing laboratory medicine services

12. POCT testing provides new opportunities for decentralisation of easy to use diagnostics from secondary care, empowering healthcare professionals from different backgrounds to provide clinical services closer to patients in alternative settings.

13. The contributions from secondary laboratory medicine services in providing POCT governance frameworks during the pilot (establishing policy and procedure for its conduct, the infrastructure for monitoring and managing ongoing performance) may serve as a model for future roles.

14. Third party performance management was contracted during the pilot to ensure that training in equipment use, maintenance, troubleshooting, quality control and quality assurance met governance expectations.

15. Future roles for laboratory medicine practitioners in service delivery, performance management and development of suitable infrastructures for quality assurance and accreditation of diagnostics testing services in primary care require further consideration.

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Increased access and choice to patients

16. HST offers a new option for the management of diabetic and CHD patients and therefore supports the choice agenda by providing access to conveniently sited services. 34% of eligible patients took up choice. However, there was considerable variability in uptake of choice dependent in part on the interpretation of the eligibility criteria by individual GP practices. Further a significant number of patients either failed to attend or were subjected to undue delays for their first appointment.

17. The number of clinically eligible patients offered choice in the pilot was less than expected due to the fact that many eligible patients did not use pharmacies in the pilot. This problem will be reduced with a larger scale rollout which includes greater coverage of pharmacies per GP practice.

Recommendations for Future Rollout

18. Future commissioning should include a broader scope of clinical and diagnostic testing services. Examples might include case finding/screening (e.g. diabetes, cancer), health promotion/ disease prevention (e.g. smoking cessation, lifestyle choices) and management of other long term conditions (e.g. arthritis, asthma/COPD). Perceived advantages of commissioning a broader range of services include:

■ Cost effectiveness in contracting/performance management and the use of pharmacy resources.

■ Enhanced opportunities to support the NHS reform agenda, particularly in delivery of a broad range of public health improvement targets.

■ A greater reduction in dependency on current health service providers.

■ An increased throughput of people/patients to ensure pharmacists’ competence in delivering patient friendly and safe services is maintained.

■ Minimising pharmacy’s risk in depending on a limited portfolio of services.

■ More widespread promotion and support for pharmacists’ roles in delivering high quality clinical care.

19. Future roll-out should include a larger number of pharmacies so as to:

■ Encourage greater ownership amongst provider organisations.

■ Minimise impact of pharmacy withdrawals from service provision.

■ Achieve better economies of scale.

■ Increase choice of access for people and patients.

■ Allow development of more cost efficient hub and spoke services amongst pharmacies and other providers.

20. One-stop pharmacy visits should encompass a repertoire of clinical and diagnostic testing services that ensures patients are offered a substitute rather than an additional journey to receive their care.

21. Given the diversity of potential stakeholders who may contribute to the NHS reform agenda, sustained services commissioning dictates the need for mutual expectations to be defined as

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part of contracting/ performance management. Potential stakeholders include pharmacy, general practice, primary care trusts, secondary care organisations, IM&T suppliers and the diagnostics industry.

22. The evaluation has indicated that successful rollout on a larger scale will depend upon a number of factors being met:

■ Better engagement with GPs and general practice staff – This should start early in the rollout process, identify and cultivate influential advocates for HST and create links with national and local professional bodies which can positively influence GP attitudes.

■ A more proactive approach to recruiting patients – This needs to consider the wording in the initial GP letter offering choice, use of publicity leaflets and posters to explain benefits, follow-up phone calls to non-responders, and direct approach by pharmacists to increase recruitment levels.

■ Review and amendment of the inclusion criteria – The overall number of patients on either the diabetes or CHD register for the pilot practices was 2,197 of which 1,340 (61%) met the clinical inclusion criteria. This is considerably lower than the Kaiser Permanente triangle which suggests 70-80% of patients with long term conditions are appropriate for self care.

■ Review and amendment of the algorithm for patient review status – The evaluation shows that there are inconsistencies in both the way in which the patient review status is acted upon and also between the inclusion criteria and patient status algorithm (e.g. BMI appears to be causing a red review status in a large number of patients despite them recently meeting the inclusion criteria).

■ Dedicated resources for project management – The pilot relied mainly on the dedication and enthusiasm of the High Street Testing Steering Committee members and associated staff. Further rollout will require greater management and coordination by dedicated staff.

■ Professional endorsement of training – Pharmacists in the pilot attended a two day POCT training session, which currently is not professionally recognised by the Royal College of Pharmacists. Professional endorsement would encourage pharmacists (and technicians) to undertake POCT.

■ Consideration of a wider role for pharmacists – The pilot did not include all the tests a diabetic or CHD patient might need to have during the course of their care. As a result they may have to visit both the pharmacist and general practice. Widening the role of pharmacists could increase benefit to patients and further reduce the cost of visits to the general practice.

■ Tariff setting – The evaluation has indicated some estimated tariffs for different volumes of provision which need to be further explored and refined to reflect any future larger scale rollout.

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1 Introduction

1.1 The High Street Testing Pilot

1.1.1 In June 2004, the Department of Health named the former Greater Manchester Strategic Health Authority (SHA) as a Diagnostics Plurality Pilot. Greater Manchester SHA supported by funding from the Access Directorate has been running three pilot projects delivering diagnostics in Primary Care:

■ High Street Testing offers patients with diabetes and/or cardiovascular disease the choice of attending a pharmacy for clinical consultation and diagnostic blood tests. Information about the outcomes of care episodes is relayed to GP practices. The system includes decision support to inform pharmacists’ intervention strategy.

■ DIAGAM (“Diagnostic Ambulance” service) compliments the Patient Transport Services (PTS) services provided by Greater Manchester Ambulance Service (GMAS) for patients requiring anticoagulant services. PTS staff sample blood and transport this to acute services for testing, saving the patient a trip to hospital.

■ Fast Track Plus enables GPs and other primary care clinicians to refer patients directly for Magnetic Resonance Imaging (MRI) in specialities including orthopaedics, Ear Not and Throat (ENT) and neurology.

1.1.2 Each pilot is designed to test and evaluate locally generated hypotheses, with a view to sharing the outcomes with the wider NHS and facilitating achievement of the 18-week patient journey target for 2008. Building on work previously undertaken within Greater Manchester SHA each pilot is focussing on the primary-care facing provision that is the key to patient-centred, patient-responsive services.

1.1.3 The DIAGAM and Fast Track Plus pilots were completed in December 2007.

1.1.4 This report relates to the evaluation of the High Street Testing pilot.

1.2 Aims and Objectives

1.2.1 The aim of the High Street Testing pilot is to offer patients with diabetes and/or cardiovascular disease the choice of attending a pharmacy for clinical consultation and diagnostic blood tests, instead of visiting their GP. The strategic objectives of the pilot are to2:

■ Provide opportunities under the new pharmacy contract for pharmacists to manage patients.

■ Assess whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions.

■ Inform the Department of Health (DH) as to the likely valuation of the new pharmacy contract.

■ Inform DH as to the contribution of Point of Care Testing (POCT) to the development of primary care facing laboratory medicine services.3

2 High Street Testing: Full Business Case, Version 1.5, May 2006.

3 Memorandum of POCT (2)

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■ To increase access and choice to patients.

1.2.2 The benefits are expected to be enhanced clinical, financial and organisational outcomes, increased patient choice, transferable clinical care pathways, electronic patient records in pharmacies and integration of pharmacy into the healthcare community.

1.2.3 Patients who work or otherwise find it difficult to attend a survey or secondary care clinic for testing are expected to gain the greatest benefits from High Street Testing.

1.3 Evaluation

1.3.1 In August 2006, the former Greater Manchester SHA commissioned an evaluation of the High Street Testing pilot, with an emphasis on: patient experience, service uptake, staff attitudes and experience, pharmacists’ competence in point of care testing, clinical effectiveness of service and economic viability of services in terms of start up and on going costs.

1.3.2 The evaluation of the High Street Testing pilot took place between August 2006 and November 2007 and focuses upon assessing whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions.

1.4 Evaluation Questions

1.4.1 Key questions for the evaluation are:

■ How is High Street Testing used by patients?

■ Is it acceptable to patients and other stakeholders?

■ How does it impact on secondary care pharmacists, lab staff and nurse led clinics?

■ Is the process clinically effective?

■ What are the financial implications?

■ Are pharmacists competent to carry out POCT?

1.5 About this document

1.5.1 This document presents the findings of the evaluation of the High Street Testing pilot. It provides detail on each individual evaluation question as well as the conclusions that have been reached on the overall outcome of the evaluation.

1.5.2 It contains the following sections:

■ Executive Summary – presents the key findings and conclusions in terms of patient experience, clinician experience, clinical quality of service and economic viability.

■ Section 1 Introduction –provides an overview of the pilot and the evaluation project.

■ Section 2 Background – provides details of the pilot in terms of the organisations involved, the aims and objectives, and the operational details.

■ Section 3 Methodology – describes how the evaluation was conducted and the evaluation questions that have been considered, as well as ethical considerations made.

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■ Section 4 Operational Data – describes the conventional and new HST processes, and explores the operational data. The data considered includes attrition data and data from the pharmacy database.

■ Section 5 External Quality Assessment Data – describes the role and performance reports of the performance monitor and outcomes of pharmacists’ participation in National External Quality Assessment Scheme for HbA1C and lipids. These are provided as separate reports in the appendices.

■ Section 6 Patient Experiences – describes the responses we received from patient questionnaires and interviews, and what can be concluded from these responses.

■ Section 7 Staff Experiences – describes the responses we received from staff interviews and questionnaires, and what can be concluded from these responses.

■ Section 8 Financial Considerations – examines the pharmacy start-up and running costs

■ Section 9 Discussion – discusses the overall findings.

■ Section 10 Conclusions and Recommendations - draws conclusions from the various analyses, examines the viability of the High Street Testing model to provide a suitable setting to deliver care for long-term conditions.

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2 Background to the Pilot

2.1 Drivers for ‘High Street Testing’ models of care

2.1.1 The pilot’s attraction was considered to lie in its alignment with future healthcare delivery models, as follows:

A. Supporting long term condition management through increased self care

2.1.2 Seventeen and a half million people in UK live with long term conditions like asthma, diabetes, arthritis, cardio-vascular disease. Management of such conditions currently accounts for up to 80% of GP consultations – around 180 million visits per year. The incidence of chronic disease in the over 65s is anticipated to double by 2030 but for conditions like diabetes far higher prevalence are projected as shown in Figure 1 below.

Amos AF et al. Diabetic Med 1997; 14 (Supply 5): S1–S85.

The size of the problem

Dia

bete

s pr

eval

ence

(tho

usan

ds)

0

500

1000

1500

2000

2500

3000

1995 2000 2010

3 million by 20103 million by 2010

Figure 1: Estimated prevalence of diabetes in the UK by 2010

2.1.3 For many such conditions assistive technologies such as diagnostics delivered closer to patients can encourage greater ownership of health, improve medicines use/drug expenditure, reduce referrals to GPs, visits to outpatient clinics and Accident and Emergency departments.

B. Accelerating transfer of healthcare to primary care

2.1.4 Advances in technology increasingly provide opportunities for decentralisation of easier-to-use diagnostics from secondary care, empowering healthcare professionals from different backgrounds to provide clinical services closer to patients in alternative settings.

2.1.5 Relevant POCT analysers deployed in pharmacies during this project include:

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Point of care blood testing device for HbA1C (left) and lipid profile (right)

C. Providing new ways of working

2.1.6 Driven by the need for a broader skills base to deliver future healthcare needs, new ways of working with diagnostics provides opportunities to escalate the role development of healthcare professionals beyond historic professional boundaries.

2.1.7 Providing more patient-centred roles under emerging common career frameworks in turn delivers the vision of a health service defined by competence and supported by an awards and qualifications framework.

2.1.8 The pilot identifies opportunities for pharmacists under their new Pharmacy contract to develop new roles in analysis and interpretation. Introduced in April 2005, the new contract will increasingly see pharmacists migrate from contracts based on volumes of prescriptions to contracts based on remuneration for essential, advanced and enhanced clinical services.

D. New ways of working with the independent sector (IS)

2.1.9 Central to the development of the pilot has been the recognition that the complementary strengths and weaknesses offered by its stakeholders provided the key elements of an NHS/IS partnership:

■ Secondary care clinical and laboratory expertise in establishing protocol driven care pathways and service governance frameworks.

■ National concerns, local chains and independent pharmacists as service providers; the diagnostics industry’s provision of the latest advances in POCT technology; IM&T software solution suppliers.

■ Primary care PCT leads and GPs for delivery of the service infrastructure, protocols and patient referrals.

2.2 Alignment with DH Priorities

2.2.1 The pilot pushes frontiers of reform in accordance with recent initiatives such as:

i. The NHS in England: the operating framework for 2008/09. Specifically to focus on:- Developing world class commissioning, using the full range of levers and

incentives to transform services and improve outcomes.

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A strong emphasis on genuine partnership working at a local level with local government to ensure that local health and wellbeing needs are better understood and addressed in partnership.

ii. Our NHS, Our Future: NHS next stage review – interim report summary: October

2007. Setting out a 10 year vision, looking at how the NHS can become fairer, more personalised, effective and safe.

iii. The NHS in England: the operating framework for 2006/7. Specifically, supporting opportunities to deliver universal coverage of practice-based commissioning by March 2007, 90% implementation of ‘choose and book’ by March 2007.

On achieving specific service priorities highlighted in the framework, the pilot aligns on:

- Reducing health inequalities, particularly reducing mortality rates from heart disease, stroke and related diseases by 40% in people under 75 by 2010, reducing adult smoking rates to 21% or less by 2010, tackling obesity, supporting people with long-term conditions, sustaining improvements in patient/user experience.

- Reducing MRSA levels, through reducing referrals to secondary care.

iv. The January 2006 white paper Our Health, Our Care, Our Say by supporting greater choice being offered to patients, improving access to community services, providing cost-effective and safe services closer to home, providing assistive technologies that encourage self-management.

v. February 2006’s Self Care – a guide to developing local strategies and good practice,

by delivering self care support packages, self care skills, education and training for individuals with long term conditions - in turn to reduce GP attendance, decrease visits to hospital and reduce drug expenditure through better medicines management.

2.3 Funding

2.3.1 The planned budget for the pilot was £750K, of which £200K were set-up costs, £71,976 of consumables, £144,008 pharmacy revenue and £281,300 project costs, with a contingency of £52,716.

2.3.2 The pilot budget was expected to fund approx. 1,500 patients in the pilot. Pharmacies received £43 for each patient that received three episodes of care (paid after the first visit). They were obliged to contact a patient who missed their second or third appointment a total of three times to re-arrange their visit. Any future use of pharmacies to undertake High Street Testing would have to be funded by PCTs.

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2.4 Pilot Implementation

Operation

2.4.1 Service delivery commenced in August 2006 and each pharmacy provided services for 15 months in one of four Greater Manchester PCTs.

2.4.2 Patients on GP practice registers who met local inclusion/exclusion criteria were offered choice to receive a minimum of two episodes of care over 12 months in confidential consultation facilities specified to standards outlined in the new pharmacy contract. Each episode of care includes:

■ A clinical consultation covering medication concordance, diet, exercise and lifestyle advice.

■ Blood tests for HbA1C, cholesterol, HDL-cholesterol, triglycerides.

■ Weight, height, BMI calculation, blood pressure measurements.

2.4.3 Outcomes of care episodes were collated on a pharmacy-based computer, in turn linked to a central server that allows electronic transfer of consultation outcomes at the point of care to the GP practice, as shown in Figure 2 overleaf.

2.4.4 The patient was given a copy of their results and management plan, which was also forwarded to the GP for inclusion in their notes. The next appointment was also arranged.

2.4.5 A traffic light alert system has been developed with treatment cut-offs based on best literature evidence and is used to grade a patient’s status as green (next appointment scheduled at 6 months), amber (3 months) or red (patients are referred back to the GP).

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Pharmacy-based IT solutions

Pharmacy GP surgery

Server

HIS

Patient info

ETP

Figure 2: IM&T Infrastructure

The Care Pathway

2.4.6 A schematic of the full care pathway is included in Appendix A and consists of five key stages as listed below.

■ Stage 1: Patient recruitment.

■ Stage 2: Appointment scheduling and patient reminders.

■ Stage 3: Interpreting test results and counselling the patient.

■ Stage 4: Closing the consultation and data transfer.

■ Stage 5: Subsequent episodes of care.

2.4.7 The differences in the conventional and new processes are:

■ Location of appointment: GP surgery versus pharmacy.

■ Time between test and result: point of care testing versus lab testing.

■ Feedback to patient: consultation with results at the appointment versus consultation and then later results.

2.4.8 The pilot process with point of care testing provides results and interpretation to the patient at the time of testing. This provides an opportunity for a face-to-face discussion about the results with the pharmacy and any next steps.

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2.5 Participants

Patients

2.5.1 The Business Case stated that the pilot was expected to serve approximately 1,500 patients. This is segmented as:

■ Patients with CHD only (780).

■ Patients with diabetes (660).

2.5.2 This assumes 80% of patients on practice registers are eligible to take part in the trial and 30% accept the offer of High Street Testing. However, the Business Case acknowledges previous experiences in which there is a 10% - 80% take up rate (i.e. 600 – 4,800 patients).

Pharmacies

2.5.3 There were nine pharmacies in the pilot, including a mixture of national multiples, local chains and independent pharmacies.

2.5.4 Pharmacists were required to carry out the counselling part of the protocol, but the choice of staff to conduct the tests was the responsibility of the pharmacy. Pharmacists and pharmacy staff were trained to ensure they were competent in the required skill set (testing, governance, clinical context and counselling skills).

2.5.5 It was estimated that most pharmacies would average one patient visit per day. This is based upon the assumption that each pharmacy takes on approx 100 patients, each of whom visits three times a year. This equals approximately 300 visits a year per pharmacy, i.e. 25 visits a month, or six to seven visits a week.

GP Practices

2.5.6 The pilot involved four PCTs covering 63 GP Practices:

■ Ashton, Leigh and Wigan.

■ Oldham.

■ Salford.

■ Stockport.

2.5.7 GP engagement was undertaken locally by the PCT pilot leads (one per PCT) and so may vary between PCTs.

2.6 Governance

2.6.1 A governance infrastructure was put in place, including a quality management system that placed expectations on the following:

■ Secondary care laboratory medicine services for establishing policy and procedure for the conduct of POCT, the infrastructure for monitoring and managing ongoing performance.

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■ A third party performance monitor who conducted monthly pharmacy visits to monitor adherence to contractual expectations, pharmacists competence in clinical consultations and performance of point of care testing.

■ A ‘High Street Testing’ steering committee that received performance monitoring reports and advise a PCT-led diagnostics board of remedial action required to restore good performance.

■ Project implementation leads in each PCT for GP engagement, issue of ‘choice’ letters and support for pharmacies during service start up.

■ The diagnostics industry for provision of CE-marked technology and continued supply of consumables and reagents.

2.7 Timescales

2.7.1 The pilot officially started in August 2006 and is due to end in April 2008.

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3 Methodology

3.1 Overview

3.1.1 A key objective of the pilot was to “assess whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions”. Therefore, the evaluation has focused in particular upon the feasibility and acceptability of High Street Testing, including patient take-up and acceptability, and clinical effectiveness. The evaluation has also looked at start-up and ongoing costs in the context of the pilot.

3.2 Evaluation Questions

3.2.1 Key questions for the evaluation are:

■ How is High Street Testing used by patients? Process maps, level of patient uptake, numbers of attendances at pharmacy, compliance, number of patients opting to return to their GP or number of referrals from pharmacist to GP, etc.

■ Is it acceptable to patients and other stakeholders? What are patient experiences and how satisfied are they with the process, perceived value, benefits, compliance, confidence in pharmacist, etc.

■ How does it impact on primary care stakeholders? Attitudes and experiences, impact on workload and role, benefits and barriers, etc.

■ Is the process clinically effective? Are the patients well controlled in a clinical sense? Do their results improve over time?

■ Are pharmacists competent to carry out point of care testing? Assessed through internal quality control monitoring and external quality assessment performance

■ What are the financial implications? What are the pharmacy start-up and running costs? What are the savings for GPs and hospital laboratory staff, etc?

3.3 Stakeholders

3.3.1 Key pilot stakeholders involved in the evaluation were:

■ Patients.

■ GPs and nurses leading clinics.

■ Pharmacy staff.

■ Primary care pharmacists (implementation leads and heads of medicines management) and laboratory staff (healthcare scientists from the 4 pathology services for the 4PCTs).

■ External stakeholders (e.g. Royal Pharmaceutical Society Great Britain, Royal College of Pathologists, Association for Clinical Biochemistry) Department of Health (Access Directorate, National Implementation Team, etc).

3.4 Data Sources

3.4.1 The key data sources are shown in Figure 3 overleaf.

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Figure 3 - Data Sources

Data Source

Process mapping of new versus conventional approach. Primary research

Patient questionnaires (all patients) and phone interviews (with a sample of patients)

Primary research

Patient questionnaires handed out to each patient (by the pharmacist) after they have had a consultation. A free post envelope was included.

Patient questionnaires also ask if the patient is willing to participate in a telephone interview.

Pharmacy staff questionnaires (all staff) and interviews (with a sample of staff)

Primary research

Interim interviews (mid pilot)

Post pilot questionnaires and interviews

Hospital pharmacist and lab staff questionnaires (all staff) and interviews (sample of staff)

Primary research

Interim interviews (mid pilot)

GPs and primary care staff questionnaires and interviews. Primary research

Interim interviews (mid pilot)

Post pilot questionnaires and interviews

Patient recruitment and participation data

Application of eligibility criteria (as may be different in different GP systems)

Number of patients offered choice, number of patients indicating they wish to participate, number of patients who attend a pharmacy, number of attendances per patient, number of DNAs, number of patients deciding to return to GP rather than be managed by pharmacy, etc.

Application of eligibility criteria, number of patients offered choice, and number of patients indicating they wish to participate collected by the PCT

Monitoring data on patient attendances from pharmacy systems

Clinical measures (Hb1C, cholesterol, HDL-cholesterol, INR), BP, weight/BMI

From the pharmacy attendance data for patients with a series of attendances

It was not possible to clinical extract data from the GP practices for evaluation.

Financial data

Start-up costs (pharmacy equipment, new staff, training)

Ongoing costs of pharmacy consultation vs. cost of GP practice consultation

Provided by the SHA, PCTs and pharmacies and collected through a financial workshop

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Governance data

Calibration and QA of equipment, review of procedures, assessment of the faculties provided for patients, etc.

Collected by the ‘Performance Monitor’ as part of monthly pharmacy visits

External stakeholder views Obtained from stakeholder interviews

3.5 Evaluation Framework

3.5.1 Figure 4 below provides an overview of the key evaluation questions, criteria for measurement and data collection methods.

Figure 4 – Evaluation questions, criteria and data sources

Evaluation Question

Criteria for Measurement Methods

How is High Street Testing used?

Process maps, level of patient uptake, numbers of attendances at pharmacy, compliance, DNAs, number of patients opting to return to their GP, number of referrals from pharmacist to GP, from pharmacist into secondary care, or from GP to secondary care, etc.

Primary research

Data from Pharmacy systems

Data from PCTs

Is it acceptable to patients and GPs?

What are patient experiences and how satisfied are they with the process, perceived value, benefits, compliance, confidence in pharmacist, etc.

GP attitudes and experiences, impact on workload, perceived value, benefits, etc.

Paper-based questionnaires given to all participating patients.

A sample of patients invited to participate in a phone interview.

All GPs given questionnaires and a sample interviewed.

How does it impact on primary care stakeholders?

How does it impact on primary care stakeholders? Attitudes and experiences, impact on workload and role, benefits and barriers, etc.

Interviews with primary care staff, pharmacists and a small cohort of PCT staff.

Is the process clinically effective?

Are the patients well controlled in a clinical sense? Do their results improve over time?

Data from the pharmacy system.

What are the financial implications?

What are the pharmacy start-up and running costs? What are the savings for GPs practices and hospital laboratory testing, etc.

Financial data from SHA, pharmacies and PCTs

Salary data and national data

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3.6 Operational Data

3.6.1 There are three main sources of operational data on the HST pilot:

■ Pharmacy attrition: this is the pharmacy uptake data. Of the 22 pharmacies originally identified only nine were actively involved in the pilot for a variety of reasons.

■ Patient attrition: this is the recruitment attrition data for the patients of GP practices involved in the pilot. This considers the eligibility of patients, through registers and criteria, and their uptake of choice to join the pilot.

■ Pharmacy data: this is data from the pharmacy system, which has been designed for the pilot to collect and transfer all of the required data. This includes both data required to record the patient episode and data required for other users, such as the GP practice.

3.6.2 As part of the evaluation each of these data sets is analysed and the findings presented in section 4.

3.7 External Quality Assessment

3.7.1 NF Burrows Consulting Ltd were employed as the performance monitor for the duration of the pilot. Their monitoring report is included as Appendix B1. They were responsible for collecting data and information in the following two areas:

■ Point of care testing – internal quality control performance and external quality assessment performance.

■ Pharmacists’ competence – assessed on a monthly basis against pre-defined performance measures

3.8 Patient Involvement

3.8.1 There were two methods used to gauge patients’ experiences of HST. Firstly there was a paper-based questionnaire with fifteen questions. Patients completing this questionnaire were also invited to give their contact details for a more in depth telephone interview to be carried out by a Tribal researcher.

3.8.2 There were 150 questionnaires given to the Performance Monitor staff for distribution to patients and 36 were returned. These were distributed via the pharmacies taking part in the pilot. Patients participating in the pilot were invited to complete and return the questionnaire, which could be completed anonymously.

3.8.3 The final section of the questionnaire invited patients to be interviewed by telephone. Twelve patients elected to do so. These interviews each lasted between 10 and 20 minutes and provided the opportunity to gather in-depth qualitative feedback about patients’ experiences of the pilot (see Appendix C).

3.9 Staff Involvement

3.9.1 The majority of GPs, practice managers, pharmacists and a small cohort of pre-selected staff from the four PCTs were sent a questionnaire (Appendix D), and / or interviewed by telephone using the interview questionnaire (Appendix E). There was a response rate of 50% (21 of 42) to the questionnaire and 12 respondents were also interviewed. The semi-structured questionnaire was designed to obtain information from all stakeholders about their experiences to date and the lessons that have been learnt.

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3.10 Financial Data

3.10.1 The financial section reports on a model built and discussed with those involved in the process at a financial workshop on the 17th October 2007. The section introduces the model and the underlying assumptions.

3.10.2 The questions we sought to explore in the financial section were:

■ What are the costs in the system?

■ How does the pharmacy approach compare to the conventional process?

■ From a pharmacy perspective how much should they get paid per visit?

3.10.3 The assumptions and values in the model need to be further considered and challenged. There needs to be a more detailed understanding of actual costs and resources and the comparability of the new service. However, the model is indicative of the approach for considering future roll out and commissioning of a HST service.

3.11 Ethical Considerations

3.11.1 Tribal was advised by Central Manchester Research Ethics Committee in early August 2006 that an ethics application would need to be submitted for the High Street Testing evaluation project.

3.11.2 The High Street Testing COREC application was submitted in mid August and in late August the Wrightington, Wigan and Leigh Research Ethics Committee advised that because it was a service evaluation, ethics approval was not required.

3.11.3 In addition, R&D applications were submitted to the following organisations in early September and approvals were given by October.

■ Ashton, Wigan and Leigh PCT.

■ Oldham PCT.

■ Salford PCT.

■ Stockport PCT.

3.12 Confidentiality

3.12.1 All system generated data has been anonymised prior to being shared with Tribal research staff.

3.12.2 Where patient details are required, for example to conduct patient interviews, the details are only seen by Tribal research staff and are stored securely within Tribal offices.

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4 Operational Data

4.1 Introduction

4.1.1 The pilot is a new approach to a service traditionally provided by GP practices. It provides a service in the community through local pharmacies and an opportunity for the integration of pharmacies into the NHS.

4.1.2 To compare the changes to the patient visit, process maps have been prepared for both the conventional process and the HST process. This section will discuss the processes and their differences. The process maps can be found in Appendices A1 and A2.

The conventional process

4.1.3 The conventional process involves a patient visit to their designated GP practice. They will schedule an appointment with their GP or practice nurse for their regular attendance. During their visit they will have samples taken for testing and a consultation with the GP or practice nurse. The samples will be sent to the local laboratory for testing from whom the GP practice will receive results several days later. The practice will use the results as required. They will inform the patient and may schedule another appointment with the patient if required.

4.1.4 These results will be used by the GP practice as part of their Quality Outcome Framework (QOF) targets. The relevant targets cover diabetes mellitus, hypertension, stroke, coronary heart disease (CHD) and smoking.

4.1.5 The entire list of QOF targets in included in the appendix, see Appendix A3.

4.1.6 The specific targets relevant to this pilot are shown in Table 1. The HST pilot meets several of the targets across the five health areas. For some aspects such as smoking all of the targets are met and for the others at least a third of the targets are met.

Table 1 – Relevant QOF targets

Diabetes CHD Stroke BP Smoking

The percentage of patients whose notes record BMI in the previous 15 months

The percentage of patients whose notes record smoking status in the past 15 months

The percentage of patients who smoke and whose notes contain a record that smoking cessation advice or referral to a specialist service, where available, has been offered in the last 15 months

The percentage of patients who have a record of HbA1c or equivalent in the previous 15 months

The percentage of patients for whom the last HbA1C is 7.4 or less (or equivalent test/reference range depending on local laboratory) in last 15

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Diabetes CHD Stroke BP Smoking

months

The percentage of patients for whom the last HbA1C is 10 or less (or equivalent test/reference range depending on local laboratory) in last 15 months

The percentage of patients who have a record of the blood pressure in the past 15 months

The percentage of patients for whom the last blood pressure is as indicated or less

The percentage of patients with diabetes who have a record of serum creatinine testing in the previous 15 months

The percentage of patients who have a record of total cholesterol in the previous 15 months

The percentage of patients whose last measured total cholesterol within the previous 15 months is 5mmol/l or less

Number of targets relevant 9 out of 22

4 out of 12

4 out of 12

2 out of 3

2 out of 2

The HST pilot process

4.1.7 The pilot capitalises on opportunities under the General Medical Service (GMS) contract for general practice to achieve its QOF targets irrespective of the site of delivery of those services.

4.1.8 Stage 1: Patient recruitment - The pilot process first involves a period of patient recruitment. This involves working with the GP surgery to identify the patients suitable for the pilot. The surgery sends these patients an invite to join the pilot. The patients may accept or decline the offer or ignore the invitation letter. The surgery will inform the pharmacy of the patients who wish to be involved.

4.1.9 Stage 2: Appointment scheduling and patient reminders - The pharmacy will then schedule a convenient appointment with the patient and send a reminder.

4.1.10 Stage 3a: Receiving the patient and performing tests - The patient will attend the pharmacy for a consultation and testing appointment. The pharmacy will check all patient information is correct and that they satisfy the eligibility criteria. They will perform the first test using the point of care testing equipment.

4.1.11 Stage 3b: Interpreting test results and counselling the patient - They will assess the results using a traffic light alert systems with diagnostics cut-offs based on national service framework recommendations, as shown in Figure 5.

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Figure 5: Traffic Light System

4.1.12 The traffic light alerts system dictates the following response from pharmacists:

■ Green (at of below target) – counsel patient and reinforce positive behaviour. Schedule next appointment at 6 months

■ Amber (above but not critical) – counsel patient and look for ways to improve.

■ Red (above and critical) – counsel the patient, refer back to the GP.

4.1.13 If the system failure parameters are exceeded the patient will be asked to wait or return the next day. The system will be recalibrated and quality control procedures run.

4.1.14 Stage 4: Closing the consultation and data transfer - The pharmacist will close the consultation. This involves ensuring patients with a red result have arrangements in place to be transferred to the GP. For all patients they will record the data and intervention giving a copy to the patient.

4.1.15 For those non red result patients they will schedule the next appointment. For all patients data will be transferred and forwarded to the GP and the other data users.

4.1.16 Stage 5: Subsequent episodes of care - The patient will return to the pharmacy on the next appointment date and the pharmacy will send out reminders as appropriate.

Comparison of processes

4.1.17 The differences in the process are:

■ Location of appointment: GP surgery versus pharmacy.

■ Time between test and result: point of care testing versus lab testing.

Rapid unexplained loss or gain of more than 10%

Over 3025 to 30Less than 25BMI/ weight

More than 2 readings over 200 telephone GP

11085 to 10985Diastolic

180More than140 to 179140Less than

SystolicBlood pressure

♀ 1.2 to 0.6♀ more than 1.2

Less than 0.6♂ 1 to 0.6♂ more than 1HDL cholesterol

Greater than 84 to 8Less than 4Total cholesterol

Greater than 107 to 10Less than 7HbA1c

RedAmberGreen

CategoryParameter

Rapid unexplained loss or gain of more than 10%

Over 3025 to 30Less than 25BMI/ weight

More than 2 readings over 200 telephone GP

11085 to 10985Diastolic

180More than140 to 179140Less than

SystolicBlood pressure

♀ 1.2 to 0.6♀ more than 1.2

Less than 0.6♂ 1 to 0.6♂ more than 1HDL cholesterol

Greater than 84 to 8Less than 4Total cholesterol

Greater than 107 to 10Less than 7HbA1c

RedAmberGreen

CategoryParameter

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■ Feedback to patient: consultation with results at the appointment versus consultation and then results.

4.1.18 The pilot process with point of care testing provides results and interpretation to the patient at the time of testing. This provides an opportunity for a face-to-face discussion of the results with the pharmacy and any next steps.

4.2 The findings

Operational Data Sources

4.2.1 There are three main sources of operational data on the HST pilot:

■ Pharmacy attrition: this is the pharmacy uptake data. Of the 22 pharmacies originally identified only nine were actively involved in the pilot for a variety of reasons.

■ Patient attrition: this is the recruitment attrition data for the patients of GP practices involved in the pilot. This considers the eligibility of patients, through registers and criteria, and their uptake of choice to join the pilot.

■ Pharmacy data: this is data from the pharmacy system, which has been designed for the pilot to collect and transfer all of the required data. This data includes both data required to record the patient episode and data required for other data users, such as the GP practice.

4.2.2 The following sections will discuss the finding from each of these in turn.

4.3 Pharmacy attrition

4.3.1 The recruitment process involved identifying and recruiting pharmacies first and then recruiting suitable GP practices to refer into the pilot. The principle was to approach the GP practices once the pilot was clearly defined and sufficiently progressed.

4.3.2 There were 22 pharmacies initially involved in the pilot which reduced down to nine. The reasons for pharmacies leaving are shown in Figure 6 many of which relate to GP engagement. The GPs did not want to refer to pharmacies, they did not have confidence in their competence and the relationships had broken down.

4.3.3 Please note there is more than one reason for some of the pharmacies, hence the number of reasons does not add up to the number of pharmacies that have left the pilot.

4.3.4 Reasons given for pharmacies leaving the pilot are shown in Figure 6 and include:

■ Concerns about the competence of pharmacists.

■ Pharmacist relocated.

■ Pharmacist resigned from employer.

■ Pharmacy sold.

■ GP/pharmacist relation breakdown.

■ GP practices unwilling to refer patients.

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Figure 6 – Reasons for leaving pilot

9

2

2

2

1

1

1

0 2 4 6 8 10

GP practices unwilling

Relationship breakdown

Pharmacy sold

Pharmacist resigned

Pharmacist moved

Concern over competence

No selection of pilot pharmacy (LIFT)

Reason

Number of pharmacies

4.4 Patient attrition

4.4.1 There were a series of stages for filtering patients from those on the practice diabetes and CHD register to those who took up choice and joined the pilot. For this process the PCT leads worked with the GP practices and pharmacies to identify patients and send information and invitations to potential participants. Once a patient accepted choice the pharmacy was informed and arranged a first visit with the patient.

4.4.2 The data set used for analysis was at a GP practice level and was completed in December 2007. It showed for the nine pharmacies:

■ The number of diabetic and CHD patients on the register.

■ The number meeting the inclusion/exclusion criteria.

■ The number offered choice.

■ The number who took up choice.

4.4.3 This section will consider the analysis of the data both at an overall pilot level and a GP practice level.

Overall picture

4.4.4 There are nine pharmacies involved in the pilot with nine associated GP practices. The overall number of patients on either the diabetes or CHD register was 2,197.

4.4.5 The following Figure 7 shows the overall picture of attrition, where patients were filtered in three stages. This graph shows the percentages at each stage as a percentage of the 100% on the registers.

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Figure 7 – Attrition profiling data – all patients

100%

61%

28%

9%

0%10%20%30%40%50%60%70%80%90%

100%

Patients onregister

Meeting incl/exclcriteria

Offered choice Taken up

4.4.6 There were 61% of patients on the register eligible for the pilot. From these 45% were subsequently offered choice, this is affected by whether the pharmacy the patient would normally visit was involved in the pilot. The final stage was those who took up choice after receiving the letter from the GP, where the average was a 34% uptake.

4.4.7 These stages will be discussed further in the following sections looking at the variation across the GP practices.

Stage 1 – Inclusion/exclusion criterion

4.4.8 The inclusion/exclusion criterion is shown in the following Table 2. The proportion meeting the exclusion criteria varied, which is shown in the subsequent Figure 8. The average percentage meeting the inclusion/exclusion criteria was 59%.

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Table 2 – Inclusion and exclusion criteria

General Conditions

Any patient considered for referral to a pharmacy must be present on the practice diabetes or CHD register

Local shared care protocols must be followed when considering newly diagnosed patients

Inclusion

People with type 2 diabetes & being treated with oral hypoglycaemic agents and/ or insulin

People with cardiovascular disease being treated with lipid lowering drugs (e.g. statins)

Patients over 18 years

Exclusion

Pregnant women

Patients under 18

Patients with type 1 diabetes

Known haemoglobinopathies

Known hyper- triglyceridaemia

Figure 8 – Percentage meeting the Inclusion/exclusion criteria by General Practice

54% 54%

83% 88%

54% 53%60%

86%

0%

20%

40%

60%

80%

100%

1 2 3 4 5 6 7 8

GP

% m

eetin

g in

clus

ion

excl

usio

n cr

iteria

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Figure 9 – Profile of inclusion/exclusion percentage

0

1

2

3

4

5

0-9 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80-89 90-100

% meeting inclusion exclusion criteria

No

of G

P pr

actic

e

4.4.9 There appears to be two populations in this data. There are four GP practices with an average of 54% meeting the criteria and another with 60%. There are also three GP practices with 80% - 90% of registered patients meeting the criteria as shown in Figure 9.

4.4.10 The expectation of the pilot was that 80% of patients on registers would be eligible, which is higher than both the average that was found in reality and higher than five out of the nine GP practices experienced.

4.4.11 There were further exclusions made at this stage by the GPs for example some practices only wanted to refer their diabetes patients and others their CHD patients. It is believed they excluded patients with additional conditions such as Alzheimer’s and cancers and they also excluded patients for reasons such as mobility.

Stage 2 – Offered choice

4.4.12 The proportion offered choice also varied across the GP practices, which is shown in the following Figure 10 and Figure 11. The patients for whom the pilot pharmacy was their normal pharmacy of use were offered choice. The PCT leads would attend the pharmacy with a list of all the patients from the previous stage and identify the eligible patients. The average percentage offered choice was 45%.

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Figure 10 – Proportion offered choice by GP

33% 36%

84%

100%

15%

34% 37%

71%

0%10%20%30%40%50%60%70%80%90%

100%

1 2 3 4 5 6 7 8

GP

% o

f tho

se m

eetin

g cr

iteria

of

fere

d ch

oice

Figure 11 – Profile of the proportion offered choice

0

1

2

3

4

5

0-9 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80-89 90-100

% of those meeting criteria offered choice

No

of G

P pr

actic

e

4.4.13 There is huge variation in the number offered choice from 15% to 100%. This was dependent on the number that would attend the pharmacy involved in the pilot. For some pharmacies and GPs this was a one to one relationship and for others there were one to many. For example the practice from which 100% were offered choice is likely to have one pharmacy to which patients regularly visit.

Stage 3 – Take up of choice

4.4.14 The proportion who took up choice also varied across the GP practices, which is shown in Figure 12 and Figure 13. The overall percentage who took up the choice was 34% which is slightly higher than the expectation for the pilot of 30%.

4.4.15 This is also a high uptake for choice in comparison to other services such as smoking cessation which has an average uptake of 17%.

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Figure 12 – Proportion taking up choice by GP

40%

22%

37%

23%

12%

23%

48%

39%

0%

10%

20%

30%

40%

50%

60%

1 2 3 4 5 6 7 8

GP

% o

f tho

se o

ffere

d ch

oice

jo

inin

g pi

lot

Figure 13 – Profile of proportion taking up choice

0

1

2

3

4

0-9 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80-89 90-100

% of those offered choice joining pilot

No

of G

P pr

actic

e

4.4.16 There is variability in the uptake of choice from 12% to 48%. The uptake of choice is dependent on a patient’s interest in a service which is affected by both the information and the messages they received. For example some of the GP surgeries managed the choice and made follow up phone calls to patients and mentioned it at their next appointment.

4.4.17 A reason for one of the low percentages may be the local demographics. One GP practice has a large Asian population and chose to send out all the letters in English, perhaps a different decision would have increased the uptake of choice at this practice.

4.4.18 The patient attrition data shows that a total of 206 patients accepted choice and opted to be involved in the pilot from a registered population of 2,197.

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4.5 Pharmacy data overview

4.5.1 The pharmacy data system records detailed information about each patient visit to the pharmacy, which is electronically shared with the patient’s GP. The data from this system was provided for the time period from the first appointment, which was the 30th August 2006, up to the end of October 2007. This time period is a total of one year and two months.

4.5.2 In the previous section we identified that 206 patients had taken up the offer of choice. The following Figure 14 provides an overview of the patients’ progress in the system.

4.5.3 The number of patient records that were entered into the pharmacy system was 121. This is lower than 206 as there was often a time lag from acceptance to a patient’s first appointment; this was dependent on how recently their last appointment was.

4.5.4 The number of patient’s who had a first appointment was 79. This is lower than the previous figure due to different pharmacy operational practices. Some of the pharmacies would enter patients’ details when they knew they had accepted choice and would attend in the future, whereas others entered the data as and when appointments were scheduled.

4.5.5 There are also 22 patients who have had subsequent appointments. This ranges between one and as many as four further appointments.

Figure 14 – Overview of patients

4.5.6 The pharmacies involved in the pilot were from four PCTs:

■ Three pharmacies in Oldham PCT.

■ Two in Salford PCT.

■ Two in Stockport PCT.

121 79 22 Patients

registered on pilot

First appointments

Subsequent appointments

206 Patients

accept choice

There is a time delay between acceptance and the time of first

appointment.

There are 121 patients in the

database of these 54% are male and

46% are female with an average age of

63 years.

There are 79 patients seen

and a total number of

Twenty-two patients have subsequent

appointments, between one and

four further appointments.

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■ Two from Aston, Leigh and Wigan PCT.

4.5.7 There were seven operational pharmacies whose involvement varied in duration from five to 14 months. The longest running pharmacy had the first appointment 14 months ago, one ran for 13 months, one ran for nine months, another for eight months and all the others for five months.

4.5.8 The following Figure 15 provides an overview of the pharmacies patients’ visits; both first and follow up. This shows the number of patients they saw and the number of months since the first appointment.

Figure 15 – Number and type of visits by pharmacy

0

5

10

15

20

25

A B C D E F G

5 9 5 15 13 5 8

Num

ber

of a

ppoi

ntm

ents

No. firstNo. follow up

4.5.9 The pharmacies saw between four and 20 patients and there is variability in the number of follow up visits they had.

4.5.10 The number of follow up patient visits is linked to the time since patients’ first visits but it is not directly correlated due to the pattern of first patient appointments. For example pharmacy B which is the third longest running has a low number of follow up episodes of care as many of their patients were started later into the pilot period. Pharmacy C has more follow up visits as they saw many of their patients in their first month of operation.

4.6 Patient consultation

4.6.1 A patient will attend for a consultation and have testing and consultation during which test results and responses to consultation questions are recorded. The test results are banded using the traffic light system of red, amber and green depending on predefined changes and limits. The results of these tests are designed to guide the consultation and its’ outcome.

Time of consultation

4.6.2 The average time of consultation was 28 minutes. The following Figure 16 shows the profile of the consultation times. The first consultation has a mode of 12 and is right-skewed.

4.6.3 The time for follow up consultations also goes up to an hour and has a high number of consultations in the 0-4 minute time band.

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Figure 16 – Time of consultation profile

0

2

4

6

8

10

12

14

16

0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59

Duration (minutes)

Num

ber o

f epi

sode

s

FU1st

Consultation questions

4.6.4 As part of the consultation the patient is asked lifestyle, diet, activity and medication questions. Several of the questions were routinely asked. The entire list of questions is shown in Appendix A4.

4.6.5 The following Figure 17 provides a flavour of the responses and questions. Many of the responses show patients are taking recommended actions and understand the issues explained to them.

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Figure 17 – Responses to yes/no consultation questions

0% 20% 40% 60% 80% 100%

Taking medication at the appropriate timeIs medication acceptable and easy to useTaking it as should more than 80% of time

Still taking the prescribed medicationKnow effect of physical activity on condition

Know why encourage physical activityDo relevant physical activity

Know why it is important to control weightUse less salt

Sprinkle food with saltCut down on fat

Eating more fruit and vegetablesEat regular meals based on starchy foods

Eat low suger and suger-free drinks and foodsCut down on sugar and sugary foods

Know why it is important to drink in moderationDrink alcohol

Not referred and would like to give upBeen referred to a smoking cessation counsellor

Patient smokes

Yes No

Point of care testing

4.6.6 There were eleven different possible tests conducted at each episode of care and recorded in the pharmacy system:

■ Diastolic Blood Pressure.

■ Systolic Blood Pressure.

■ Total Cholesterol.

■ HDL Cholesterol.

■ Cholesterol Ratio.

■ Triglycerides Cholesterol.

■ LDL Cholesterol.

■ HbA1c.

■ Height.

■ Weight.

■ BMI.

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4.6.7 There were a total of 1,195 tests conducted across the patient episodes. There were usually 10 or 11 of the tests conducted; the first would include a height measurement which would not be necessary at subsequent visits.

4.6.8 Most of the tests were carried out for at least 90% of the episodes except the LDL Cholesterol test and the HbA1c test, 87% and 71% respectively. This information is provided in Appendix A5.

4.6.9 For most of these tests, excluding height and cholesterol ratio, there are score ranges for red, amber and green ratings. . The assumption is if a patient has at least one red result they are a red result patient, if a patient has at least one amber result they are an amber result patient and patients with only green results are considered green patients.

4.6.10 As previously discussed there are different actions to be taken depending on the outcome:

■ Green results - counsel the patient and reinforce positive behaviour. Schedule next appointment at 6 months

■ Amber results - counsel the patient and look for ways to improve. Schedule next appointment at 3 months

■ Red results - counsel the patient, refer back to the GP.

4.6.11 The following Table 3 shows the red, amber, green profile of results for each test. The test results for BMI are more frequently red whereas all the other tests are either most frequently green or amber.

4.6.12 The tests most frequently green are Blood pressure, Triglycerides Cholesterol and HbA1c. The Total Cholesterol test is green and amber in equal proportions. The tests most frequently amber are HDL Cholesterol and LDL Cholesterol. This variation suggests the criteria may need reviewing.

Table 3 – Test results

Test type Green Amber Red N/A Total

Diastolic blood pressure 80% 20% 0% 0% 100%

Systolic blood pressure 67% 30% 3% 0% 100%

BMI 14% 41% 45% 0% 100%

Total Cholesterol 49% 49% 3% 0% 100%

HDL Cholesterol 40% 47% 13% 0% 100%

Triglycerides Cholesterol 57% 36% 7% 0% 100%

LDL Cholesterol 48% 50% 3% 0% 100%

HbA1c 56% 37% 7% 0% 100%

Cholesterol Ratio 0% 0% 0% 100% 100%

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Test type Green Amber Red N/A Total

Height 0% 0% 0% 100% 100%

Weight 29% 0% 1% 70% 100%

Grand Total 40% 28% 7% 25% 100%

4.6.13 The following Figure 18 shows the red results obtained as a percentage of the total red test results. This shows that a high proportion, 57%, of the red test results obtained were for BMI tests. BMI was not part of the original referral inclusion/exclusion criteria and raises the question whether it should be included.

Figure 18 – Red test results as percentage of total red results

57%

16%

9%

7%

3%

3%

3%

1%

0%

0% 10% 20% 30% 40% 50% 60%

BMI

HDL Cholesterol

Triglycerides Cholesterol

HbA1c

Total Cholesterol

Systolic blood pressure

LDL Cholesterol

Weight

Diastolic blood pressure

% of red test results

Outcomes

4.6.14 There are seven potential outcomes recorded following a patient visit:

■ Advised of next appointment.

■ Requires re-test.

■ Referred back to GP.

■ Referral to a diabetes clinic.

■ Referral to a lipid clinic.

■ Referral to an INR clinic.

■ Ambulance called.

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4.6.15 The majority, 91%4, are advised of their next appointment and 9% are referred back to their GP. One patient withdrew from the pilot as they were on kidney dialysis at Salford Hope Hospital. They were due to see the consultant in the next couple of weeks and were intending to also see their GP with these results.

4.6.16 The majority of those who are advised of their next appointment have no outcome notes and most are given a next appointment date. Those who have recorded notes include high cholesterol, a need to check weight, an amber result and that the results are on target.

4.6.17 Eleven patients are referred back to their GPs; nine of which had red results and two had amber results. The following Table 4 shows the red results recorded for those nine patients with red results. Five of these patients had one red result and the others had two or three.

4.6.18 These patients referred back to the GP represent less than 20% of those with red results. A total of 50 patients over 64 episodes had red results recorded, 56% of all episodes. This is a high percentage of the patients.

4.6.19 The two patients referred back to their GPs with amber results were referred for raised cholesterol and high blood pressure.

Table 4 – Red results for patients referred to GP

BMI HbA1c HDL Cholesterol

Blood pressure

Total Cholesterol

Triglycerides Cholesterol

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

Patient 6

Patient 7

Patient 8

Patient 9

Total 5 1 2 1 1 4

4 21% were coded as requiring re-testing. However all of these are with one pharmacy and they are booked in for subsequent appointments so it is assumed that this is an error in selecting the outcome and they are all “Advised of next appointment”.

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4.6.20 The following Figure 19 shows the percentage of those with red test results referred back to their GP for each test. This shows variability in the outcome following a red result for the different tests from 0% to 50%. There is no test for which a red result triggers a referral in all cases.

Figure 19 – Percentage of patients with red test results referred back to the GP

50%

33%

16%

14%

10%

0%

0%

0%

0% 10% 20% 30% 40% 50% 60%

Triglycerides Cholesterol

Total Cholesterol

HbA1c

HDL Cholesterol

BMI

Systolic blood pressure

LDL Cholesterol

Weight

% with red test result referred back to GP

4.6.21 The following Figure 20 shows all the red test results by outcome and again highlights the small proportion referred back.

Figure 20 – Red test results for all patients by outcome

0 10 20 30 40 50 60

BMIHDL Cholesterol

Triglycerides CholesterolHbA1c

Total CholesterolSystolic blood pressure

LDL CholesterolWeight

Diastolic blood pressure

Number of red test results

Given appointment Referred back

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4.6.22 This analysis shows that there is variation in how red results were dealt with and the pharmacists were using different rules for the referral of patients back to their GP. If all patients with red results for BMI had been referred back to their GP an additional 41 patients would have been referred back. This would have been more than half of the patients in the pilot being referred back to the GP.

4.7 Clinical data

4.7.1 The previous section has shown that pharmacists used their own discretion as well as the traffic light alert system when considering referral of patients back to their GP. BMI is an aspect of the testing which was not included in the referral criteria but many patients are getting a red result.

4.7.2 To look at the clinical aspect of the pilot the test results for patients with two or more visits can be considered. However, due to the numbers involved in the pilot and the number of follow up visits being a total of 22 patients, it is difficult to draw any firm conclusions about the clinical effectiveness.

4.7.3 Appendix A6 show the different test results recorded for these patients indexed, which can be used as a framework to consider patient management. The tests considered are:

■ HbA1c.

■ Total cholesterol.

■ HDL cholesterol.

■ LDL cholesterol.

■ Systolic blood pressure.

■ Diastolic blood pressure.

4.7.4 The charts show the subsequent test results compared to the original test result. The original test result has an index value of 100 and the other test results are expressed as a percentage of this i.e. a second result of 120 is 20% higher than the first result. Similarly a second result of 80 is 20% lower than the first result.

4.7.5 The tests overall show an improvement on the original test result for 55% of the subsequent results. An equal result is obtained in 4% of cases and 41% of results were higher than the original result.

4.7.6 Some results showed more variation than others. The most variation was evident for HDL and LDL cholesterol.

4.7.7 Appendix A6 provides a graphical and statistical summary of the clinical comparisons available at the time of evaluation. It does not make a clinical evaluation of the management of the patients due to the small number of patients involved.

4.8 Pharmacy scheduling

4.8.1 There is variation in the scheduling of patient visits in terms of the number of patients arranged for the same date, the time until the next appointment and the day and the time of the visit.

4.8.2 This raises the questions about different practices and what is the best model for operation, patient choice and convenience?

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Number of visits on a day

4.8.3 Despite low numbers many tried to have visits on the same day. The following Figure 21 is a scatterplot of the pharmacies average appointment time and the average number of visits they have on any day when testing is conducted.

4.8.4 The data has a downward trend and a trend line has been fitted. This suggests that the average appointment time is reduced by arranging several patient visits on the same day.

4.8.5 This could be due to a saving in preparation time as when preparing for the first appointment the pharmacist can prepare for all of that day’s appointments. This would include switching on computers, login and preparing test equipment.

Figure 21 – Scatterplot: average appointment time versus average number of appointments on a day

05

10152025303540

0 1 2 3

Average number of visits on a day

Ave

rage

app

oint

men

t tim

e

Scheduling next appointment

4.8.6 The guidance for scheduling the next appointment is three months for patients with amber results and six months for patients with green results. The patients with red results should be referred back to their GP practice. The following Figure 22 shows the profile of months for next appointment as a percentage of the appointments scheduled. This has a peak at both 3 months and 6 months which was the expected profile.

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Figure 22 – Time until next appointment

1% 0%4%

38%

8%

15%

33%

1%0%5%

10%15%20%25%30%35%40%

0 1 2 3 4 5 6 7

Months between appointments

% o

f tho

se o

ffer

ed n

ext

appo

intm

ent

4.8.7 There are two points to note. Firstly, there are patients with red results who are offered future appointments and, secondly, different practices occur regardless of patient test result colour.

4.8.8 Figure 23 considers the patients test results following the traffic light system. The assumption is if a patient has at least one red result they are a red result patient, if a patient has at least one amber result they are an amber result patient and patients with only green results are considered green patients.

Figure 23 – Time until next appointment by RAG

0

5

10

15

20

25

30

0 1 2 3 4 5 6 7

Months between appointments

% o

f tho

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ffere

d ne

xtap

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Red Amber Green

4.8.9 There are a high number of red result patients who are having their next appointment scheduled. These are being scheduled between 2 months and 7 months ahead.

4.8.10 There were 50 patients who had red results over 64 episodes. The majority of these red results were BMI, which was not included in the original referral criteria. For this reason all BMI red results have been excluded from our analysis which is shown in the following chart.

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Figure 24 – Time until next appointment (RAG without BMI)

0

5

10

15

20

25

30

1 2 3 4 5 6 7

Months between appointments

% o

f tho

se o

ffere

d ne

xt

appo

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Red Amber Green

4.8.11 This analysis without BMI does not highlight a pattern that is dependent on the results of the patient. That is although the overall profile appears to fit the expected profile, appointments either 3 months or 6 months, this is not determined by the patients’ amber or green results.

4.8.12 Although there are a high number of red results that are confusing the picture there do appear to be issues with the scheduling of the next appointment. Hence further consideration of the traffic light system and the outcomes is necessary, particularly with BMI.

4.8.13 The following Figure 25 shows the time until the next appointment date entered in the system by pharmacy. This does suggest there may be differences across the pharmacies. The consistency and the use of the traffic light system should be reviewed.

Figure 25 – Time until next appointment date by pharmacy

5.5 5.5

4.1 4.1

3.0

4.2

5.1

0.0

1.0

2.0

3.0

4.0

5.0

6.0

A B C D E F G

Pharmacy

Mon

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betw

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appo

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nd n

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Day and time of visit

4.8.14 The day of visit is variable across the pharmacies but overall a higher number of visits occur on Mondays and Fridays. The following Figure 26 shows the different profiles of visits. Some such as Pharmacy D have visits Monday to Friday whereas others such as Pharmacies A and C have two main days for patient visits.

Figure 26 – Day of visit

0%10%

20%30%

40%50%

60%70%

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Day of week

% o

f vis

its

A B C D E F G

4.8.15 The following Figure 27 shows the day scheduled for subsequent visits. This shows a flattening of the profile and visits scheduled for Saturdays and even a Sunday. However it should be noted that some may be using this as a reminder service to schedule appointments rather than agreeing the actual appointment date with the patient.

Figure 27 – Day scheduled for subsequent visit

0%

10%

20%

30%

40%

50%

60%

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Day of week

% o

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A B C D E F G

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4.8.16 The time of visit is also variable across pharmacies. The following Figure 28 shows the time of appointment for all visits. A high proportion is done between 11am and 1pm and during the morning period.

Figure 28 – Time of day of appointment

13% 12%

16%15%

16%

8%

10%

6%4%

0%2%4%6%8%

10%12%14%16%18%

9 10 11 12 13 14 15 16 17

Hour of day

% o

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4.8.17 The time of day by pharmacy is shown in the following Figure 29 which highlights potentially different operational practices.

■ Morning only e.g. pharmacy B.

■ Morning to mid afternoon e.g. pharmacy C.

■ All day e.g. pharmacy A.

■ Lunch time and the end of the day e.g. pharmacy D.

Figure 29 – Time of day of appointment by pharmacy

0%10%20%30%40%50%60%

9 10 11 12 13 14 15 16 17

Hour of day

% o

f tho

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next

app

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A B C D E F G

4.8.18 These aspects are dependent on the staffing levels. Typically appointments are scheduled for times at which there are two pharmacists in the pharmacy.

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4.8.19 In order to offer patients more choice the scheduling of appointments throughout the week needs to be considered. For example a skill mix can be used for HST. A technician in the pharmacy can conduct the tests and a pharmacist can conduct the patient consultation. This approach was used for 43, 37%, of tests and could be used more widely to give more flexibility to the scheduling of patient visits.

4.9 Summary

4.9.1 The pilot began with 22 pharmacies which reduced to nine active pharmacies in the pilot at the time of evaluation. The majority of the reasons for withdrawal from the pilot related to GPs and whether they wanted to refer patients to their local pharmacy. The issue of GP engagement needs to be considered for a wider roll out.

4.9.2 The attrition data showed that the GP was using additional criteria for the referral of patients, e.g. just diabetic patients or just CHD patients. The GP is taking a role in patient choice and the impact of this for true choice needs to be considered.

4.9.3 The pilot has relied in many aspects on people volunteering their time to the pilot. This is believed to have had an impact on the uptake of choice, where the uptake was seen to vary from 12% to 48%. If GP practices were able to dedicate time to the pilot to phone up patients and answer any questions this may have improved their patients’ uptake. Similarly if pharmacies were able to take a more proactive approach to those patients identified by the GP this may have also improved uptake.

4.9.4 There is a need to look at the clinical red, amber and green categories and the outcomes. There is some confusion with the current set up and a high percentage of red results being found. 10% of all tests results are red and 50 patients had red results for BMI, which is more than half of the patients who have visited the pharmacies. The BMI should be considered for the inclusion/exclusion criteria at the outset and the limits, once in the system, should be reconsidered. This should include some case studies of the patients with red results who are not referred back.

4.9.5 The clinical data showed that an improvement was made on the previous test results on subsequent visits for 55% of the subsequent tests and an equal result 4% of the time. There is no comparable data available from primary care but should it be made available in the future, a further question may be whether this a clinically acceptable level?

4.9.6 The answers to consultation questions showed positive outcomes with patients demonstrating understanding and taking management of their conditions following the advice given.

4.9.7 Further work may be necessary to identify when appointments should be scheduled. There is variation in the length of patient consultations and the scheduling of next appointments. The following questions should be considered

■ What is the best approach to scheduling appointments? There is limited evidence that increasing the number of patients seen on a day reduces the time necessary for the consultation.

■ How long should they last?

■ When should the next appointment be, and how much choice of time/date (including weekends and evenings) should be offered?

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5 External Quality Assessment Data

5.1 Introduction

5.1.1 NF Burrows Consulting Ltd were employed as the performance monitor for the duration of the pilot. Their monitoring report is included as Appendix B1. They were responsible for collecting data and information in the following two areas:

■ Point of care testing – internal quality control performance and external quality assessment performance.

■ Pharmacists’ competence – assessed on a monthly basis against pre-defined performance measures.

5.2 External Quality Assessment

5.2.1 This involved monitoring the results of samples distributed by United Kingdom National External Quality Assessment Scheme (UKNEQAS). Participating clinical laboratories are sent samples on a regular basis which they analyse as if they had come from patients. Results are returned to UKNEQAS centres (for HbA1C and lipids) which provide a report that compares the participant's performance with that of all laboratories and/or groups of laboratories using the same test method(s).

5.2.2 More information is available on their website http://www.ukneqas.org.uk/

5.2.3 A full commentary on pharmacists’ performance is provided in appendix B1. In summary, this matched that of central laboratories, typical variability within the group for, respectively, HbA1C and cholesterol was 2.9% and 3.9%, compared to all laboratory reproducibility of 3.1% and 3.4% (reproducibility that is low enough to meet clinical need in all instances).

5.3 Pharmacists’ competence

5.3.1 A full commentary is provided in appendix B1. A summary outcome of their performance against pre-defined compliance/adherence measures was as follows:

■ Standard operating procedures (100% compliance).

■ Clinical protocols (89% - on one occasion HbA1C was measured on a non-diabetic patient).

■ Health and safety expectations (100% - based on cleanliness, hand washing, wearing Personal Protective Equipment, correct waste disposal).

■ Maintaining their POCT skills (100% - based on QC records, adherence to sample taking techniques, stepwise approach to analyses).

■ Consultation skills (100% - based on observation during clinical consultations and records of discussion of lifestyle, diet, exercise).

■ Stock control/record keeping (91% - relatively poor performance due to unpredictable flow of patients and pharmacists’ desire for economy).

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6 Patient Experiences

6.1 Introduction

6.1.1 Patients participating in HST were invited to complete and return a paper-based questionnaire.

6.1.2 The questionnaire consisted of 15 questions, which were divided into three sections (see Appendix C). It was anticipated that the questionnaire would take between five to ten minutes for a patient to complete. It also stated that the information would be kept completely safe and confidential. Upon return, the details of each questionnaire were entered into a database for analysis.

6.1.3 Patients were also invited to give their contact details if they consented to a telephone interview. These lasted 20 to 30 minutes and provided the opportunity to gather in-depth qualitative feedback about patients’ experiences of the pilot.

6.2 Questionnaires

Responses

6.2.1 There were 150 questionnaires sent to the Performance monitor staff, who in turn distributed to the patients via the Pharmacies.

6.2.2 A total of 36 questionnaires were completed, returned and analysed at the time of writing this report. An additional four questionnaires were returned after analysis had been completed, but these responses did not significantly differ from the previous 36.

Findings by question/section of the questionnaire

6.2.3 The 15 questions were divided into three sections, namely:

■ ‘About this visit’.

■ ‘Planning the next visit’.

■ ‘Overall Assessment of the Service’.

Section 1: About this visit

Were you seen by the pharmacist at the time allocated for your consultation?

6.2.4 All 36 patients stated that they were seen at the time allocated.

Were you satisfied with the surroundings in which your consultation with the pharmacist took place?

6.2.5 Thirty four out of the 36 patients stated that they were satisfied with the surroundings in which their consultation took place.

Did you find the advice given by the pharmacist useful?

6.2.6 There were four options for this question: very useful; moderately useful; quite useful; and not useful. The overwhelmingly majority of patients (30) found the advice given by the pharmacist to be ‘very useful’; with three finding it ‘moderately useful’ and a further three ‘quite useful’. No patient considered the advice to be ‘not useful’.

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Did you have confidence in the advice given by the pharmacist?

6.2.7 All 36 patients stated they had confidence in the advice given by the pharmacist.

Would you have rather seen a doctor and/or nurse for your consultation?

6.2.8 There were 33 patients who stated ‘no’; that they would not rather have seen a doctor or nurse for their consultation. Three of the patients stated that they would have preferred to see a doctor or nurse. Two patients did not state their reasons for the preference. The one patient that did state a reason commented:

“My doctor/nurse has all the relevant information and has known me for many years.”

How satisfied were you with the visit overall?

6.2.9 There were four options for this question: very satisfied; moderately satisfied; quite satisfied; and not satisfied. The overwhelmingly majority of patients (31) stated that they were ‘very satisfied’. Three were ‘moderately satisfied’ and two were ‘quite satisfied’. No patient stated they were not satisfied. See Figure 30 below.

Figure 30 - How satisfied were you with your visit overall?

Satisfaction with the visit

31

3 2 005

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Very satisfied Moderately satisfied Quite satisfied Not satisfied

Num

ber o

f pat

ient

s

Did finger prick blood testing give you any concerns?

6.2.10 Finger prick blood testing did not give any concerns to any patients, with 35 patients stating ‘no’ and one patient not responding to the question.

Have you visited your GP since you last visited the pharmacist?

6.2.11 Only three patients stated they had visited their GP since last visiting the pharmacist, (33 had not) and none of these visits were related to diabetes and/or heart disease. One was for an annual review.

Section 2: Planning the next visit

Have you arranged your next appointment date and time with the pharmacy?

6.2.12 There were 28 patients who had arranged their next appointment and eight who had not. Of those 28 who had arranged a future appointment, 26 stated that they were offered a convenient date and time, whilst two stated they were not. However, one of these two

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patients still went on to state that they were ‘very satisfied’ with the overall service. (See below, Section 3: Overall Assessment of the Service).

Section 3: Overall assessment of the service

How satisfied are you overall with the High Street Testing service?

6.2.13 There were four options for this question: very satisfied; moderately satisfied; quite satisfied; and not satisfied. The overwhelming majority of patients (30) stated that they were ‘very satisfied’. Five patients were ‘moderately satisfied’ and one patient was ‘quite satisfied’. There was one patient who, although stating he was very satisfied, also commented that he would prefer to return to the GP Practice, but would continue with HST but “only as an intermediate test.” He could not be contacted to give a reason.

How well does the High Street Testing service compare to having your condition managed in your GP Practice?

6.2.14 Patients were given four options to choose from: Better; the same; slightly worse; and much worse. Just under half of the patients (17) reported that they found HST to be a better way to have their condition managed than at their GP Practice. A further 18 patients stated they felt that HST and their GP Practice were ‘the same’. No patients stated ‘slightly worse’, but one patient considered the HST service to be ‘much worse’ than the GP Practice service. See Figure 31 below:

Figure 31 - High Street Testing compared to GP Practice

Comparison to GP Practice

17 18

0 10

5

10

15

20

Better Same Slightly worse Much worse

Num

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s

Would you wish to continue using the High Street pharmacy to manage your condition?

6.2.15 For this question 34 out of 36 answered that they would wish to continue using their High Street pharmacy to manage their condition. One respondent did not give an answer to this question. One patient stated they would not wish to continue and explained why:

■ “No point in seeing two people for the same review.”

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Does the service encourage you to take greater charge of managing your condition?

6.2.16 For this question 35 out of 36 answered that the service did encourage them to take greater charge of their condition. The remaining one respondent did not give an answer to this question.

How confident do you feel about managing your condition yourself?

6.2.17 Eighteen patients stated that they were ‘very confident’ about managing their condition themselves and a further 17 patients stated that they were ‘quite confident’. No patients stated they were ‘not confident at all’. The remaining one respondent did not give an answer to this question.

6.3 Patient Interviews

6.3.1 Of the 36 completed and returned questionnaires, 12 patients agreed to a telephone interview. The aim of this interview was to gain an in-depth qualitative understanding of patients’ views and experiences of using High Street Testing Service.

6.3.2 The telephone interview consisted of eight sections; About the Patient; Age, gender and occupation; Recruitment process; Motivations; First appointment; General; Consultation with the Pharmacist; and Perceptions. The interviews involved patients who had had one consultation at their pharmacy.

Section 1: About the Patient

6.3.3 Of the 12 patients, eight had diabetes and four had coronary heart disease. All 12 stated that their condition was usually managed in the GP practice jointly by their GP and by the practice nurse. Eleven patients felt that they had no problems with this process. One stated that she felt she was rarely given enough time during her appointments at the GP Practice to discuss her condition, with either the GP or nurse.

Rate how well you feel your condition is currently managed

6.3.4 Given five options as to how well they felt their condition was managed at their GP Practice, nine stated ‘very well’, two stated ‘quite well’, and one ‘fairly well’. No patients considered their condition to be managed ‘not very well’ or ‘badly’ at their GP Practice.

Do you worry about your condition?

6.3.5 Given five options of how much the patient worried about their condition, of: a lot; quite a lot; a little; not much; or not at all, six patients stated ‘a little’; two ‘a lot’; two ‘quite a lot’ and two ‘not much’.

Patients’ age, gender and occupation

6.3.6 The interviews were undertaken by eight females and four males, aged 55 to 77 years old. Nine were retired, two were in full time work and one was in part time work.

Recruitment process

6.3.7 Details of the HST pilot were received by nine patients late in 2006 and three patients received details early in 2007. All 12 patients felt that the information they had received clearly explained what was involved in the scheme. Comments illustrating this included:

■ “Clearly explained to me and easy enough to understand.”

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■ “Sounded like a very good idea and just right for people like me who don’t want to be bothering the doctor or nurse all the time when I can have my condition managed at the pharmacy.”

6.3.8 All patients felt that they had enough information given to them about the scheme. One patient commented:

■ “Just the right amount of information. There’s already so much to take on board with my illness and I just want things explained simply, and to know what’s best for me. [HST] is something that could save me time and give my [GP Practice] appointment to someone who really needs it.”

Motivations for joining the pilot

6.3.9 All twelve patients stated they opted-in to the pilot as they felt it might provide them with a more convenient method of monitoring and managing their condition. A further four also considered that they might benefit from any changes in their condition being picked up quicker then at their GP practice.

6.3.10 The benefits patients expected form the pilot before they joined centred mostly around convenience and a perceived better management of their condition. It was considered that an appointment at the pharmacy could be more convenient and quicker than an appointment at the GP Practice.

6.3.11 Patients had no major concerns about the service prior to using it. The only concerns expressed by four patients before they first visited the pharmacy were that the service might turn out to be less comfortable or less convenient than at their GP practice For example they were concerned that they might have a longer wait to be seen:

■ “I was slightly concerned I might have to wait an age to be seen like I sometimes do when collecting my wife’s and my prescriptions.”

■ “I weren’t [sic] sure if it [pharmacist’s consultation room] would have facilities as good as the nurse’s room.”

6.3.12 All twelve patients reported they were satisfied with making an initial appointment to see the pharmacist. They were offered a date and time that were convenient,

■ “I was given a time that I wanted, or the next best day for me.”

■ “It were [sic] no different from making an appointment to see my doctor or nurse really. I could choose what suited me, and what best suited them [the pharmacist] It’s champion.“

Patient travel to the pharmacy

6.3.13 All patients reported that travelling to the pharmacy for their appointment was the same as, or more convenient than, a visit to their GP practice. Six drove themselves or were driven by family or friends to the pharmacist, and there were no significant issues arising over access (for instance, car parking).

6.3.14 Four patients took a bus to their appointments, and one walked. None of the three patients interviewed who were in employment needed to take any additional time off work for their appointment, fitting it around time off or their shifts.

6.3.15 Eight out of 12 patients considered HST appointments to be more convenient than attending an appointment at their GP practice. Reasons given for this were:

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■ Many patients perceived there would be more choice over their appointment time.

■ Many patients felt their condition could be managed equally well by a pharmacist as by a GP or nurse, and this would free up more time for other patients to have GP Practice appointments.

■ Mention was also made by two patients of fitting an appointment in with other activities such as shopping locally or meeting friends.

The consultation: appointment time and location

6.3.16 Most of the patients were seen at their allotted appointment time (10 out of 12 patients). Two patients reported they were seen “a few minutes late”. This was deemed to be acceptable however. The consultations took place in what were described by two patients as a “small office” or “back room”. Most patients (again, 10 out of 12) felt that the privacy, comfort and convenience of the consultation location in the pharmacies were perfectly acceptable. Positive patient comments included:

■ “It was clean, bright and cheerful. More like going to the opticians than the doctors.”

■ “I was seen as soon as I arrived, given a seat and attended to in private. What a good idea and a super service.”

■ “Seemed a lot quicker than at the doctor’s surgery, with less hanging around and less people queued up. I would recommend it to anyone.”

■ “Nice and warm, friendly staff.”

6.3.17 The only less than positive comments expressing concerns or dislikes about the surroundings came from two patients: One patient complained about the temperature of the room being too cold and another that the room was too small:

■ “The room were a bit too nippy for me”.

■ “The room in which I was interviewed was very cramped.”

6.3.18 The consultations lasted for between five and 15 minutes each, with three patients reporting they were seen for approximately five minutes, eight for between six and ten minutes, and one patient for over ten minutes.

6.3.19 Where blood was taken via finger prick in the consultation patients reported that the process was painless, and no different to the process undertaken at their GP Practice.

6.3.20 All 12 patients considered the service and information offered by the pharmacist to be as good as the service they would have expected or received at their GP Practice. Where advice was given or questions answered regarding their condition (which occurred for all 12 patients), the information was clear, useful and considered to be as effective as they would have received at their GP Practice.

6.3.21 There were nine patients who considered that seeing a pharmacist rated the same as being seen at the GP Practice. Three patients considered it to be better. They felt the service was of the same standard but the pharmacy was more convenient and provided results quicker. For instance:

■ “You know the outcome immediately instead of waiting for seven to ten days for the result.”

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■ ”There was no real difference [in HST] to seeing the nurse or my doctor regarding the treatment and advice I was given. It’s easy and nice to be able to pop into the pharmacist when you are already out.”

■ “It doesn’t matter who I see. I have plenty of confidence in my doctor and the pharmacist.”

6.3.22 All 12 of the patients interviewed said they wished to continue to have their condition managed by the pharmacist and were confident in the pharmacist’s ability. One patient who was doubtful of the High Street Testing pilot at the time of opting-in was won over after his first appointment, as illustrated by:

■ “I would have preferred to have seen a doctor or nurse [than a pharmacist] because I was slightly anxious of what to expect from the visit at the time, but these doubts were completely unfounded and I found the pharmacist very capable.”

6.3.23 Four patients stated that they had a preference for HST because as well as being more convenient for them they felt it freed up time for their GP Practice to see patients in their place. For instance:

“HST is better than the GP practice for me, but this doesn’t mean that I’m unsatisfied with my GP practice. I feel it now gives doctors and nurses more time to spend with more urgent cases.”

6.4 Summary

6.4.1 From the views expressed by the 36 patients who completed a questionnaire, HST is clearly considered to be an acceptable process. This was further ratified by the twelve patients who also agreed to be interviewed.

6.4.2 The vast majority of patients stated they were satisfied with all aspects of their HST appointments. This included booking the appointment, the time allocated for them to be seen by a pharmacist, the location, the process and any advice given to them by the pharmacist.

6.4.3 HST also compared very favourably with the traditional method of managing a patient’s condition at the GP Practice. Just under half of the patients questioned (17) considered HST to be a better way of managing their condition than at their GP Practice.

6.4.4 The overall satisfaction level of HST was extremely positive amongst patients who completed a questionnaire. This is borne out by fact that the majority of patients (30) stated that they were ‘very satisfied’, and by the 34 out of 36 who wished their High Street pharmacy to continue to manage their condition.

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7 Staff Experiences

7.1 Introduction

7.1.1 The majority of GPs, practice managers, pharmacists and a small cohort of pre-selected staff from Primary Care Trusts involved in the pilot were sent a questionnaire (Appendix D) and / or interviewed by telephone using the interview questionnaire (Appendix E).

7.1.2 The semi-structured questionnaire was designed to obtain information from all stakeholders about the progress of the pilot and their experiences to date. It was anticipated that the questionnaire would take ten minutes to complete and it was designed to be completed electronically or in hard copy. The questionnaire was sent to 42 key stakeholders, refer to Appendix F.

7.1.3 The questionnaires invited respondents to participate in a telephone interview (or the interviewees were contacted directly). The semi-structured interview was designed to explore ideas and obtain additional information.

7.1.4 The questionnaire and interview schedule were divided into the following sections:

■ Respondent: context and background.

■ Current status: information about the pilot sites.

■ Experiences: Staff experiences in terms of support, systems and processes.

■ Overall: Lessons learnt.

7.1.5 The “experiences” section within the questionnaire (and interview schema supplement) asked respondents to provide a judgement by rating a number of statements from 1 to 5, where 1 was strongly disagree and 5 was strongly agree. This was based on the Likert rating scale. For example:

Please rate the following statements using the scale below, where

1 2 3 4 5

Strongly Disagree

Disagree Agree nor Disagree

Agree Strongly Agree

9. My overall experience of the pilot was excellent.

1 2 3 4 5 please tick

7.1.6 This section outlines the key findings from a small cohort of staff questionnaires and interviews around their experiences and lessons to be learnt from the pilot.

7.2 Results

Responses

7.2.1 21 stakeholders responded to the questionnaire, a response rate of 50%, of which there were six pharmacists plus one pharmacy technician, eight PCT members, three GPs, two practice managers and one practice nurse. There were also a small number of stakeholders interviewed although unfortunately there were no interviews with staff from general practice (Table 5).

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7.2.2 Questionnaires were received from staff within all four PCTs (Table 6).

Table 5 - Respondents#

Organisation Number sent Questionnaire

Number of Respondents

Number Interviewed

PCT Member 8BC 8 7

GP 11 3 0D

Practice Manager 10 2 0D

Practice Nurse 1 1 0

Pharmacist 11 7A 5

Other 1 0 0

Total 42 21 12 o AOne respondent was a pharmacy technician o BTwo of which were not sent a questionnaire but contacted and completed by phone; Cone of which

completed interview only thus no scoring in experience section. o DHowever one GP and one practice manager agreed to an Interview but the evaluation had drawn to a

close o # Information from a letter from a GP and a short conversation with a member of one of the PCTs has also

been included in the evaluation but not recorded in the respondent profiles above.

Table 6 – PCT

PCT Number

Ashton, Leigh and Wigan 5*

Oldham 6*

Salford 3

Stockport 7

Other 1

Total 22

* 1 person representing 2 different PCTs

7.3 Participation

7.3.1 The majority of respondents (13 of 21) were in organisations participating in the pilot, two of the three who answered no and those who answered that the question was not applicable were PCT staff members (Table 7, column A). Only three respondents gave reasons for sites opting out of the pilot, these reasons included issues around GP participation, GP workload and LMC sign up.

7.3.2 Just over half of the respondents, 11 out of 21, felt that everyone in the organisation was equally happy with the decision to participate in the pilot (Table 7, column B). However seven respondents felt that not everyone was happy to participate. Unfortunately limited

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information was captured as to the reasons why although from those who did comment it appears that the GPs were not so keen to participate. Comments illustrating this include:

■ “GPs not so keen as there were problems with the confidence with the pharmacy”.

■ “GPs as they could not see the benefits”.

■ “LMC against it from the start”.

Table 7 - Participation in the pilot

Participation A B

Yes 13 11

No 3 7

N/A 5 1

Total 21 19

What were your motivations for taking part?

7.3.3 Respondents were asked what their three key motivations for taking part in the pilot were. There were a number of motivations provided sometimes more than three, however there were some common themes identified (Table 8). The top three key themes were that it would help develop new ways of working, utilise pharmacist skills as well as improving the patients experience in terms of access and choice. Comments illustrating this include:

■ “Taking Pharmacies forward”.

■ “It is good to skill up pharmacists”.

■ “Opportunities for pharmacists to demonstrate and utilise other skills”.

■ “Decrease time spent waiting for results”.

■ “Foster relationship with GPs”.

7.3.4 Other motivations ranged from reducing workload for GPs and hospitals, providing a community service and PCT pressure.

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Table 8 - Motivations for taking part

Motivations Number

New ways of working 10

Utilise Pharmacists Skills 9

Improve patient experience (inc access, choice, flexibility, convenience, waiting time)

9

Outcomes 7

New Services 6

Others 18

Total 59

What, if any, reservations, fears, concerns did you have about participating in the pilot?

7.3.5 Respondents were also asked what their three key reservations were in taking part in this pilot. There were a variety of reservations (Table 9) however there were key themes around the operational impact of the pilot i.e. the effect on workload and manpower, IT integration and GP Participation in the pilot. Comments illustrating this include:

■ “Competency and Training”.

■ “The IT system was not totally up and running” or “IT was delivered very late and not fully working”.

■ “Should have gone to the PCTs first and looked at the infrastructure with GPs i.e. which ones are likely to participate”.

■ “None really, however needed to get a pharmacist”.

■ “Couldn’t provide a full range of tests because of the lack of venepuncture”.

7.3.6 Other issues included the set up of the pilot (i.e. people felt that the approach taken to set up the pilot in terms of approaching pharmacies first and also the criteria used to identify and approach GP practices and pharmacies), staff turnover and patient movements.

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Table 9 - Reservations about the pilot

Reservations Number

Operational impact (inc manpower, workload, training etc)

10

IT integration 8

GP participation in pilot 6

Pharmacy participation in pilot

4

Range of tests 4

Quality and confidence in the results

4

Others 7

None 3

Total 45

7.4 Current Status

Has your practice / pharmacy gone live? If so, when?

7.4.1 Of those who responded, 12 of the 21 respondents were in organisations or pilot sites that had gone live (Table 10), when these sites went live varied from August 2006 to now.

Table 10 - Current Status

Status Number

Live 12

Not Live 2

N/A 7

Total 21

How many patients have been enrolled and been seen by the pharmacy?

7.4.2 The numbers of patients enrolled or that have been seen by the pharmacy were provided for some of the pilot sites. The numbers enrolled ranged from 13 to 60, on average 30, and the numbers seen ranged from 0 to 29, on average 13, and the length of time the pilot sites had been seeing or enrolling patients varied from 6 to 15 months. To note that

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one pharmacy stated that they had also seen some of their patients more than once, up to 4 times.

7.5 Experiences

My overall experience of the pilot was excellent?

7.5.1 Overall the experiences of the respondents have been fairly mixed with seven agreeing, six disagreeing or strongly disagreeing and six neither agreed or disagreed with the statement “My overall experience of the pilot was excellent” (Table 11). There were many reasons given, positives included improved job satisfaction and patient satisfaction, negatives included the problems with IT and the low participation. Reasons given included:

■ “Good overall. Practices and Pharmacies are positive about the pilot and have nothing negative to say”.

■ “Good for the pharmacy, improving the relationship with the patients and increasing my job satisfaction and skills”.

■ “Took too long from training to going live due to IT/equipment problems. Too ambitious with patient groups chosen. Ideas good but translation into practice was harder than expected”.

■ “Need to involve the practice before setting up anything like this. Asthma would be a better place to start”.

■ “Low participation makes the service a bit pointless and not cost effective”.

■ “The patients we saw and my own satisfaction at implementing the scheme was very positive”.

Table 11 - Initial experiences

Overall Experience Number Respondents

Strongly Agree 0

Agree 7 1 GP practice staff

2 PCT staff

4 Pharmacy staff

Neither Agree or Disagree 6 3 GP practice staff

2 PCT staff

1 Pharmacy staff

Disagree 5 1 GP Practice staff

2 PCT staff

2 Pharmacy staff

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Strongly Disagree 1 1 GP practice staff

Total 19

The support provided to us by the strategic health authority was adequate?

7.5.2 The majority of respondents (13 of 19) felt that the support from the Strategic Health Authority was adequate (Table 12). However some felt it although it was adequate that there were also a few issues to be addressed in terms of the time taken to resolve issues. Comments illustrating this include:

■ “Always helpful”.

■ “Material support good, engaging GP's and solving issues slow. Quality control issues, IT, admin and finance, training was excellent”.

■ “Adequate, although IT have had problems which were late to solve”.

■ “Have always given support/help when asked but the pilot was very slow to take off (over 12 months after training) so cannot say strongly agree”.

Table 12 - SHA Support

Support Number Respondents

Strongly Agree 2 1 Pharmacy staff

1 PCT staff

Agree 11 4 Pharmacy staff

5 PCT staff

2 GP practice staff

Neither Agree or Disagree 5 2 Pharmacy staff

3 GP practice staff

Disagree 1 1 GP practice staff

Strongly Disagree 0

Total 19

The training provided to the pharmacists was adequate?

7.5.3 Just over half of the respondents (11 out of 19) felt that the training was adequate (Table 13) however there were some issues with the training mainly in terms of the length of time between training and going live. Quotes that illustrate this include:

■ “Delay between training and implementation”.

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■ “Very good, comprehensive, refresher courses would be useful as staff changes”.

■ “Casualty of the timescales stretching, just about adequate at the time but lag caused problems”.

The protocols developed for the pharmacists were comprehensive and provided adequate information?

7.5.4 The majority of respondents (13 out of 19) felt that the protocols for pharmacists were adequate and provided adequate information (Table 13). Comments to demonstrate this include.

■ “Those I did see looked overly complex”.

■ “Very good”.

■ “Yes, we have used in other situations they are a good starting point”.

■ “Have covered all eventualities so far”.

■ “Simplification for some might help. Summary of how to we equipment in flow chart from may be useful overview / quick reference”.

Table 13 - Pharmacist Training and Protocols

Training Protocols

Number Respondents Number Respondents

Strongly Agree 3 2 PCT staff

1 Pharmacy

4 2 PCT staff

2 Pharmacy

Agree 8 3 GP practice staff

1 PCT staff

4 Pharmacy

9 3 GP practice staff

2 PCT staff

4 Pharmacy

Neither Agree or Disagree

3 1 GP practice staff

2 PCT staff

1 1 PCT staff

Disagree 3 1 PCT staff

2 Pharmacy

2 1 GP practice staff

1 Pharmacy

Strongly Disagree

0 0

Not known 2 2 GP practice staff

3 2 GP practice staff

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1 PCT staff

Total 19 19

The communication between GPs and Pharmacists is excellent?

7.5.5 There were mixed views as to whether the communication between GPs and pharmacists is excellent, with 7 respondents strongly agreeing or agreeing and 7 disagreeing with the statement. Interestingly GPs were more positive about the communication between themselves and pharmacists with 4 out of 6 GP practice staff either agreeing or strongly agreeing with the statement where as only 2 out of 7 pharmacy staff did (Table 14). Those that did comment were generally fairly negative, as illustrated below:

■ “GP are not interested / informed about the pilot”.

■ Issues but “because communication is good the scheme continued”.

■ “Depends on the place - yes in some but not in others and there were IT issues”.

■ “Could be backed by a meeting between GP and Pharmacist”.

The IT systems in place are adequate.

7.5.6 Again there were mixed views as to whether the IT systems were adequate, however the majority thought that they were not with 11 out of 19 disagreeing or strongly disagreeing with the statement “the IT systems in place are adequate”. GP practice staff (four out of six) in particular thought that the IT systems were inadequate (Table 14). This mixed response could be due to the delay in integrating and linking IT. From the information we have it does not appear to be linked to the date that the pilot sites went live. Quotes to illustrate this include:

■ “Results only recently being sent into the GP systems”.

■ “Links to surgery have been non existent so far. Took too long to set up pharmacy link although it does seem to work well now”.

■ “The link between pharmacy and GP computers still not sorted”.

■ ”Basic, easy to manage”.

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Table 14 – Communication and IT

Communication IT

Communication Number Respondents Number Respondent

Strongly Agree 2 1 GP practice staff

1 Pharmacy

2 2 Pharmacy

Agree 5 3 GP practice staff

1 PCT staff

1 Pharmacy

3 2 PCT staff

1 Pharmacy

Neither Agree or Disagree

4 2 PCT staff

2 Pharmacy

2 2 GP practice staff

Disagree 7 2 GP practice staff

2 PCT staff

3 Pharmacy

8 4 GP practice staff

2 PCT staff

2 Pharmacy

Strongly Disagree 0 3 1 PCT staff

2 Pharmacy

N/A 1 1 PCT staff 1 1 PCT staff

Total 19 19

Patients were very interested in the pilot? Patients were willing to sign-up to the pilot?

7.5.7 There were mixed views from the respondents as to whether patients were interested in and willing to sign up to the pilot (Table 15). This appears to be due to the mixed responses of patients in that there has been a low response rate however there is positive feedback from those patients who are involved in the pilot. Comments that illustrate this are:

■ “Convenient, really good to get results immediately, whereas results usually take up to a week. Helps them to manage their condition”.

■ “Fairly low response to leaflet, but those who have been to pharmacies do seem to like it”.

■ “In general patients were but the link is missing with doctors so there's no referral”.

■ “Fragmented service therefore interest waned due to delays”.

■ “Positive response so far”.

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■ “Probably need to give more explanation than just the letter and leaflet, personal approach would be better”.

■ “Varies on location. Those that have signed up have been really keen”.

Table 15 - Patient experiences

Interest Willingness

Interest Number Respondents Number Respondents

Strongly Agree 0 0

Agree 7 1 GP practice staff

2 PCT staff

4 Pharmacy

6 2 GP practice staff

2 PCT staff

2 Pharmacy

Neither Agree or Disagree

5 3 GP practice staff

2 Pharmacy

8 3 GP practice staff

1 PCT staff

4 Pharmacy

Disagree 5 2 GP practice staff

2 PCT Staff

1 Pharmacy

3 1 GP practice staff

1 Pharmacy

1 PCT Staff

Strongly Disagree

0 0

N/A 2 2 PCT staff 2 2 PCT staff

Total 19 19

What were the key benefits that you have experienced with the pilot?

7.5.8 There were a number of different benefits experienced in the pilot, the key benefits appeared to be the flexibility and convenience for patients in terms of opening hours, improved relationships between the participants including the promotion of integrated working, along with health promotion (including self care and patient education) (Table 16). Thus it appears that the majority of benefits identified are in terms of patient benefits.

■ “Improved engagement between GP and Pharmacists”.

■ “Convenience to the patient”.

■ “Demonstrated where POCT sits in community pharmacy”.

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■ “Patients got medication reviews that they might not have had otherwise”.

■ “Health promotion messages reinforced via another method”.

■ “Educate patient i.e. around life style”.

Table 16 - Key Benefits

Benefits Number

Improve relationships / integrated working

16

Flexibility and Convenience

13

Health promotion, education and self care

9

Promote PoCT / near patient testing

6

Other 5

None 1*

Total 48

*GP Practice

What were the key problems/challenges (barriers) experienced with the pilot?

7.5.9 There were a number of problems and challenges to the pilot however there were a number of key challenges which included the problems with IT, in terms of a lack of Integration / linkage and the engagement of GPs. Other issues included small practice numbers, maintaining the pharmacist skills (due to small numbers of patients), retaining pharmacists and the range of tests available (Table 17). Comments illustrating this include:

■ “GPs - they want the money to do themselves they don’t want someone else to do”.

■ “Getting it started i.e. the training in place, the IT system up and running (GPs having to deal with paper)”.

■ “Getting the community pharmacies to remain engaged”.

■ “GPs want the full phlebotomy service – expand to cover all tests”.

■ “IT Links – not getting the information”.

■ “Finding and engaging suitable patients”.

■ “Negative attitude of practices and GPs towards pharmacists and their abilities”.

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Table 17 - Key Problems / Challenges

Problems Number

IT 12

GP* involvement 11

Practice and Pharmacy Numbers

6

Pilot Processes 5

Maintaining Pharmacist skills

3

Pharmacist involvement 2

Range of Tests available 2

Other 3

None Given 1

Total

*and practice nurse

7.6 Overall

High street pharmacies provide a suitable setting to deliver care for long term conditions?

7.6.1 Respondents were asked if they felt that high street pharmacies provide a suitable setting to deliver care for long term conditions. 14 out of 20 felt that high street pharmacies do provide a suitable setting, however four out of six GP practice staff said they did not (Table 18). They were also asked to rate the following statement: “High street pharmacies provide a suitable setting to deliver care for long term conditions”. 15 of the 20 respondents stated that they agreed or strongly agreed that high street pharmacies provide a suitable setting to deliver care for long term conditions. However the majority of those respondents were pharmacy or PCT staff, with six pharmacy and seven PCT staff agreeing or strongly agreeing with the statement. Where as four out of six GP practice staff disagreed or strongly disagreed with this statement (Table 19). Reasons given for this include:

■ “More accessible, more relaxed environment, opens doors to wider discussions around life style”.

■ “Finger prick blood tests available in pilot are only useful for screening work, so better to target CV risk screening and obesity/diabetes identification. Need lower risk stable patients e.g. hypertensive not CHD”.

■ “This is utilising the pharmacists and staff considerable untapped potential”.

■ “More patient choice, wider range of times to work in with their jobs and lives”.

■ “They have a role but it is unclear how”.

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■ “Convenience/access are key attributer with instant results”.

Table 18 – Are high street pharmacies suitable?

Number Respondents

Yes 14 1 GP practice staff

7 Pharmacy

6 PCT staff

No 5 4 GP practice staff

1 PCT staff

Don’t Know 1 1 GP practice staff

Total 20

Table 19 – Are high street pharmacies suitable?

Number Respondent

Strongly Agree 8 5 Pharmacy

3 PCT staff

Agree 7 2 GP practice staff

1 Pharmacy

4 PCT staff

Neither Agree or Disagree 0

Disagree 4 3 GP practice staff

1 Pharmacy

Strongly Disagree 1 1 GP practice staff

Total 20 20

What three improvements (lessons to be learnt) could be made to the scheme?

7.6.2 The respondents felt that the key improvements to be made to the pilot were to ensure that IT systems integrated and to improve the communication and networking of participants (Table 20). Other issues included GP engagement, the need to provide a full compliment of tests, provide on-going training (i.e. refresher courses) and engage patients.

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■ “Improve IT systems”.

■ “Need Improved communication”.

■ “Early engagement of GPs and GP board representation”.

■ “If pharmacist going to test need to test other parameters routinely checked e.g. thyroid function, liver function”.

■ “On-going training for Pharmacists”.

■ “Needed selling well to patients, it was not done in the right way, needed a personal recommendation from GPs and Pharmacies”.

What opportunities are there for the future?

7.6.3 There were a large number of different opportunities identified for taking the pilot forward, however the key theme was to increase the number of tests provided at the pharmacy (i.e. provide liver function and INR tests) (Table 20). Others included provide health promotion and health checks, increase the range of services, introduce pharmacist prescribing, improve patient choice, and improve relationships.

■ “Extend the range of tests”.

■ “Add phlebotomy training”.

■ “Lots especially if could also do kidney function as could do instead of GPs / Surgery tests as well”.

■ “Use in a complete health check up on the high street (particularly men)”.

■ “Tie in with medicines management”.

Table 20 - Improvements

Improvements Number

IT 7

Networking / communication – GP – Pharmacist

6

GP engagement 5 (6)

More Tests i.e. the full range

4

Training – ongoing 4

Patient Engagement 4

Other 17 (16)

Total

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Table 21 - Opportunities

Opportunities Number

Range of Tests (Phlebotomy, INR / Warfarin, Kidney Function tests etc).

10

Health promotion / health checks

5

Other 16

Total 31

Do you think you will want to continue with the scheme after the pilot?

7.6.4 The majority of interviewees were in favour of continuing the scheme after the pilot, particularly the pharmacies themselves and the GP practice staff (Table 22). Those that were unsure as to whether they will continue were the PCT members of staff. Also a number of those who said yes also stated that changes would need to be made. Reasons given for these responses included:

■ “But not necessarily in the same form, possibly need GP to nominate suitable people to be monitored in pharmacy and very keen and knowledgeable pharmacist with adequate staff capacity”.

■ “If patients want to”.

■ “Yes, I'd like to however more GP involvement is needed to increase participation and make it cost effective”.

■ “Extend the scheme to other GPs and also do INR”.

■ “Too early to say as not enough data”.

■ “But in a different way”.

■ “Probably dependent on funding levels, patient recruitment and to involve more GPs”.

■ “It would be a shame not to as just getting off the ground”.

Table 22 - Continue

Continuation Number Respondents

Yes 11 7 Pharmacy

4 GP Practice staff

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2 PCT staff

No 2 1 PCT staff

1 GP

Don’t Know 3 3 PCT staff

N/A 4 1 PCT staff

3 Pharmacy

Total 20

7.7 Summary

7.7.1 From the views expressed by the 21 who completed the questionnaire and the 12 that were also interviewed it shows that there are mixed opinions about the suitability of the HST process. However overall it has been fairly positive with the majority wanting to continue with the scheme after the pilot.

7.7.2 It was generally felt that the support provided by the SHA was adequate, that the pharmacist training and protocols were adequate (although there was an issue around the time delay between training and going live). There were mixed feelings around the communication between stakeholders (GP and Pharmacist) and there were issues around IT integration.

Key Findings

■ PCT staff and pharmacy staff feel that high street pharmacies provide a suitable setting to deliver care for long term conditions. However GP practice staff do not feel this is the case.

■ Benefits seen so far have included improved access in terms of flexibility and convenience for the patient, improved stakeholder relationships and health promotion.

■ Improvements to be made to the scheme include the need to make sure IT systems are in place and up and running before going live, to improve the communication (networking) between participants and to improve GP engagement.

■ The opportunities for the future include the review and possible increase in the range of tests on offer.

7.7.3 These findings have shown that pharmacists are very keen to be involved in patient care and diversify their skills, moving away from purely dispensing. They feel that high street pharmacies provide a suitable setting to deliver care for long term conditions. However GP practice staff are less certain with the majority feeling that high street pharmacies are not suitable.

7.7.4 Thus the staff interviews have identified the some key lessons including engaging GPs early, improving the communication between stakeholders, ensuring IT systems are in place and reviewing the range of tests available (to help avoid duplication of work). It also identified the need to review the referral process, patient criteria and the methods for engaging with patients, along with looking at pharmacist retention and maintenance of pharmacist skills.

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8 Financial Considerations

8.1 Introduction

8.1.1 The pilot is a stand alone operation and has associated costs and income. However these are not necessarily the cost and income streams that would occur if this pilot was implemented as routine practice and rolled out wider. For this reason we have not explored how the HST pilot is funded instead how future funding could operate.

8.1.2 The section discusses the financial issues relating to the pilot and explores the following questions:

■ What are the costs in the system?

■ How does the pharmacy approach compare to the conventional process?

■ For a pharmacy perspective how much should they get paid per visit?

8.1.3 This section highlights the issues for future commissioning. It also outlines the caveats with the current assumptions and the necessary further work to fully understand suitable tariffs.

8.2 Financial model

8.2.1 A model has been developed to explore the costs under the HST pilot process and the conventional process. The process maps for these processes are in the appendices, Appendix A1 and Appendix A2. Earlier we noted three key differences in the processes:

■ Location of appointment: GP surgery versus pharmacy.

■ Time between test and result: point of care testing versus lab testing.

■ Feedback to patient: consultation with results at the appointment versus consultation and then results.

8.2.2 It is the first two aspects, the location and the point of care testing as opposed to laboratory testing, which drive the different costs under the different processes.

8.2.3 The following section will discuss the model and the results, which reflect the assumptions and costs discussed in the finance workshop on the 17th October 2007.

8.2.4 The excel spreadsheet model is included in the appendices document as an embedded file, Appendix G. This is provided as an additional resource. It is an interactive tool with which to explore the impact of future changes to the cost assumptions.

8.3 Financial principles applied

8.3.1 To explore the financial side of the pilot we have taken a cost to the commissioner and provider approach. This has involved considering both:

■ The set up, fixed and variable costs the provider (the pharmacy) incurs.

■ Any savings made by the commissioner under the new process i.e. looking at the whole systems cost.

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8.3.2 The following Figure 32 provides a summary of the financial principles applied in the model. This is further described below.

Figure 32 – Principles of the financial model

8.3.3 If a pharmacy were to provide a service like HST they would first have set up costs. This would include testing equipment, training and the information management and technology costs. These costs are a one off cost in order to be able to offer the service.

8.3.4 Once the pharmacies are set up to offer the service they will also have the fixed costs of maintaining and providing the service. These would include ongoing training, performance management and quality assurance. These costs and the set up costs are paid regardless of the number of patients; they are the cost involved to be able to continually offer the service to patients. These costs will be incurred whether they see no patients or 200 patients.

8.3.5 The final sort of costs that the pharmacy will have is the variable costs. These costs are incurred on a per patient visit basis. For example for every patient visit they will have the cost of consumables and testing costs.

These costs and payment are on incurred on a patient visit basis i.e. no patients no cost

These costs are incurred regardless of the number of patients

Fixed costs

e.g. training

Variable costs

e.g. consumables,

test costs

Set up

e.g. testing equipment, IM&T and computers

Saving or Payment

e.g. Whole system

saving or payment to pharmacy

Assumption 1: for every visit the cost of a GP practice visit and laboratory test is saved.

Assumption 2: there are 120 episodes of care a year

Cost model per pharmacy in HST

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8.3.6 The principle of our cost model is that there is a saving or payment for each patient visit that is greater than the variable cost per patient visit. This principle enables the pharmacy to recoup the costs they have already paid in setting up and maintaining the service.

8.3.7 When we consider the pharmacy perspective we are looking at the financial attractiveness of the system and the payment they would receive for their service. When considering the local health economy we are examining the whole system and the savings that can be made within the system.

8.3.8 The model also has two additional assumptions. The first that the saving made per visit is the cost of the conventional process i.e. the GP practice visit and a laboratory cost. The second assumption is on the patient volume it is assumed that there are 120 episodes of care a year. This is equivalent to between 40 – 60 patients depending on the frequency of visits.

8.3.9 If the payment or saving was less than the variable costs then the service would never breakeven or make a profit and would lose more money every patient visit. This would not be a financially viable model for the commissioner or provider. This would lead to a situation where either the commissioner would pay more for the service or the provider would be providing a loss making service.

8.4 Costs in the system

8.4.1 Our first question to address is what are the costs in the system? As shown in the diagram (Figure 28), there are set up, fixed and variable costs for the pharmacy to be able to provide HST.

8.4.2 The following tables, Table 23 to Table 25, show the costs for the pharmacy as agreed in the financial workshop. There is a one off set up cost of £3,650, annual fixed costs of £3,246 and variable costs of £22.70 per patient visit.

Table 23 – Set up costs

Set up costs

Equipment

PCs £500

IM&T links £250

Testing equipment £1500 For blood pressure monitors and fridge

Other £250 e.g. software licence

Consulting Room – set up £200

Training £1000

Total set up costs £3,650

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Table 24 – Fixed costs

Fixed Costs

Fixed staff cost £746

Training £500

Consulting room £500

Performance management £750

Quality Assurance £750

Total Fixed Costs £3,246

Table 25 – Variable costs

Variable Costs

Staff cost per patient visit £10.20

Equipment cost per visit £8.00

Consumables per visit £0.50

Margin for the pharmacy* £4.00

Total variable cost per visit £22.70

* The model assumes that for financial attractiveness pharmacies require a margin per patient in order to make a profit from the service.

8.5 Comparison of pharmacy approach to conventional process

8.5.1 Our second question is how does the cost of the pharmacy approach compare to the cost of the conventional process?

8.5.2 For this we are examining the whole system and the savings that can be made within the system. Hence we compare the estimated saving from the conventional approach to the cost of the pharmacy approach.

8.5.3 As previously introduced, we need the saving to be greater than the variable costs of £22.70 in order for the service to be a financially viable approach for both the commissioner and the provider.

Saving per visit

8.5.4 Our assumption is that for every visit to the pharmacy a saving is made at the GP practice and a laboratory test cost is saved. The estimates for the cost saved are as follows:

■ £50 for a 20 minute GP consultation.

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■ £0.01 for sample transportation (the costs is assumed to be negligible but can be varied in the Excel based model).

■ £1.39 for a HbA1C test.

■ £3.22 for a lipid profile.

■ £54.62 Total cost.

8.5.5 Thus the total cost saved is £54.62.

8.5.6 The GP practice appointment is assumed to be £50 based on Curtis and Netten’s report on Unit Costs of Health and Social Care 2006 and a consultation time of 20 minutes. This can be considered as either one appointment of 20 minutes or two appointments of 10 minutes.

8.5.7 This cost is based on a GP cost where it is understood that, depending on the GP practice, that practice nurses may also conduct these consultations. The Curtis and Netten’s report estimate a GP practice nurse cost at £53 per clinic hour. Hence a 20 minutes consultation with a practice nurse would cost an estimated £17.67, which is £32.33 less than our current assumption.

8.5.8 This is an aspect that needs to be further explored and the processes at GP practices better understood. In practice it may be that a combination of both GP time and practice nurse time would provides a better reflection of the cost of a comparable service at the GP practice.

Contribution to covering costs per patient visit

8.5.9 For our model we assume the GP cost is our cost for comparison and compare it to the cost per visit for the pharmacy to give the cost saving. This is the financial contribution for recouping the costs already outlaid:

■ The financial contribution per visit is £54.62 - £22.70 = £31.92.

8.5.10 Under our assumption that there are 120 episodes of care per year the total contribution per year is the contribution per visit * the number of visits. Hence £31.92 * 120 = £3,831.

8.5.11 We can think of this as the annual income for the pharmacy.

Recouping costs and payback

8.5.12 The costs to cover are the annual fixed costs and the one off set up costs.

8.5.13 First let this annual income cover the annual fixed costs. Hence the total contribution of £3,831 minus the total fixed costs of £2,496. This leaves £1,335 per annum once the fixed costs have been paid. This is an annual profit that can be used to recoup the original set up costs.

8.5.14 To consider how quickly the set up costs are recovered we consider the payback period. The payback period is the time taken to recover the initial investment and is often used as a criteria for investment.

■ The payback period is the set up costs divided by the annual return i.e. £3,650/£1,335 = 2.8 years.

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8.5.15 This tells us that in 2.8 years all the set up costs are recovered and from this point forward any annual profit, i.e. income minus variable and fixed costs, made after this is a saving to the overall payment system in this example.

8.6 The pharmacy perspective

8.6.1 Our final question for the financial consideration is for a pharmacy perspective how much should they get paid per visit? The cost saving from the GP and laboratory cost is irrelevant to the pharmacy. For the HST service to be financially attractive to pharmacies they need to breakeven. They need to cover all of their costs and possibly make a profit.

8.6.2 The model assumes that the pharmacies require a profit of £4 per patient for financial attractiveness. This has already been built into the variable costs.

8.6.3 For this section we have made an additional assumption:

■ Assumption 3: the pharmacy requires the set up costs to be covered in three years.

8.6.4 To explore the payment level per patient for the pharmacy consider the following Figure 33. This shows the cost per episode of care for the pharmacy. It clearly shows as the number of episodes of care increases the cost per episode decreases.

Figure 33 – Average cost per episode of care

£0£50

£100£150£200£250£300£350£400£450

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150

Number of episodes of care

Cost

per

epi

sode

(£s)

8.6.5 We can use this curve to explore what payment level per patient gives the pharmacy a margin of £4 per episode of care. To do this we read across a payment level on the cost axis and where it meets the curve this is the level of patients necessary for the £4 margin.

8.6.6 For example see Figure 34 this shows at a payment level of £50 the necessary number of patient visits to make a margin of £4 this is 136 visits. If the number of visits is higher than this the pharmacy makes a higher margin per patient and if the number of visits is lower the pharmacy makes a lower margin.

8.6.7 At a payment level of £30 there is a need for 508 patient visits for the pharmacy to have a margin of £4 per patient.

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Figure 34 – Reading the necessary number of episodes of care for a payment level

8.7 Summary

8.7.1 If these costs are realistic it shows that the service can be made financially viable for both commissioners and providers of services.

8.7.2 To attract pharmacies financially there needs to be a different level of patient visits agreed depending on the payment level. We considered the payment range £30 - £50 which required patient visits between 136 – 508 for a margin of £4 per patient. Under these assumptions the required patient throughput level is very sensitive to the payment level.

8.7.3 However the key conclusion from considering the financial model is that for future roll out and tariff setting further work is necessary. Specifically:

■ The actual costs and resources required need to be challenged and reviewed.

■ A detailed understanding of the comparability of the new service is needed. The questions to consider are: Are the patients still going to the GP for others test? Are the patients going to the GP for reassurance? Would the patient have seen a GP or a practice nurse as an alternative to the pharmacy?

■ The key question is: is there a true saving in the system?

8.7.4 Once these issues have been resolved there is the question of how many patient visits are operationally and clinically ‘ideal’? This is relevant for the financial consideration as the patient level has been seen to affect the required payment level.

£0£50

£100£150£200£250£300£350£400£450£500

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150

Number of episodes of care

Cos

t per

epi

sode

(£s)

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9 Discussion

9.1 Introduction

9.1.1 The aim of the High Street Testing pilot is to offer patients with diabetes and/or cardiovascular disease the choice of attending a pharmacy for clinical consultation and diagnostic blood tests, instead of going to hospital.

9.1.2 The Greater Manchester High Street Testing pilot began offering clinical consultations and POCT for the management of diabetes and (secondary prevention) cardiovascular disease for up to 3000 people in nine pharmacies across four Greater Manchester PCTs in August 2006.

9.1.3 The evaluation of the High Street Testing pilot took place between August 2006 and November 2007 and focuses upon assessing whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions.

9.1.4 This section presents an overview of the findings of the evaluation and examines the incentives and barriers to implementation from different stakeholder perspectives. It also discusses the role of HST in supporting NHS strategy. Finally, it puts forward recommendations for further rollout.

9.2 Overview of the Findings

Recruitment of Pharmacies and GP Practices into the Pilot

9.2.1 The pilot included nine pharmacies and nine GP practices.

9.2.2 Pharmacies were identified and recruited first. Once these were signed-up, local GP practices were approached.

9.2.3 Initially 22 pharmacies expressed an interest in being involved in the pilot but 13 dropped out, mainly for reasons associated with GP reluctance to participate.

9.2.4 Given the pivotal role of GPs to the pilot, it would have been more effective to approach and secure GP sign-up to the pilot before pharmacies were recruited although success of such an approach when participation in the pilot was voluntary is unknown.

Pilot Processes

9.2.5 The pilot process with point of care testing provides results and interpretation to the patient at the time of testing. This provides an opportunity for a face-to-face discussion about the results with the pharmacy and any next steps.

9.2.6 Outcomes of care episodes were collated on a pharmacy-based computer, in turn linked to a central server that allows electronic transfer of consultation outcomes at the point of care to the GP practice.

9.2.7 The patient was given a copy of their results and management plan, which was also forwarded to the GP for inclusion in their notes. The next appointment was also arranged.

9.2.8 A protocol has been developed and is used to grade a patient’s status as green, amber or red. Patients whose status is red are referred back to the GP.

9.2.9 The differences in the conventional and new processes are:

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■ Location of appointment: GP surgery versus pharmacy.

■ Time between test and result: point of care testing versus lab testing.

■ Feedback to patient: consultation with results at the appointment versus consultation and then later results.

Patient Eligibility and Take-up of choice

9.2.10 The Business Case stated that the pilot was expected to serve approximately 1,500 patients. This is segmented as:

■ Patients with CHD only (780).

■ Patients with diabetes (660).

9.2.11 This assumes 80% of patients on practice registers are eligible to take part in the trial and 30% accept the offer of High Street Testing. However, the Business Case acknowledges previous experiences in which there is a 10% - 80% take up rate (i.e. 600 – 4,800 patients).

9.2.12 The overall number of patients on either the diabetes or CHD register for the pilot practices was 2,197 of which 1,340 (61%) met the clinical inclusion criteria. However, only 603 (45%) of these eligible patients were offered choice, the remainder were excluded because the pharmacy they used was not part of the pilot.

9.2.13 Of the 603 patients offered choice, 206 took up the offer (34%), which is slightly higher than the 30% predicted in the Business Case.

9.2.14 There was considerable variation in patient uptake across the nine GP practices in the pilot (ranging from 12% to 48%) which reflected different approaches to offering choice, in particular the enthusiasm of GPs in persuading patients and the level of follow-up after the initial choice letter had been sent.

9.2.15 Of the 206 patients accepting choice, 121 attended a pharmacy appointment (79 had a first appointment and 22 a second appointment).

Patient Management

9.2.16 There were 11 potential tests included in the pilot and a total of 1,195 tests were carried out for the 121 patients who had a first and second appointment.

9.2.17 For most of these tests, excluding height and cholesterol ratio, there are score ranges for red, amber and green ratings. The assumption is if a patient has at least one red result they are a red result patient, if a patient has at least one amber result they are an amber result patient and patients with only green results are considered green patients.

9.2.18 Depending on the patient result status, different actions are prescribed:

■ Green results - counsel the patient and reinforce positive behaviour. Schedule next appointment at 6 months

■ Amber results - counsel the patient and look for ways to improve. Schedule next appointment at 3 months

■ Red results - counsel the patient, refer back to the GP.

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9.2.19 Eleven (9%) patients who attended a pharmacy appointment were referred back to their GP. However, 50 patients had red results recorded in the pharmacy system.

9.2.20 The analysis shows that there is variation in how red results were dealt with and the pharmacists were using different rules for the referral of patients back to their GP. If all patients with red results for BMI had been referred back to their GP an additional 41 patients would have been referred back. This would have been more than half of the patients in the pilot being referred back to the GP.

9.2.21 BMI is in the initial selection criteria used to determine if a patient is eligible for being offered choice. Given that all the patients recruited into the pilot met this criteria, yet 41 subsequently failed it (within less than a year and in many cases within a few months), this indicates there may be some mismatch between the inclusion/exclusion criteria and algorithm for assigning patient result status.

Patient Experiences

9.2.22 Patient experiences were captured using a mixture of semi-structured questionnaires (36) and in-depth telephone interviews (12).

9.2.23 The vast majority of patients stated they were satisfied with all aspects of their HST appointments. This included booking the appointment, the time allocated for them to be seen by a pharmacist, the location, the process and any advice given to them by the pharmacist. However, it should be noted that it is unclear how much actual choice of time and day of the week is actually offered by pharmacists.

9.2.24 HST also compared very favourably with the traditional method of managing a patient’s condition at the GP Practice. Just under half of the patients questioned considered HST to be a better way of managing their condition than at their GP Practice.

9.2.25 Overall, patients were extremely positive about HST. Of the 36 patients who completed a questionnaire, the majority of patients stated that they were ‘very satisfied’ with the service and wished their High Street pharmacy to continue to manage their condition.

Staff Experiences

9.2.26 Twenty one stakeholders responded to the questionnaire, a response rate of 50%, of which there were six pharmacists plus one pharmacy technician, eight PCT members, three GPs, two practice managers and one practice nurse. There were also a small number of stakeholders interviewed although no one from general practice agreed to be interviewed.

9.2.27 The findings show that pharmacists are very keen to be involved in patient care and diversify their skills moving away from purely dispensing. They feel that high street pharmacies provide a suitable setting to deliver care for long term conditions.

9.2.28 GP practice staff are less certain that this diversification is the way forward with the majority feeling that high street pharmacies are not a suitable setting for managing patients with CHD and/or diabetes.

9.2.29 The pilot has also identified key lessons to be learnt in terms of engaging GPs early (including liaising with the PCT to identify GP practices and pharmacies and clearly identifying benefits for GPs), improving the communication between stakeholders, ensuring IT systems are in place before pharmacies go live and possibly reviewing the range of tests that are currently on offer (to help avoid duplication of work).

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9.2.30 Other issues that have also been mentioned on several occasions are the need to review the referral process and patient criteria, to review the methods for engaging with patients looking at a more personal approach i.e. personal recommendations from GPs or pharmacists, problems with pharmacist retention, and to avoid the loss of momentum (reduce the time delay) as this resulted in the loss of pharmacists skills and patient interest in the pilot.

Financial Considerations

9.2.31 The pilot is a stand alone operation and has associated costs and income. However these are not necessarily the cost and income streams that would occur if this pilot was implemented as routine practice and rolled out wider. For this reason the evaluation has not explored how the HST pilot is funded instead how future funding could operate.

9.2.32 The approach used looks at the costs to the commissioner and provider, which are:

■ The set up, fixed and variable costs that the provider (the pharmacy) incurs.

■ Any savings made by the commissioner under the new process i.e. looking at the whole systems cost.

9.2.33 Assuming a pharmacy makes £4 margin per appointment and carries out 120 patient appointments per year, then it will take 2.8 years for them to recoup the set-up costs, after which they will start to make a profit.

9.2.34 Once the initial set-up costs have been recouped, the required patient throughput level is very sensitive to the payment level. At a payment level of £50 the necessary number of patient visits to make a margin of £4 is 136 visits. At a payment level of £30 there is a need for 508 patient visits for the pharmacy to have a margin of £4 per patient.

9.2.35 These calculations show that HST can be a commercially viable service for both commissioners and providers of services. However, this is based upon assumptions about the cost of a GP practice appointment and that a visit to the pharmacy removes the need for the patient to visit their GP in relation to the management of their CHD or diabetes.

9.2.36 Therefore, further work is still needed to determine future roll out and tariff setting:

■ The actual costs and resources required need to be challenged and reviewed.

■ A detailed understanding of the comparability of the new service is needed. The questions to consider are: Are the patients still going to the GP for others test? Are the patients going to the GP for reassurance? Would the patient have seen a GP or a practice nurse as an alternative to the pharmacy?

■ The key question is: is there a true saving in the system?

9.2.37 Once these issues have been resolved there is the question of how many patient visits are operationally and clinically ‘ideal’? This is relevant for the financial consideration as the patient level has been seen to affect the required payment level.

9.3 Caveats

9.3.1 The evaluation of the High Street Testing pilot took place between August 2006 and November 2007. However, the number of patients who have used the service is lower than anticipated and there is consequently limited operational data available for analysis.

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9.3.2 There is data for 79 patients who have had a first appointment and 22 who have had a second. Whilst the analysis of this data shows that some patients improved their tests results and for others they become worse, there is insufficient data to make any inferences about how well HST manages patients.

9.3.3 A further limitation of the evaluation is the low level of feedback from GPs and GP practice staff, which may reflect their reluctance to participate in the pilot, as reported by pharmacists and other staff.

9.3.4 Finally, the financial aspects of the evaluation require further work in order to accurately define future tariffs and levels of operation.

9.4 Barriers and Incentives

9.4.1 Table 26 shows the potential incentives and barriers to uptake of HST by different stakeholder groups.

Table 26: Incentives and Barriers to uptake by stakeholder group

Stakeholder Incentives Barriers

Patients More choice

Increased convenience

Longer consultation, more information provided and greater scope for discussion

Empowerment and better self management

Not eligible for participation

Recruitment letter not enticing

Lack of GP enthusiasm

Pharmacists do not offer sufficient choice of time and date, pharmacist or pharmacy

Surroundings may be less comfortable/confidential

May still need to visit general practice for additional blood tests not undertaken in pilot

Pharmacists Improved service to patients

Expanded job role and greater job satisfaction

Support for new pharmacy contract and public health

Small numbers of patients, so lack of practice and confidence in POCT

Lack of professional recognition/endorsement of training course

Requirement for at least two pharmacists to be

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Stakeholder Incentives Barriers

agenda

Increased payment to the pharmacy

available during times of patient appointments

Need for greater flexibility in opening hours in order to offer choice of appointment time/day (e.g. weekend and late night opening)

Lack of mechanism for disposing of sharps

GPs/practice staff

Reduced workload allowing concentration on other areas

Potential reduction in costs of managing patients

Patient choice and requirement for alternative service delivery

Work required to identify and enrol patients

View of threat to QOFF payments

Seen as erosion of professional role

Lack of confidence in HST concept

Patients still need to be seen for blood tests

Lack of IT integration (initial phase of pilot only)

9.5 Fit with NHS Strategy

9.5.1 Patients with long term conditions use a greater proportion of healthcare resources than other patients use. The Department of Health (2004)5 estimates that people with chronic conditions account for up to 80% of general practitioner (GP) consultations 60% of hospital bed days and two-thirds of emergency medical admissions.

9.5.2 Long term conditions were highlighted as a national priority in the NHS Improvement Plan (2004), form a core element of several national service frameworks and finally became the subject of the NHS and Social Care Long-Term Conditions Model (2005).

5 Department of Health (2004a) Improving Chronic Disease, Management. The Stationery Office, London.

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9.5.3 The purpose of the Model is to improve the health and quality of life of those with long term conditions by providing personalised, yet systematic on-going support, based on what works best for people in NHS and social care systems and is based on the US Kaiser Permanente model.

9.5.4 HST addresses level 1 patients, the 70-80% of those with long term conditions for whom supported self care is appropriate. Self care is defined as collaboratively helping individuals and their carers to develop the knowledge, skills and confidence to care for themselves and their condition effectively.

9.5.5 The new contractual framework for community pharmacy agreed for England and Wales between the Department, the Pharmaceutical Services Negotiating Committee (PSNC) and the NHS Confederation, completes a long-held ambition to modernise and shape NHS community pharmacy services for the future. It went live from 1 April 2005. HST will underpin the contract, drawing on community pharmacy’s assets of the skills, expertise and experience of pharmacists and their staff and its presence in the heart of the communities it serves with a tradition of ready access to all, community pharmacy should:

■ Be – and be seen to be – an integral part of the NHS family in providing primary care and community services.

■ Support patients who wish to care for themselves.

■ Respond to the diverse needs of patients and communities.

■ Be a source of innovation in the delivery of services.

■ Help deliver the aspirations within the National Service Frameworks.

■ Help tackle health inequalities.

9.5.6 In particular, HST fits into the category of enhanced services, commissioned and funded locally by Primary Care Trusts, for example, anticoagulant monitoring, medicines assessment and compliance support and medication review.

9.5.7 The Darzi Report (2007) highlights that the care of patients with long term conditions is not always as good as it could be and does not always meet recommended guidelines. Taking diabetes as an example, the National Service Framework recommends that patients with diabetes should agree to a care plan to manage their conditions, as the best results are achieved by:

■ Patients engaged in their own care and empowered to manage it themselves or with the help of carers.

■ Organised diabetes teams that actively seek out people to ensure they get the best care.

■ Partnerships between people with diabetes and health and social care professionals to solve problems and plan care.

9.5.8 Darzi points out that despite this guidance, the 2006 Healthcare Commission survey of people with diabetes showed that less than 50% of people actually have an agreed care plan to manage their diabetes. He also quotes some initial analysis across a range of long term conditions, including CHD, undertaken by the department of public health and

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epidemiology at the University of Birmingham which suggests les than 50% of patients eligible for treatment were receiving optimal treatment for their condition.

9.5.9 HST can provide additional capacity to manage more patients with CHD and diabetes and also improve their care planning and engagement.

9.6 Conclusions and recommended further work

9.6.1 Despite the limited evaluation data obtained during the pilot, the South Manchester pilot has demonstrated that HST is operationally feasible and attractive to patients and pharmacists. Initial findings show that patients are no less well managed than in general practice, although this is based on limited data and should be further validated.

9.6.2 Many of the barriers to wider implementation are a consequence of the small size of the pilot. For example, many potentially clinically eligible patients could not be invited to take up choice if their local pharmacy was not included in the pilot.

9.6.3 Scaling up the pilot to cover more pharmacists and GP practices and increasing the coverage of pharmacies for each GP practice would reduce these barriers and provide increased data to explore how well HST manages patients with diabetes and CHD.

9.6.4 However, the evaluation has indicated that successful rollout on a larger scale will depend upon a number of factors being met:

■ Successful engagement with general practice – will require GPs and their staff to benefit from referring patients to pharmacists.

■ A more proactive approach to recruiting patients – particularly, supporting pharmacists’ roles in offering choice through use of publicity material and posters to explain benefits, follow-up phone calls to non-responders.

■ Review and amendment of the inclusion criteria – The overall number of patients on either the diabetes or CHD register for the pilot practices was 2,197 of which 1,340 (61%) met the clinical inclusion criteria. It was anticipated that up to 80% of patients (in the Kaiser Permanente triangle) would be eligible. The discrepancy and wide variation in percentages of patients offered choice may reflect local interpretation of the criteria and additional GP practice jurisdiction.

■ Review and amendment of diagnostic cut-offs deployed in the traffic light clinic alert system. Current cut-offs were based on national recommendations rather than GP QOF targets. .The evaluation shows that there are inconsistencies in both the way in which the patient review status is acted upon and also between the inclusion criteria and patient status algorithm (e.g. BMI appears to be causing a red review status in a large number of patients despite them recently meeting the inclusion criteria).

■ Dedicated resources for project management – The pilot relied mainly on the dedication and enthusiasm of the High Street Testing Steering Committee members and associated staff. Further rollout will require dedicated resources deployed with performance management expectations defined in contractual frameworks.

■ Establishment of competence to practice frameworks. – Although pharmacists in the pilot attended a two day training programme in clinical consultations and POCT and were expected to carry out background training/education/CPD, there is currently no nationally endorsed competency framework. The pilot relied on the

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support of professional organisations and secondary care clinical and scientific expertise to develop locally endorsed programmes.

■ Robust IT infrastructure – The pilot experienced initial problems with IT infrastructure (linking the pharmacy system with GP systems) which deterred some general practices from participating and fostered negativity towards the pilot

■ Consideration of a wider role for pharmacists – The pilot did not include all the tests a diabetic or CHD patient might need to have during the course of their care. In particular, phlebotomy was not provided. As a result they may have to visit both the pharmacist and general practice. Widening the role of pharmacists could increase benefit to patients and further reduce the cost of visits to the general practice.

■ Changes in roles and responsibilities at the pharmacy – The pilot approach was for pharmacists to conduct the POCT and consultation with a patient. However, technicians could be trained to undertake POCT, leaving pharmacists to concentrate on consultations. This would provide greater flexibility and economies of staff time.

■ Tariff setting – The evaluation has indicated some estimated tariffs for different volumes of provision which need to be further explored and refined to reflect any future larger scale rollout.

9.7 Summary

9.7.1 The Greater Manchester HST pilot has demonstrated the feasibility of delivering POCT to diabetic and CHD patients. However, the pilot did not achieve the patient numbers anticipated in the Business Case. Patient take-up of choice was higher than predicted but the actual number of patients offered choice was lower. Lack of GP engagement and confidence in the service meant that many eligible patients were not offered choice.

9.7.2 HST is well liked by patients. They value the convenience of HST and regard it as comparable, or better, to being managed in their general practice. Pharmacists also view the service as a positive experience, citing increased job satisfaction as a key benefit.

9.7.3 HST underpins many areas of NHS strategy. Further rollout and evaluation on a larger scale, taking into account the lessons learnt during this pilot, will serve to demonstrate its potential to provide a mainstream service.

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Appendix A1 – Conventional Process

Labo

rato

ryP

atie

ntG

P S

urge

ry

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Appendix A2 – HST Process

High Street Testing Process

GP

Sur

gery

Pat

ient

Pha

rmac

y

Pharmacy schedule

appointment with patient

Point of care testing and consultation

Close consultation and data transfer

to GP surgery and other data users

Surgery uses data

Surgery offers choice to eligible

patients

Surgery informs pharmacy of those wishes to take up

choice

High Street Testing pilot

Letters to patients

Patient receives letter and chooses

Accepts offer

Declines pilot

Pharmacy informed of

patient

Patient attends

Test result with surgery

Initiation of unscheduled

review

Supplement/substitute for annual review

Assimilation of QOF targets

Pharmacy reminds patient of future episodes of care

Test result & Patient

counselled

Next episode of

care booked

Paper report given to patient

Patient transferred to

GP

Patient withdrawn

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Point of care testing and consultationP

harm

acy

Patient attends

Pharmacist receives patient and checks referral information

Is the information

provided sufficent?

Does the patient satisfy referral criteria

Perform first tests

Collect additional information from

appropriate source

Transfer patient back to GP with

explanation

Yes

No No

Patient suitable for

referralYes

Patient transferred to

GP

Are results in line with

expectations

Are results in green,

amber or red category?

At or below target

Above but not critical

Counsel patient & reinforce positive

behaviour

Counsel patient & look for ways to

improveamber

red

green

Are system failure

parameters exceeded?

Test results

Above and

critical

Recalibrate and run quality control

procedures

Counsel patient on need to transfer

back to GP

Ask the patient to wait or return the

same day

Recalibrated

equipmentRe-test the patient

Patient returns

Re-test results

Test result & Patient

counselled

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Close of consultation and data transferP

harm

acy

Paper report given to patient

Concern over result

Test result with surgery

Record data and intervention. Copy

to patient

Make arrangements for transfer of care as

appropriate

Red result or new info’ causing serious concern?

Forward data to GP and other data

users

Forward data to GP and other

users

Record data and intervention. Copy

to patient.

Test result & Patient

counselled

Agree time for next episode of

care

Next episode of

care booked

Patient transferred to

GP

Transfer of care

OK results

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Close of consultation and data transferP

harm

acy

Patient attends

Next episode of

care booked

Pharmacist reminds patient of

need to attend

Does the patient

respond?

No patient

response

No response

x3

Pharmacist reminds patient

Withdraw patient from pilot. Notify

GP and other data users.

Patient withdrawn

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Appendix A3 – Quality outcome framework targets All QOF indicators

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Appendix A4 – Consultation questions and responses Questions

Lifestyle:

■ Does the patient smoke

■ if yes, how many a day

■ if yes, have you been referred to a smoking cessation counsellor

■ if smoker and not referred, would you like help to give up

■ Does the patient drink alcohol

■ if yes, how much

■ do you know why it is important to drink only in moderation

■ How would you describe your stress levels recently

■ Lifestyle Comments

Diet

■ Have you cut down on sugar and sugary foods

■ Do you eat low sugar and sugar-free drinks and foods

■ Do you eat regular meals based on starchy foods such as bread, pasta, potatoes, rice

■ How many portions of fruit and vegetables do you eat each day

■ Are you eating more fruit and vegetables

■ On average how many times a week do you eat fried foods

■ On average how many portions of red meat do you eat

■ Have you cut down on the fat you eat, particularly saturated fats

■ Do you sprinkle your food with salt

■ Do you use less salt

■ Do you know why it is important to control your weight

■ Diet Comments

Activity

■ On average how many times a week do you exercise or do other physical activity for 30 minutes or more

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■ Do you do relevant physical activity

■ Do you know why we encourage physical activity

■ Do you know what effect physical activity has on your condition

■ Activity Comments

Medication

■ Is the patient still taking the prescribed medication

■ Is the patient taking the prescribed medicines as they should be more than 80% of the time

■ Is the patient finding the form of the medication acceptable and easy to use

■ If no, do they need any help in taking their medication (see 'Comments' below)

■ Is the patient taking the medication at the appropriate time

■ If no, are there any changes that would make the medication more effective or easier to take (see 'Comments' below)

■ Medication Comments

Number of responses to questions recorded

Question Total % of

episodes

Have you cut down on sugar and sugary foods 115 97%

On average how many times a week do you eat fried foods 114 96%

How many portions of fruit and vegetables do you eat each day 114 96%

Do you use less salt 114 96%

Do you sprinkle your food with salt 114 96%

Do you eat low sugar and sugar-free drinks and foods 114 96%

Do you know why it is important to control your weight 114 96%

Is the patient still taking the prescribed medication 113 95%

Do you know what effect physical activity has on your condition 113 95%

Is the patient finding the form of the medication acceptable and easy to use 113 95%

Do you know why we encourage physical activity 113 95%

Do you eat regular meals based on starchy foods such as 113 95%

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Question Total % of

episodes

bread, pasta, potatoes, rice

Do you do relevant physical activity 113 95%

Have you cut down on the fat you eat, particularly saturated fats 113 95%

Does the patient smoke 113 95%

On average how many times a week do you exercise or do other physical activity for 30 minutes or more 112 94%

Is the patient taking the medication at the appropriate time 112 94%

Is the patient taking the prescribed medicines as they should be more than 80% of the time 111 93%

On average how many portions of red meat do you eat 110 92%

Does the patient drink alcohol 110 92%

Are you eating more fruit and vegetables 109 92%

How would you describe your stress levels recently 101 85%

do you know why it is important to drink only in moderation 81 68%

if yes, how much 62 52%

if yes, have you been referred to a smoking cessation counsellor 50 42%

if smoker and not referred, would you like help to give up 44 37%

Activity Comments 42 35%

Lifestyle Comments 34 29%

Diet Comments 34 29%

Medication Comments 32 27%

if yes, how many a day 18 15%

Grand Total 2,865

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Responses to questions

Question Yes No Note made Other responses

Does the patient smoke 21 92

if yes, how many a day

7 – less than 10

8 – 10 to 20

3 – 20 to 40

if yes, have you been referred to a smoking cessation counsellor 7 43

if smoker and not referred, would you like help to give up 7 37

Does the patient drink alcohol 58 52

if yes, how much

33 – less than 10 units

24 – 10 to 21 units

5 – over 21 units

do you know why it is important to drink only in moderation 67 14

How would you describe your stress levels recently

21 – high

47 – medium

33 – low

Lifestyle Comments 34 Free text field

Have you cut down on sugar and sugary foods 94 21

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Question Yes No Note made Other responses

Do you eat low sugar and sugar-free drinks and foods 89 25

Do you eat regular meals based on starchy foods such as bread, pasta, potatoes, rice 100 13

How many portions of fruit and vegetables do you eat each day 2

39 – 1 to 2

54 – 3 or 4

19 – 5 or more

Are you eating more fruit and vegetables 72 37

On average how many times a week do you eat fried foods 49

56 – 1 to 2

8 – 3 or 4

1 – 5 or more

On average how many portions of red meat do you eat 25

57 – 1 or 2

26 – 3 or 4

2 – 5 or more

Have you cut down on the fat you eat, particularly saturated fats 99 14

Do you sprinkle your food with salt 46 68

Do you use less salt 89 25

Do you know why it is important to control your weight 108 6

Diet Comments 34 Free text field

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Question Yes No Note made Other responses

On average how many times a week do you exercise or do other physical activity for 30 minutes or more 29

28 – 1 or 2

30 – 3 or 4

25 – 5 or more

Do you do relevant physical activity 73 40

Do you know why we encourage physical activity 109 4

Do you know what effect physical activity has on your condition 109 4

Activity Comments 42

Is the patient still taking the prescribed medication 110 2

Is the patient taking the prescribed medicines as they should be more than 80% of the time 105 5

Is the patient finding the form of the medication acceptable and easy to use 109 3

Is the patient taking the medication at the appropriate time 105 6

Medication Comments 32

Grand Total 1,577 511 247

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Appendix A5 – Tests conducted Number of tests conducted

Test type Total Percentage of episodes

Diastolic blood pressure 116 97%

Systolic blood pressure 115 97%

Height 113 95%

Weight 112 94%

BMI 112 94%

Total Cholesterol 111 93%

HDL Cholesterol 110 92%

Cholesterol Ratio 110 92%

Triglycerides Cholesterol 109 92%

LDL Cholesterol 103 87%

HbA1c 84 71%

Grand Total 1,195

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Appendix A6 – Clinical data

Clinical data

Introduction

1. This appendix section shows the test results for these patient for

■ HbA1c

■ Total cholesterol

■ HDL cholesterol

■ LDL cholesterol

■ Systolic blood pressure

■ Diastolic blood pressure

2. The following charts show the different test results recorded for these patients indexed, which can be used as a framework to consider patient management.

3. The charts show the subsequent test results compared to the original test result. The original test result has an index value of 100 and the other test results are expressed as a percentage of this i.e. a second result of 120 is 20% higher than the first result.

4. The tests overall show an improvement on the original test result for 55% of the subsequent results. An equal result is obtained 4% of the time and 41% of results were higher than the original result.

5. Some results showed more variation than others, there was the most variation in HDL and LDL cholesterol.

6. This section provides a graphical and statistical summary of the clinical comparisons available at the time of evaluation. It does not make a clinical evaluation of the management of the patients due to the small number of patients.

HbA1c

7. The following chart shows the results for HbA1c for those patients who had two or more tests recording during the pilot.

8. The index values range from 68.8 to 106.8. The results do not increase significantly on subsequent visits with a maximum increase is 6.8%. Two thirds, 12 out of 18, of the subsequent tests were an equivalent result or showed an improvement on the first test result.

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6065707580859095

100105110

1 2 3

Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14

Total cholesterol

9. The following chart shows the results for total cholesterol for those patients who had two or more tests recording during the pilot.

10. The index values range from 50.4 to 120.8. The results increase at most 20.8% on the first test result. Over two thirds, 23 out of 34, of the subsequent tests showed an improvement on the first test result.

40

50

60

70

80

90

100

110

120

130

1 2 3 4 5Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)

patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14patient 15patient 16patient 17patient 18patient 19

HDL cholesterol

11. The following chart shows the results for HDL cholesterol for those patients who had two or more tests recording during the pilot.

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12. There is variation with index values ranging from 39 and 180. Over two thirds of the subsequent tests, 23 out of 34, showed an improvement on or equalled the first result. However there are three results that have increased by more than 50%.

20406080

100120140160180200

1 2 3 4 5Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14patient 15patient 16patient 17patient 18patient 19

LDL cholesterol

13. The following chart shows the results for LDL cholesterol for those patients who had two or more tests recording during the pilot.

14. There is large variation with index values between 30 and 250. There are five results that have increased by more than 50%, two of which have more than doubled. Slightly under half, 14 out of 29, of the subsequent tests showed an improvement on or equalled the first result.

0

50

100

150

200

250

300

1 2 3 4Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)

patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14patient 15patient 16patient 17

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Systolic blood pressure

15. The following chart shows the results for Systolic blood pressure for those patients who had two or more tests recording during the pilot.

16. The index values range from 81.3 to 121.7. The results increase at most 21.7% on the first test result. Over half, 21 out of 37, of the subsequent tests showed an improvement on or equalled the first result

70

80

90

100

110

120

130

Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)

patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14patient 15patient 16patient 17patient 18patient 19patient 20patient 21patient 22

Diastolic blood pressure

17. The following chart shows the results for diastolic blood pressure for those patients who had two or more tests recording during the pilot.

18. The index values range from 77.5 to 135.5. The results increase at most 35.5% on the first test result. Slightly under half, 18 out of 37, of the subsequent tests showed an improvement on or equalled the first result.

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70

80

90

100

110

120

130

140

1 2 3 4 5Test result number

Inde

x va

lue

(Firs

t tes

t=10

0)patient 1patient 2patient 3patient 4patient 5patient 6patient 7patient 8patient 9patient 10patient 11patient 12patient 13patient 14patient 15patient 16patient 17patient 18patient 19patient 20patient 21patient 22

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Appendix B1 – Performance Monitor Report

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Appendix B1: PHARMACISTS’ PERFORMANCE MONITORING:

OUTCOMES REPORT

1 INTRODUCTION

Key Objectives for Performance Management

The pilot’s performance monitor (NFBurrows Consulting Ltd) visited participating pharmacies on a monthly basis and reported compliance with agreed Standard Operating Procedures to the POCT Steering Committee. 2 FINDINGS

2.1 AUDIT OF READINESS

In November 2006, before patient testing commenced, an audit of all pharmacists expected to participate in Salford, Oldham and Stockport PCTs was undertaken. The results are shown in table 1 below.

November 2006

PARAMETER MONITORED YES NO

Does the facility comply with schedule 2? 12 2

Is the DCA on site? 13 1

Is the DCA operational? 7 7

Is the Cholestech on site? 13 1

Is the Cholestech operational? 8 6

Is the fridge on site? 13 1

Is the fridge operational? 11 3

Is the BP monitor on site? 14 0

Is the BP monitor operational? 11 3

Does the BP monitor require calibrating? 8 6

Is the PC on site? 11 3

Is the PC operational? 6 8

Are DCA reagents in date? 8 6

Are Cholestech reagents in date? 5 9

Is Cholestech optics check in date? 3 11

Monitoring process explained - 14 0

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Patient referral sheet explained - 14 0

Is there an appointment system in operation? 13 1

Are posters on display? 1 13

Is QC logged? 5 9

Questionnaire forms left 8 6

Table 1 Audit of pharmacy readiness November 2006

Of the 2 pharmacies which did not comply with schedule 2, 1 was being refurbished and the other (Rowlands, Littleton Road, Salford) was relocating.

2.2 EXTERNAL QUALITY ASSESSMENT PERFORMANCE

The first external quality assurance samples were distributed by United Kingdom National External Quality Assessment (UKNEQAS) scheme for HbA1C and lipids on Monday 29th January 2007 to 7 pharmacies. 4 sites returned test results in the time scale allowed. By October 2007, 8 pharmacies were returning results to UKNEQAS with 80% return rate within expected timescales. Possible reasons for 100% return rate not being achieved include:-

1) Patient visits not co-inciding with receipt of UKNEQAS samples 2) The additional time required to analyse samples. On offering remuneration for

carrying out UKNEQAS samples analysis, return rate targets improved from 65% to 85%

3) Failure to recognise arrival of UKNEQAS samples.

The relatively low return rate (compared to central labs near 100% rate) perhaps reflects challenges in managing new ways of working, particularly not appreciating the penalties imposed by EQA scheme organisers for failure to meet deadlines.

An example return for HbA1C and lipids (July 2007) shown below in appendix x.1 provides a representative overview of pharmacists performance in external quality assessment schemes.

HbA1C results

Using the Bayer DCA 2000 analyser, pharmacists’ performance can be shown to rival that of central laboratories. This may in part reflect the recognised robustness of the DCA 2000, an easy to use, widely deployed point of care testing analyser. The accuracy (lack of bias) of its reported results reflects its alignment to the Diabetes Control and Complications Trial (DCCT) standards. The reproducibility reflects the performance achieved by the pharmacists

Lipid results

Parameters include total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol and calculated Low Density Lipoprotein (LDL) cholesterol by the Friedewald formula:

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Cholesterol

Generally, satisfactory accuracy (lack of bias against all laboratory trimmed mean) and reproducibility was achieved. The July O7 return provided here indicates a negative bias for all 3 samples, potentially an analyser calibration issue to which the analyser’s UK distributor (Point of Care Services) has been alerted

Triglycerides

Although not a reportable parameter during the pilot, triglycerides is one of a panel of investigations carried out on the LDX-Cholestech analyser and is included in UKNEQAS’s lipid EQA scheme. Although pharmacists showed excellent reproducibility as a group amongst themselves, the Cholestech analyser returned frequently significantly lower results than that reported by central laboratories. The negative bias occurs to varying degrees depending on sample characteristics and has been reported to the analyser’s UK distributor as an instrument rather than operator performance issue. Possible causes include calibration, samples matrix issues

HDL-cholesterol

Excellent reproducibility was achieved amongst the pharmacists. This parameter also demonstrated closest concordance to the all laboratory trimmed mean

LDL- cholesterol

A calculated parameter from the following inputs:

LDL-C = Total chol – HDL-chol – (triglycerides/2.19)

A conglomerate of all parameters above for which accumulated errors of individual measures contribute to the calculation. Despite the strong negative bias of triglycerides, LDL-cholesterol showed satisfactory performance when compared to that achieved by central laboratories perhaps reflecting the proportionally low influence of triglycerides on a calculated LDL-cholesterol value

2.4 MONITORING VISITS

64 monitoring visits have taken place, 9 of these with patients present. A summary outcome of pharmacists’ performance against the pre-defined compliance/adherence measures was as follows:-

Standard operating procedures (100% compliance)

Clinical protocols (89% - on one occasion HbA1C was measured on a non-diabetic patient)

Health and safety expectations (100% - based on cleanliness, hand washing, wearing Personal Protective Equipment, correct waste disposal)

Maintaining their POCT skills (100% - based on QC records, adherence to sample taking techniques, stepwise approach to analyses )

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Consultation skills (100% - based on observation during clinical consultations and records of discussion of lifestyle, diet, exercise)

Stock control/record keeping (91% - relatively poor performance due to unpredictable flow of patients and pharmacists’ desire for economy).

3 DISCUSSION

The pharmacies taking part in the pilot study have shown through external quality assessment that they are capable of performing HbA1c and Lipid analyses to acceptable standards. Typically, this matched that of central laboratories - variability within the group for, respectively, HbA1C and cholesterol was 2.9% and 3.9%, compared to all laboratory reproducibility of 3.1% and 3.4% (reproducibility that is low enough to meet clinical need in all instances). Poor performance, particularly that of triglycerides, more likely reflects unreliable technology than the operator. Issues of non-comparability of results from different analysers may stifle opportunities for further roll-out of POCT technology in primary care given that clinical expectations, standards and guidelines relating to diagnostic testing are based on longer established technologies at secondary care.

Compliance with/adherence to the performance measures developed by the High Street Testing Committee has been at high levels when observed by the external monitoring team. Results have been recorded in accordance with agreed protocols and consultations have covered the areas agreed. The IT system provided has been used satisfactorily by the pharmacists and when the system has been down a paper back-up has been used and results transferred at a later date.

The equipment selected for the pilot has proven to be robust and reagent and control ordering and delivery systems have proven to be generally satisfactory. A typical set of EQA results is shown below:-

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Appendix C – Patient Questionnaire BACKGROUND INFORMATION

Why have you been given this questionnaire?

Greater Manchester Strategic Health Authority (SHA) is piloting High Street Testing for patients with diabetes and/or cardiovascular disease. The pilot gives patients the choice of attending a high street pharmacy for clinical consultation and diagnostic blood tests, instead of going to hospital.

Greater Manchester SHA has commissioned Tribal’s research and evaluation team to undertake an evaluation of the High Street Testing pilot which will inform the decision as to whether to make the service main stream.

You have been given this questionnaire because you have agreed to participate in this pilot. You are under no obligation to complete the questionnaire but your input would be very helpful.

What is the purpose of the questionnaire?

This questionnaire asks your views about your experience of using the high street testing service. You will be given the same questionnaire after each appointment at the high street pharmacy.

What will we do with the information you give us?

The information you give us in this questionnaire cannot be traced back to you because we don’t ask for your name or address. It will be kept completely safe and confidential. The researchers involved in the study will be the only people to see the questionnaires. They will produce a report of the findings for Greater Manchester SHA. No one will know that you completed a questionnaire or what you wrote in it.

Directions for completing the questionnaire

Your input to this project is very important but if you do not feel comfortable about completing the questionnaire now that you have received it then you are under no obligation to do so.

If you are happy to contribute then please take the 5-10 minutes to complete this questionnaire and return it in the stamp addressed envelope provided. If you are happy to complete a questionnaire after each appointment at the high street pharmacy then we will be able to assess whether the service is improving, deteriorating or staying the same throughout the lifetime of the pilot.

1 About this visit

Q1 Were you seen by the pharmacist at the time allocated for your consultation?

Yes

No, I had to wait

If you had to wait, then please state how long ________________

Q2 Were you satisfied with the surroundings in which your consultation with the pharmacist took place?

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Yes

No

If No then please state why

Q3 Did you find the advice given by the pharmacist useful?

Very Useful

Moderately Useful

Quite Useful

Not Useful

Q4 Did you have confidence in the advice given by the pharmacist?

Yes

No

If No then please state why

Q5 Would you have rather seen a doctor and/or nurse for your consultation?

Yes

No

If Yes then please state why

Q6 How satisfied were you overall with the visit?

Very Satisfied

Moderately Satisfied

Quite Satisfied

Not Satisfied

Q7 Did finger prick blood testing give you any concerns?

Yes

No

If Yes then please state why

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2 Planning the next visit

Q8 Have you arranged your next appointment date and time with the pharmacy?

Yes

No

If yes then were you offered a convenient time and date?

Yes

No

Q9 Please state the time and date of your next appointment.

Date _____________________

Time _____________________

3 Overall Assessment of the Service

Q10 How satisfied are you overall with the High Street Testing service?

Very Satisfied

Moderately Satisfied

Quite Satisfied

Not Satisfied

Q11 How well does the High Street Testing service compare to having your condition managed in your GP practice?

Better

The same

Slightly worse

Much worse

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Q12 Would you wish to continue using the high street pharmacy to manage your condition?

Yes

No

If No, then please explain why

Q13 Does the service encourage you to take greater charge of managing your condition?

Yes

No

If No, then please explain why

Q14 How confident do you feel about managing your condition yourself?

Very confident

Quite confident

Not confident at all

Thank you for your time in completing this questionnaire. Your feedback is extremely helpful as it will assist Greater Manchester Strategic Health Authority in deciding whether this service should be

continued.

SECTION FOR PHARMACY USE ONLY

Pharmacy Name _____________________________________________

Date of Appointment _____________________________________________

NHS Number _____________________________________________

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Appendix D – Staff Questionnaire

Greater Manchester Strategic Health Authority has commissioned Tribal Group to undertake an independent evaluation of the Point of Care Testing Pilot. This questionnaire has been designed to help us undertake this evaluation and gain an understanding of the experiences of those involved.

We are aware of how busy you are and would be extremely grateful if you could find the time to complete this questionnaire. It should take no longer than 10 minutes to complete. Please follow the instructions carefully as the response options are varied.

If you have any questions or queries about this questionnaire, require the questionnaire in large print or would like a hard copy then please contact Emma Gibbard on 078973382853 or at [email protected].

Please return the questionnaire by 23rd November 2007 to Dr E Gibbard, Tribal Consulting, 87-91 Newman Street, London W1T 3EY or to the e-mail address above.

All the information you provide will be anonymous and will be kept completely confidential. The researchers involved in the study will be the only people to see the completed questionnaires and they will produce a report of the findings for Greater Manchester SHA.

Thank you very much for your time and we look forward to receiving your response.

Best Wishes,

Emma Gibbard

Participation

1. Which PCT* does your organisation (practice / pharmacy) belong to? please tick

Ashton, Leigh and Wigan PCT Oldham PCT

Salford PCT Stockport PCT

Other, please specify ….

2. What is your job title? please tick

General Practitioner Practice Manager

Pharmacist PCT member

Other, please specify……

3. Are you or your practice / pharmacy participating in the pilot? please tick

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Yes No N/A

4a. IF YES, what were your motivations for taking part? please tick up to three

Provide new ways of working Provides new services

Improve patient outcomes Clinical effectiveness

Serving the Community Utilise Pharmacists Skills

Lessen workload for the Hospital Lessen workload for the GP

Improve patient experience (i.e. access, choice, None

flexibility, convenience, waiting time) N/A

Other, please specify……..

4b. IF NO, what were the main reasons you chose to opt out? please tick up to three

Lack of GP sign up Lack of Pharmacy sign up

Financial pressures Workload

Tests available None

N/A Other, please specify ……

5a. What, if any, reservations, fears, concerns did you have about participating in the pilot? please tick / provide up to three

IT Integration Staff competency

Range of tests available Quality/reliability/confidence in results

GP participation in pilot Pharmacy participation in pilot

None Operational impact (inc manpower,

workload, training etc)

Others, please specify……………

5b.Do you still hold these reservations? Please explain

6. Was everyone in the organisation equally happy with the decision to participate (or not)? Please tick

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Yes No N/A

7a. Has your practice / pharmacy gone live? Please tick

Yes No N/A

7b. If so, when? Please provide the date…..

8a. If applicable, how many patients have been enrolled and been seen by the pharmacy?

Enrolled - Number: Period (months): Not Known

Seen - Number: Period (months): Not Known

8b. Are these estimates or an actual figures?

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Experience

Please rate the following statements using the scale below, where

1 2 3 4 5

Strongly Disagree

Disagree Agree nor Disagree

Agree Strongly Agree

9. My overall experience of the pilot was excellent.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

10. The support provided to us by the strategic health authority was adequate.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

11. The training provided to the pharmacists was adequate.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

12a. The communication between GPs and Pharmacists is excellent.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

12b.The IT systems in place are adequate.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

13. The protocols developed for the pharmacists were comprehensive and provided adequate information.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

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14a. Patients were very interested in the pilot.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

14a. Patients were willing to sign-up to the pilot.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

15. High street pharmacies provide a suitable setting to deliver care for long term conditions.

1 2 3 4 5 please tick

Please provide a brief explanation for this score

16. What were the key benefits that you have experienced with the pilot? please tick / provide up to three

Flexibility

Convenience

Improve relationships

Integrated working

Health promotion, education and self care

Promote PoCT** / near patient testing

None

Other, please specify

17. What were the key problems/challenges (barriers) experienced with the pilot? please tick / provide up to three

IT

Pilot Processes

GP involvement

Pharmacy involvement

GP numbers and or Pharmacy numbers

Maintaining Pharmacist skills

Other, please specify

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Overall

18. Do you feel that high street pharmacies provide a suitable setting to deliver care for long term condition? Please tick

Yes No Do not know

19. What three improvements (lessons to be learnt) could be made to the scheme?

20. What opportunities are there for the future?

21. Do you think you will want to continue with the scheme after the pilot?

Yes No N/A

Please explain

22. Do you have any additional comments that would help in the evaluation of this pilot?

23. Would you be prepared to take part in a 40 minute telephone interview about the point of care testing pilot? Please tick

Yes No

If prepared to take part in an interview could you provide me with your contact details, thank you.

Name:

Role and Title:

Organisation: (Name, Address)

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Appendix E – Staff Interview Schema

HIGH STREET TESTING: Interim Interview with Pilot Sites Overview

■ Purpose: To capture interim progress and experiences from those who are involved in the pilot (sites that went live early and late starters) as well as some of those who chose not to participate in the pilot after initial discussions with the SHA.

■ Sample: To be used for a small cohort of pre-selected staff (approx. 12 - 15) from PCTS and pharmacies.

■ Mode: Telephone.

About the Respondent

• Name

• Role, title

• Organisation

• Configuration - PCTS and Pharmacy footprint.

o PCT – o GP(s) – o Pharmacy(s) –

Decision to Participate

• Are you/your organisation participating in the pilot? Yes No

o If so, How did you originally hear about the pilot?

When did you agree to participate?

What were your motivations for taking part? I.e. what benefits did you expect? (List up to three)

o Or, why did you choose to opt out?

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• What, if any, reservations, fears, concerns did you have about participating in the pilot? Do you still hold these?

• Was everyone in the organisation equally happy with the decision to participate (or not)? Yes No

o Who was most enthusiastic and why? o Who was the least enthusiastic and why?

Current Status

• Have you gone live yet? Yes No

o If so, when?

o How long did it take to set up the pilot scheme and go live?

• How many patients have been enrolled?

No: Period:

• How many patients have been seen by a pharmacist and/or have appointments booked?

No: Period:

Experiences to Date

• What are your initial experiences, good or bad, with the pilot? Please explain • How adequate do you feel the support provided by the SHA has been? Please explain • How adequate do you feel the training provided to the pharmacists has been? Please explain • What is the communication like between the GPs and Pharmacists? Please explain • How did you find the protocols? Please explain • What are the patient’s interest and willingness to sign-up to the pilot? What are the patient’s

experiences i.e. have you had any complaints or compliments from patients? • Can you provide three key benefits that you have experienced with the pilot? • Can you provide three key problems/challenges (barriers) experienced with the pilot?

Overall

• Do you feel that high street pharmacies provide a suitable setting to deliver care for long term condition?

Yes No

• Or High street pharmacies provide a suitable setting to deliver care for long term conditions. 1. Strongly disagree 2. Disagree 3. Neither agree or disagree 4. Agree 5. Strongly Agree

o If so, why? If not, why not?

• What three improvements (lessons to be learnt) could be made to the scheme?

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• What opportunities are there for the future? • Do you think you will want to continue with the scheme after the pilot? • In retrospect are you glad you agreed to participate? Why or why not? • Do you have any additional comments that would help in the evaluation of this pilot?

Point of Care Testing: Pilot Site Questionnaire.

Interview Supplement

Experience

Please rate the following statements using the scale below, where

1 2 3 4 5

Strongly Disagree

Disagree Agree nor Disagree

Agree Strongly Agree

9. My overall experience of the pilot was excellent.

1 2 3 4 5 please tick

10. The support provided to us by the strategic health authority was adequate.

1 2 3 4 5 please tick

11. The training provided to the pharmacists was adequate.

1 2 3 4 5 please tick

12a. The communication between GPs and Pharmacists is excellent.

1 2 3 4 5 please tick

12b.The IT systems in place are adequate.

1 2 3 4 5 please tick

13. The protocols developed for the pharmacists were comprehensive and provided adequate information.

1 2 3 4 5 please tick

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14a. Patients were very interested in the pilot.

1 2 3 4 5 please tick

14a. Patients were willing to sign-up to the pilot.

1 2 3 4 5 please tick

15. High street pharmacies provide a suitable setting to deliver care for long term conditions.

1 2 3 4 5 please tick

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Appendix F – List of participating staff

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Contact PCT Hard copy / e-mail

GPs

Dr A.F. Wild Stockport PCT Hard

Dr N. Hussain Stockport PCT Hard

Dr Malcomson Salford PCT Hard

Dr Joshi Salford PCT Hard

Dr A. Rahman Salford PCT Hard

Dr Jeet Salford PCT Hard

Dr SAXENA A, L and W PCT Hard

Dr TREWINNARD Oldham PCT Hard

Dr Sidhu Oldham PCT Hard

Dr BAYMAN A, L and W PCT Hard

Dr David Valentine Oldham PCT Hard

Practice Managers

Liz Clarke Stockport PCT Hard (resent via e-mail)

Mrs Dawn Weatherhead Stockport PCT Hard

Ina Pownall Salford PCT Hard

Clare Richardson Salford PCT Hard

Mrs Rahman Salford PCT Hard

Debbie Regan Salford PCT Hard

Jo Culshaw A, L and W PCT Hard

April Hall Oldham PCT Hard

Liz Miller Oldham PCT Hard

Vivien Dawber A, L and W PCT Hard

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Pharmacies

Olivier Marginez at Alliance Pharmacy

Salford PCT Hard

Roselyn, Rowland Pharmacy Salford PCT Hard

Caroline Tinkler Alliance A, L and Wigan Hard

Darren Eccles Focus Pharmacy A, L and Wigan Hard

Mike Spencer, Cohens, Reddish Stockport PCT E-mail

Julian Hickman, Lloyds Pharmacy

Stockport and Salford PCTs E-mail

Vivien Farrell Stockport PCT Hard

Bhimji Patel Oldham PCT Hard

Amanda Laing Oldham PCT Hard

Alliance Pharmacy Oldham PCT Hard

Nilesh Sanghri Oldham PCT E-mail

PCT

Gilbert Wieringa SHA E-mail

Monica Ropper Salford PCT E-mail

Jane Roberts Stockport PCT E-mail

Lynne McDonagh Stockport PCT E-mail

Umesh Patel A, L and W PCT E-mail

Robert Hallworth A, L and W PCT E-mail

Zuber Ahmed Oldham PCT E-mail

Steve Wood Salford PCT

Other

Catherine Hodkinson Hard

Katherine Brownbill E-mail

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Appendix G – Financial model See separate file financial model.xls