TY - JOUR

T1 - CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD)

T2 - study protocol for a UK-based open randomised pilot trial

AU - Poolman, Marlise

AU - Roberts, Jessica

AU - Byrne, Anthony

AU - Perkins, Paul

AU - Hoare, Zoe

AU - Nelson, Annmarie

AU - Hiscock, Julia

AU - Hughes, Dyfrig

AU - Foster, Betty

AU - O'Connor, Julie

AU - Reymond, Liz

AU - Healy, Sue

AU - Roberts, Rossela

AU - Wee, Bee

AU - Lewis, Penney

AU - Johnstone, Rosalynde

AU - Roberts, Sian

AU - Holmes, Emily

AU - Wright, Stella

AU - Hendry, Annie

AU - Wilkinson, Clare

PY - 2019/2/7

Y1 - 2019/2/7

N2 - BACKGROUND: While 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.METHODS: This 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.DISCUSSION: This 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 REGISTRATION: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

AB - BACKGROUND: While 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.METHODS: This 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.DISCUSSION: This 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 REGISTRATION: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

KW - Analgesics/administration & dosage

KW - Antiemetics/administration & dosage

KW - Attitude to Death

KW - Caregivers/education

KW - Delivery of Health Care/methods

KW - Education, Nonprofessional/methods

KW - Feasibility Studies

KW - Health Knowledge, Attitudes, Practice

KW - Home Care Services

KW - Humans

KW - Hypnotics and Sedatives/administration & dosage

KW - Injections, Subcutaneous

KW - Multicenter Studies as Topic

KW - Palliative Care/methods

KW - Pilot Projects

KW - Randomized Controlled Trials as Topic

KW - Terminal Care/methods

KW - Time Factors

KW - Treatment Outcome

KW - United Kingdom

U2 - 10.1186/s13063-019-3179-9

DO - 10.1186/s13063-019-3179-9

M3 - Article

C2 - 30732624

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 105

ER -