Developing an implementation fidelity checklist for a vocational rehabilitation intervention

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.publishedVersio

How does mentoring occupational therapists improve intervention fidelity in a randomised controlled trial? A realist evaluation

Background: Integrating complex interventions within healthcare settings can be challenging. Mentoring can be embedded within a randomised controlled trial (RCT) to upskill and support those delivering the intervention. This study aimed to understand, from a realist perspective, how mentoring worked to support implementation fidelity for occupational therapists (OTs) delivering a vocational rehabilitation (VR) intervention within the context of an RCT. Methods: A realist evaluation using secondary data (emails, mentoring record forms, interviews) collected as part of an RCT. Three researchers coded the data following content analysis, focused on refining or refuting an initial programme theory by exploring the interactions between context, mechanisms, and outcomes. The research team met to further refine the programme theories. Results: Data from 584 emails, 184 mentoring record forms, and 25 interviews were analysed following a realist approach. We developed a programme theory consisting of two contexts (trial set-up, ongoing mentoring), nine mechanisms (collective understanding, monitoring, timely support, positive reinforcement, reflective practice, support data completeness, facilitation strategy, shared learning experience, management of research and clinical duties), and three outcomes (improved confidence, improved fidelity, reduced contamination). Conclusions: Offering mentoring support to OTs delivering a VR intervention as part of an RCT improves intervention fidelity and reduces the risk of contamination. It improves OTs’ understanding of the differences between their clinical and research roles and increases their confidence and competence in trial paperwork completion and identification of potential contamination issues

Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Background: Little guidance exists regarding how best to upskill and support those delivering complex healthcareinterventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupationaltherapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimedto explore mentors’ roles in supporting OTs with intervention delivery and fidelity, and to describe factors affectingthe mentoring process and intervention delivery.Methods: Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoringrecords and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to interventiondelivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions ofintervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring werecalculated per trial site. Qualitative data were analysed thematically.Results: Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring wasprovided by phone or Microsoft Teams (range: 88.6–100%), with the remainder via email and SMS (Short MessageService) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs’ understanding ofandadherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving.Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balancementoring with clinical roles. Facilitators included support from the trial team and mentors having protected timefor mentoring.Conclusions: Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTSwould have been able to deliver the intervention without mentoring support, or how this might have impactedfidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihoodof intervention effectiveness being observed and sustained in real-life contexts. Further research is needed toinvestigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. Theclinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requirestesting in a future trial

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

Objectives: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. Setting: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. Participants and outcome measures: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists’ attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. Ethics and dissemination: Approval obtained through the East Midlands—Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. Trial registration number: ISRCTN12464275

Peer mentoring for people with acquired brain injury – a systematic review

Introduction: Over 100 million people worldwide live with disabilities resulting from an acquired brain injury (ABI). ABI survivors experience cognitive and physical problems and require support to resume an active life. They can benefit from support from someone who has been through the same issues (i.e., peer mentor). This review investigated the effectiveness of peer mentoring for ABI survivors.Method: Eleven databases, two trial registers, and PROSPERO were searched for published studies. Two reviewers independently screened all titles, abstracts, and full texts, extracted data, and assessed quality. The PRISMA 2020 guidelines were followed to improve transparency in the reporting of the review.Results: The search returned 4,094 results; 2,557 records remained after the removal of duplicates and 2,419 were excluded based on titles and abstracts. Of the remaining 138, 12 studies met the inclusion criteria. Five were conducted in the United States, three in Canada, three in the UK, and one in New Zealand. Meta-analysis was inappropriate due to the heterogeneity of study designs. Therefore, a narrative synthesis of the data was undertaken.Conclusion: Although peer mentoring has the potential to positively influence activity and participation among ABI survivors, further research is needed to understand the extent of the benefits

The effectiveness of occupational therapy supporting return to work for people who sustain serious injuries or develop long-term (physical or mental) health conditions: A systematic review

Introduction:People with long-term conditions or recovering from serious injuries can struggle to return to work. The evidence for occupational therapy supporting return to work is limited. We aimed to identify and explain how occupational therapy interventions work.Methods:Systematic review. Seven databases were searched between 1 January 1980 and 15 June 2022. Studies measuring work-related outcomes among individuals receiving occupational therapy during absence from paid work were included. Multiple reviewers independently contributed to screening, quality appraisal and data extraction processes. Data were analysed as a narrative.Results:Twenty studies with 3866 participants were included; 17 were assessed as having high risk of bias. Occupational therapy was inconsistently acknowledged affecting study identification and occupational therapy components were poorly described. Meta-analysis was unfeasible due to outcome heterogeneity. Individually tailored occupational therapy focused on return to work in musculoskeletal conditions indicated the most promising outcomes. Key intervention components included vocational assessment, goal setting and self-management. Key mechanisms of action included early intervention, individualised support and being responsive to needs.Conclusion:Occupational therapists’ contributions supporting return to work should be clearly attributed. Future effectiveness research should standardise the measurement of work outcomes to support meta-analysis. Developing a taxonomy for occupational therapy supporting return to work could facilitate comparisons across studies, highlighting occupational therapists’ roles and facilitating training and benefits to patients