Work And Vocational advicE (WAVE) in primary care: a randomised controlled trial

Research Question: In patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice (VA) intervention lead to fewer days lost from work than usual primary care, and is it cost-effective? Background: Offering vocational advice early, in primary care, where most patients with health conditions resulting in time off work consult may help them back into the workplace and reduce time off work. We have recently shown the benefits of this for adults with musculoskeletal pain. Design: WAVE includes a feasibility phase to adapt the VA intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis. Setting: Primary care. Target population: Adults in paid employment, with a current work absence of at least 2 weeks but not more than 6 months, who have received a fit note and can receive and respond to SMS text messages and communicate in English. Health technologies being assessed: Vocational advice following a stepped care model based on the principles of case management in addition to usual primary care. Participants randomised to receive vocational advice will all receive Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) identifying obstacles to Return to Work (RTW) and beginning RTW planning. Step 2 will be face-to-face or by videoconferencing and provide more in-depth discussion of obstacles to RTW and RTW planning. Step 3 will include contact with participants’ workplace (with consent). The frequency of contact will be individualised to the needs of participants and continue until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services. The intervention is underpinned by a logic model describing the intervention content, anticipated mediators and outcomes. Outcomes: Primary outcome: number of days of work absence over 6 months. Secondary outcomes: proportion achieving sustained RTW, RTW self-efficacy, work performance, work interference, symptom bothersomeness, global assessment of change, anxiety, depression. A mixed methods process evaluation will help to interpret the trial findings. A health economic evaluation (cost utility analysis) of vocational advice vs usual primary care will estimate cost/QALY gained over 6 months and decision modelling will extrapolate costs and outcomes beyond the trial. Sample size: 720 participants randomised over 18 months to detect a 25% reduction in days absent from work over 6 months (incidence Rate Ratio of 0.75), with 2-sided 5% significance, 80-90% power and allowing for 20% loss to follow-up. Recruitment rate: 4 patients/practice/month from a total practice population of 60,000 registered patients in approx. 12 GP practices. Timelines: Total 54 months. Feasibility phase: Months 0-18: convene expert advisory and PPIE groups, adapt the VA intervention, develop intervention manual and train VAs, feasibility study with 30 participants, process evaluation including interviews with up to 20 participants, set-up and approvals for the trial. Trial: Months 19-23: Internal pilot, Months 24-38: Main trial recruitment, Months 22-44: 6 week, 4 and 6 months follow-up, Months 45-48: Medical record reviews, Months 49-54: Analysis and dissemination.