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

Musculoskeletal Pain Clinical Trial

— WAVE  

Official title:

Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04543097
• Other study ID #: RG-0283-19
• Secondary ID: HTA 17/94/49
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Keele University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 31, 2024
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Keele University	Newcastle Under Lyme

Sponsors (5)

Lead Sponsor	Collaborator
Keele University	Aston University, Guy's and St Thomas' NHS Foundation Trust, University of Birmingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days absent from work	Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).	6 months
Secondary	Return to work	RTW - Self reported number of days until return to work over 6 months, or until a sustained return to work is achieved (defined as return to any work for 4 consecutive weeks).	6 months or until sustained return to work (return to any work for 4 consecutive weeks)
Secondary	Work interference	Work Productivity Activity Impairment (WPAI) Questionnaire to measure impairments to work and activities in the past seven days. The WPAI provides four sets of scores; absenteeism, presenteeism, work productivity loss and activity impairment. Scores are multiplied by 100 to express percentages with higher numbers indicating greater impairment and less productivity i.e. worse outcomes.	6 months
Secondary	Work performance	Single Item Productivity Questionnaire (SIPQ) measured using a Visual Analogue Scale with scores ranging from 0 (health has not impacted on work performance at all) to 10 (health is so bad participant has been unable to do their job) a higher score indicates a worse outcome. The scores will be reported as a percentage perceived loss in productivity.	6 months