Title: Work And Vocational advicE (WAVE) in primary care: a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Maintaining the population’s fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). Few GPs are confident in providing vocational advice. _x000D_ _x000D_ AIMS: The WAVE study will take a vocational advice intervention that we previously developed and tested for patients with joint aches and pains (musculoskeletal or MSK pain) and adapt it so it is suitable for all patients consulting their general practice with health conditions affecting their ability to work. This includes patients with other physical health conditions and mental health conditions. Next, the adapted intervention will be tested in a trial to find out if it reduces the number of days off work in adults who have received a fit note (previously known as a sick certificate). We will also test whether it offers value for money (health economic analysis). _x000D_ _x000D_ DESIGN AND METHODS: We will adapt the vocational advice intervention through: 1: Workshops with stakeholders, including patients, to discuss the intervention and agree how to adapt it to meet the needs of patients with mental health and other conditions, 2: Convening an independent expert advisory group (patients, academics, psychologists, clinicians, employers) to advise on the intervention content, and methods of the trial. 3: Development of a training programme to enable vocational support workers (VSWs) to deliver the intervention, 4: Testing ways to identify patients suitable for the intervention and exploring whether they engage with it. _x000D_ _x000D_ Next, we will conduct the trial to test the vocational advice intervention. We will recruit patients consulting in general practice who are absent from work for at least 2 weeks and given a fit note. They will be posted information about the trial (with a consent form and questionnaire). Eligible patients returning the consent form and questionnaire and agreeing to take part will be randomised (allocated by chance) to either the vocational advice intervention plus usual care, or usual care alone. The vocational advice intervention starts with a phone call from the VSW to discuss obstacles to return to work (RTW) and develop a RTW plan with the patient (step 1). Where appropriate a further phone call, face-to-face or videoconferencing (eg. Skype) meeting will occur (step 2) to review, amend and support the RTW plan (if needed). If agreed by the patient and VSW, contact will be made with the workplace in order to help overcome obstacles, agree and implement the RTW plan (step 3). We will also interview some patients, GPs, VSWs and employers to understand their views about the intervention and RTW. Participants in the trial will be followed-up over 6 months with brief, weekly text messages asking about their health and work, and with postal questionnaires sent at 6 weeks, and 6 months. Patient and public involvement: Patients have helped shape the research question and plans for the WAVE study, including methods of patient identification, data collection and wording of the questions asked via text messages. _x000D_ _x000D_ Dissemination: We will ensure the results of the WAVE study are shared widely, including with patients, doctors, employers and people in health and work policy roles.

Lay abstract: 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? _x000D_ _x000D_ 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ Setting: Primary care. _x000D_ _x000D_ 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ 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.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE