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
Allbwn ymchwil: Cyfraniad at gyfnodolyn › Erthygl › adolygiad gan gymheiriaid
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Yn: Trials, Cyfrol 20, Rhif 1, 105, 07.02.2019.
Allbwn ymchwil: Cyfraniad at gyfnodolyn › Erthygl › adolygiad gan gymheiriaid
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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 -