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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Patient-Perceived Care Coordination (Coordination PREM) — Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
  Single-item patient-reported experience measure (PREM) on a 0-10 numerical rating scale, where 0 = "no perceived coordination" and 10 = "perfect coordination among all professionals who treated me." Expected minimum clinically important difference (MCID) = 1.5 points; SD of differences approximately 2.5; effect size d = 0.60. Single-item coordination PREMs on 0-10 scales have demonstrated convergent construct validity with multi-item coordination measures (r = 0.72-0.81), discriminant validity for differentiating between integration levels, and test-retest reliability ICC = 0.78-0.85 at 2 weeks.

Trial sites (2)

More Universidad Autonoma de Madrid trials in Spain

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