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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Arthritis | Study protocol

The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis

Authors: Alison Hammond, Kathryn A. Radford, Angela Ching, Yeliz Prior, Rachel O’Brien, Sarah Woodbridge, June Culley, Jennifer Parker, Paula Holland

Published in: Trials | Issue 1/2022

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Abstract

Background

The Workwell trial is a multi-centre randomised controlled trial with the aims of evaluating the effectiveness and cost-effectiveness of job retention vocational rehabilitation for employed people with inflammatory arthritis, who are experiencing work difficulties due to their arthritis. Vocational rehabilitation is delivered by health service occupational therapists, who have received additional training in providing this Workwell intervention. A process evaluation will be undertaken alongside the main trial to investigate implementation fidelity; understand key stakeholders’ perspectives of the intervention and the social and structural context in which the intervention is provided; and explore issues related to future implementation in clinical practice. This protocol describes the aims, objectives, and methodology of the Workwell trial process evaluation.

Methods

This mixed methods process evaluation will follow the Medical Research Council’s Guidance on process evaluations for complex interventions. It will be underpinned by the conceptual framework for implementation fidelity (CFIF) and normalisation process theory (NPT). We will analyse treatment records, work assessments, and treatment notes to ascertain implementation fidelity. Semi-structured interviews with trial participants, their employer/line managers, treating therapists, and their therapy service managers will be undertaken to explore perceptions of the intervention, contextual factors, and potential for future implementation in practice. Interview topic guides will be informed by NPT. Therapists’ views about Workwell training will be explored via questionnaires following training, and interviews and focus groups following treatment delivery to inform future implementation. Quantitative data will be analysed descriptively. Qualitative data will be analysed using thematic analysis. NPT will guide data analysis and interpretation. Findings from the different elements of this embedded design process evaluation will be reported separately and then the elements integrated. The process evaluation data will be analysed independently of the Workwell trial outcome evaluation. The process evaluation data will then be reviewed in the light of the trial findings.

Discussion

Few trials of job retention vocational rehabilitation in arthritis have included process evaluations. This process evaluation will assist in understanding factors influencing trial outcomes and identifying potential contextual barriers and facilitators for the potential implementation of Workwell vocational rehabilitation into clinical services.

Trial registration

ClinicalTrials.gov NCT03942783. Registered on 08 May 2019. ISRCTN Registry ISRCTN61762297. Registered on 13 May 2019. Retrospectively registered.
Appendix
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Metadata
Title
The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis
Authors
Alison Hammond
Kathryn A. Radford
Angela Ching
Yeliz Prior
Rachel O’Brien
Sarah Woodbridge
June Culley
Jennifer Parker
Paula Holland
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Arthritis
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06871-z

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