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

NCT07451587 | Not Yet Recruiting

• 1 other identifier: GAP-421-MM-2026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Physiotherapy Management; Chronic Pain; Primary Care; Care Coordination; Invisible Work; Organizational Model; Mixed Methods

Outcome Measures

Primary Outcomes (1)

• Patient-Perceived Care Coordination (Coordination PREM)

  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.

  Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)

Secondary Outcomes (9)

• Plan Comprehension - Patient Reported Experience Measure

  End of GAP window at 6 weeks (T1), 3 months post-closure (T2)

• Health-Related Quality of Life (EQ-5D-5L)

  Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)

• Chronic Pain Magnitude (Graded Chronic Pain Scale - GCPS)

  Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)

• Pain Intensity (Numerical Rating Scale - NRS)

  Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)

• Functional Limitation Scale

  Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)

Study Arms (1)

GAP-421 Intervention

EXPERIMENTAL

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.

Other: GAP-421 Personalized Care Management Model

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.

GAP-421 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead
• Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid: collaborator

Study Sites (2)

CS Valleaguado

Coslada, Madrid, Spain

Location

Centro de Salud Buenos Aires - Physiotherapy Unit

Madrid, Madrid, Spain

Location

Related Publications (6)

• Fetters 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 BACKGROUND

• Proctor 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 BACKGROUND

• May 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 BACKGROUND

• May 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 BACKGROUND

• Treede 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 BACKGROUND

• Raja 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.

  PMID: 32694387 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Raúl Ferrer-Peña, Dr

  Gerencia Asistencial de Atención Primaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Ferrer-Peña, Dr

CONTACT

+34607712148; raul.ferrer@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label organizational intervention. Partial blinding applies only to the assessment of system sustainability outcomes (Domain C): electronic health record review for avoidable re-consultations is conducted by two independent evaluators blinded to intervention timing (Cohen's kappa minimum 0.60 required for inter-rater agreement).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenter pre-post single-arm pilot study with convergent mixed-methods design. Three primary care health centers (clusters) implement the GAP-421 organizational model in a staggered fashion over a 7-month inclusion period. Each patient receives the 6-week GAP-421 intervention window with 3-month follow-up. No randomization is performed as this is a feasibility pilot study; all centers receive the intervention.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of primary results. Available for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to raul.ferrer@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (2)