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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Musculoskeletal Pain Mental Health Issue Mental Health Disorder Other Physical Health Condition Absence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Vocational Support

Intervention Type BEHAVIORAL

Participants randomised to receive vocational advice will all be offered:

Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning.

Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning.

Step 3, contact by the VSW (with participant consent) with the participants' workplace.

The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services.

Interventions

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Vocational Support

Participants randomised to receive vocational advice will all be offered:

Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning.

Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning.

Step 3, contact by the VSW (with participant consent) with the participants' workplace.

The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No