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

Starting soon · Not applicable

Conditions studied: Chronic Pain, Chronic Non-cancer Pain, Care Coordination, Primary Health Care, Musculoskeletal Pain

In brief

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.

Key facts

Study ID: NCT07451587
Run by: Universidad Autonoma de Madrid
People needed: 66
Starts: 2026-09-01
Expected to finish: 2029-08-01
Last updated by the study team: 2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

CS Valleaguado — Coslada, Madrid, Spain
Centro de Salud Buenos Aires - Physiotherapy Unit — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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