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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Pain; Chronic Pain; Primary Health Care; Care Coordination; Chronic Non-cancer Pain
• Intervention / Treatment: Other: GAP-421 Personalized Care Management Model

Detailed Description

BACKGROUND:

Primary care faces a structural mismatch between the growing complexity of patients with chronic pain and an organizational architecture designed for acute episodes and independent schedules. International guidelines (NICE NG193, WHO 2023) recommend multimodal approaches with a function-centered focus consistent with physiotherapy competencies, yet interprofessional coordination relies on unrecognized informal work, generating hidden workload, care fragmentation, and inappropriate transfer of organizational responsibilities to patients.

The Burden of Treatment Theory and Cumulative Complexity Model explain that when organizational burden exceeds patient capacity, the result is organizational design failure rather than patient non-adherence. Recent evidence from the Community of Madrid (Izquierdo Enriquez et al., 2026) revealed a striking paradox: 72.8% of primary care physicians consider education and exercise superior to pharmacological treatment, yet 62.8% still consider opioids effective for chronic non-cancer pain, illustrating the gap between declarative adherence to biopsychosocial approaches and pharmacologically-dominated practice.

THE GAP MODEL:

The GAP (Personalized Care Management) model proposes a time-limited functional modality that reconfigures the interaction between schedules, resources, and professionals so that care is organized around a specific person and their trajectory. It operates through four features: temporality (activates and deactivates), reconfiguration (reorganizes existing resources without creating parallel structures), person-centeredness (designed from the patient trajectory), and organizational legitimacy (converts invisible coordination into explicit, recorded, and evaluable work).

INTERVENTION:

The GAP-421 model operates on Service 421 (chronic pain) of the Primary Care Service Portfolio of the Community of Madrid through a 6-week window structured in four phases:

• Day 0 (Activation): Lead physiotherapist identifies 2 or more organizational mismatch signals. Documented in standardized GAP Activation Form.
• Week 1 (Characterization): Concentrated comprehensive assessment. Protected non-face-to-face coordination time. Classification of functional status, burden-capacity profile, shared clinical message.
• Weeks 2-4 (Intervention): Therapeutic education, graded exercise, pharmacological adjustment if indicated. Aligned messages across professionals. Exercise plan with adherence monitoring.
• Weeks 4-6 (Closure): Semi-annual plan with milestones, de-escalation criteria, return to standard circuit. Follow-up plan, reactivation signals, patient feedback.

Key organizational changes include: physiotherapist schedule incorporating comprehensive GAP assessment slot (45-60 min), weekly protected interprofessional coordination time (15-20 min), and closure session (30-40 min); family physician allocating 5-15 min/week for coordination and message alignment; nursing conducting socio-familial assessment when indicated.

THEORETICAL FRAMEWORK:

The study is grounded in Normalization Process Theory (NPT), Burden of Treatment Theory, and the GAP conceptual model.

SAMPLE SIZE:

n=66 patients (22 per center) calculated with design effect correction (DEFF=2.05, ICC=0.05, effect size d=0.60, 20% attrition).

ANALYSIS:

Quantitative: Wilcoxon/paired t-tests, exploratory multilevel mixed models (patients nested within centers), Cohen's d with 95% CI. R v4.3.

Qualitative: Reflexive thematic analysis with inductive-deductive coding using NPT constructs. Atlas.ti v24.

Integration: Joint Display convergence matrix, Pillar Integration Process, Onwuegbuzie and Johnson 9-type legitimation framework. Quality: MMAT 2018, GRAMMS checklist.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raúl Ferrer-Peña, Dr; Phone Number: +34607712148; Email: raul.ferrer@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Coslada, Madrid, Spain
      • CS Valleaguado
      • Contact: Patricia Moreno-Carrero; Phone Number: +34 617 77 90 96; Email: pmcarrero@salud.madrid.org
    • Madrid, Madrid, Spain
      • Centro de Salud Buenos Aires - Physiotherapy Unit
      • Contact: Raqueñ Blázquez-Cembellin; Phone Number: +34 651 95 59 14; Email: raquel.blazquezcem@salud.madrid.org
      • Sub-Investigator: Raquel Blázquez-Cembellin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plan Comprehension - Patient Reported Experience Measure	Two dichotomous items from the King's Fund Patient Reported Experience Measure framework and the NHS Patient Experience Questionnaire (each item scored 0-1, no/yes). Scores can be reported per item (range 0-1) or as a summed total (range 0-2), where higher scores indicate better plan comprehension, meaning a better outcome.	End of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Health-Related Quality of Life (EQ-5D-5L)	EQ-5D-5L with Spanish value set. Five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with 5 levels. Utility index calculated using Spanish tariff. ICC = 0.86 for utility index. MCID = 0.05-0.08 points	Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Chronic Pain Magnitude (Graded Chronic Pain Scale - GCPS)	Spanish version of the Graded Chronic Pain Scale (GCPS). Classifies chronic pain into 5 grades (0-IV) based on pain intensity and disability. Cronbach's alpha = 0.84-0.91; weighted kappa = 0.81 for grade classification.	Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Pain Intensity (Numerical Rating Scale - NRS)	0-10 Numerical Rating Scale for pain intensity. ICC = 0.90-0.95. MCID = 2 points or 30% relative change.	Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Functional Limitation Scale	Functional Limitation Scale from Annex 54 of the Community of Madrid Primary Care Service Portfolio. Score of 2 or higher indicates functional limitation warranting Service 421 enrollment.	Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Coordination Burden (Professional Activity Diary)	Ad hoc activity diary differentiating formal from informal coordination time, following recommendations by Bratt et al. and Poghosyan et al. for measuring invisible work in primary care settings. Professionals document daily coordination activities, distinguishing between recognized (scheduled) and unrecognized (informal) coordination time.	Continuous during 6-week GAP window, summarized at T1
Interprofessional Role Clarity - Assessment of Interprofessional Team Collaboration Scale II (AITCS-II)	the Assessment of Interprofessional Team Collaboration Scale II (AITCS-II). Assesses clarity of professional roles and responsibilities within the GAP-421 coordination framework. Total score range 23-115, where higher scores indicate better interprofessional team collaboration.	Baseline, end of GAP window at 6 weeks (T1)
Avoidable Re-consultations	Number of new consultations in Service 421 or family medicine for the same pain episode without relevant trajectory change, extracted from electronic health records through blind review by two independent evaluators (inter-rater agreement: Cohen's kappa, minimum 0.60 required).	30 and 60 days post-closure of GAP window
Emergency Department Use for Chronic Pain	Proportion of patients with one or more emergency department visits for the chronic pain condition during the GAP window (6 weeks) plus 30 days post-closure.	6 weeks plus 30 days post-closure

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
• Investigators: Principal Investigator: Raúl Ferrer-Peña, Dr, Gerencia Asistencial de Atención Primaria

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Primary Care; Mixed Methods; Care Coordination; Physiotherapy Management; Invisible Work; Organizational Model
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Chronic Pain
• Other Study ID Numbers: GAP-421-MM-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data will be made available upon reasonable request to the corresponding author after publication of primary results. Data will be deposited in an open-access repository.
• IPD Sharing Time Frame: Beginning 6 months after publication of primary results. Available for 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No