Title

CARiAD - CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in home-based dying patients: a UK study 

Principal / Lead Investigator
Co-Investigators
Type of study

Feasibility study and external randomised pilot trial

Summary

This project focusses on timely administration of as-needed medication for dying patients being cared for at home, in particular whether lay carer role-extension (to be trained to give as-needed SC injections) is feasible and acceptable in the UK.

We hope to conduct a RCT comparing injections given by carers to dying patients looked after at home (the new care) versus HCP-given injections (the usual care). Before doing a large trial, it is good practice to first test the feasibility in a smaller group of patients. Our study is such a feasibility study.

Firstly, we will ensure that everyone understands it is legal for carers to give symptom-relieving injections to dying patients as long as they are supported to do so. Our Australian partners have a time-tested education package: we will ensure this is reworked for UK patients, carers and HCPs. We will hold workshops to do this, and decide how best to explain the study to carers and patients.

Then we will ask patients and their carers whether they are willing to be randomised to ‘usual care’ or ‘new care’. Carers in the ‘new care’ part will be trained how to recognise symptoms, to give injections and then see if they work to relieve the symptom. Carers in the ‘usual care’ group will be asked to call a HCP if their loved one has breakthrough symptoms. Carers in both parts will be asked to keep a diary of symptoms and treatments. They will be invited to talk about how they found the study and the experience of giving injections.

Information from this feasibility study will help us to understand if a large trial, to give a final answer, is possible.

See also: CARiAD study summary on ISRCTN registry

Please describe how the public / patients were involved in the development of the study design, and how they will be involved in the funded study?

Two service users are co-applicants. Insights gained from their experiences of giving injections to dying loved ones at home were crucial in designing the project. They have offered to be involved at all stages of the project. Their involvement will be fundamental in disseminating the research results to patients, carers and healthcare professionals. Two additional groups of bereaved carers have been consulted and their suggestions on consent mechanisms, drug safety, training and ongoing support have been incorporated into the study design.

How could this research potentially benefit patients?

This study aims to improve the quality of experience (and thus increase the likelihood of a ‘good death’) for the patient who chooses to be at home by providing speedier symptom control and supporting their wish to die at.

Health care / Social care / Mixed?

Health care 

Who is the study sponsor?

Bangor University

Funder

NIHR Health Technology Assessment (HTA) Programme

Total grant value

£ 490,856

Start date

31/05/2017

End date

31/10/2019

Outputs generated (Reports / Publications / Impact)

NIHR Blog article: 'Should family members be given more power to help relatives dying at home'.
Clare Wilkinson, 17 March 2017

News article: 'Should family members be given more power to help relatives dying at home', The Conversation
Clare Wilkinson, Deputy Head of Research, School of Healthcare Sciences and Professor of General Practice, Bangor University, 15 March 2017

Publication: Poolman M, Roberts J, Byrne A, Perkins P, Hoare Z, Nelson A, Hiscock J, Hughes D, Foster B, O’Connor J, Reymond L, Healy S, Roberts R, Wee B, Lewis P, Johnstone R, Roberts S, Holmes E, Wright S, Hendry A, Wilkinson C. 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. Trials 201920:105 https://doi.org/10.1186/s13063-019-3179-9