Clinical trial · Interventional
Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Care Coordination | — | UNRESOLVED | — |
| Chronic Non-cancer Pain | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Musculoskeletal Pain | — | UNRESOLVED | — |
| Primary Health Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GAP-421 Personalized Care Management Model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GAP-421 Intervention
- description
- 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.
- interventionNames
- Other: GAP-421 Personalized Care Management Model
Primary outcomes (1)
- measure
- Patient-Perceived Care Coordination (Coordination PREM)
- timeFrame
- Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDFetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23. PMID 24279835
- BACKGROUNDProctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
- BACKGROUNDMay CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, Murray E, Elwyn G, Legare F, Gunn J, Montori VM. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci. 2009 May 21;4:29. doi: 10.1186/1748-5908-4-29. PMID 19460163
- BACKGROUNDMay CR, Eton DT, Boehmer K, Gallacher K, Hunt K, MacDonald S, Mair FS, May CM, Montori VM, Richardson A, Rogers AE, Shippee N. Rethinking the patient: using Burden of Treatment Theory to understand the changing dynamics of illness. BMC Health Serv Res. 2014 Jun 26;14:281. doi: 10.1186/1472-6963-14-281. PMID 24969758
- BACKGROUNDTreede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384. PMID 30586067
- BACKGROUNDRaja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.