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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Methodology

Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses

Authors: Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn, Victoria J. Palmer

Published in: Trials | Issue 1/2017

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Abstract

Background

Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study. The purpose of the model is to embed engagement across the continuum of the trial which will test if an experience-based co-design intervention improves psychosocial recovery for people affected by severe mental illness.

Methods

The model was developed in three stages and used a structured iterative approach. A context mapping assessment of trial sites was followed by a literature review on recruitment and retention of hard-to-reach groups in complex interventions and RCTs. Relevant theoretical and philosophical underpinnings were identified by an additional review of literature to inform model development and enactment of engagement activities.

Results

Policy, organisational and service user data combined with evidence from the literature on barriers to recruitment provided contextual information. Four perspectives support the theoretical framework of the relational model of engagement and this is organised around two facets: the relational and continuous. The relational facet is underpinned by relational ethical theories and participatory action research principles. The continuous facet is supported by systems thinking and translation theories. These combine to enact an ethics of engagement and evoke knowledge mobilisation to reach the higher order goals of the model.

Conclusions

Engagement models are invaluable for trials research, but there are opportunities to advance their theoretical development and application, particularly within stepped wedge designed studies where there may be a significant waiting period between enrolment in a study and receipt of an intervention.
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Metadata
Title
Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses
Authors
Lauralie Richard
Donella Piper
Wayne Weavell
Rosemary Callander
Rick Iedema
John Furler
David Pierce
Kali Godbee
Jane Gunn
Victoria J. Palmer
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1878-7

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