Background: Inflammatory arthritis (IA) causes work disability, absenteeism (sick leave) and presenteeism (reduced productivity) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) amongst people with IA in the US showed that VR reduced work disability. However, it is unknown whether this approach transfers to the United Kingdom (UK) with a different social and welfare structure. Previously, we modified the VR for the UK, funded by Arthritis Research UK (the WORKWELL programme) and demonstrated it to be deliverable and acceptable in a feasibility trial. Our aim now is to move to the definitive UK trial testing the effectiveness and cost-effectiveness of WORKWELL. Methods: A multicentre randomized controlled trial will be conducted. Employed people with rheumatoid, psoriatic or inflammatory arthritis (n=240), with concerns about continuing working due to arthritis, will be randomized to receive WORKWELL or control (written advice). WORKWELL includes individualised VR (maximum 4.5 hours over several months): assessing work problems; encouraging arthritis self-management in the workplace; addressing ergonomics; considering fatigue and stress management; providing orthoses and educating on employment rights and support services, assistive technology and work modifications. It also includes psychological and disclosure support, workplace visits and employer liaison (as applicable). Outcomes will be assessed at 0, 6 and 12 months by questionnaire. The primary outcome is the Work Limitations Questionnaire-25 (measuring presenteeism: summed score) at 12 and 36 months, with cost-effectiveness analysis at 12 months. Discussion: If effective and cost-effective, WORKWELL can be rolled out in Rheumatology services to help improve the quality and duration of people with arthritis' working lives.
Background Work problems are common in people with inflammatory arthritis (IA). In rheumatoid arthritis (RA) 33% stop working within two years and 50% within 10 years. Work difficulties include: pain (particularly hand pain); fatigue; unadapted work environments, equipment and work schedules; poor work self-efficacy (i.e. lack of confidence about working); job strain; limited use of self-management strategies; and limited support from employers and work colleagues. Two USA trials of brief (3 hours) job retention vocational rehabilitation (VR) identified job loss was postponed by modifying such factors. A UK proof-of-principle trial (n=32) identified 10 hours (minimum) of VR reduced work instability. VR is not routinely available in the NHS and Rheumatology departments. It is unclear from the evidence if brief VR provided by therapists is effective and cost-effective in the UK. Aims 1. Assess if there is a difference in work presenteeism between people with RA, undifferentiated IA (UIA) or psoriatic arthritis (PsA) who receive either: usual care, written work self-help information plus brief VR (WORKWELL) provided by a therapist trained in providing VR; or usual care and written work self-help information only (WP1). 2. To assess if there are differences in self-reported work instability, work, activity limitations, work productivity, absenteeism, work status, work self-efficacy, health status, NHS and societal costs between people receiving WORKWELL or written work self-help information only (WP1) 3. To assess the cost-effectiveness of WORKWELL from the perspective of: the NHS using health-related quality of life as the primary outcome; the employer using presenteeism as the primary outcome; and the employer using health-related quality of life as the primary outcome and including presenteeism as a cost. (WP5) 4. To update and evaluate a VR programme for occupational therapists and physiotherapists to help them keep people with RA, IA or PsA in work (WP2). 5. To measure fidelity to the WORKWELL intervention (WP3). 6. To understand the social and structural context in which the intervention is delivered and to identify factors which may influence the quality of implementation (WP3). 7. Investigate contextual factors influencing participants' presenteeism (WP4). Design A pragmatic, multi-centre individually randomised controlled trial (RCT) comparing the effects of brief VR (intervention) with written self-help advice only (control). Cost-effectiveness and process evaluations will also be conducted. Methodology Employed people with RA/ UIA/ PsA who have concerns about being able to continue to work in future due to arthritis, will be consented into the study. They will complete a baseline questionnaire (hard copy or online according to participant preference) and will then be randomly allocated in equal numbers, stratified by participants' job skill levels, to either intervention or control groups. Participants (in both groups) will be mailed a self-help work information pack. Participants' in the intervention group will be referred to receive the WORKWELL intervention from a trained occupational therapist/ physiotherapist. The Lancashire Clinical Trials Unit (CTU: University of Central Lancashire) will contact participants monthly by text/ e-mail/ telephone to identify numbers of days on sick leave. Six months after completing the baseline questionnaire, participants will complete a short postal/online questionnaire including presenteeism, productivity health status measures and resource data. At 12 months, participants will complete a third postal/online questionnaire with most of the measures collected at baseline. Two sub-samples from the intervention and control groups will be interviewed: employed participants about their views of VR; and any unemployed/ retired due to ill-health participants about factors contributing to job loss. At 36 months, participants will complete a fourth postal/online questionnaire with some of the key work status measures collected at baseline. Two sub-samples from the intervention and control groups will be interviewed: employed participants about their views of VR; and any unemployed/ retired due to ill-health participants about factors contributing to job loss. Planned Sample Size 240 people will be recruited from 18 sites. On completion of the trial, qualitative interviews will be completed with 15 employed participants and up to 7 (if any) unemployed / early retired through ill-health from the intervention group. WORKWELL participants' line managers/employers will also be interviewed (where possible: n=10). WORKWELL Therapists and their line managers will also be interviewed (one each from each site, or less if data saturation is reached (n=18 for each). Analyses Statistical analyses will investigate differences in outcomes at 12 and 36 months after baseline between intervention and control groups using mixed effects linear, logistic or ordinal logistic regression modelling, adjusted for baseline values and stratification variables (as applicable). The primary outcome is the summed score of the Combined Work Activities Limitations Scale -Work Limitations Questionnaire-25 (a measure of work presenteeism) at 12 and 36 months after baseline assessment. The health economic analysis will be conducted from the UK National Health Service (NHS) and employer perspectives. Interviews will be thematically analysed. Records will be analysed using content analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
249
North Bristol NHS Trust
Bristol, Avon, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, Cheshire, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust.
Newcastle upon Tyne, Co Tyne and Wear, United Kingdom
Northern Devon Healthcare NHS Trust
Barnstaple, Devon, United Kingdom
NHS Fife
Kirkcaldy, Fife, United Kingdom
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
St Helens, Merseyside, United Kingdom
Aneurin Bevan University Health Board
Chepstow, Monmouthshire, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Hexham, Northumberland, United Kingdom
...and 8 more locations
Combined Work Activities Limitations Scale - Work Limitations Questionnaire-25
Measure of presenteeism (i.e. productivity at work). Scale range 0-111Higher values indicate worse outcome
Time frame: Change between 0 to 12 months; 0 to 36 months
Rheumatoid Arthritis Work Instability Scale
Measure of the degree of mismatch between functional abilities and workplace demands. Scale range 0-23. Higher scores indicate worse problems.
Time frame: Change 0 to 12 months
Work status
Options are whether in full- or part-time work; early retired; retired; unemployed
Time frame: Change between 0 and 12 months; 0 to 36 months
Absenteeism
Number of days sick leave/month. Total number of sick days over 12 month period is calculated.
Time frame: Monthly for 12 months
Work Self-Efficacy Scale
Confidence about working; 0-10 scale; higher scores indicate greater confidence
Time frame: Change 0 to 12 months
Work Productivity and Activity Impairment Scale
Measures time off on sick leave or for any other reason, hours worked; health problems effect on work productivity and ability to do other daily activities; percentage absenteeism - all in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows: Scoring instructions available at: http://www.reillyassociates.net/WPAI\_Scoring.html
Time frame: Change 0 to 12 months
Short Form-12 (SF-12) Health Survey
Physical and mental health.
Time frame: Change 0 to 12 months
EuroQol Five Dimensions QuestionnaireEQ5DL-5
Quality of Life Scale
Time frame: Change 0 to 12 months.
Rheumatoid Arthritis Impact of Disease Scale
Domains of impact of RA: coping, helplessness, fatigue, physical function, sleep, global assessment and pain. RAID final value = (pain NRS value (range 0-10) x 0.21) + (function NRS value (range 0-10) x 0.16) + (fatigue NRS value (range 0-10) x 0.15) + (phys well being NRS value (range 010) x 0.12) + (sleep NRS value (range 0-10) x 0.12) + (emotional well being NRS value (range 0-10) x 0.12) + (coping NRS value (range 0-10) x 0.12). Thus, the range of the final RAID value is 0-10 where higher figures indicate worse status.
Time frame: Change 0 to 12 months
RA Disease Activity Index-5
The RADAI contains five items on global disease activity during the past 6 months (item 1), current disease activity as measured by swollen and tender joints (item 2), current amount of arthritis pain (item 3), current duration of morning stiffness (item 4) and current number of tender joints in a joint list (item 5). The first three items are scored on an 11-point numerical rating scale, with verbal anchors from ''no disease activity''/''no pain'' (score 0) to ''extreme disease activity''/''extreme pain'' (score 10). The last two items are scored on a seven-point (item 4) and four-point (item 5) verbal rating scale.
Time frame: Change 0 to 12 months
Health Resource Use Questionnaire
Measure of health resource use (secondary and primary care; social care; private health care)
Time frame: cumulative health recourse use over 12 months
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