Clinical Trial

Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy

Study acronym: GAP-421
Not Yet Recruiting
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Summary
This multicenter pilot study evaluates the feasibility, implementation fidelity, and preliminary effects of the GAP-421 (Personalized Care Management) model for chronic pain management in primary care physiotherapy. The GAP model is a time-limited organizational modality that reconfigures schedules, resources, and professional roles during a defined 6-week window to organize care around the individual patient and their trajectory, formalizing coordination work that previously occurred informally. The study uses a convergent mixed-methods design across three primary care health centers in the Southeast Healthcare District (DASE) of the Community of Madrid, Spain. The quantitative component is a prospective multicenter pre-post case series with 3-month follow-up (n=66 patients, 22 per center). The qualitative component includes semi-structured interviews (n=12) and focus groups (3 groups, n=6 each). Integration occurs through Joint Display, Pillar Integration Process, and a 9-type legitimation framework. The primary outcome is patient-perceived care coordination measured on a 0-10 numerical scale (PREM). Secondary outcomes span five domains: patient-reported outcomes (EQ-5D-5L, Graded Chronic Pain Scale, pain intensity), professional outcomes (coordination burden, role clarity), system sustainability (avoidable re-consultations, emergency department use), implementation fidelity, and feasibility indicators. Results will generate feasibility parameters, intraclass correlation coefficient estimates, and process indicators essential for designing definitive cluster-randomized trials testing organizational interventions in primary care physiotherapy.
Trial Details
NCT Number NCT07451587
Lead Sponsor Universidad Autonoma de Madrid
Collaborators: Colegio de Fisioterapeutas de la Comunidad de Madrid
Conditions Chronic Pain, Chronic Non-cancer Pain, Care Coordination, Primary Health Care, Musculoskeletal Pain
Enrollment 66 participants
Start Date 2026-09
Primary Completion 2028-02 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-05