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

Trials, Jul 2015

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 non-inferiority 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 non-inferiority 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 (<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).

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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

Beemster et al. Trials 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 Timo T. Beemster 0 1 2 Judith M. van Velzen 0 2 Coen A.M. van Bennekom 0 2 Monique H.W. Frings-Dresen 2 Michiel F. Reneman 1 0 Department of Research and Development, Heliomare Rehabilitation Center , Wijk aan Zee , The Netherlands 1 Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen , Groningen , The Netherlands 2 Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam , Amsterdam , The Netherlands 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 non-inferiority 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 non-inferiority 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 (<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. (Continued on next page) - (Continued from previous page) 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). Background Chronic musculoskeletal pain is a major health problem associated with decreased functioning and quality of life, sick leave, and increased direct and indirect medical costs [1–4]. The majority of the costs (48 to 88 %) are attributed to indirect costs due to sick leave from work or productivity loss while at work [5, 6]. Chronic musculoskeletal pain arises when acute musculoskeletal pain does not disappear within 6 weeks, which occurs in 10–20 % of the cases [7]. After a duration of 6 weeks, it is considered subacute musculoskeletal pain (SMP), and if the pain is still present after 12 weeks, it is considered chronic musculoskeletal pain (CMP) [8]. If there is no clear medical explanation, the chronic musculoskeletal pain is called “nonspecific.” Vocational rehabilitation is a widely advocated intervention for sick-listed workers with subacute or chronic nonspecific musculoskeletal pain [9–12]. Vocational rehabilitation is “a multiprofessional evidence-based approach that is provided in different settings, services, and activities to working-age individuals with healthrelated impairments, limitations, or restrictions with work functioning and whose primary aim is to optimize work participation” [13]. In addition, work participation is conceptualized as the involvement in work roles or the lived experience of work. Work participation restriction refers to problems an individual may experience at work. Examples include number of hours lost from work (that is, absenteeism), underperforming job expectations, reduced desired employment (for example, part-time employment, short-term disability, long-term disability, premature retirement, or fewer working hours than desired), and reduced car (...truncated)


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Timo Beemster, Judith van Velzen, Coen van Bennekom, Monique Frings-Dresen, Michiel Reneman. 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, Trials, 2015, pp. 317, 16, DOI: 10.1186/s13063-015-0861-4