Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

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). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain. The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective? WAVE includes a feasibility phase to adapt a vocational advice 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. Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs). The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work. Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.

NCT Number	NCT04543097
Lead Sponsor	Keele University Collaborators: University of Southampton, Guy's and St Thomas' NHS Foundation Trust, University of Birmingham, Aston University
Conditions	Musculoskeletal Pain, Mental Health Issue, Mental Health Disorder, Other Physical Health Condition, Absence
Enrollment	130 participants
Start Date	2020-12-23
Primary Completion	2023-04-20 (estimated)
Study Completion	2025-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-30