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 healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors' roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery. METHODS: Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated 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 was provided by phone or Microsoft Teams (range: 88.6-100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs' understanding of- and adherence 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 balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring. CONCLUSIONS: Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 13th March 2018.

What do employers need when supporting stroke survivors to return to work?: a mixed-methods study.

BACKGROUND: Employers are key in supporting stroke survivors to return to work (RTW) but do not always have knowledge/skills or guidance to do so. OBJECTIVES: To explore employers' needs for provision of post-stroke RTW support. METHODS: Mixed-methods study. Participants recruited through voluntary response/purposive sampling. Survey of employers investigated stroke knowledge (maximum score: 7), RTW process knowledge (maximum score: 8), and perceived competency for actions supporting RTW (maximum score: 100%). Regression analyses explored relationships between employers' demographic/contextual characteristics and knowledge and perceived competency scores. Interviews with employers explored factors influencing their post-stroke RTW support. Interview data were analyzed using a framework analysis. Survey/interview findings were synthesized with those from a qualitative systematic review. RESULTS: Across the survey (n = 50), interviews (n = 7), and review (25 studies), employers' support was influenced by stroke survivors' decisions to disclose stroke-related limitations, employers' knowledge regarding roles/responsibilities, employers' communication skills, and information provided by healthcare. Regression analyses: Human resources/occupational health support was positively associated with stroke knowledge (ß = 2.30, 95% CI 0.36-4.41, p = 0.013) and RTW process knowledge (ß = 5.12, 95% CI 1.80-6.87, p = 0.001). Post-stroke RTW experience was positively associated with stroke knowledge (ß = 1.36, 95% CI 0.46-2.26, p = 0.004) and perceived competency (ß = 31.13, 95% CI 18.40-44.76, p = 0.001). Organization size (i.e. working in a larger organization) was positively associated with RTW process knowledge (ß = 2.96, 95% CI 1.52-4.36, p = <.001). CONCLUSIONS: Employers' RTW support was influenced by personal and environmental factors; they may benefit from education and guidance on stroke and their roles/responsibilities during the RTW process.

The Impact of COVID-19 on the Employment of People With Multiple Sclerosis: A Multiple Methods Study.

BACKGROUND: The COVID-19 pandemic led to approximately half of the working population in the United Kingdom being unable to work temporarily. This study aims to understand the employment needs and experiences of people with multiple sclerosis (MS) in the UK during this period. METHODS: Multiple methods were used, including an online survey and follow-up interviews with people with MS who were employed prior to the start of the pandemic restrictions in March 2020. RESULTS: The online survey was completed by 101 eligible participants and we interviewed 15 of them for qualitative data in the follow-up. Survey data indicated that the work experience of people with MS improved during the pandemic because they were allowed to work from home. However, participants experienced increased feelings of anxiety and loneliness. From the interviews, we extracted 5 themes: (1) the benefits of working from home; (2) the challenges of working during the COVID-19 pandemic; (3) the relevance of managers; (4) returning to "normal"; and (5) the need for vocational support. CONCLUSIONS: The pandemic showed that MS symptom management was improved by work flexibility (eg, working from home, breaks, flexible working hours); for people with MS, these accommodations improved both their ability to work and their self-perceived productivity. Future research should explore the support needs of people with MS who work remotely and determine whether pandemic-influenced work accommodations are sustainable over time.

The RETurn to work After stroKE (RETAKE) trial: Findings from a mixed-methods process evaluation of the Early Stroke Specialist Vocational Rehabilitation (ESSVR) intervention.

INTRODUCTION: A key goal for working age stroke survivors is to return to work, yet only around 50% achieve this at 12 months. Currently, there is limited evidence of effectiveness of early stroke-specialist vocational rehabilitation (ESSVR) interventions from randomised controlled trials. This study examined fidelity to ESSVR and explored social and structural factors which may have influenced implementation in the RETurn to work After stroKE (RETAKE) randomised controlled trial. METHODS: Mixed-methods process evaluation assessing intervention fidelity and incorporating longitudinal case-studies exploring stroke survivors' experiences of support to return to work. Normalisation Process Theory, and the Conceptual Model for Implementation Fidelity, informed data collection and analysis. RESULTS: Sixteen sites across England and Wales participated in RETAKE. Forty-eight occupational therapists (OTs), supported by 6 mentors experienced in vocational rehabilitation (VR), delivered the intervention (duration 12 months) between February 2018 and April 2022. Twenty-six participants (15 ESSVR, 11 usual care (UC)) were included in longitudinal case-studies. An additional 18 participants (8 ESSVR and 10 UC) were interviewed once. Nineteen OTs, 6 mentors and 19 service managers were interviewed. Fidelity was measured for 39 ESSVR participants; mean fidelity score was 78.8% (SD:19.2%, range 31-100%). Comparison of the experiences of ESSVR and UC participants indicated duration and type of support to return to work were perceived to be better for ESSVR participants. They received early, co-ordinated support including employer liaison and workplace adjustments where appropriate. In contrast, UC participants reported limited or no VR or return to work support from health professionals. Typically, UC support lasted 2-8 weeks, with poor communication and co-ordination between rehabilitation providers. Mentor support for OTs appeared to increase fidelity. Service managers indicated ESSVR would enhance post-stroke services. CONCLUSIONS: ESSVR was valued by participants and was delivered with fidelity; implementation appeared to be facilitated by mentor support for OTs.

Exploring the Association between Individual-Level Attributes and Fidelity to a Vocational Rehabilitation Intervention within a Randomised Controlled Trial.

Understanding what attributes or characteristics of those delivering interventions affect intervention fidelity and patient outcomes is important for contextualising intervention effectiveness. It may also inform implementation of interventions in future research and clinical practice. This study aimed to explore the relationships between attributes of Occupational Therapists (OTs), their faithful delivery of an early stroke specialist vocational rehabilitation intervention (ESSVR), and stroke survivor return-to-work (RTW) outcomes. Thirty-nine OTs were surveyed about their experience and knowledge of stroke and vocational rehabilitation and were trained to deliver ESSVR. ESSVR was delivered across 16 sites in England and Wales between February 2018 and November 2021. OTs received monthly mentoring to support ESSVR delivery. The amount of mentoring each OT received was recorded in OT mentoring records. Fidelity was assessed using an intervention component checklist completed using retrospective case review of one randomly selected participant per OT. Linear and logistic regression analyses explored relationships between OT attributes, fidelity, and stroke survivor RTW outcome. Fidelity scores ranged from 30.8 to 100% (Mean: 78.8%, SD: 19.2%). Only OT engagement in mentoring was significantly associated with fidelity (b = 0.29, 95% CI = 0.05-0.53, p < 0.05). Increased fidelity (OR = 1.06, 95% CI = 1.01-1.1, p = 0.01) and increasing years of stroke rehabilitation experience (OR = 1.17, 95% CI = 1.02-1.35) was significantly associated with positive stroke survivor RTW outcomes. Findings of this study suggest that mentoring OTs may increase fidelity of delivery of ESSVR, which may also be associated with positive stroke survivor return-to-work outcomes. The results also suggest that OTs with more experience of stroke rehabilitation may be able to support stroke survivors to RTW more effectively. Upskilling OTs to deliver complex interventions, such as ESSVR, in clinical trials may require mentoring support in addition to training to ensure fidelity.

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. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275. Registered on 13 March 2018.

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.

Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.

OBJECTIVE: To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth. DESIGN: Parallel group randomised (1:1) trial. SETTING: Eight UK tertiary maternity units. PARTICIPANTS: Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32+0 weeks' gestation. INTERVENTIONS: Deferred cord clamping (≥2 min) and immediate neonatal care with cord intact or immediate (≤20 s) clamping and immediate neonatal care after clamping. MAIN OUTCOME MEASURE: Composite of death or adverse neurodevelopmental outcome at 2 years corrected age. RESULTS: Six babies born after 35+6 weeks were excluded. At 2 years corrected age, outcome data were not available for a further 52 children, leaving 218 for analysis (115 deferred clamping, 103 immediate clamping). Overall, 24/115 (21%) children allocated deferred clamping died or had an adverse neurodevelopmental outcome compared with 35/103 (34%) allocated immediate clamping; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave an RR 0.69 (95% CI 0.44 to 1.09) and RD -9% (95% CI -21% to 2%). CONCLUSIONS: Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature. Confirmation in larger studies is needed to determine the real benefits and harms. TRIAL REGISTRATION NUMBER: ISRCTN21456601.

An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial.

BACKGROUND: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. METHODS: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. DISCUSSION: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 26 February 2018.

Manual transmission enhances attention and driving performance of ADHD adolescent males: pilot study.

OBJECTIVE: Inattention is a major contributor to driving mishaps and is especially problematic among adolescent drivers with ADHD, possibly contributing to their 2 to 4 times higher incidence of collisions. Manual transmission has been demonstrated to be associated with greater arousal. This study tests the hypotheses that manual transmission, compared to automatic transmission, would be associated with better attention and performance on a driving simulator. METHOD: Ten adolescent drivers with ADHD practice driving on the simulator in the manual and automatic mode. Employing a single-blind, cross-over design, participants drive the simulator at 19:30 and 22:30 hr for 30 min in both transmissions and rate their attention to driving. RESULTS: Subjectively, participants report being more attentive while driving in manual transmission mode. Objectively, participants drive safer in the manual transmission mode. CONCLUSION: Although in need of replication, this pilot study suggests a behavioral intervention to improve driving performance among ADHD adolescents.