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
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialClinical Trials: NCT04543097
Funding StatementThe WAVE trial is funded by the NIHR Health Technology Assessment programme (NIHR 17/94/49). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). CCG is part funded by West Midlands Applied Research Collaboration (WM ARC).
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethical approval was granted by National Research Ethics Service (NRES) Committee West of Scotland Research Ethics Committee (REC) 5, September 2020 (REC reference: 20/WS/0127).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityThis is a protocol for a trial and no data is available from the current manuscript. D All data produced as part of the trial will be available on reasonable request to the authors and following Keele University Data Request procedures.
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