Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Keele University
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Number of days absent from work
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Participants, their treating clinicians and VSWs cannot be blinded to allocation due to the nature of the intervention. The data will be analysed independently by two statisticians one of whom will be blinded to intervention allocation the other statistician will be unblinded to allow intervention delivery details to be reported to the Trial Steering Committee (TSC) / Data Monitoring Committee (DMC) if required.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years and over
- •currently in paid employment (full or part time)
- •current absence from work of at least two consecutive calendar weeks but not more than six continuous months
- •received a fit note
- •access to a mobile phone that can receive and respond to SMS text messages
- •able to read and write English
- •able to give full informed consent
- •willing to participate.
Exclusion Criteria
- •Long-term work absence defined as over six continuous months
- •pregnancy or on maternity leave
- •patients presenting with signs or symptoms indicative of serious illness requiring urgent medical attention ('red' flags)
- •severe mental health problems (e.g. severe depression with risk of self-harm, exacerbation of schizophrenia or bipolar disorder, cognitive impairment or lack of capacity)
- •high vulnerability (e.g. palliative stages of illness, recent bereavement, dementia).
Arms & Interventions
Usual care plus vocational support
Vocational support following a stepped care model based on the principles of case management in addition to usual primary care.
Intervention: Vocational Support (Behavioral)
Usual care
Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice.
Outcomes
Primary Outcomes
Number of days absent from work
Time Frame: 6 months
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
Number of Days Absent From Work
Time Frame: 6 months
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
Secondary Outcomes
- Return to work(6 months or until sustained return to work (return to any work for 4 consecutive weeks))
- Work interference(6 months)
- Work performance(6 months)
- Work Interference(6 months)
- Work Performance(6 months)
- Return to Work Self-efficacy (RTW-SE)(6 months)