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

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ClinicalTrials.gov Identifier: NCT04543097
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : May 4, 2022
University of Southampton
Guy's and St Thomas' NHS Foundation Trust
University of Birmingham
Aston University
Information provided by (Responsible Party):
Keele University

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

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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

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.

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543097

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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

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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
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Principal Investigator: Gwenllian Wynne-Jones, PhD Keele University
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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    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
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.

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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:
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Musculoskeletal Pain
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations