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

Kim de Nooijer, Lara Pivodic, Nele Van Den Noortgate, Peter Pype, Lieve Van den Block

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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.

Originele taal-2English
Artikelnummere043663
Aantal pagina's11
TijdschriftBMJ Open
Volume11
Nummer van het tijdschrift1
DOI's
StatusPublished - 20 jan 2021

Bibliografische nota

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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