Plain English Summary
Background and study aims
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 recent studies, and from talking with patients and carers, showed problems in getting the right prescriptions, at the right time, and from an accessible health care professional. They experienced problems with obtaining GP prescriptions and medicines from local pharmacies, getting hold of medicines outside of normal NHS hours can be very difficult, and confusion 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. However, none of these issues have been researched systematically, in-depth or on a large scale. The aim of this study is to provide an evaluation of patient and carer access to medicines at the end-of-life within the context of models of service delivery.
Who can participate?
This study includes GPs, nurses, pharmacists and end of life patients.
What does the study involve?
This study looks at services designed to help people access medicines in their last year of life and is split into phases. The first phase of the study fully reviews previous research to check what is already known and what the gaps and key issues are. Then, 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 is conducted. This survey is used 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 the study, six different types of end of life services, including new or novel services, are evaluated in detail, using each one as a case study. In each type, 10 patients and carers are asked to keep a log of their experiences of accessing medicines and then undergo interviews initially face-to-face, and then over the telephone four and eight weeks later. Health professionals involved in prescribing, supplying and giving information about their medicines are also interviews. In each case study, patient pathways to accessing medicines are mapped out 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 helps to identify problems and where actions could be taken to improve services. The costs and outcomes for each type of service are also analysed. In the next phase of the study, a sample of 20-30 community pharmacists and a sample of companies that make and distribute medicines to pharmacies are interviewed over the phone to understand the “medicines supply chain” and why disconnections happen. Finally, after analysing the data, up to 40 people with interest and expertise in end of life medicines are invited to a workshop to debate our findings and make recommendations for policy, practice and future research.
What are the possible benefits and risks of participating?
It is not anticipated that there will be any direct benefits or risks from taking part in the study, other than those benefits associated with knowingly contributing to scientific knowledge through participation in research.
Where is the study run from?
This study is being run by University of Southampton (UK).
When is the study starting and how long is it expected to run for?
January 2018 to July 2020
Who is funding the study?
Health Services and Delivery Research Programme (UK)
Who is the main contact?
Dr Natasha Campling (Scientific)
Dr Natasha Campling
Faculty of Health Sciences
University of Southampton
IRAS 231837, IRAS 253133, HS & DR 16/52/23
Accessing medicines at end-of-life: a multi-stakeholder, mixed method evaluation of service provision
The aim of this study is provide an evaluation of patient and carer access to medicines at end-of-life within the context of models of service delivery.
1. To produce a critical overview of existing research on experiences and outcomes of medicines access within EoL models of service delivery, through a systematic literature review (Phase 1).
2. To undertake a large scale survey to evaluate EoL care professionals’ current practices, identify factors influencing professionals' contributions, the potential of the community-based nurse and pharmacist workforce to improve patient access to medicines at EoL, and provide an overview of current models of service delivery (Phase 2)
3. To evaluate and compare patient and carer experience of medicines access within models of EoL service delivery, including those featuring innovations in care, and to investigate their integration and sustainability through undertaking mixed methods case studies of practice (Phase 3)
4. To estimate the cost-effectiveness of service models (Phase 3)
5. To map patient ‘access to medicines pathways' at EoL, including time-lines of problems, decisions, actions and use of services (Phase 3)
6. To identify barriers and facilitators to maximising the contribution of the nurse and pharmacist workforce to medicines access at EoL (Phases 2 & 3)
7. To interview community pharmacists and wholesalers and distributors to evaluate supply chain processes and identify challenges in providing access to EoL medicines (Phase 4)
8. To convene an expert consensus-building workshop to review study findings and generate recommendations on key characteristics of EoL service delivery that result in responsive, person-centred, coordinated medicines access, together with identification of factors that will embed and sustain characteristics in routine practice (Phase 5)
9. To use the expert consensus workshop to identify models to evaluate in a follow on study, comparing the effectiveness and cost-effectiveness of service delivery models (Phase 5)
Current ethics approval as of 31/01/2020:
Phase 2 approved 26/06/2018, Health Research Authority, IRAS ref: 231837
Phase 3 and 4 approved 06/02/2019, amendment approved 09/07/2019, Health Research Authority, IRAS ref: 253133, REC ref: 18/SC/0675
Previous ethics approval:
Request for approval for Phase 2 submitted to Faculty of Health Sciences Ethics Committee 26.01.2018
Request for approval of Phase 3 to be made in May 2018 to HRA
Request for approval of Phase 4 to be made in October 2018 to HRA
Not provided at time of registration
Mixed methods design
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Phase 1: This phase consists of a systematic review of research evaluating medicines access experiences, influences and outcomes within EoL service delivery models.
Phase 2: This phase includes sending on-line questionnaire surveys to GPs, nurses and pharmacists providing community-based EoL care. These are sent to 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 is doing using descriptive and inferential statistics.
Phase 3: This phase consists of evaluative case studies (n=6) of medicines access experiences within different service delivery models. The unit of analysis is the service delivery model. Within each case, mixed methods are conducted which 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 are analysed using descriptive statistics and visual display techniques. Patient / carer interview data is audio-recorded, fully transcribed and analysed using Framework Analysis. Health care professional interviews are audio-recorded, fully transcribed and analysed using Framework Analysis. Annotated time-lines aree 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, the main pathways and healthcare resources used therein are identified, 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 are undertaken within each case and cross-case comparison will be used for theory-building.
Phase 4: This phase consists of interviews with pharmacists and pharmaceutical companies. Telephone interviews are 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 is analysed using Framework Analysis (9).
Phase 5: An expert consensus-building workshop, to critically review and refine the study’s preliminary findings and recommendations. Sample participants are 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 generate policy, service delivery, practice and future research recommendations based on identification of: a) features of service delivery models that facilitate optimum access to medicines at EoL b) the mechanisms required to lever change and embed best models in routine practice.
Primary outcome measure
1. Identification of gaps in service provision and deficits in care experienced by patients and carers is assessed using a systematic review of literature (Phase 1), questionnaire survey (Phase 2), patient logs, patient and health care professional interviews, data on service use from patient records within evaluative case studies (Phase 3), and interviews with community pharmacists and pharmaceutical wholesalers and distributors
2. Models of good practice of EoL in service delivery is assessed using a systematic review of literature (Phase 1), questionnaire survey (Phase 2), patient logs, patient and health care professional interviews, data on service use from patient records within evaluative case studies (Phase 3), and interviews with community pharmacists and pharmaceutical wholesalers and distributors
Secondary outcome measures
There are no secondary outcome measures.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
2. Community-based palliative care clinical nurse specialists
3. Community nurses
4. Community pharmacists
Purposively selected 3 service delivery models in the north of England and 3 in the south, using a sampling frame derived from Phase 2 respondent EoL service models and informed by logic models.
Purposive and snowball sampling will be used to identify national experts, including EoL policy, service delivery, professional, and education leads at the Department of Health, NHS England, Health Education England, Royal College of Nursing, Royal College of General Practitioners, Royal Pharmaceutical Society, Health Education England workforce development leads, Clinical Commissioning Group leads for EoL, EoL and Non-Medical Prescribing programme leads from HEIs, charity representatives e.g. Marie Curie, Macmillan Cancer Care, pharmaceutical wholesaler representatives, and key EoL health care professionals. Our PPI co-applicant and Advisory Group PPI members will represent EoL informal carer perspectives.
Target number of participants
Phase 2: We will aim for a sample of at least 200 in each professional group. Phase 3: Six case studies. sub-units: a) 10 patients (and their carers where appropriate), sampled within each case; b) up to a maximum of 5 health care professionals who are the main providers of EoL care to each of the 10 patients in the case study service model; c) A retrospective sample of 40 patient records (including patients taking part in logs and interviews) will be reviewed, to map medicines access patient pathways. Phase 4: interviews with 20-30 community pharmacists and approximately 10 key pharmaceutical wholesalers and distributors. Phase 5: up to 40 experts
Participant exclusion criteria
Those who do not fit the inclusion criteria.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Southampton
University of Southampton
+44 238 059 5058
Health Services and Delivery Research Programme
Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Dissemination and outputs will include:
1. Study website outlining the study and key findings
2. Dedicated study twitter account to tweet study launch, headlines and links to outputs
3. Publications in international peer reviewed research journals
4. Policy briefs targeted at policy makers responsible for EoL care and prescribing services
5. Publications in professional journals
6. Presentation at conferences
7. Executive summary with clearly identified policy, commissioning, workforce, education and
8. Practice implications.
9. Full report detailing all work undertaken, with supporting technical appendices
Dissemination and impact activities, peer review publications and conference presentations will complete by 31/10/2020.
The protocol is not currently publically available –NIHR will publish this when it is ready.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
- ISRCTN12762104_PROTOCOL_16Apr2019.pdf uploaded 08/08/2019