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

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,

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

Most people in the UK would prefer to die at home, but only half of them achieve this. This usually depends on having able and willing lay carers (family or friends) to help look after them. Once swallowing is not possible, medicine is given continually under the skin (syringe driver). If common problems such as pain, vomiting or agitation break through, health-care professionals attend to give extra doses. The wait for a health-care professional to arrive can be distressing. In the UK, it is legal (but not routine) for lay carers to give needle-free subcutaneous injections themselves. We reworked an Australian carer education package for UK use. The best way to find out if this would work well is to do a randomised controlled trial. This is a test in which, at random, half of the people taking part receive ‘usual care’ and the other half receive the ‘new care’ or intervention. A pilot randomised controlled trial (a ‘test’ trial to see if a larger one is worth doing) was carried out to determine if lay carer injections were possible in the UK. We approached 90 dyads (a dying person and a key carer) and, of these, 40 were willing to take part and 22 completed the follow-up visit, so we could analyse their data. Of these 22 dyads, 16 were in the intervention group (lay carer injects) and six were in the control group (usual care). All carers were asked to keep a diary. Carers and health-care professionals were interviewed (qualitative study) and carer preferences were assessed. This new practice was safe, acceptable and welcomed. Carer confidence increased rapidly, symptom control was quicker and the interviews backed up these findings. Recruitment was low owing to overstretched health-care professionals. Only certain families were picked. Dyads in the usual-care group often wished they were in the intervention group. Carers found it difficult to complete some of the questionnaires that were used to measure the effect of the intervention. Therefore, uncertainty remains as to whether or not a full trial should proceed. Because the practice is already legal, some areas in the UK are already undertaking it. We plan to study what makes this practice possible or less possible to achieve.

Déclaration de conflit d'intérêts

Anthony Byrne reports grants from Marie Curie (London, UK), Health and Care Research Wales, the End of Life Board for Wales and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme outside the submitted work; he is also a member of the End of Life Board for Wales, which is responsible to the Welsh Government for developing and implementing strategy for end-of-life care in Wales. Bee Wee reports that she is National Clinical Director for End of Life Care, Chairperson of the National Institute for Health and Care Excellence Quality Standards Advisory Committee and has a NIHR-funded grant outside the submitted work. She has also received royalties for a book published by Oxford University Press (Oxford, UK). Dyfrig Hughes reports that he was a member of the HTA Programme Pharmaceuticals Panel (2008–12) and member of the HTA Programme Clinical Evaluation and Trials Board (2010–16). Marlise Poolman was a member of the HTA Prioritisation Committee: Integrated Community Health and Social Care (A) from 2013 to 2019. Zoe Hoare reports that she is an associate member of NIHR Health Services and Delivery Research board. Clare Wilkinson reports that she was chairperson of the HTA Commissioning Panel – Primary Care, Community, Preventive Interventions (2013–18) and a member of the HTA Rapid and Add-0n Trials Board (2012–13).