Clinical trial NCT04543097: Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care
Official title: Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Mental Health Issue
Mental Health Disorder
Other Physical Health Condition
Absence
Keywords: Work absence
Other health conditions
Return to work
Musculoskeletal pain
Mental health
Lead sponsor: Keele University
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: Guy's and St Thomas' NHS Foundation Trust
name: University of Birmingham
name: Aston University
First posted: 2020-09-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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).

Primary outcomes:
measure: Number of days absent from work
timeFrame: 6 months
Secondary outcomes:
measure: Return to work
timeFrame: 6 months or until sustained return to work (return to any work for 4 consecutive weeks)
measure: Work interference
timeFrame: 6 months
measure: Work performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Newcastle Under Lyme
country: United Kingdom
facility: Keele University
Study officials:
affiliation: Keele University
name: Gwenllian Wynne-Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: