Evaluation of the National Infarct Angioplasty Project Pilots (NIAPP): summary of proposed research. Background, aims and objectives.The Department of Health is currently funding a number of pilot sites as part of theNational Infarct Angioplasty Project Pilots to test the feasibility of implementing acountrywide primary angioplasty service for patients with acute ST-elevationmycocardial infarction (STEMI). We aim to evaluate the pilot sites and address the fiveelements 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. Plan of investigationWe plan to compare the pilot (intervention) sites to four control sites that have notformally established a primary angioplasty service. Evaluation will take a whole-systemapproach. We anticipate that even pilot sites that successfully implement 24-hourprimary angioplasty will still use thrombolysis for at least a residual proportion ofpatients. Likewise, control sites that do not develop a primary angioplasty service maystill 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, ratherthan focussing upon those who received the intended or principal service.Patient and carer experienceWe propose to use a phased approach of developing an instrument specific to thepatient and carer experience of primary angioplasty. We will use the instrument todescribe experiences in a range of pilot and control sites.
Phase 1 will involve two sites with designated special responsibility for the evaluation ofthe patient and carer experience. Qualitative interviews post-discharge will be based ona maximum-diversity sample of patients and carers attending the pilot sites to includedifferent ages, genders, arrival routes and living distance from pilot sites. We willinterview between 15 and 25 people in their own homes using the critical incidenttechnique to determine positive and negative aspects of the process, including issuessuch as communication and quality of care. We will also use these interviews to assessthe feasibility of using a postal questionnaire in phase 2, specifically addressing theissue of identification of carers.The interviews will be used alongside other published instruments to develop a NIAPP-specific instrument to measure patient and carer satisfaction. A generic questionnairewill also be developed for patients in the context of emergency cardiac care.Questionnaires will be reviewed and piloted by the project consumer group.Phase 2 will involve a questionnaire developed from the interviews as well as othergeneric instruments for assessing patient satisfaction. We will send a postalquestionnaire 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, ensuringthat the samples are suitably screened for severe adverse events. The patientquestionnaire will include the NIAP-specific and generic instruments, the carerquestionnaire will include the NIAP-specific instrument only. We expect a minimum of 75patients 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% withtwo reminders.To provide data for comparison, we will send questionnaires to 300 patients with ST-elevation AMI in four control hospitals. We will only post the generic instrument topatients at control sites for direct comparison with pilot-site patients. We will aim toselect the four pilot sites with the highest proportion of patients receiving angioplasty sothat this aspect of the evaluation maximises the contrast between intervention andcontrol care. This sample size will have 80% power to detect a 0.75 point change oneach 5-point patient satisfaction question (alpha=0.05).Patients will be identified by staff within the cardiology department at the hospitals.Patients will need to consent to their postal details being sent to researchers at theUniversity of Sheffield. Questionnaires and reminders will then be administered byresearchers at the University.Phase 3 will involve up to 20 qualitative interviews with patients and carers from the twooriginal pilot sites to expand upon results from the survey and identify possible solutionsto issues identified. Patients will be identified from the questionnaire respondents.Workforce implications, implementation and feasibilityWe will use a mixture of quantitative and qualitative methods to address the questionsoutlined in the brief. Staff involved with providing angioplasty services will be identifiedby prior contact with the Trust.Six of the pilot sites will be selected to take part in the workforce assessment. It isanticipated that specific material will be produced for this study. These will be developedon sites working closely with the teams who are collecting economic data to produce aholistic model of investigation, and will involve close collaboration with researchersworking at two other sites to develop the patient and carer satisfaction evaluation. Oncepiloted these materials and methods will be developed, edited and then used with theother intervention sites.We will administer self-complete questionnaires to staff who work with patients that havetreatment for AMI. We will send the questionnaire to relevant staff by internal mail
suggesting completion during work time. The questionnaire will examine the changingaspects of their work role, flexible working and managing a 24 hour service, support andtraining, teamworking and work factors (e.g., autonomy, role clarity, role conflict,influence in decision-making, peer and leader support).Questionnaire data will be complemented by the use of focus groups and semi-structured interviews with key stakeholders to examine the impact of the angioplastyservice on the workforce and explore the wider implications of providing an emergencyangioplasty service, such as cardiologists not being available for the general medicalrota and changes to emergency referral patterns. Additional focus groups will examinethe impact of angioplasty on other associated workforces (e.g. radiography, ambulanceservices and the emergency department). These focus groups and interviews will alsoexplore issues of implementing the service and factors perceived to have facilitated oropposed effective delivery. Observational data will be collected, and where this is notpossible it will be collected retrospectively through discussion of cases after treatment.A one-day site visit will be used as the principal vehicle to arrange and conductinterviews and focus groups. We will try to arrange this around an elective PCI sessionto minimize any inconvenience to staff. The visit will be supplemented, as necessary bytelephone interviews, if staff are unavailable at the time of the visit. The visit will also beused to undertake the specialist teamworking interviews and ethnographic observation(or where not possible retrospective case discussion) that will address theimplementation and feasibility issues.Teamworking interviews will examine the exact nature of the service delivery team, howteam members work together and how their specific roles integrate. The model for thesite visit will be piloted within the first six months of the project (phase one) to enableany practical adjustments to be made. It is anticipated data will be collected on 6 sitesduring the period September 2006 to March 2007.Data will be analysed using quantitative and qualitative methods. This material will bepresented in an anonymous manner and integrated into a final report looking at variousaspects of pilot project evaluation. A summary of this report and access to the finaldocument will be made available to all who take part in the studyDescription of models of service deliveryWe will use data from routine sources (NIAPP, MINAP, BCIS, CCAD, HES), a telephonesurvey and site visits to describe the models of service delivery developed by the pilotsites. We will seek information on the following parameters: Service setting: urban orrural; area covered; catchment population (number, age and gender, coronary heartdisease morbidity and mortality rates, ethnicity and social deprivation); transport andcommunications networks. Service overview: participating hospitals; teaching status;referral networks between hospitals; ambulance services; other prehospital care; accessroute to the service. Service infrastructure: staff numbers, grades, profession andspecialties; interventional cardiology skills; rostering and on-call arrangements; facilitiesand equipment; bed availability (general, coronary care and intensive care); cardiacsurgery services. Service activity levels: number of AMI treated (prehospitalthrombolysis, in-hospital thrombolysis and angioplasty), numbers of emergency andelective admissions, revascularisation procedures, and cardiac operations performed.Economic evaluationMark Sculpher and colleagues at the University of York have already developed a cost-effectiveness model to compare angioplasty to thrombolysis. It considers cost-effectiveness from the perspective of the NHS and uses data from the literature androutine 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 toangioplasty. The value of the model for the pilot evaluation is that it can be used toexplore how the cost-effectiveness of primary angioplasty might vary between thedifferent types of service configuration seen in the pilot centres. In particular, it can usecentre-specific data on costs and times to reperfusion to assess variation in cost-effectiveness across different models of service delivery.We will increase the robustness and scope of the cost-effectiveness analysis byundertaking a microcosting study to measure the true costs of providing angioplasty indifferent models of service delivery and check the validity and completeness of MINAPdata. Working alongside the workforce and feasibility evaluations, we will identify factorsthat determine the true cost of providing angioplasty.We will collect resource use data from four intervention and four control sites for 60patients at each site, giving a total of 240 patients in each arm. At each of these sites,data will be collected on staff costs, equipment, consumables, drugs and proceduresassociated with the intervention (angioplasty or thrombolysis). Care will be taken tostratify patients by day and night time admission in order to capture any differences thatmay arise due to the timing of the admission.The resource use data will be valued using local unit costs where available or nationalunit costs. We will use, as far as possible, centre-specific cost data, estimated incollaboration with local finance departments using a standardised protocol. Staffingcosts will be assessed in conjunction with cath lab management. The staffingarrangements will be costed according to whether procedures take place in or out ofhours and the specific trust arrangements regarding out of hours staff includingsensitivity analyses that assume different costs of knock on cancellations from out ofhours work.It is anticipated that much of the data can be collected retrospectively using routinelycollected data (MINAP / NIAPP / BCIS datasets). Where required, we will supplementthis with detailed examination of patient and ambulance notes. Data will be gathered onthese patients individual characteristics, including time to needle/balloon, for use ascovariates in the cost analysis.We also intend to ask staff to complete a short questionnaire immediately aftercompleting a sample of PCIs in order to record staff involved and their perception ofknock on effects the following day. An additional adjustment that must be included is toidentify the proportion of patients that are referred as ST- elevation AMI and thereforemay trigger the out of hours team but are subsequently found not to be “true” cases.All the new data collected will be synthesized with the data in the existing cost-effectiveness model and an incremental cost per QALY will be estimated. Probabilisticsensitivity analysis will be used to address the uncertainty in the input parameters of thecost-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 todetermine how much of the variation in cost can be explained by differences in themodels of service delivery used, having controlled for case mix. Findings from theworkforce and feasibility evaluations will be used to explain how different models ofservice delivery may be associated with different costs. The different costs for eachpotential model of service delivery will then be used in the cost-effectiveness model toexplore the relative cost-effectiveness of the different approaches to service delivery.
Summary of research elements and timescales.Element of No. sites What is involved for each site? Timescalesresearch involvedPatient & Carer 2-3 Recruiting around 10 patients and May-Augustevaluation: intervention their carers at each site for a face- 2006phase 1 sites to-face interview.(developmentinterviews)Patient & Carer 4 intervention Recruiting @75 patients and their Octoberevaluation: sites and 4 carers (where possible) in each site /Novemberphase 2 (postal control sites to be sent a questionnaire. 2006 – Julyquestionnaires) Checking patient status for any 2007 patients to whom we send a reminderPatient & Carer Any of the Patients and carers will be recruited Novemberevaluation: sites involved from the questionnaire study. Staff 2006-Julyphase 3 in phase 2. may be asked to check the status of 2007(exploratory a patient before us contacting them.interviews)Description of All A researcher will undertake site March 2006-service models intervention visits and telephone questionnaire January 2007 and control with PI/key staff. sites We will require access to routine data sources (MINAP, CCAD, NIAPP etc)Workforce 6 intervention Staff working with STEMI patients Septemberevaluation: staff sites (in variety of roles) will be asked to 2006- Aprilsurvey complete a questionnaire around 2007 workforce issues.Workforce, 6 intervention Some of the above staff and other Septemberimplementation sites staff in roles affected by PPCI may 2006- Apriland feasibility: be asked to participate in focus 2007focus groups & groups or semi-structured interviewsinterviews to discuss teamworking, implementation and feasibility issues.Economic 4 intervention A health economist will discuss August 2006evaluation: sites and 4 economic issues with finance and – June 2007identification of control sites cardiology staff.cost data We will require access to routine data and patient notes for 60 patients at each site.Economic 4 intervention For a subset of patients, staff will be August 2006evaluation: sites and 4 asked to complete a short survey – June 2007survey of staff control sites about time spent on PCI procedurestime. and consequences of on-call.