Title: Accessing medicines at end-of-life: a multi-stakeholder, mixed method evaluation of service provision
Funder: Department of Health and Social Care

Abstract: Background: Patient / carer access to medicines at end-of-life (EoL) is critical for control of symptoms, including pain and distress and recent evidence confirms end-of-life medicines optimisation is a research priority for patients and carers. Anecdotal data from our recent studies suggests the prescription, dispensing, supply and associated information given about medicines (medicines access) is experienced by patients as often difficult, complex, demanding, lacking co-ordination and involves a multiplicity of professionals and services. Some of these problems were associated with GPs’, who are main providers of EoL care delivery. Nurses often also take a lead role in providing community-based EoL care, but evidence suggests that here too there might be problems: prescribing by palliative care nurses has not been exploited to its full potential and nurses find it difficult to access GPs for EoL prescriptions. Moreover, community pharmacists’ expertise in palliative care medicines optimisation remains under-developed. Furthermore, whilst there are promising innovations in EoL service delivery, little is known about the impact of these on patient access to medicines, and their cost effectiveness remains largely un-evaluated. We will investigate these issues and draw together findings to provide a comprehensive, critical evaluation of current practice, highlighting best practice, challenges and generating expert-informed solutions. Aim: To provide an evaluation of patient and carer access to medicines at EoL within the context of current models of service delivery. Design and methods: The study employs a number of distinct, related phases. Phase 1: Systematic review of research evaluating medicines access experiences, influences and outcomes within EoL service delivery models. Phase 2: On-line questionnaire surveys of GPs, nurses and pharmacists providing community-based EoL care: GPs (n=200), community-based clinical nurse specialists (n=200), community nurses (n=200) and community pharmacists (n=200) to identify current practices in facilitating EoL medicines access, barriers and facilitators to improving access, and identification of models of service provision for Phase 3 evaluation. Data analysis will use descriptive and inferential statistics. Phase 3: Evaluative case studies (n=6) of medicines access experiences within different service delivery models. The unit of analysis will be the service delivery model. Within each case, mixed methods will include 10 patient / carer medicines access logs and interviews (study entry and at 4 and 8 weeks), case note review of 40 patient records, health care professional interviews, and an economic evaluation. Logs will be analysed using descriptive statistics and visual display techniques. Patient / carer interview data will be audio-recorded, fully transcribed and analysed using Framework Analysis. Health care professional interviews will be audio-recorded, fully transcribed and analysed using Framework Analysis. Annotated time-lines will be constructed from patient records for each patient with decisions, action points, services used, information accessed, to understand medicines access processes and identify points that would benefit from action. From patient records, we will identify the main pathways and healthcare resources used therein, and use sources e.g. NHS Reference costs and the Personal Social Services Research Unit cost report to cost these pathways. Method and data source triangulation will be undertaken within each case and cross-case comparison will be used for theory-building. Phase 4: Telephone interviews will be conducted with 20- 30 community pharmacists, and a national sample of key pharmaceutical wholesaler distribution companies (n=10) to illuminate the supply chain and barriers and facilitators to the effective supply of EoL medicines to patients and carers. Data will be analysed using Framework Analysis. Phase 5: An expert consensus-building workshop, to critically review and refine the study’s preliminary findings and recommendations. Sample participants will be EoL experts (n=40) including national policy leads (for service & workforce development), commissioners, EoL regional leads, patients, carers and health care professionals. With the study team, experts will generate policy, service delivery, practice and future research recommendations based on identification of: a) features of service deliverymodels that facilitate optimum access to medicines at EoL b) the mechanisms required to lever change and embed best models in routine practice. Study endpoints: identification of gaps in service provision and deficits in care experienced by patients and carers, as well as models of good practice and the context that supports and embeds these into EoL service delivery. The research will identify critical points for service intervention and workforce development to improve patient access to medicines at EoL.

Lay abstract: Patients and carers are recommending that finding ways of effectively managing medicines at the end of life should be a priority for research. Experience from our recent studies, and from talking with patients and carers while we were preparing this proposal, showed problems in getting the right prescriptions, at the right time, and from an accessible health care professional. They told us about problems with obtaining GP prescriptions and medicines from local pharmacies, that getting hold of medicines outside of normal NHS hours can be very difficult, and they are sometimes confused about how and who to get their medicines from. Our recent research also suggests that patients and carers need more information when medicines are first prescribed and supplied. Currently, accessing medicines (i.e. prescription, dispensing and information-giving processes) can cause patients and carers extra work and worry. These problems may also lead to under- or over-use of medicines, poor control of symptoms and avoidable use of NHS services. Some difficulties accessing medicines are related to the services that GPs provide. But there is also some evidence to suggest that what nurses do could be better: e.g. fewer than expected have trained to prescribe medicines. It has also been suggested that pharmacists could play more of a role in helping patients access end of life medicines. There are also new end of life services that might help with access, e.g. 24 hour services. But none of these issues have been researched systematically, in-depth or on a large scale. We will study services designed to help people access medicines in the last year of life. First we will fully review previous research to check what is already known and what the gaps and key issues are. Next we will carry out an on-line survey of approximately 200 each of GPs, nurses and pharmacists who provide care to patients at the end of life in the community. We will use the survey to analyse their current practice and what needs to change to improve prescribing, supplying and giving information to patients about medicines. In the next phase of the study, we will then evaluate 6 different types of end of life services – including new or novel services – in detail, using each one as a case study. In each we will ask 10 patients and carers to keep a log of their experiences of accessing medicines and we will interview them initially face-to-face, and then over the telephone 4 and 8 weeks later. We also will interview the health professionals involved in prescribing, supplying and giving information about their medicines. In each case study, we will also map out patient pathways to accessing medicines by looking at a sample of 40 patients’ records to analyse what medicines were prescribed, by whom, when, how often and what services were used. This will help us identify problems and where actions could be taken to improve services. We will also analyse the costs and outcomes for each type of service. In the next phase of the study, we will interview over the telephone a sample of 20-30 community pharmacists and a sample of companies that make and distribute medicines to pharmacies, to understand the “medicines supply chain” and why disconnections happen. Finally, after analysing our data, we will invite up to 40 people with interest and expertise in end of life medicines to a workshop to debate our findings and make recommendations for policy, practice and future research.

Research activity codes: 7.2 END OF LIFE CARE;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE