The WAVE Study
Work And Vocational advicE (WAVE) in primary care: a randomised controlled trial
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.
| Chief Investigator: | Dr Gwenllian Wynne-Jones |
| Trial Manager: | Angela Clifford |
| Sponsor / reference number: | Keele University / RG-0283-19 |
| Funder / reference number: |
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme / 17/94/49 |
| UKCRN study portfolio reference number: | 46606 |
| Registration reference number: |
Clinialtrials.gov: NCT04543097 |
| Start date: | 1 May 2019 |
| End date: | 31 Oct 2023 |
Study design
This is an interventional study.
Aim and objectives
The overall aims of the WAVE trial are to determine, in patients consulting in general practice who receive a fit note, whether the addition of a brief vocational support intervention to usual primary care leads to fewer days lost from work, and whether offering this vocational support is cost-effective.