Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT

Health Technology Assessment

卷:24

Rosalynde Johnstone¹  Sian Roberts¹  Liz Reymond²  Penney Lewis³  Paul Perkins⁴  Bee Wee⁵  Anthony Byrne⁶  Annmarie Nelson⁶  Sue Healy⁷  Zoe Hoare⁸  Nia Goulden⁸  Betty Foster⁹  Annie Hendry¹⁰  Marlise Poolman¹⁰  Jessica Roberts¹⁰  Emily AF Holmes¹⁰  Julia Hiscock¹⁰  Clare Wilkinson¹⁰  Stella Wright¹⁰  Dyfrig Hughes¹⁰  Rossela Roberts¹¹  Anne Parkinson¹²  Julie O’Connor¹² 

[1] Betsi Cadwaladr University Health Board, Bangor, UK;

[2] Brisbane South Palliative Care Collaborative, School of Medicine, Griffith University, Southport, QLD, Australia;

[3] Centre for Medical Law and Ethics, King’s College London, London, UK;

[4] Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK;

[5] Harris Manchester College, University of Oxford, Oxford, UK;

[6] Marie Curie Research Centre, School of Medicine, Cardiff University, Cardiff, UK;

[7] Metro South Palliative Care Service, Brisbane, QLD, Australia;

[8] North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK;

[9] Public Contributor, North Wales Cancer Patient Forum, North Wales Cancer Treatment Centre, Bodelwyddan, UK;

[10] School of Health Sciences, Bangor University, Bangor, UK;

[11] School of Psychology, Bangor University, Bangor, UK;

[12] Sue Ryder Leckhampton Court Hospice, Cheltenham, UK;

关键词: palliative care medicine;    terminal care;    community health care;    symptom assessment;    pain, breakthrough;    carers;    injections;    subcutaneous;   

DOI  :  10.3310/hta24250

来源: DOAJ

【 摘 要 】

Background: Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person’s home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries. Objectives: To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial. Design: We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods. Setting: Home-based care without 24/7 paid care provision, in three UK sites. Participants: Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency. Intervention: Intervention-group carers received training by local nurses using a manualised training package. Main outcome measures: Quantitative data were collected at baseline and 6–8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Results: In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n = 10; usual care, n = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care. Conclusion: The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial. Trial registration: Current Controlled Trials ISRCTN11211024. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.

【 授权许可】

Unknown