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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)
Other interventionInterdisciplinary treatment (IDT) combined with Clinical Decision Support System (CDSS)
Interdisciplinary treatment (IDT)
Other interventionInterdisciplinary treatment (IDT)
Treatment groups
Trial outcomes
Primary outcomes
Change from Baseline in Patient-Prioritized Health-Related Well-being Composite at 12 Months
A person-centred composite score based on eight validated domains: pain intensity (NRS; 0-10), sleep problems (ISI; 0-28), physical health (SF-36 PF; 0-100), mental health (SF-36 MH; 0-100), depression and anxiety (HADS-A/D; 0-21), work ability (WAI single item; 0-10), and pain interference (single item; 0-10). At baseline, participants prioritize these domains together with the interdisciplinary treatment (IDT) team. The Clinical Decision Support System (CDSS) stores these weights. Each domain is normalized to 0-100 and combined into a weighted composite. Higher scores indicate better health-related well-being. Although composed of several scales, the outcome is reported as a single, aggregated primary measure.
Secondary outcomes
Change from Baseline in Pain Intensity (NRS) at 12 Months
Measured using the Numeric Rating Scale (NRS, 0-10), where 0 = no pain and 10 = worst imaginable pain. Participants report average pain over the last seven days. A reduction in score indicates clinical improvement.
Change from Baseline in Sleep Problems Measured by the Insomnia Severity Index (ISI) at 12 Months
The ISI assesses perceived sleep difficulties through seven items. Total scores range from 0 to 28, with higher values indicating more severe insomnia. A lower score reflects improved sleep quality.
Change from Baseline in Physical Health Functioning (SF-36 PF) at 12 Months
Measured using the SF-36 Physical Functioning subscale (10 items). Scores range from 0 to 100, with higher scores representing better physical functioning.
Change from Baseline in Mental Health (SF-36 MH) at 12 Months
Measured using the SF-36 Mental Health subscale (5 items). Scores range from 0 to 100; higher values indicate better mental well-being.
Other outcomes
Change in Sickness Absence (Register-Based) at 12 Months
Data obtained from the Swedish Social Insurance Agency (MiDAS) detailing sickness absence (full- or part-time) in number of net days. Fewer days indicate clinical or occupational improvement. Scores range from 0 to an open upper limit, where 0 indicates no sickness absence and higher values indicate more days of absence.
Change in Total Prescribed Medication Volume (Register-Based) at 12 Months
Data will be extracted from the Swedish Prescribed Drug Register. Medication volume will be calculated using the Defined Daily Dose (DDD) methodology, as defined by the World Health Organization (WHO). For each prescribed medication, the total number of dispensed units will be converted into DDDs based on the standard daily maintenance dose for its main indication in adults. The total DDDs per individual will be summed across all medications to reflect overall pharmacological treatment intensity. Scores range from 0 to no predefined upper limit, where higher values indicate greater medication burden.
Change in Comorbidity Burden Over Time
Comorbidity burden will be derived from the Swedish National Patient Register using established ICD-10 codes. A validated multimorbidity index (e.g., the Charlson Comorbidity Index or a count of chronic conditions) will be calculated for each individual at multiple time points. Higher scores reflect a greater burden of comorbid disease. Scores typically range from 0 (no comorbid conditions) to 15 or more, depending on the index used and the number/severity of conditions present.
Change in Pain Location Complexity Over Time
Self-reported pain drawings will be analyzed to determine the number of distinct anatomical pain locations reported by each participant. This measure reflects the spatial complexity of pain presentation. Scores range from 0 (no reported pain) to approximately 36, based on a standardized body map divided into predefined regions. Higher scores indicate more widespread or complex pain distribution.
Sponsors and contacts
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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
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