Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy
Not yet recruitingNot applicableNCT07451587
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Multicenter Mixed-Methods Pilot Study Evaluating a Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy: Feasibility, Care Coordination, and Patient-Reported Outcomes
- Conditions
- Chronic Pain
- Chronic Non-cancer Pain
- Care Coordination
- Primary Health Care
- Musculoskeletal Pain
- Interventions
- Other: GAP-421 Personalized Care Management Model
- Sponsor
- Universidad Autonoma de Madrid
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Start date
- 2026-09
- Primary completion
- 2028-02
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults aged 18 years or older * Enrolled in Service 421 of the Madrid Primary Care Service Portfolio (chronic non-cancer pain of at least 3 months duration) * Pain intensity NRS of 4 or higher in the last 2 weeks OR functional limitation score of 2 or higher (Annex 54, SERMAS Service Portfolio) * Ability to understand and sign informed consent * Ability to complete study questionnaires in Spanish Exclusion Criteria: * Active cancer pain * Documented moderate-to-severe cognitive disorder (ICD-10 diagnosis or registered functional assessment) * Decompensated psychiatric disorder that, in the clinical judgment of the physiotherapist and/or family physician, interferes with study participation * Immediate clinical emergency at enrollment * Simultaneous participation in another clinical trial or organizational intervention study * Anticipated inability to complete 3-month follow-up (planned relocation, imminent institutionalization) * Explicit refusal to participate
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07451587