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

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.

• 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.

Primary outcomes

• 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.

Secondary outcomes

• Plan Comprehension - Patient Reported Experience Measure [End of GAP window at 6 weeks (T1), 3 months post-closure (T2)]: 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.
• Health-Related Quality of Life (EQ-5D-5L) [Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)]: 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
• Chronic Pain Magnitude (Graded Chronic Pain Scale - GCPS) [Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)]: 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.
• Pain Intensity (Numerical Rating Scale - NRS) [Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)]: 0-10 Numerical Rating Scale for pain intensity. ICC = 0.90-0.95. MCID = 2 points or 30% relative change.
• Functional Limitation Scale [Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)]: 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.
• Coordination Burden (Professional Activity Diary) [Continuous during 6-week GAP window, summarized at T1]: 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.
• Interprofessional Role Clarity - Assessment of Interprofessional Team Collaboration Scale II (AITCS-II) [Baseline, end of GAP window at 6 weeks (T1)]: 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.
• Avoidable Re-consultations [30 and 60 days post-closure of GAP window]: 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).
• Emergency Department Use for Chronic Pain [6 weeks plus 30 days post-closure]: 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.

Sex: All, ages: 18 Years to any

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

• 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
• 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
• 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
• 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
• 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
• 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

• Raúl Ferrer-Peña, Dr, Principal investigator, Gerencia Asistencial de Atención Primaria