Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 15, 2025
Date Accepted: Oct 14, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Is a stepped model of care cost-effective compared to usual care for musculoskeletal disorders (Edu-First trial)? Study protocol for a multi-arm randomized controlled trial
ABSTRACT
Background:
Musculoskeletal disorders (MSKDs) are a leading cause of disability, and pain, placing a substantial burden on healthcare systems. To address this, optimizing resource use through innovative interventions is essential. Evidence from randomized controlled trials (RCTs) suggests that not all individuals with MSKDs require ongoing follow-up with a healthcare provider; for many, education alone is sufficient for symptom resolution. A Stepped Care Model that prioritizes patient education as the first-line intervention and reserves usual care for those with persistent symptoms may improve healthcare efficiency and reduce costs.
Objective:
This RCT aims to evaluate the effectiveness of a Stepped Care Model compared to the two most common approaches for managing MSKDs: Usual Medical Care and Usual Rehabilitation Care. A secondary objective is to assess cost-utility. We hypothesize that the Stepped Care Model will be as effective as the other models in reducing functional limitations while being more efficient.
Methods:
This pragmatic, non-inferiority, multi-arm, parallel-group RCT will enroll 369 adults with MSKDs, who will be randomly assigned to one of three 12-week intervention groups: Stepped Care, Usual Medical Care (physician-led intervention), or Usual Rehabilitation Care (physiotherapist-led intervention). Participants in the Stepped Care group will first complete a 6-week education program. After 6 weeks, those with persistent symptoms will receive rehabilitation interventions, while those whose symptoms have resolved will receive no further intervention. The primary outcome will be functional limitations at 24 weeks. Secondary outcomes will include pain severity, health-related quality of life, pain-related fear, and pain self-efficacy, assessed at baseline and at 6, 12, and 24 weeks. Groups will be compared using linear mixed models, and cost estimates will be calculated to assess incremental cost-effectiveness.
Results:
Non applicable
Conclusions:
Non applicable Clinical Trial: NCT06832852
Citation
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