About this trial
This cluster randomized controlled trial evaluates whether a person-centred, AI-supported Clinical Decision Support System (CDSS) can improve outcomes and cost-effectiveness in interdisciplinary rehabilitation for people with complex chronic pain. The CDSS is designed to assist clinicians in making personalized treatment decisions within standard interdisciplinary treatment (IDT). It has been developed using machine learning models trained on real-world data from over 100,000 patients in the Swedish Quality Registry for Pain Rehabilitation (SQRP), linked to several national registers, including the National Patient Register, the Prescribed Drug Register, the Social Insurance Agency database (MiDAS), and the Cause of Death Register. This enables individualized predictions of treatment outcomes, work ability, and healthcare utilization.
The trial includes 400 adult patients with chronic pain, enrolled at 20 IDT clinics randomized to either CDSS-supported or standard IDT. The study has three phases: feasibility, effectiveness, and implementation. The primary outcome is a patient-prioritized composite single-index of health-related well-being, based on domains such as pain, sleep, physical and mental health, emotional distress, and work ability. Patients prioritize these domains together with their clinical team, enabling a person-centred assessment. Secondary outcomes include HRQoL (EQ-5D, SF-36), emotional distress (HADS), and work ability (WAI), measured at baseline, post-treatment, 6- and 12-month follow-up.
A parallel mixed-methods process evaluation will examine implementation outcomes such as usability, clinician adherence, and workflow integration, using logs, surveys (e.g., S-NoMAD), and interviews. Normalization Process Theory guides the analysis. Cost-utility will be assessed using QALYs and ICERs from a societal perspective, with long-term projections using simulation models. Results will be reported in peer-reviewed publications.
Eligibility criteria
Qualifiers
Aged 18 to 67 years
Diagnosed with chronic non-malignant pain persisting longer than 3 months
Pain condition includes, but is not limited to: fibromyalgia, widespread pain, back pain, neck pain, or shoulder pain
Eligible for and referred to interdisciplinary rehabilitation (IDT) at a participating clinic
Disqualifiers
Pain caused by malignancy or cancer-related treatment
Pain caused by systemic diseases such as rheumatoid arthritis, lupus, or other autoimmune or inflammatory conditions
Severe psychiatric conditions interfering with study participation (e.g., untreated psychosis or severe depression requiring immediate psychiatric care)
Documented cognitive impairment limiting ability to understand study participation or complete self-reported measures
Trial design
Treatments tested in this trial
- Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)
- Interdisciplinary treatment (IDT)
Treatment groups
Sponsors and collaborators
Bjorn Ang
Lead sponsor
Dalarna University
Sponsor institution
Göteborg University
Collaborator
Forte
Collaborator
Dalarna County Council, Sweden
Collaborator
Karolinska Institutet
Collaborator
The Swedish Research Council
Collaborator