Absence, Mental Health Disorder, Mental Health Issue, Musculoskeletal Pain, Other Physical Health Condition
Conditions
Keywords
Work absence, Other health conditions, Return to work, Musculoskeletal pain, Mental health
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.
Interventions
BEHAVIORALVocational 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.
Sponsors
Keele University
University of Southampton
Guy's and St Thomas' NHS Foundation Trust
University of Birmingham
Aston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Absent From Work | 6 months | Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work Interference | 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. It calculates four main scores calculated and expressed as percentages ranging from 0% to 100%. A higher percentage means a greater reduction in productivity and a higher level of impairment due to a health problem: 1. Absenteeism (\[hours missed due to health, divided by total hours should have worked\] multiplied by 100) 2. Presenteeism (how much health affected productivity 0 to 10, multiplied by 10) 3. Overall Work Impairment (total hours missed, plus \[remaining hours worked multiplied by the presenteeism score\]) 4. Activity Impairment (score for how much health affected regular activities 0 to 10, multiplied by 10). |
| Work Performance | 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. |
| Return to Work Self-efficacy (RTW-SE) | 6 months | Return to work self-efficacy evaluates an employee's confidence in their ability to successfully resume their job while managing a health condition. This is indicated with scores ranging from 1 (not at all confident) to 10 (totally confident), a lower score indicates poorer confidence. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORGwenllian Wynne-Jones, PhD
Keele University
Participant flow
Recruitment details
Patients were recruited from GP practices in three regions of England
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.97 Years STANDARD_DEVIATION 11.32 |
| Race/Ethnicity, Customized Missing or not stated | 11 Participants |
| Race/Ethnicity, Customized Other ethnicity | 4 Participants |
| Race/Ethnicity, Customized White | 97 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 66 |
| other Total, other adverse events | 0 / 64 | 0 / 66 |
| serious Total, serious adverse events | 0 / 64 | 0 / 66 |
Outcome results
None listed