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

Sponsor
Universidad Autonoma de Madrid
Study ID
NCT07451587
Status
Not Yet Recruiting

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Conditions

  • Care Coordination
  • Chronic Non-cancer Pain
  • Chronic Pain
  • Musculoskeletal Pain
  • Primary Health Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GAP-421 Personalized Care Management Model — OTHER
    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.

Study Details

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 Dates

First listed
Mar 5, 2026
Start date
Sep 30, 2026
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: GAP-421 Intervention
    All participants receive the GAP-421 (Personalized Care Management) organizational intervention. The GAP-421 is a time-limited 6-week window that reorganizes existing primary care resources for chronic pain management through four phases: activation (Day 0), characterization (Week 1), intervention with coordinated care (Weeks 2-4), and closure with sustainability plan (Weeks 4-6). No new clinical intervention is introduced; rather, the sequence, temporality, and coordination of actions already defined in the Service Portfolio are reorganized. The physiotherapist serves as the primary process manager. Three primary care centers implement the model in a staggered fashion.

Primary Outcome Measure

Patient-Perceived Care Coordination (Coordination PREM) [ Time Frame: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2) ]

Central Contacts

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