RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Radford, Kathryn; McKevitt, Christopher; Clarke, Sara; Powers, Katie; Phillips, Julie; Craven, Kristelle; Watkins, Caroline L; Farrin, Amanda; Holmes, Jain; Cripps, Rachel; McLellan, Vicki; Sach, Tracey; Brindle, Richard; Holloway, Ivana; Hartley, Suzanne; Bowen, Audrey; O’Connor, Rory J; Stevens, Judith; Walker, Marion F; Murray, James F.; Shone, Angela; Clarke, David

doi:10.1136/bmjopen-2021-053111

Cited by 7 publications

(8 citation statements)

References 24 publications

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“…Assessing whether interventions are delivered as planned helps trialists understand effectiveness outcomes [12] and researchers to understand implementation issues for future trials [40]. This learning has since informed fidelity assessment in other trials [26,41]. This study has indicated the most useful methods for measuring fidelity in a future trial, so that we better understand why a complex intervention works or fails [42] and improve future trial designs [43].…”

Section: Discussionmentioning

confidence: 99%

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Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study

Holmes

Fletcher-Smith

Merchán-Baeza

et al. 2022

Pilot Feasibility Stud

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Background Determining whether complex rehabilitation interventions are delivered with fidelity is important. Implementation fidelity can differ between sites, therapists delivering interventions and, over time, threatening trial outcomes and increasing the risk of type II and III errors. This study aimed to develop a method of assessing occupational therapists’ fidelity to deliver a complex, individually tailored vocational rehabilitation (VR) intervention to people with traumatic brain injury (TBI) and assess the feasibility of its use in a randomised controlled trial. Methods Using mixed methods and drawing on the intervention logic model, we developed data collection tools to measure fidelity to early specialist TBI VR (ESTVR). Fidelity was measured quantitatively using intervention case report forms (CRF), fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with intervention therapists, participants with TBI, employers and NHS staff at trial sites explored moderators of implementation fidelity. The conceptual framework of implementation fidelity (CFIF) guided measurement and analysis of and factors affecting fidelity. Data were triangulated and benchmarked against an earlier cohort study. Results Fidelity to a complex individually tailored VR intervention could be measured. Overall, OTs delivered ESTVR with fidelity. Different fidelity measures answered different questions, offering unique insights into fidelity. Fidelity was best assessed using a fidelity checklist, intervention CRFs and clinical notes. The OT clinical notes and mentoring records were best at identifying fidelity moderating factors. Interviews added little insight into fidelity moderating factors over and above mentoring or clinical records. Data triangulation offered a comprehensive assessment of fidelity, highlighting limitations of measurement methods and learning for future trials but was resource intensive. Interviews, fidelity visits and analysing clinical notes were also resource intense. Comparing fidelity data to a benchmark and using CFIF as a framework for organising the fidelity assessment helped. Conclusions OTs delivered the VR intervention with fidelity. A fidelity checklist and benchmark plus mentoring may offer a practical and effective way of measuring fidelity and identifying fidelity moderating factors in trials of complex individually-tailored rehabilitation interventions. Mentoring provided real-time indicators of and reasons for fidelity deviations. These methods require further evaluation. Trial registration ISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014).

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Section: Discussionmentioning

confidence: 99%

“…Fidelity was measured as part of an embedded mixed methods process evaluation [25,26] and involved multiple methods. The conceptual framework CFIF [19] was used to guide both the measurement of fidelity and understand factors affecting its delivery.…”

Section: Methodsmentioning

confidence: 99%

Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study

Holmes

Fletcher-Smith

Merchán-Baeza

et al. 2022

Pilot Feasibility Stud

Self Cite

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“…To assist future comparative evaluations of VR trials, the process evaluation protocol was planned to be similar to that within the RETAKE trial, evaluating Early Stroke Specialist Vocational Rehabilitation to enable people in returning to work [31,32].…”

Section: Methodsmentioning

confidence: 99%

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

Hammond

Radford

Ching

et al. 2022

Trials

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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.

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“…The initial structure of the ESSVR fidelity checklist was based on a checklist developed for an earlier VR study [ 42 ] for people with traumatic brain injury. The logic model and intervention descriptions [ 43 ] provided the initial content for the development of the ESSVR fidelity checklist.…”

Section: Methodsmentioning

confidence: 99%

Developing an implementation fidelity checklist for a vocational rehabilitation intervention

Powers

Clarke

Phillips

et al. 2022

Pilot Feasibility Stud

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Background Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures used within the study were developed. This study aimed to develop a fidelity checklist for measuring the implementation fidelity of an early, stroke-specialist vocational rehabilitation intervention (ESSVR) in the RETAKE trial. Methods To develop the fidelity measure, previous checklists were reviewed to inform the assessment structure, and core intervention components were extracted from intervention descriptions into a checklist, which was ratified by eight experts in fidelity measurement and complex interventions. Guidance notes were generated to assist with checklist completion. To test the measure, two researchers independently applied the checklist to fifteen stroke survivor intervention case notes using retrospective observational case review. The scoring was assessed for interrater reliability. Results A fidelity checklist containing 21 core components and 6 desirable components across 4 stages of intervention delivery was developed with corresponding guidance notes. Interrater reliability of each checklist item ranged from moderate to perfect (Cohen’s kappa 0.69–1). Conclusions The resulting checklist to assess implementation fidelity is fit for assessing the delivery of vocational rehabilitation for stroke survivors using retrospective observational case review. The checklist proved its utility as a measure of fidelity and may be used to inform the design of future implementation strategies. Trial registration ISRCTN, ISRCTN12464275. Registered on 13 March 2018.

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RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Cited by 7 publications

References 24 publications

Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study

Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study

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

Developing an implementation fidelity checklist for a vocational rehabilitation intervention

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