Protocol for the Work And Vocational advicE (WAVE) randomised controlled trial testing the addition of vocational advice to usual primary care (Clinical Trials: NCT04543097)

Abstract

Objectives: To investigate the effectiveness of adding a brief vocational advice intervention to usual care in reducing the number of days absent from work over a period of 6 months in adults given a fit note by their general practice. Design: Multicentre, pragmatic, two parallel-arm, randomised controlled trial with health economic analyses and nested qualitative study. A computer-generated stratified block randomisation (ratio 1:1) was used to allocate arms. Setting: Participants will be recruited from general practices in the UK. Participants: 720 adults consulting in general practice, for any health condition, and receiving a fit note who have been absent from work for more than two-weeks but less than six months. Interventions: Participants in the intervention arm will be offered usual care and vocational advice delivered by a Vocational Support Worker (VSW) remotely via phone or videoconferencing. Participants in the control arm will be offered usual care. Main outcome measure: Number of days off work over 6 months. Follow-up data collection is via questionnaires at 6 weeks and 6 months. Conclusions: This paper presents the rationale, design and methods of the Work And Vocational advicE (WAVE) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for patients with work absence. Trial registration: Clinical Trials: NCT04543097 Protocol number: Version 5.1