Person-Centred AI Support in Interdisciplinary Rehabilitation for Chronic Pain

Sponsor
Bjorn Ang
Study ID
NCT07081737
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain, Widespread
  • Pain Management
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 67 Years
Healthy Volunteers
Not accepted

Interventions

  • Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS) — OTHER
    Interdisciplinary treatment (IDT) combined with Clinical Decision Support System (CDSS)
  • Interdisciplinary treatment (IDT) — OTHER
    Interdisciplinary treatment (IDT)

Study Details

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.

Key Dates

First listed
Jul 23, 2025
Start date
May 1, 2026
Status verified
Jul 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)
    Participants in this arm receive standard interdisciplinary treatment (IDT) for complex chronic pain, supported by a Clinical Decision Support System (CDSS). The CDSS provides individualized prognostic and predictive outputs using advanced AI-clustered models trained on linked national registry data. Clinicians access the CDSS through a secure interface integrated into clinical workflows, offering data-driven support for person-centred treatment planning and goal setting. The intervention is designed to enhance decision-making, treatment precision, and long-term outcomes such as work ability, well-being, and quality of life. The CDSS is used by the care team prior to and during the rehabilitation program.
  • Active Comparator: Interdisciplinary treatment (IDT)
    Participants in this control-arm receive standard interdisciplinary treatment (IDT) for complex chronic pain. IDT is delivered by a coordinated team of healthcare professionals-typically including physicians, psychologists, physiotherapists, and occupational therapists-and is based on evidence-informed rehabilitation protocols. The program emphasizes biopsychosocial assessment, goal setting, and individually tailored interventions aimed at improving function, coping, and quality of life. No use of the Clinical Decision Support System (CDSS) is included in this arm.

Primary Outcome Measure

Change from Baseline in Patient-Prioritized Health-Related Well-being Composite at 12 Months [ Time Frame: (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice). ]

Central Contacts

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