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. 2018 Jul 11;19(1):368.
doi: 10.1186/s13063-018-2683-7.

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

Natasha K Hardicre  1 , Thomas F Crocker  1 , Alan Wright  1 , Louisa-Jane Burton  1 , Seline Ozer  1 , Ross Atkinson  1 , Allan House  2 , Jenny Hewison  3 , Christopher McKevitt  4 , Anne Forster  5   6 , Amanda J Farrin  7 ; LoTS2Care Programme Management Group
Affiliations

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

Natasha K Hardicre et al. Trials. .

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.

Keywords: Complex intervention; Interviews; Logic model; New Start; Observations; Outcomes chain; Process evaluation; Self-management; Stroke.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been obtained through the Yorkshire and the Humber – Leeds West Research Ethics Committee (REC) (16/YH/0390).

Ethical approval includes agreed processes for obtaining consent (or consultee declaration) from (or with regard to) all staff, stroke survivors and carers with and without capacity, in line with the provisions of the Mental Capacity Act.

Any protocol amendments will be approved by the REC prior to informing researchers and participating sites of any related process changes. Amendments impacting participants’ involvement will be communicated to them in an appropriate manner, as agreed by the REC. At the time of writing, the current approved protocol is version 2, dated 20 March 2017.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
New Start intervention logic model. QoL quality of life
Fig. 2
Fig. 2
New Start outcomes chain. CCG Clinical Commissioning Group, QoL quality of life
See this image and copyright information in PMC

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