An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

Abstract

Background: Whilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors’ quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings.

Methods/design: This mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial.

Discussion: This process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care.

Trial registration: ISRCTN Registry, ISRCTN38920246. Registered on 22 June 2016.

Metadata

Item Type:	Article
Authors/Creators:	Hardicre, NK Crocker, TF https://orcid.org/0000-0001-7450-3143 Wright, A Burton, L-J Ozer, S Atkinson, R House, A https://orcid.org/0000-0001-8721-8026 Hewison, J https://orcid.org/0000-0003-3026-3250 McKevitt, C Forster, A Farrin, AJ LoTS2Care Programme Management Group
Copyright, Publisher and Additional Information:	(c) The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords:	Process evaluation; Complex intervention; Self-management; Stroke; New Start; Logic model; Outcomes chain; Interviews; Observations
Dates:	Accepted: 10 May 2018 Published: 11 July 2018
Institution:	The University of Leeds
Academic Units:	The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds)
Funding Information:	Funder Grant number NIHR National Inst Health Research 122676
Depositing User:	Symplectic Publications
Date Deposited:	13 Jul 2018 09:53
Last Modified:	13 Jul 2018 09:55
Status:	Published
Publisher:	BioMed Central
Identification Number:	10.1186/s13063-018-2683-7
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:133278

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An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

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