Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy
NCT07451587 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-03-05
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.
Conditions
- Chronic Pain
- Chronic Non-cancer Pain
- Care Coordination
- Primary Health Care
- Musculoskeletal Pain
Interventions
- OTHER
-
GAP-421 Personalized Care Management Model
It reorganizes existing resources through a 6-week window: Phase 1 - Activation (Day 0): The lead physiotherapist identifies 2 or more organizational mismatch signals. Documented in a standardized GAP Activation Form. Phase 2 - Characterization (Week 1): Comprehensive assessment in protected time slot (45-60 min). Establishment of shared clinical message across professionals. Phase 3 - Coordinated Intervention (Weeks 2-4): Therapeutic education, graded exercise, pharmacological adjustment if indicated Phase 4 - Closure (Weeks 4-6): Semi-annual plan with milestones, de-escalation criteria. Return to standard Service 421 circuit Key organizational features: The physiotherapist becomes the primary process manager for the chronic pain episode.
Sponsors & Collaborators
-
Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
collaborator UNKNOWN -
Universidad Autonoma de Madrid
lead OTHER
Principal Investigators
-
Raúl Ferrer-Peña, Dr · Gerencia Asistencial de Atención Primaria
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-02-29
- Completion
- 2029-08-31
Countries
- Spain
Study Locations
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