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

• ClinicalTrials.gov Identifier: NCT04543097
• Recruitment Status: Recruiting
• First Posted: September 9, 2020
• Last Update Posted: March 1, 2021
• Sponsor: Keele University
• Collaborators: University of Southampton; Guy's and St Thomas' NHS Foundation Trust; University of Birmingham; Aston University
• Information provided by (Responsible Party): Keele University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Musculoskeletal Pain; Mental Health Issue; Mental Health Disorder; Other Physical Health Condition; Absence	Behavioral: Vocational Support	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 720 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Primary Purpose: Supportive Care
• Official Title: Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
• Actual Study Start Date: December 23, 2020
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: October 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Return to work [ Time Frame: 6 months or until sustained return to work (return to any work for 4 consecutive weeks) ]
   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).
2. Work interference [ Time Frame: 6 months ]
   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.
3. Work performance [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Contacts

Contact: Gwenllian Wynne-Jones, PhD; 01782 733962; g.wynne-jones@keele.ac.uk

Contact: Kendra Cooke, BSc (Hons); 01782 734996; k.cooke@keele.ac.uk

Locations

United Kingdom

Keele University; Recruiting

Newcastle Under Lyme, United Kingdom

Contact: Kendra Cooke

Sponsors and Collaborators

Keele University

University of Southampton

Guy's and St Thomas' NHS Foundation Trust

University of Birmingham

Aston University

Investigators

• Principal Investigator: Gwenllian Wynne-Jones, PhD; Keele University

More Information

• Responsible Party: Keele University
• ClinicalTrials.gov Identifier: NCT04543097
• Other Study ID Numbers: RG-0283-19; HTA 17/94/49 ( Other Grant/Funding Number: NIHR Health Technology Grant )
• First Posted: September 9, 2020
• Last Update Posted: March 1, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keele University:

Work absence; Other health conditions; Return to work; Musculoskeletal pain; Mental health

Additional relevant MeSH terms:

Musculoskeletal Pain; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations