Centre for Human Movement and Rehabilitation, University of Salford, Allerton, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.
Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
Trials. 2022 Nov 9;23(1):937. doi: 10.1186/s13063-022-06871-z.
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.
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.
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.
ClinicalTrials.gov NCT03942783 . Registered on 08 May 2019. ISRCTN Registry ISRCTN61762297 . Registered on 13 May 2019. Retrospectively registered.
Workwell 试验是一项多中心随机对照试验，旨在评估针对因关节炎而工作困难的在职炎性关节炎患者的保留工作职业康复的有效性和成本效益。职业康复由接受过提供这种 Workwell 干预措施额外培训的卫生服务职业治疗师提供。一项过程评估将与主要试验同时进行，以调查实施的保真度；了解关键利益相关者对干预措施的看法以及干预措施提供的社会和结构背景；并探讨与临床实践未来实施相关的问题。本方案描述了 Workwell 试验过程评估的目的、目标和方法。
这项混合方法过程评估将遵循医学研究委员会（MRC）对复杂干预措施的过程评估指南。它将以实施保真度的概念框架（CFIF）和正常化过程理论（NPT）为基础。我们将分析治疗记录、工作评估和治疗记录，以确定实施保真度。将对试验参与者、他们的雇主/直线经理、治疗治疗师及其治疗服务经理进行半结构化访谈，以探讨对干预措施的看法、背景因素以及在实践中未来实施的潜力。访谈主题指南将根据 NPT 提供信息。培训后将通过问卷探讨治疗师对 Workwell 培训的看法，治疗后将通过访谈和焦点小组探讨，以提供未来的实施信息。定量数据将进行描述性分析。定性数据将使用主题分析进行分析。NPT 将指导数据分析和解释。从这个嵌入式设计过程评估的不同元素中获得的发现将分别报告，然后再进行整合。该过程评估数据将与 Workwell 试验结果评估分开分析。然后将根据试验结果审查过程评估数据。
很少有关于关节炎保留工作职业康复的试验包括过程评估。这项过程评估将有助于了解影响试验结果的因素，并确定 Workwell 职业康复纳入临床服务的潜在背景障碍和促进因素。
ClinicalTrials.gov NCT03942783。于 2019 年 5 月 8 日注册。ISRCTN 注册 ISRCTN61762297。于 2019 年 5 月 13 日注册。回顾性注册。
