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Innovations in major system reconfiguration in England: a study of the effectiveness, acceptability and processes of implementation of two models of stroke care

1. Aims/Objectives:

The proposed research aims to use formative evaluation methods to support and analyse reconfiguration of stroke services in two regions of England and, in doing so, identify lessons that will guide future reconfiguration work in other services.

To identify the barriers and facilitators for major system reconfiguration, implementation and sustainability.

To study whether the reconfigurations have delivered clinical and cost effective improvements that patients and public think are worthwhile.

To identify lessons about major service reconfiguration that might be applied in other settings (i.e. other locations and other service domains).

To achieve our research objectives, we will address the following questions:

1. What were the key processes of and factors influencing the development and implementation of the two stroke service reconfigurations?

2. To what extent have system changes delivered process and outcome improvements?

3. Have changes delivered improvements that stakeholders (e.g. commissioners, staff, patients and the public, and reconfiguration leads) think are worthwhile?

4. Have changes delivered value for money? 5. Has the additional investment in London provided better outcomes than that

achieved for less resource in Manchester?

2. Background:

A major review of the literature on the diffusion of innovations in service organisations drew attention to the lack of research on the processes by which innovations in healthcare organisations are implemented and sustained (or not) and in what particular contexts (1). This project aims to contribute to the development of this evidence base by studying in depth the implementation of major service innovation, using the example of stroke services. Research, including that funded by the NIHR SDO programme, has highlighted challenges in implementing acute service reconfiguration (2), as has previous research on mergers of healthcare providers (3), particularly where there is resistance from professionals and the public (4). Other research has highlighted challenges of major system delivery change at local level (5). This project will build on this work by studying the implementation of system reconfigurations across a whole patient pathway in two major cities in England focused on the same clinical condition but in different contexts and using different models.

Organisation of clinical care within the NHS is undergoing significant restructuring, with concentration of specialist services in fewer centres. Stroke has led the way over the last two years. Major trauma, cardiology, specialist paediatrics and others are


likely to go through a similar process. The case for change for stroke is strong, with clear evidence of unacceptable variations in the quality of care, and many patients denied access to evidence based care (6). Major system change for stroke was prompted by the publication of the Department of Health National Stroke Strategy (7) and London and Manchester have led the way in the process.

The London reconfiguration was conducted at the request of the London SHA. An additional £20m per annum were provided by PCTs to be paid through an enhanced tariff providing that the quality standards set by a multidisciplinary steering group were met. The model was developed with the support of a Joint Committee of PCTs representing all Commissioners in London. The Greater Manchester (GM) and Cheshire Cardiac and Stroke Network (GMCCSN) was charged by the Greater Manchester Association of PCTs to reconfigure services to allow universal access to hyperacute stroke treatment in the area.

In London, Trusts participated in a bidding process to host Hyperacute Stroke Units, Stroke Units and Transient Ischaemic Attack (TIA) services. Following this process, of the stroke services provided by 32 London hospitals pre-reconfiguration, 8 services were designated as Hyperacute Stroke Units, 20 as Stroke Units, while 4 services were withdrawn. 400 additional nurses and 87 additional therapists were recruited to the reconfigured services. In Manchester, the network proposed a single Comprehensive Stroke Centre to provide 24/7 access to hyperacute stroke services in a neurosciences centre with access to interventional neuro-radiology and neurosurgery, two Primary Stroke Centres to provide within hours IV thrombolysis, and District Stroke Centres to provide stroke rehabilitation nearer to home. All acute Trusts were invited to bid for stroke centre status. Following this process, Salford Royal Hospital was awarded Comprehensive Stroke Centre status, while Fairfield and Stockport became Primary Stroke Centres. £3.5m per year was allocated to the providers including the NW ambulance service.

London’s reconfigured model was implemented in February 2010 and provides all stroke patients with hyperacute care for an average of 3 days, through 8 Hyperacute Stroke Units, which operate 24/7. Since reconfiguration, significant process changes have been recorded: over 90% of patients now go directly to a Hyperacute Stroke Unit; stroke thrombolysis rates have risen from approximately 3% to 14%; average length of hospital stay has fallen. The mean ambulance transit time from home to a Hyperacute Stroke Unit is 14 minutes. In Manchester, the reconfiguration was achieved in a stepwise fashion, commencing in December 2008 and completed in April 2010. The proposed pathway was initially for all patients presenting within 24 hours to be taken to their nearest Comprehensive Stroke Centre or Primary Stroke Centre. This was subsequently adjusted, following concerns from District Stroke Centres that they would lose services. As a result, only patients presenting within 4 hours are referred directly to a Primary Stroke Centre or Comprehensive Stroke Centre.

Since reconfiguration in Manchester, improvements in process have also been recorded: thrombolysis rates have increased from 1% to over 10% of all stroke patients entering the hyperacute pathway; and ambulance transfer times and time to CT scan have reduced; access to TIA clinic slots within 24 hours has improved, as has time to carotid imaging and carotid intervention. Early supported discharge services are now in place in a number of sites across the city with network wide policies and documentation. The rehabilitation pathway is piloting common standards


and assessments to improve access to therapy and reduce length of stay; the life after stroke pathway is working with the GM stroke Collaboration for Leadership in Applied Health Research and Care (CLARHC) to develop and implement a 6 month post stroke assessment.

There has been local resistance to the London reconfiguration, for example to service closure, or to being designated a Stroke Unit rather than a Hyperacute Stroke Unit; there was also concern from central government over a perceived ‘top down’ approach to implementing change. Although not yet formally evaluated, there appear to have been no major concerns from patients or their families about the reconfigured model. In Manchester, there was initial resistance from some service providers and commissioners about a perceived centralisation of services, but the network reports high levels of satisfaction with the redesigned pathway. Early reports from service users of the pathway are generally very favourable with high levels of satisfaction with care in the Comprehensive Stroke Centre and Primary Stroke Centres. However, it is not known what effect the change from within 24 hours of onset to within 4 hours of onset has made to the service model costs or to patient outcome.

While there have been significant reconfigurations of acute services over recent years, there have been few similar examples within the NHS of services being completely restructured across a whole pathway for such large populations (8.28 million in Greater London and 2.24 million in Greater Manchester (8)) over such a short period of time; and nowhere else in the world has attempted anything similar for stroke.

The lessons learned, such as how to develop innovative structures and processes from these two projects should be directly applicable to other situations where major reconfiguration is being planned, such as cardiac and vascular surgery and major trauma. This work also provides an opportunity to investigate health economic arguments about investing to save for stroke (9). The coalition Government has stated its commitment to continuing improvement in the quality of stroke care and the proposed changes to the organisation of the NHS, including abolition of the SHAs and PCTs, are unlikely to significantly affect service redesign of stroke. The lessons learned from this project will therefore continue to have relevance not only for stroke but future service reconfigurations. However, the plans presented in the Government’s White Paper (10) are likely to bring with them significant organisational upheaval: new NHS organisations will come into being; others will cease to exist; and, while many organisations may not change so dramatically, it remains to be seen how this turbulence will impact on service delivery. We will need to take this into account in this study – it represents an opportunity to learn whether and how these reconfigurations can be sustained through a period of huge structural change.

3. Need:

HEALTH NEED

In England, 120,000 people experience a stroke each year; of these people, approximately 30% die within a year; and half the remainder are left with lifelong impairments and disability. A National Audit Office (NAO) report on stroke care in England was highly critical of the quality and cost effectiveness of services, with the majority of patients not receiving the most effective treatment (11). Co-applicants on this bid (Wolfe and McGuire) estimated for the NAO that stroke costs the English


economy £7 billion per annum, much of which is spent providing long term support to people disabled by strokes that might either be prevented altogether or their effect minimised by high quality acute care and rehabilitation.

The National Stroke Strategy (7) identifies 24 markers of high quality services, to be achieved by health and social care services within 10 years. It is argued that achieving these markers may improve quality and cost-effectiveness of services.

Greater Manchester and London are in the process of radically reconfiguring their stroke services. Both sites have concentrated initially on delivery of acute stroke and Transient Ischaemic Attack (TIA) care, but have active plans to improve the quality of treatment at the transition between hospital and home and for longer term rehabilitation. The reconfigurations differ in several ways, including the development process; investment per annum (£23m in London v £3.5m in Manchester); the model of care chosen (though both broadly based around a hub and spoke system for hyperacute care); and the methods used in testing these systems. This project represents an opportunity to evaluate the ways in which implementing these reconfigurations has influenced improvements in clinical outcomes, service quality and cost effectiveness; and to identify ways in which such improvements might be transferred to support similar improvements in other parts of the UK and in other health domains.

RESEARCH NEED

In addition to its potential to address this significant health need, the proposed evaluation will address a number of gaps in the evidence base in areas that are of current and growing relevance to UK healthcare organisations. For the National Audit Office economic research, McGuire et al modelled the effects of introducing specialist hyperacute stroke units, stroke units and early supported discharge, producing results that showed them to be cost effective with costs well below the NICE threshold of £30,000 per QALY (12). This proposal provides the opportunity to develop these models in London and Manchester.

Reorganisation of healthcare provision is likely to continue at an increasing pace over the coming years, reflecting the drive to improve overall quality of care, reduce health inequalities and support efficient use of resources (13). Although the Strategic Health Authorities will cease to exist in 2012, it is likely that the London and Manchester plans will continue relatively unmodified under the supervision of the Stroke and Cardiac networks.

A review of the evidence on diffusion of innovations in service organisations identifies the need for further research on the processes by which innovations in healthcare organisations are implemented and sustained, and in what particular contexts (1). Research, some commissioned by the NIHR SDO programme, has identified significant challenges faced by attempts to change the ways in which services are organised and delivered (2-5).

The proposed evaluation represents an opportunity to spread innovative approaches to the reconfiguration of stroke care by improving our understanding of the implementation issues. It will provide lessons both to other geographical areas reconfiguring their stroke services, and also to the reconfiguration of other services. It will add to the research evidence base by examining the processes and impact of service redesign, guided by previous learning, and by applying it to a novel setting (i.e. reconfigurations of unprecedented size in the stroke domain). It will also improve


understanding of factors influencing service reconfiguration and development, including the changing financial environment and organisational context, including major changes to the way in which services are commissioned.

4. Methods:

a. Setting

The evaluation will focus on the two SHA areas where reconfiguration is being carried out, i.e. Manchester and London. Participants will be drawn from staff in related organisations (including service providers – both active and decommissioned – and commissioners) and relevant communities (including patients and local networks). While the SHAs themselves are to be abolished over the period of this research, the reconfigured services will still cover these geographical locations.

b. Design

We propose to study these major system innovations in two contrasting, but complementary ways. First, we will take a more traditional health technology assessment approach to address 'what works and at what cost?'. On its own, however, this approach pays little attention to structural pressures, e.g. professional pressures or processes whereby organisations innovate as a result of economic, regulatory or legal reasons (14, 15). This approach also assumes innovation is always progressive and poor adopters are conservative, whereas resistance may be a rational response (16).

A major review of the evidence on diffusion of innovations identifies the characteristics of innovations that are more likely to be sustainable (1):

the nature of the innovation (relative advantage, low complexity, scope for reinvention) and its fit with the organisation’s existing skill mix, work practices and strategic goals

motivation, capacity and competence of individual practitioners

elements of organisational structure (e.g. devolved decision making, internal networks) and capacity (e.g. change skills, evaluation skills)

resources and leadership

early involvement and co-operation of staff at all levels

personalised, targeted and high-quality training

evaluation and feedback

linkage with the resource system from development of the innovation through to implementation

embeddedness in inter-organisational networks

conducive external pressures e.g. synchrony with local priorities and policymaking streams.

While the study period precludes establishing the long term sustainability of the changes brought about by reconfiguration, the evaluation will assess the extent to


which the approaches taken by the reconfigurations reflect these characteristics, particularly in the light of unprecedented changes to the English NHS.

Drawing on the innovations theory, particularly that which emphasises the role of structural factors, we propose to study the implementation of these innovations in terms of Webster's (16) notion of a 'social matrix' i.e., not as a technical, rational set of issues but in terms of requiring 'co-creation' by a range of stakeholders - where such processes create a 'social matrix' that is only as strong as the network of relations that hold it together. Studying the implementation of different models of system innovation in two contexts (London and Manchester) will allow us to understand the relationship to organisational context. Given the changing nature of the healthcare landscape, we are proposing a formative evaluation, providing lessons to the two cases involved and the wider NHS over the course of the study.

c. Data collection

A multi-method approach will be employed including documentary analysis, analysis of relevant performance data and interviews.

DOCUMENTARY ANALYSIS (Research Question 1)

We will collect documentation on the reconfigurations at both sites. These documents will cover how the reconfigurations developed and the processes of implementation. They will include records of public consultations conducted by SHAs and Stroke and Cardiac networks; Gateway reviews (where available); reconfiguration proposals; and project documentation. Project update documentation will be collected over the lifespan of the evaluation. The list of documents for both sites that will be collected for this study will include:

All project plans including operating model documentation and governance arrangements

Minutes of the Stroke Board, Project Board, Emergency Response Group, Joint Implementation Group and Clinical Governance Group

All paperwork pertaining to the financial side i.e. tariff papers, minutes of meetings with Directors of Finance and Directors of Commissioning

The business case data model (operational research modelling) which contains all the activity and financial data and the documentation that describes the process for developing the model and the stakeholders involved

The Strategic Outline Case and the Economic Case

The service specification and clinical pathway

The documentation relating to the request for expressions of interest, provider business cases and options appraisal

The documentation relating to the criteria for selection of hyper acute sites

The communication plan and stakeholder engagement documentation (including presentations and progress reports)

Patient information leaflets and awareness raising campaign details (including an evaluation of the local campaign)


Documentation relating to the operational aspects i.e. the Standard Operating Procedures and repatriation policies (including minutes of meetings where these were agreed)

Workforce development – Terms of Reference of the group; and workforce plans including training and education programmes

PERFORMANCE DATA (Research Questions 2, 3, 4 & 5)

We will access available baseline data on quality of care pre-reconfiguration, including in-hospital and three month mortality; length of stay in different bed types (hyper acute, stroke unit and other); vital signs data (proportion of patients spending over 90% of their hospital stay on a stroke unit and TIA management); thrombolysis rates; data from PCTs on structure of stroke services in the community; National Royal College of Physician’s sentinel audit data; carotid endarterectomy audit data; and data from London and Manchester Stroke Networks collected during development of the strategy.

A dataset including measures of structure, process and outcome covering the whole of the in-patient pathway and some aspects of care after discharge will be used. London and Manchester stroke units already submit data to the SINAP prospective audit of acute care and additional items covering in-patient rehabilitation, secondary prevention and out-patient specialist care will be agreed and implemented in London and Manchester. The data will include those items defined in the NICE Quality Standards and will be augmented by outcome data including discharge destination, length of hospital stay, readmission rates (from HES data) and 1 month and 1 year mortality (from ONS data).

From 2011, Greater Manchester will have a set of patient experience measures (PEMs) for stroke patients, collected as part of the Advancing Quality programme [http://www.advancingqualitynw.nhs.uk/index.php] in which all acute trusts are enrolled. Whilst the details of this are not yet determined, any PEM data will be made available to this project for analysis and will support the ongoing formative evaluation of the reconfiguration.

A pan-London patient experience questionnaire, based on the Picker survey of 2006, is also currently in development. It will be active from the end of 2010 and the data will again be made available to the proposed study.

ECONOMIC COMPONENT (Research Questions 4 & 5)

Research questions 4 and 5 will be addressed in the economic component to the study and this has the following aims:

develop a health economic risk model based on patient level data from the South London Stroke Register (SLSR) to estimate patient outcomes and use in a predictive manner;

estimate patient level resource and cost use associated with different treatments in the London and Manchester reconfigurations which will be calculated using data on the long term care pathways defined by SLSR;

model different reconfiguration options, outcomes and costs using the developed risk model and the estimated costs as based on data from the SLSR.

The model will address different phases of the service care pathway to include:


Stroke onset to admission, focussing on time to admission

time spent in hospital, where the hyperacute treatment phase and acute treatment phase will be distinguished. Admission and discharge policies will be defined, including the use of scanning on admission, the use of thrombolysis, timing of ward movements and for example any early supported discharge policies. This methodology has been developed in our NAO models in 2005 and 2010 (9, 11)

post-discharge care, which will analyse the use of early supported discharge policies, destinations on discharge and long-term care and follow-up. This will develop methods used to asses early supported discharge and stroke unit care previously developed using SLSR data (17)

Resource use and unit cost data will be collected for both London and Manchester existing treatment pathways and for any future re-configurations. Data will be collected on existing treatment pathways and unit costs associated with these pathways, as well as outcome data on mortality (1-month, 3-month, discharge and 1-year where possible). This methodology was developed for the NAO 2005 and 2010 models (9, 11) and in Saka et al (17) for estimating the costs of stoke care. The use of site visits will determine resource inputs to pathways of care in London and Manchester and these have been employed previously in cross county health economics comparisons of stroke care we have undertaken (18).

INTERVIEWS (Qs 1, 2 & 3)

Semi-structured one-to-one interviews will be conducted with a range of people who commission, plan, and deliver stroke services in the two sites, including people who led the reconfigurations; local commissioners; staff working in relevant services; and staff who worked in decommissioned services (for details of sampling, please see Sampling section).

Interview schedules will be developed over the initial phase of the project and will be informed in part by evidence provided by the documentary analysis. The main themes of interviews are summarised below.

Interviews with leaders of the reconfigurations will include the following topics

how reconfigurations were developed, e.g. national and local contextual factors influencing selection of models, consultations, process mapping, etc (Q1);

processes of implementation (Q1, 5);

impact on staff and services, including health and social services (Qs 2, 3, 5); and

impact on patients and the public (Qs 2, 3, 5) ; and

contextual factors influencing the reconfiguration (e.g. finance, the organisational setting, etc) (Q1, 5).

Interviews with local stroke services staff (including those in decommissioned services) and local commissioners will address

processes of implementation (Q1, 5);

impact on staff and services, including health and social services (Qs 2, 3, 5);

impact on patients and the public (Qs 2, 3, 5); and


contextual factors influencing the reconfiguration (e.g. finance, the organisational setting, etc) (Q1, 5).

Finally, interviews will be conducted with patients and carers who experienced services post reconfiguration to further explore views on the reconfigured services (Qs 2, 3). Patients and carers will be recruited when awaiting discharge from services and will be interviewed approximately three months after discharge.

d. Data analysis

DOCUMENTARY ANALYSIS (Research Question 1)

The reconfigurations at both sites have been documented effectively (see above) and the proposed evaluation will have full access to these data.

Documentary evidence will inform the evaluation in terms of the development and progress of the reconfigurations. We will analyse the documentary evidence – with a focus on documents covering planning, events and progress of the reconfigurations to build an understanding of the development and implementation of the work. Themes will be drawn from the evidence base on effective organisational change (19), covering issues such as

preconditions – e.g. organisational context, drivers for change, and local leadership ‘buy in’;

planning – e.g. consultation with relevant stakeholders, consideration of resource needs and selection of effective methods;

implementation – e.g. engagement and training of relevant staff, provision of resources to support engagement, effective measurement and ongoing, constructive feedback on progress of the work; and

follow-up – e.g. whether the work is evaluated in terms of generating evidence and developing theory.

This information will structure the overall evaluation. It will reveal the approaches taken to the reconfigurations and identify events that may have influenced progress of the work.

PERFORMANCE DATA (Research Questions 2, 3, 4 & 5)

Data will be analysed for changes in performance from base line over the study period (Q2, Q4). Univariate and multivariable comparisons will be made between the Centres and hospitals within each centre. The analyses will look for trends in uptake of effective interventions: Access to accident and emergency within 4 hours of stroke; thrombolysis rates; hyperacute and stroke unit care, including multidisciplinary input; aspirin treatment in acute phase for ischaemic stroke; rehabilitation assessment and treatment; early supported discharge; follow up by primary care and management of risk factors for recurrent stroke (hypertension, atrial fibrillation, cholesterol, endarterectomy). Comparisons will be made between Manchester and London overall in these processes of care and multivariable analyses will adjust for age, sex, severity of stroke and subtype of stroke. Predictive models will be developed to identify those factors in Manchester and London that predict good outcome (survival, independence).


To gain an insight on patient experiences of services pre, during and post reconfigurations, we will analyse frequency of hospital complaints and performance on local patient surveys (Q3)

ECONOMIC COMPONENT (Research Questions 4 & 5)

To establish the cost-effectiveness of the reconfigured services, a Markov health state transition model (20) will be developed. The decision analytic model was constructed using Treeage Pro 2007 software (Treeage Software; Williamstown, Mass).

The main outcome for the model will be the combination of death and activities of daily living score as measured by the Barthel Index (BI) (21) (mild: BI score 15 to 20; moderate: BI score 10 to 14; severe: BI score 0 to 9). BI index scores were expressed in health-related quality-of-life values to calculate the quality-adjusted life-years (QALYs) gained from the model using the conversion method developed by Van Exel et al. (22). Ideally BI scores will be collected within 1-month, 3-month, discharge and 1-year follow-up). Where this is not possible BI will be collected on an opportunistic basis and matched to treatment at a patient level such that, assuming treatment to have a predictive impact on quality of life we can allocate quality of life scores to all patients.

Incremental cost-effectiveness ratios (ICERs) will be calculated as cost per QALY to assess the cost-effectiveness of the different strategies. Univariate deterministic and stochastic sensitivity analyses were performed to illuminate the importance of the assumptions made for the baseline case and to test the robustness of the model (23). Parameters analyzed for the univariate sensitivity analysis will include the cost multipliers, probabilities of death, hospital length of stay by type of bed (HASU,SU), distribution of patients across the functional outcome groups, cost of medication management, outpatient physician visits and durable equipment, health usefulness weights, and discount rates. The effect of varying individual parameters will be examined using plausible ranges of values from the literature, 95% CIs, or by varying estimates by 20% in each direction.

Deterministic sensitivity analysis is useful for understanding key parameters that determine cost-effectiveness and for examining the range of a variable, which results in the ICER falling below a certain threshold level. However, the likelihood of achieving an ICER that falls below that threshold value cannot be inferred from such analysis (24). Available information may be used to perform a Monte Carlo simulation and estimate the probability of cost-effectiveness. For the probabilistic sensitivity analysis, a Monte Carlo simulation method will be used to vary model parameters simultaneously using distributions (25). The parameters varied will include the cost, length of stay, and health-related quality-of-life variables. It will be assumed that parameter estimates followed a lognormal distribution for cost multipliers and for length of stay in the hospital. A normal distribution was assumed for the QALY values. The Monte Carlo simulation will be run 10000 times to achieve stability of results. The sensitivity analyses will be applied to all arms of the decision model.

INTERVIEWS (Research Questions 1, 2 & 3)

All interviews will be digitally recorded for transcription in full. Fieldwork notes will also be kept by the researcher. Data will be managed with NVIVO software. Ongoing iterative and thematic analysis of all data will be undertaken concurrently, according to well established procedures of constant comparative analysis (26). Initial analysis and


category building will be conducted by the researcher and will include category mapping and constant comparison. Validity will be assessed in relation to Patton’s four criteria of validity in qualitative research: verification, rival explanations, negative cases and triangulation (27).

5. Dissemination:

One product of the proposed work will be the report to NIHR SDO. Alongside the main report, which will describe the research and its findings in detail, we will provide short summaries of the research; and appendices presenting e.g. data tools, raw data where appropriate, and an archive of the stakeholder update reports.

To ensure national and international dissemination of the learning from this proposed research, we will aim to publish our findings in high impact peer reviewed journals.

Additionally, we will produce summaries of our ongoing findings for professional healthcare & management journals.

In tandem with development of peer reviewed publications, the project will present its findings to national and international scientific meetings and conferences.

As we propose a formative evaluation, we will disseminate our learning to stakeholders by presenting at regular events held by the participating Stroke Networks, covering progress of reconfiguration, process, outcome and cost measures; and any learning relevant to progressing work further. These will be supplemented by electronic updates, to be distributed to all relevant stakeholders every six months.

A ‘lay’ version of these updates will be produced to ensure that patients and the public are suitably informed. Co-applicant (CM) supports a regular bulletin for Stroke SUs and this expertise will be extremely valuable in ensuring production of useful and accessible bulletins.

6. Plan of Investigation:

Task Period (months)

Research tool development 1-4

Baseline data (documents, performance, economic), collection and analysis

5-13

Post reconfiguration data (documents, performance, economic) collection and analysis

5-30

Phase 1 interviews - data collection 13-16

Phase 1 interviews - analysis 14-19

Phase 2 interviews - data collection 23-27

Phase 2 interviews - analysis 24-30

Progress reports 6, 12, 18, 24, 30


Final write-up, including journal articles 30-36

7. Project Management:

Management arrangements

As Chief Investigator, NF will provide overall oversight and leadership of the of the project team. She will also manage the London-based researcher.

The London-based researcher will be responsible for day-to-day management of the project. S/he will have responsibilities for coordinating the research and preparing research team meetings, e.g. providing regular electronic updates to the research team and PAG. Also, s/he will make frequent visits to the Manchester site to ensure effective collaboration with Manchester co-investigators and, from month 13, with the Manchester-based researcher.

The Manchester researcher will be appointed in month 13, and will lead data collection in the Manchester area. S/he will be managed by co-applicant RB, and will have regular update meetings with the London researcher.

The whole research team will meet monthly over the course of the project. To ensure maximum participation, teleconference facilities will be used. The research team will meet in person once per year.

Project Advisory Group

The Project Advisory Group (PAG) will be composed of the applicants and any researchers attached to the study. Additional stakeholder representatives will include appropriate staff from provider organisations and other organisations, taking into account the organisational changes occurring over the study period, along with service user representatives from the Manchester and London Stroke Service User Groups.

The PAG will meet three times over the course of the project; should members have difficulty in attending, participation will be facilitated using KCL teleconferencing facilities. The PAG will receive regular updates on progress of the work from the project manager.

8. Service users/public involvement:

SERVICE USER INVOLVEMENT

The patient experience is increasingly prioritised as an indicator of a high quality, safe healthcare provision. In carrying out a formative evaluation, the service user and carer perspective will be extremely valuable throughout the proposed work.

We have discussed the proposed study with members of the KCL Stroke Research Patients and Family Group (http://www.kcl.ac.uk/schools/medicine/research/hscr/sections/stroke/strokeuser.html).

Having taken part in Health Care for London consultations, group members are already engaged with the issues and support our proposal. Nanik Pursani has agreed to be named as a co-applicant. He and another group member (Anne Underdown) are keen to join the study PAG. The KCL Stroke Research Patients and Family Group


(http://www.kcl.ac.uk/schools/medicine/research/hscr/sections/stroke/patients.html) , and other stroke service user groups the applicants work with, including the NW LRN Research User Panels and the Cardiac and Stroke Network Service User Groups, will provide a wider reference group for on-going service user input to the study.

To increase validity of our analysis, the research team will present the thematic analysis to groups of patients and carers (as carried out by applicant CM in a previous study of costs of Stroke (28).

As part of our formative evaluation, we will provide regular feedback to local stakeholders (see above). To ensure local service users are kept suitably informed of the progress of our work, we will produce accessible and meaningful summaries of these reports as update bulletins. Co-applicant CM leads on production of stroke research newsletter for service users (see http://www.kcl.ac.uk/content/1/c6/07/75/75/Newsletter9July10.pdf) and this expertise will be extremely valuable in ensuring production of useful and accessible bulletins.

END-USER INVOLVEMENT

End-users of this research are directly involved in the development of the proposal and will remain so throughout all stages. Two of the co-applicants have roles within the SHA and Cardiac and Stroke Networks. Through Professor Wolfe's links, the NHS Confederation Health Services Research Network and the SDO network will be involved.

9. References:

1. Greenhalgh T, Robert G, Bate P, Kyriakidou O, Macfarlane F, Peacock R. How to spread good ideas: a systematic review of the literature on diffusion, dissemination and sustainability of innovations in health service delivery and organisation. London: National Co-ordinating Centre for NHS Service Delivery and Organisation, 2004 Contract No.: 12th May 2009. 2. Spurgeon P, Cooke M, Fulop N, Walters R, West P, 6 P, et al. Evaluating models of service delivery: reconfiguration principles. Southampton: Final report to NIHR SDO Programme, 2010. 3. Fulop N, Protopsaltis G, King A, Allen P, Hutchings A, Normand C. Changing organisations: a study of the context and processes of mergers of health care providers in England. Social Science & Medicine. 2005;60(1):119-30. 4. Fulop N, 6 P, Spurgeon P. Processes of change in the reconfiguration of hospital services: the role of stakeholder involvement. In: McKee L, Ferlie E, Hyde P, editors. Organising and Reorganising - Power and Change in Health Care Organisations. Basingstoke: Palgrave MacMillan; 2008. 5. Greenhalgh T, Humphrey C, Hughes J, Macfarlane F, Butler C, Pawson R. How do you modernize a health service? A realist evaluation of whole-scale transformation in london. The Milbank Quarterly. 2009;87(2):391-496. 6. Intercollegiate Stroke Working Party. National Sentinel Audit of Stroke. London: Royal College of Physicians, 2008. 7. Department of Health. National Stroke Strategy. London: Crown, 2007.


8. Office for National Statistics. Usual resident population: Census 2001, Key Statistics for urban areas. 2001 [June 2010]; Available from: http://www.statistics.gov.uk/StatBase/ssdataset.asp?vlnk=8271&More=Y. 9. National Audit Office. Progress in improving stroke care: modelling paper. London: National Audit Office, 2010. 10. Department of Health. Equity and excellence: liberating the NHS. London: Crown, 2010. 11. National Audit Office. Reducing brain damage: faster access to stroke care. London: The Stationery Office, 2005. 12. Pearson S, Rawlins M. Quality, innovation, and value for money: NICE and the British National Health Service. Jama. 2005;294(20):2618. 13. Department of Health. NHS 2010-2015: from good to great. London: Crown, 2009. 14. Ferlie E, Dopson S. Studying complex organizations in health care. In: Dopson S, Fitzgerald L, editors. Knowledge to action? Evidence based health care in context. Oxford: Oxford University Press; 2005. 15. Lemieux-Charles L, Barnsley J. An innovation diffusion perspective on knowledge and evidence in health care. In: Lemieux-Charles L, Champagne F, editors. Using Knowledge and Evidence in Health Care: Multidisciplinary Perspectives. Toronto, ON: University of Toronto Press; 2005. 16. Webster A. Health, Technology, and Society: A Sociological Critique. Basingstoke: Palgrave Macmillan; 2007. 17. Saka O, Serra V, Samyshkin Y, McGuire A, Wolfe C. Cost-effectiveness of stroke unit care followed by early supported discharge. Stroke. 2009;40(1):24. 18. Grieve R, Hutton J, Bhalla A, Rastenyte D, Ryglewicz D, Sarti C, et al. A comparison of the costs and survival of hospital-admitted stroke patients across Europe. Stroke. 2001;32(7):1684-91. 19. Worrall A, Ramsay A, Gordon K, Maltby S, Beecham J, King S, et al. Evaluation of the Mental Health Improvement Partnerships programme. London: National Co-ordinating Centre for NHS Service Delivery and Organisation, 2008. 20. Sonnenberg F, Beck J. Markov models in medical decision making. Medical decision making. 1993;13(4):322. 21. Mahoney F, Barthel D. Functional evaluation: the Barthel index. Maryland state medical journal. 1965;14:56-61. 22. Van Exel N, Scholte op Reimer W, Koopmanschap M. Assessment of post-stroke quality of life in cost-effectiveness studies: The usefulness of the Barthel Index and the EuroQoL-5D. Quality of Life Research. 2004;13(2):427-33. 23. Briggs A. A Bayesian approach to stochastic cost-effectiveness analysis. International Journal of Technology Assessment in Health Care. 2001;17(01):69-82. 24. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Economics. 2001;10(8):779-87. 25. Claxton K, Sculpher M, McCabe C, Briggs A, Akehurst R, Buxton M, et al. Probabilistic sensitivity analysis for NICE technology assessment: not an optional extra. Health Economics. 2005;14(4):339-47.


26. Mays N, Pope C. Qualitative research: rigour and qualitative research. BMJ. 1995;311(6997):109. 27. Patton M. Qualitative evaluation and research methods. Thousand Oaks, CA: Sage; 2002. 28. McKevitt C, Fudge N, Wolfe C. What is involvement in research and what does it achieve? Reflections on a pilot study of the personal costs of stroke. Health Expectations. 2010;13(1):86-94.

This protocol refers to independent research commissioned by the National Institute for Health Research (NIHR). Any views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the SDO programme or the Department of Health.

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