Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial

Introduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a...

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Autores principales:	Lieve Van den Block, Kim de Nooijer, Lara Pivodic, Peter Pype, Nele Van Den Noortgate
Formato:	article
Lenguaje:	EN
Publicado:	BMJ Publishing Group 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/a29b72a89fb94d5c85a9cdf8f46d1b47
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spelling	oai:doaj.org-article:a29b72a89fb94d5c85a9cdf8f46d1b472021-11-20T18:00:07ZTimely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial10.1136/bmjopen-2020-0436632044-6055https://doaj.org/article/a29b72a89fb94d5c85a9cdf8f46d1b472021-01-01T00:00:00Zhttps://bmjopen.bmj.com/content/11/1/e043663.fullhttps://doaj.org/toc/2044-6055Introduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a pilot randomised controlled trial (RCT) with a process evaluation that aims to assess the feasibility and preliminary effectiveness of the Frailty+ intervention.Methods and analysis We will conduct a pilot RCT in Flanders, Belgium. Frail older people who are discharged to home from hospital will be identified and recruited. Seventy-six will be randomly assigned either to the control group (standard care) or the intervention group (Frailty+ intervention alongside standard care). Data will be collected from patients and family carers. At the core of the Frailty+ intervention is the provision of timely short-term specialised palliative care facilitated by a nurse from the specialised palliative home care service over a period of 8 weeks. We will assess feasibility in terms of recruitment, randomisation, acceptability of the intervention, retention in the programme and data completion. The primary outcome for assessing preliminary effectiveness is a mean score across five key symptoms that are amenable to change (ie, breathlessness, pain, anxiety, constipation, fatigue), measured at baseline and 8 weeks post-baseline. The process evaluation will be conducted in the intervention group only, with measurements at 8–11 weeks post-baseline to evaluate implementation, mechanisms of change and contextual factors.Ethics and dissemination The study has been approved by the ethics committee of University Hospital Ghent. Results will be used to inform the design of a full-scale RCT and will be published in a peer-reviewed, open access journal.Trial registration number ISRCTN39282347; Pre-results.Lieve Van den BlockKim de NooijerLara PivodicPeter PypeNele Van Den NoortgateBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 11, Iss 1 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
description	Introduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a pilot randomised controlled trial (RCT) with a process evaluation that aims to assess the feasibility and preliminary effectiveness of the Frailty+ intervention.Methods and analysis We will conduct a pilot RCT in Flanders, Belgium. Frail older people who are discharged to home from hospital will be identified and recruited. Seventy-six will be randomly assigned either to the control group (standard care) or the intervention group (Frailty+ intervention alongside standard care). Data will be collected from patients and family carers. At the core of the Frailty+ intervention is the provision of timely short-term specialised palliative care facilitated by a nurse from the specialised palliative home care service over a period of 8 weeks. We will assess feasibility in terms of recruitment, randomisation, acceptability of the intervention, retention in the programme and data completion. The primary outcome for assessing preliminary effectiveness is a mean score across five key symptoms that are amenable to change (ie, breathlessness, pain, anxiety, constipation, fatigue), measured at baseline and 8 weeks post-baseline. The process evaluation will be conducted in the intervention group only, with measurements at 8–11 weeks post-baseline to evaluate implementation, mechanisms of change and contextual factors.Ethics and dissemination The study has been approved by the ethics committee of University Hospital Ghent. Results will be used to inform the design of a full-scale RCT and will be published in a peer-reviewed, open access journal.Trial registration number ISRCTN39282347; Pre-results.
format	article
author	Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate
author_facet	Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate
author_sort	Lieve Van den Block
title	Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
title_short	Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
title_full	Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
title_fullStr	Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
title_full_unstemmed	Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
title_sort	timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
publisher	BMJ Publishing Group
publishDate	2021
url	https://doaj.org/article/a29b72a89fb94d5c85a9cdf8f46d1b47
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Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial

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