Cost-effectiveness of 40-hour versus 100-hour vocational rehabilitation on work participation for workers on sick leave due to subacute or chronic musculoskeletal pain: study protocol for a randomized controlled trial
Study protocol
1 Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
2 Department of Research and Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands
3 Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Trials 2015, 16:317Â
doi:10.1186/s13063-015-0861-4
Published: 28 July 2015
Abstract (provisional)
Background Although vocational rehabilitation is a widely advocated intervention for
workers on sick leave due to subacute or chronic nonspecific musculoskeletal pain,
the optimal dosage of effective and cost-effective vocational rehabilitation remains
unknown. The objective of this paper is to describe the design of a noninferiority
trial evaluating the effectiveness and cost-effectiveness of 40-h multidisciplinary
vocational rehabilitation compared with 100-h multidisciplinary vocational rehabilitation
on work participation for workers on sick leave due to subacute or chronic musculoskeletal
pain. Methods/Design A noninferiority study design will be applied. The study population
consists of workers who are on part-time or full-time sick leave due to subacute or
chronic nonspecific musculoskeletal pain. Two multidisciplinary vocational rehabilitation
programs following the bio-psychosocial approach will be evaluated in this study:
40-h vocational rehabilitation and 100-h vocational rehabilitation, both delivered
over a maximum of 15 weeks. The 100-h vocational rehabilitation comprises five modules:
work participation coordination, graded activity, cognitive behavioral therapy, group
education, and relaxation. The 40-h vocational rehabilitation comprises work participation
coordination and a well-reasoned choice from the other four modules. Four rehabilitation
centers will participate in this study, each delivering both interventions. Patients
will be randomized into one of the interventions, stratified for the duration of sick
leave (lt;6 weeks or ?6 weeks) and type of sick leave (part-time or full-time). The
primary outcome is work participation, measured by self-reported sick leave days,
and will be assessed at baseline, mid-term, discharge, and at 2, 4, 6, 8, 10, and
12 months follow-up. Secondary outcomes are work ability, disability, quality of life,
and physical functioning and will be assessed at baseline, discharge, and at 6 and
12 months follow-up. Cost outcomes are absenteeism, presenteeism, healthcare usage,
and travelling costs. Cost-effectiveness will be evaluated from the societal and employer
perspectives. Discussion The results obtained from this study will be useful for vocational
rehabilitation practice and will provide stakeholders with relevant insights into
two versions of vocational rehabilitation. Trial registration Dutch Trial Register
identifier: NTR4362 (registered 17 March 2014).