Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 EVALUATION OF THE NATIONAL INFARCT ANGIOPLASTY PROJECT PILOTS A. Background, Aims & Objectives The Department of Health is currently funding up to ten pilot sites as part of the National Infarct Angioplasty Project (NIAP) to test the feasibility of implementing a countrywide primary angioplasty service for patients presenting with acute STelevation myocardial infarction (AMI). We aim to evaluate the pilot sites and address the five elements of the brief produced by the NHS Service Delivery and Organisation (SDO) R&D Programme. The specific objectives will be: To gain an in depth understanding of patient and carer experience of receiving care at the pilot sites, and measure differences in satisfaction between the pilot sites and sites providing standard, thrombolysis-based care. To assess the workforce implications of setting up an angioplasty service at the pilot sites, and measure the effect of providing the service upon the angioplasty team, support staff, and related staff groups. To describe the models of service delivery established at the pilot sites in terms of their setting (geography, population, transport and communications), structure (hospitals, referral networks, transfer and access points) and components (staff, facilities, and equipment). To explore implementation and feasibility issues by describing the processes involved in establishing primary angioplasty (particularly the development of teams and leadership roles), identifying facilitating factors and barriers to implementation, and assessing the implications of establishing primary angioplasty for cardiology and other services. To compare the costs and outcomes of providing angioplasty and thrombolysis, and estimate the incremental cost-effectiveness of a comprehensive primary angioplasty service, compared to standard, thrombolysis-based care, for the different organisational service models adopted in the pilot sites. B. Relevance to SDO Call for Proposals This proposal is submitted directly in response to the SDO call for proposals “Evaluation of the National Infarct Angioplasty Project Pilots” and addresses the specific issues outlined in the brief. C. Background, including NHS context and relevant literature Acute ST-elevation myocardial infarction (heart attack) occurs when a coronary artery is occluded by a blood clot. Treatment with an intravenous thrombolytic agent to break down the clot is cheap, simple and effective, and can be provided in all acute hospitals and by some ambulance services. Primary angioplasty, where a catheter and a stent and/or balloon is used to restore blood flow, is more effective for many patients, probably more costly and delivery requires specialist staff and facilities. Meta-analysis of randomised trials comparing primary angioplasty to intravenous thrombolysis has established that primary angioplasty is associated with reduced mortality, reinfarction, stroke and need for coronary artery bypass grafting, compared to thrombolysis.1-3 Economic analyses suggest that, if both interventions are routinely available, then primary angioplasty is likely to be cost-effective, although this costeffectiveness is likely to be dependent on the additional time it takes to initiate angioplasty compared to thrombolysis.4 Although, on average, primary angioplasty is likely to be considered cost-effective, the costs and benefits of the two alternative Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 reperfusion strategies are likely to vary according to the type of centre (e.g. rural versus urban setting). These data provide evidence that, if both interventions are routinely available, then primary angioplasty is likely to be the appropriate choice for most patients. However, primary angioplasty is currently not routinely available to patients presenting to the National Health Service (NHS) with AMI. It is available to some patients, depending upon where and when they present to hospital, but routine provision of primary angioplasty will require substantial re-organisation of services to ensure widespread availability 24 hours per day. Establishing such a service requires a number of organisational and economic questions to be addressed. What models of service delivery could be used? Primary angioplasty requires specialist staff and facilities. Several models have been suggested for providing widespread access to primary angioplasty,5,6 but little data exist to compare these models. Meta-analysis suggests that angioplasty is superior to thrombolysis even when it requires inter-hospital transfer.7 Data from the United States (US) suggest that centres with a higher volume of angioplasty procedures have a lower mortality rate,8 and that the advantages of angioplasty over thrombolysis are limited to hospitals with a high or intermediate volume of cases.9 Meanwhile, regionalisation of angioplasty services does not appear to increase travel distances for most patients.10 This has prompted researchers to suggest a network model similar to US trauma networks,6 in which patients bypass or are transferred from local hospitals to specialist centres, although this approach does not appear to be appropriate to the NHS.11 What are the barriers to implementing a primary angioplasty service? A number of barriers to implementation of primary angioplasty have been identified,6 mainly related to the difficulty of providing timely access to appropriate staff and facilities, and strategies have been suggested to overcome these barriers. However, both the barriers and solutions identified have been based on a paucity of empirical data and those identified in other health care systems may not be transferable to the NHS. For example, there are important international differences in the professional groups delivering services and in the way health services are funded and organised. What are the workforce implications of implementing a primary angioplasty service? One of the principal barriers to implementation of a primary angioplasty service is the 24-hour requirement for specialist medical and nursing staff.12 As outcomes from AMI are related to staffing levels and staff specialisation,13,14 appropriate staffing is essential to achieve anticipated outcomes. However, successful implementation may take trained staff away from other important roles, such as on-call commitments and emergency cover, and may have some negative consequences for the NHS. What is the most cost-effective approach to providing primary angioplasty? A number of cost-effectiveness analyses have established that, if both services are routinely available, then primary angioplasty is likely to be considered a more costeffective use of resources than thrombolysis.3,15,16 However, these studies assume that primary angioplasty is routinely available and use an average angioplasty cost based upon current angioplasty service costs, which does not vary according to the specific circumstances under which it is performed. This assumption is unlikely to represent the true cost of providing emergency primary angioplasty. If provision requires a substantial re-organisation of services, rearrangement of staff rosters or knock-on effects for other services then the true cost of an emergency primary angioplasty may be much higher than the average cost. Furthermore, it is probably Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 inappropriate to consider primary angioplasty and thrombolysis to be distinct, mutually exclusive strategies. Instead, the most cost-effective alternative to a comprehensive angioplasty service will probably involve some selective, opportunistic use of primary angioplasty, with thrombolysis as a back up. Therefore the more appropriate comparison would be between a strategy that seeks to maximise use of primary angioplasty (intervention), and one that only provides it in an opportunistic manner (standard care). Finally, it is possible that costs and additional time it takes to initiate angioplasty (compared to thrombolysis) may vary between different models of service provision, such that some models may be more cost-effective than others. What do patients think of primary angioplasty and thrombolysis? The views of service users should help determine the development of NHS services. It is self-evident that patients and carers want effective services, but other factors may have an important influence upon their experience. For example, implementation of primary angioplasty may require centralisation of services, which may run counter to patient and carer preferences. Patient views have been sought in developing cardiac care,17 in the attempt to weigh the risks and benefits of reperfusion strategies for myocardial infarction,18-20 and in comparing diagnostic strategies for chest pain.21,22 The patient experience of angioplasty has been explored,23 but comparison of primary angioplasty to thrombolysis has focussed upon mortality, morbidity and cost-effectiveness. The National Infarct Angioplasty Pilots The British Cardiac Society (BCS) and the Department of Health have established a joint working group to establish the feasibility of implementing a countrywide primary angioplasty service. Up to ten pilot sites will be funded to set establish a service and collect data. Meanwhile, other hospitals will continue to collect data from patients with acute myocardial infarction as part of the Myocardial Infarction National Audit Project (MINAP) database. We propose to evaluate the pilot sites and address the issues outlined above. D. Plan of investigation Evaluation of changes to the organisation and delivery of emergency services requires a multidisciplinary approach, involving researchers with experience of working in this challenging area. We will use a mixture of qualitative and quantitative methods, involving health service research, organisational research, work psychology, epidemiology, and health economics. Members of our research team have evaluated the role of chest pain units in the NHS (SG, SJC, KS, SC), the influence of organisational factors upon waiting times in Accident and Emergency (AC, SG), the role of NHS Direct (AOC), human resources in the health sector (SW), and the value of revascularisation (RS,MJ). A core research team of Steve Goodacre, Fiona Sampson, Alicia O’Cathain, Katherine Stevens, Mark Sculpher (University of York), and Angela Carter will undertake the project, with expert guidance from Simon Capewell (epidemiology), Stephen Campbell (cardiology), Rod Stables (cardiology), Stephen Wood (work psychology and organisational research), James Wardrope (prehospital care) and Mark Jackson (Clinical Audit). A consumer representative (Enid Hirst) is helping to develop the project and will establish a consumer group of people who have experience of heart attack and/or angioplasty. A Steering Group comprising of an independent Chair, independent member, consumer representative, stakeholder representatives and the co-applicants will guide the project. Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 We plan to compare the pilot (intervention) sites to four control sites that do not formally establish a primary angioplasty service. Evaluation will take a whole-system approach. We anticipate that even pilot sites that successfully implement 24-hour primary angioplasty will still use thrombolysis for at least a residual proportion of patients. Likewise, control sites that do not develop a primary angioplasty service may still use angioplasty opportunistically for some patients arriving during working hours. Our evaluation will compare the overall effect on all patients with AMI at each site, rather than focussing upon those who received the intended or principal service. Routine data will be collected from all sites. Two intervention sites will be used for detailed evaluation of the patient and carer experience. Two other intervention sites will be selected to develop workforce and feasibility methods and identify the economic implications of providing primary angioplasty. The Research Team will meet regularly for joint discussions of methods and findings from these two pairs of sites to ensure that the project benefits from the complimentry nature of the evaluations. We have requested an additional £25,000 to undertake micro-costing at four of the intervention sites and all four control sites, and to cross-check routine data collected at these sites. Micro-costing will allow us to accurately measure the actual costs of primary angioplasty and thrombolysis, and measure variation in costs between the different models of service delivery. Validation of MINAP data will allow us to address concerns about the quality and completeness of this dataset, particularly at the control hospitals where we would otherwise have very little control over data collection. These additions to the project will substantially improve the quality of data used in the economic model and hence the reliability of our estimates of costeffectiveness. Patient and carer experience Although patient satisfaction has been measured in the context of angioplasty,17 there is no validated instrument specific to the patient and carer experience of angioplasty. Even if such an instrument existed, it might fail to fully capture experience when used in the context of an innovative service such as the NIAP pilot sites. We therefore propose a phased approach of developing an instrument, followed by the use of this instrument to describe experiences in a range of pilot sites and comparator hospitals. Phase 1 will involve the two sites with designated special responsibility for the evaluation of patient and carer experience. We will use qualitative methods to identify key elements of the patient experience and develop NIAP-specific instruments for measuring patient and carer satisfaction. We will then test the feasibility of using this instrument, alongside a generic instrument, in a postal questionnaire. In phase 2 we will use this questionnaire to measure patient and carer satisfaction at four of the pilot sites and patient satisfaction at four control hospitals providing standard thrombolysis-based care. We will select the four pilot sites with the highest proportion of patients receiving angioplasty so that this aspect of the evaluation maximises the contrast between intervention and control care. In Phase 3 we will use qualitative interviews with patients and carers from the two original pilot sites to expand upon results from the survey and identify possible solutions to issues identified. Workforce implications We will use a mixture of quantitative and qualitative methods to address the questions outlined in the brief. We will administer self-complete questionnaires to staff who work with patients that have treatment for AMI. We will then conduct semi- Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 structured interviews and focus group discussions with these staff and others who are associated with treatment for AMI, including members of the angioplasty team, emergency department staff, ambulance staff and paramedics. A two/three day site visit will be used as the principal vehicle to arrange and conduct interviews and focus groups. This visit will also be used to undertake the specialist teamworking interviews and ethnographic observation (or where not possible retrospective case discussion) that will address the implementation and feasibility issues It is anticipated that specific material will be produced for this study. These will be developed on two sites working closely with the teams who are collecting economic data to produce a holistic model of investigation, and will involve close collaboration with researchers working at two other sites to develop the patient and carer satisfaction evaluation. Once piloted these materials and methods will be developed/edited and then used with the other intervention sites. Description of models of service delivery We will use data from routine sources, a telephone survey and site visits to describe the models of service delivery developed by the pilot sites in terms of the following parameters: Service setting: urban or rural; area covered; catchment population (number, age and gender, coronary heart disease morbidity and mortality rates, ethnicity and social deprivation); transport and communications networks. Service overview: participating hospitals; teaching status; referral networks between hospitals; ambulance services; other prehospital care; access route to the service. Service infrastructure: staff numbers, grades, profession and specialties; interventional cardiology skills; rostering and on-call arrangements; facilities and equipment; bed availability (general, coronary care and intensive care); cardiac surgery services. Service activity levels: number of AMI treated (prehospital thrombolysis, in-hospital thrombolysis and angioplasty), numbers of emergency and elective admissions, revascularisation procedures, and cardiac operations performed. Implementation and feasibility We will explore these issues alongside the evaluation of the workforce implications and address the questions outlined in the brief by using a multiple case study approach. This will involve face-to-face interviews, focus group discussions, and observational / retrospective case study methods. The vehicle for the collection of these data will be the site visit outlined in the workforce implications section. Economic evaluation Mark Sculpher and colleagues at the University of York have already developed a cost-effectiveness model to compare angioplasty to thrombolysis.4 It considers costeffectiveness from the perspective of the NHS and uses data from the literature and routine sources to provide an estimate of the incremental cost per QALY. The analysis also looks at the variation in cost-effectiveness according to the time delay to angioplasty. The value of the model for the pilot evaluation is that it can be used to explore how the cost-effectiveness of primary angioplasty might vary between the different types of service configuration seen in the pilot centres. In particular, it can use centre-specific data on costs and times to reperfusion to assess variation in costeffectiveness across different models of service delivery. We will collect data from the MINAP database and from a micro-costing study at intervention and control sites to increase the robustness and scope of the costeffectiveness analysis. We will explore how variation in the models of service delivery influences the cost-effectiveness of providing angioplasty and, working alongside the Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 workforce and feasibility evaluations, we will identify factors that determine the true cost of providing angioplasty. E. Methods (including the plan of analysis) Patient and carer experience In phase 1 we will undertake qualitative interviews with both patients and carers post discharge. Interviews will be based on a maximum-diversity sample of patients and carers attending the pilot sites to include different ages, genders, arrival routes, and living distance from the pilot sites. We will interview between 15 and 25 people in their own homes using the critical-incident technique24 to determine positive and negative aspects of key stages of the process, ensuring that we include issues highlighted within the funding brief. We will also assess the feasibility of using a postal questionnaire in Phase 2, specifically addressing difficult issues, such as the identification of carers. We will develop an NIAP-specific instrument for patients, and one for carers, based on Phase 1, other relevant qualitative studies,23 and evidence around measuring patient satisfaction.25 We will also use a generic instrument relevant to patients undergoing emergency care, based on refining the Picker Institute patient experience questionnaires (www.pickereurope.org), and questionnaires we have developed in the context of emergency cardiac care.21 The NIAP-specific instrument is intended to capture views and experiences in detail, while the generic questionnaire is intended to allow comparison between intervention and control sites. The Consumer Group will review the questionnaires during their development and, towards the end of this phase, we will pilot the use of the questionnaires. In Phase 2 we will send a postal questionnaire one week after hospital admission to every patient with ST-elevation AMI, and their main carer, attending four of the pilot sites over a nine-month period, ensuring that the samples are suitably screened for severe adverse events. The patient questionnaire will include the NIAP-specific and generic instruments, the carer questionnaire will include the NIAP-specific instrument only. We expect a minimum of 75 patients from each site in this time period, totalling at least 300 patients, and 200 carers (given that not all patients may have carers). We will aim for a response rate of 75% with two reminders. To provide data for comparison, we will identify 300 patients with ST-elevation AMI in four hospitals offering the traditional approach to care based on thrombolysis. We will only post the generic instrument to patients for direct comparison with pilot-site patients. This sample size will have 80% power to detect a 0.75 point change on each 5-point patient satisfaction question (alpha=0.05).21 Phase 3 will involve up to 20 interviews with patients and carers from the two original pilot sites. Interviews in phases 1 and 3 will be tape recorded and transcribed verbatim. The priority of this element of the study is development of the patient and carer survey and so the main role of the qualitative interviews will be to identify themes, items, and language for the questionnaire, and elaborate upon findings of the survey. A simple descriptive analysis, applying the early stages of the Framework approach will be undertaken to identify emerging themes. A more in-depth qualitative analysis may be undertaken if the quality of the data and time allow. The general patient questionnaire will be analysed using SPSS to identify differences in patient’s experiences and views between the new and traditional services overall. The NIAP specific patient and carer questionnaires will be analysed using SPSS to identify differences in Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 patient and carer experiences and views between the different models of the new service. Workforce implications Staff involved with providing angioplasty services will be identified by prior contact with the Trust. We will send a questionnaire to relevant staff by internal mail (25-50 anticipated at each site) who will complete this questionnaire during work time. It will examine the changing aspects of their work role, flexible working and managing a 24 hour service, support and training, teamworking and work factors (e.g. autonomy, role clarity, influence in decision-making peer and leader support). This survey will be developed specifically for this study but will use measures found reliable and valid for health service populations.26 These data will be complemented by the use of focus groups and semi-structured interviews with key stakeholders to examine the impact of the angioplasty service on the workforce and explore the wider implications of providing an emergency angioplasty service, such as cardiologists not being available for the general medical rota and changes to emergency referral patterns. Additional focus groups will examine the impact of angioplasty on other associated workforces (e.g. radiography, ambulance services and the emergency department). Observational data will be collected, and where this is not possible it will be collected retrospectively through discussion of cases after treatment. The questionnaire will be issued to staff two weeks before the site visit. A team of researchers and a clinician will conduct the interviews (including teamworking interviews that will examine the exact nature of the service delivery team, how team members work together and how their specific roles integrate) and focus groups supervised and trained by a chartered occupational psychologist. The occupational psychologists will also be responsible for the design and delivery of the questionnaire survey. The model for the site visit will be piloted within the first six months of the project (phase one) to enable any practical adjustments to be made. It is anticipated data will be collected on 6-8 sites during the period September 2006 to March 2007. Data will be analysed using quantitative and qualitative methods. Themes gathered at interview and focus groups will be validated by the participant(s). Content analyses will be used to develop a complete description of the activities that take place during the treatment of AMI and the challenges this work presents to the workforce, key stakeholders and the Trust in developing a 24-hour service. Description of models of service delivery We will use the following data sources to assemble this information: the NIAP pilot study database, the MINAP database, the British Cardiovascular Intervention Society (BCIS) database, the Central Cardiac Audit Database (CCAD), Hospital Episode Statistics (HES), and routine Department of Health statistics. We will also undertake a telephone questionnaire survey of each pilot site after one year of operation to cross-check data from routine sources and obtain data not identified elsewhere. We will use the site visits to further characterise models of service delivery and explore whether quantitative descriptions of services reflect staff perceptions of the actual services delivered. Implementation and feasibility Specialist teamworking interviews will be conducted with key members of staff (supported by data from the staff survey) to describe the size and composition of the teams and the impact the emergency angioplasty service may have had on teamworking. In addition, semi-structured interviews and focus groups will be conducted with staff to explore the issues of implementing the service and factors Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 perceived to have facilitated or opposed effective delivery. The site visit will also allow a period of ethnographic observation/case study exploration of the service delivery. The timetable for site visits and analysis will be as for the workforce implications element of the proposal. Economic evaluation Data on the time to angioplasty, the time to thrombolysis and the type of thrombolysis used will be extracted from the MINAP database at all of the intervention sites and the four control sites. In addition, at four intervention and four control sites we will undertake micro-costing to measure the true costs of providing angioplasty in different models of service delivery, and we will check the validity and completeness of the MINAP data. At each of these sites, data will be collected on staff costs, equipment, consumables, drugs and procedures associated with the intervention (angioplasty or thrombolysis). Resources will be identified in collaboration with staff at the unit. A resource-use questionnaire will be developed from these discussions, which will subsequently be administered by a research nurse at each site. Data will be collected on 60 patients at each site, which is approximately 30% of the annual throughput of patients in each unit. This will give a total of 240 patients in each arm. Care will be taken to stratify patients by day and night time admission in order to capture these potentially important differences. The resource use data will be valued using local unit costs where available or national unit costs. We will use, as far as possible, centre-specific cost data, estimated in collaboration with local finance departments using a standardised protocol. We will also use the MINAP database to collect centre-specific data on case mix. This will allow us to develop the model, which currently uses effectiveness data from clinical trials, to estimate the cost-effectiveness of angioplasty in a typical NHS population. All the new data collected will be synthesized with the data in the existing costeffectiveness model and an incremental cost per QALY will be estimated. Probabilistic sensitivity analysis will be used to address the uncertainty in the input parameters of the cost-effectiveness analysis. The decision uncertainty will be described using a cost-effectiveness acceptability curve. We will develop a regression model using the patient-level cost data and MINAP data to determine how much of the variation in cost can be explained by differences in the models of service delivery used, having controlled for case mix. Findings from the workforce and feasibility evaluations will be used to explain how different models of service delivery may be associated with different costs. The different costs for each potential model of service delivery will then be used in the cost-effectiveness model to explore the relative cost-effectiveness of the different approaches to service delivery. References Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003; 361: 13–20. Cucherat, M., E. Bonnefoy, and G. Tremeau, Primary angioplasty versus intravenous thrombolysis for acute myocardial infarction.[update of Cochrane Database Syst Rev. 2000;(2):CD001560; PMID: 10796812]. Cochrane Database of Systematic Reviews, 2004. 3. Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 Hartwell D, Colquitt J, Loveman E, et al. Clinical effectiveness and cost-effectiveness of immediate angioplasty for acute myocardial infarction: systematic review and economic evaluation. Health Technol Assess 2005;9. Asseburg C, Bravo Y, Palmer S, Fenwick E, Abrams K, de Belder M, Sculpher M et al. “A cost-effectiveness analysis comparing primary percutaneous coronary interventions to thrombolytic therapy for acute myocardial infaction.” Centre for Health Economics Technical Report, 2005. Waters RE, Singh KP, Roe MT et al. Rationale and strategies for implementing community-based transfer protocols for primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction. J Am Coll Cardiol 2004;43:2153-9. Keeley EC, Grines CL. Primary percutaneous coronary intervention for every patient with ST-segment elevation myocardial infarction: what stands in the way? Ann Intern Med 2004;141:298-304. Dalby M, Bouzamondo A, Lechat P, Montalescot G. Transfer for primary angioplasty versus immediate thrombolysis in acute myocardial infarction - A meta-analysis. Circulation 2003;108:1809-1814. Canto JG, Every NR, Magid DJ et al. The volume of primary angioplasty procedures and survival after acute myocardial infarction. National Registry of Myocardial Infarction 2 Investigators. N Engl J Med 2000;342:1573-80. Magid DJ, Calonge BN, Rumsfeld JS et al. Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy. JAMA 2000;284:3131-8. Kansagra SM, Curtis LH, Schulman KA. Regionalization of percutaneous transluminal coronary angioplasty and implications for patient travel distance. JAMA 2004;292:1717-23. Nicholl J and Turner J. Effectiveness of a regional trauma system in reducing mortality from major trauma. BMJ 1997;315:1349-54. Fye WB. Introduction: The origins and implications of a growing shortage of cardiologists. J Am Coll Cardiol 2004;44:221-32. Person SD, Allison JJ, Kiefe CI et al. Nurse staffing and mortality for Medicare patients with acute myocardial infarction. Med Care 2004;42:4-12. Ayanian JZ, Landrum MB, Guadagnoli E, Gaccione P. Specialty of ambulatory care physicians and mortality among elderly patients after myocardial infarction. N Engl J Med 2002;347:1678-86. Stone GW, Grines CL, Rothbaum D et al. Analysis of the relative costs and effectiveness of primary angioplasty versus tissue-type plasminogen activator: the Primary Angioplasty in Myocardial Infarction (PAMI) trial. The PAMI Trial Investigators. J Am Coll Cardiol 1997;29:901-7. Le May MR, Davies RF, Labinaz M et al. Hospitalization costs of primary stenting versus thrombolysis in acute myocardial infarction - Cost analysis of the Canadian STAT study. Circulation 2003;108:2624-2630. Niles N et al. Using qualitative and quantitative patient satisfaction data to improve the quality of cardiac care. Joint Commission Journal on Quality Improvement 1996; 22: 323-35. Heyland DK, Gafni A, Levine MA. Do potential patients prefer tissue plasminogen activator (TPA) over streptokinase (SK)? An evaluation of the risks and benefits of TPA from the patient's perspective. J Clin Epidemiol 2000;53:888-94. Tsui W, Pierre K, Massel D. Patient reperfusion preferences in acute myocardial infarction: mortality versus stroke, benefits versus costs, high technology versus drugs. Can J Cardiol 2005;21:423-31. Stanek EJ, Cheng JW, Peeple PJ, Simko RJ, Spinler SJ. Patient preferences for thrombolytic therapy in acute myocardial infarction. Med Decis Making 1997;17:46471. Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 Goodacre SW, Quinney D, Revill S, Morris F, Capewell S & Nicholl J. Patient and Primary Care Physician Satisfaction with Chest Pain Unit and Routine Care. Acad Emerg Med 2004;11:827-833. Rydman RJ, Zalenski RJ, Roberts RR, Albrecht GA, Misieswicz VM, Kampe L et al. Patient satisfaction with an emergency department chest pain observation unit. Ann Emerg Med 1997; 29:109-15. Gulanick M, Bliley A, Perino B, Keough V. Patients’ responses to the angioplasty experience: a qualitative study. American Journal of Critical Care 1997; 6:25-32. Flanagan JC. The critical incident technique. Psychological Bulletin 1954; 51: 327358. Crow et al. The measurement of satisfaction with health care: implications for practice from a systematic review of the literature. HTA 2002; 6(32). Wall TD, Bolden RI, Borrill CS, Carter AJ, Golya DA, Hardy GE, Haynes CE, Rick JE, Shapiro DA, and West MA. Minor psychiatric disorder in NHS Trust staff: Occupational and gender differences. British Journal of Psychiatry 1997;171:519523. F. Benefits of this research to the NHS Primary angioplasty has the potential to save lives and reduce morbidity from heart attacks and stroke throughout the NHS. However, this potential will only be realised if appropriate services are established to deliver primary angioplasty, and resources are used efficiently. Failure to establish appropriate services could result in poor outcomes, disruption of other key cardiac services, inefficient use of resources or the development of services that are unacceptable to patients. This project will have the following benefits for the NHS: Identification of the important elements of the patient experience and measurement of patient and carer satisfaction will allow development of services that are acceptable to patients and carers. Investigation of workforce issues will allow strategic planning so that any future service development is appropriately staffed and is not detrimental to other services. Identification of barriers to implementation, and potential solutions, will help to ensure that countrywide implementation, if undertaken, is appropriate. Characterisation of different models of angioplasty service delivery that would be feasible in the NHS will assist planners to develop services that are appropriate for their local setting. Economic evaluation will assist policy-makers in deciding whether the costs of establishing primary angioplasty services are worthwhile, compared to a realistic alternative of an opportunistic use of angioplasty alongside thrombolysis, and will identify which model(s) of service delivery is (are) most cost-effective. G. Stakeholder involvement The Project Steering Group will include a patient representative (Enid Hirst), and professionals responsible for managing and delivering cardiac (Stephen Campbell, Rod Stables) and emergency (Jim Wardrope) services. We have also approached the British Heart Foundation and British Cardiac Patients association for representatives to assist with project guidance. Enid Hirst is assembling a consumer group of people who have experience of AMI or angioplasty to help to guide the project. This group will review the proposal, advise on any ethical issues arising from the research, help to develop materials for the patient and carer evaluation, and will provide feedback on outputs from the project. Evaluation of the National Infarct Angioplasty Project Pilots Version 001 18/11/2005 H. Plans for the dissemination of results At the end of the project we will produce an integrated report of the research that will be sent to the National Co-ordinating Centre for SDO, the National Institute for Clinical Excellence, the Department of Health, the British Cardiac Society and the British Cardiac Intervention Society.Copies of the Executive Summary of the report will be sent to individuals responsible for commissioning and providing acute cardiac services, patient representative groups, professional organisations involved in acute cardiac care, and key policy-makers. Copies of the report will be made available to participants of the studies. We will build upon contacts developed in previous projects with the Coronary Heart Disease and Emergency Services Collaboratives to disseminate findings through meetings, email and personal contacts. We will write scientific articles based on the findings that will draw wider conclusions regarding the development and organisation of cardiac services, for presentation at scientific meetings and for publication in international, peer-reviewed journals, in both the medical and health management areas. I. Project Timetable Description of service models Implementation and feasibility Workforce implications Patient & carer experience Economic evaluation Month of project 1-3 4-6 7-9 10-12 Collection of routine data 13-15 16-18 19-21 22-24 Survey of Analysis & pilot sites reporting Piloting site Data Analysis & visit collection reporting (site visits) Piloting site Data Analysis & visit collection reporting (site visits) Phase 1 Phase 2 & 3 Analysis & data collection data collection reporting Set up data Data collection and Analysis and collection and extraction modelling extraction J. Interim Reports We will produce an interim report at 12 months that will outline the models of service delivery developed, the results of piloting site visits, early information on patient and carer needs, initial cost data, and the planned model for economic evaluation. We will also produce progress reports at 6 and 18 months.