CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial

Abstract

BackgroundWhile the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them.Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries.Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK.MethodsThis paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life and wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval.DiscussionThis study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care.The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37).Trial registrationISRCTN, ISRCTN 11211024. Registered on 27 September 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3179-9) contains supplementary material, which is available to authorized users.

Family and health-care professionals managing medicines for patients with serious and terminal illness at home: a qualitative study

“…132 Such practices remain uncommon in the UK, with only a small body of exploratory work and local policy having been developed to date. [133][134][135][136] The prescribing and subsequent use of AMs is a very significant moment in the patient's dying trajectory.…”

“…Other participants were willingsometimes keento extend their role in managing medicines and learn techniques of administration, such as giving injections, administering AMs, replacing syringe driver cartridges or managing dialysis. 112,133 Taking a proactive role could be valued as a means of providing rapid pain relief and reducing dependence on HCPs. FCGs could be frustrated when professionals did not acknowledge their competence and expertise.…”

“…57,129,131 Local schemes or research projects have been undertaken in the UK, but are not widespread. 133 Regardless of the role that patients and families wish to take in medicines management, it is important that this should be explicitly discussed, agreed and kept under review throughout different stages of the patient's illness. All patients and FCGs should have round-the-clock access to responsive, expert help and advice about medicines management and symptom control.…”

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