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.

Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.

BACKGROUND: Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma. METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere. DISCUSSION: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS. TRIAL REGISTRATION: ISRCTN: 43115471. Registered 27/07/2021.

Factors Affecting the Delivery and Acceptability of the ROWTATE Telehealth Vocational Rehabilitation Intervention for Traumatic Injury Survivors: A Mixed-Methods Study.

BACKGROUND: Returning to work after traumatic injury can be problematic. We developed a vocational telerehabilitation (VR) intervention for trauma survivors, delivered by trained occupational therapists (OTs) and clinical psychologists (CPs), and explored factors affecting delivery and acceptability in a feasibility study. METHODS: Surveys pre- (5 OTs, 2 CPs) and post-training (3 OTs, 1 CP); interviews pre- (5 OTs, 2 CPs) and post-intervention (4 trauma survivors, 4 OTs, 2 CPs). Mean survey scores for 14 theoretical domains identified telerehabilitation barriers (score ≤ 3.5) and facilitators (score ≥ 5). Interviews were transcribed and thematically analysed. RESULTS: Surveys: pre-training, the only barrier was therapists' intentions to use telerehabilitation (mean = 3.40 ± 0.23), post-training, 13/14 domains were facilitators. Interviews: barriers/facilitators included environmental context/resources (e.g., technology, patient engagement, privacy/disruptions, travel and access); beliefs about capabilities (e.g., building rapport, complex assessments, knowledge/confidence, third-party feedback and communication style); optimism (e.g., impossible assessments, novel working methods, perceived importance and patient/therapist reluctance) and social/professional role/identity (e.g., therapeutic methods). Training and experience of intervention delivery addressed some barriers and increased facilitators. The intervention was acceptable to trauma survivors and therapists. CONCLUSION: Despite training and experience in intervention delivery, some barriers remained. Providing some face-to-face delivery where necessary may address certain barriers, but strategies are required to address other barriers.