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NCT Number: NCT07451587

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CS Valleaguado, Coslada, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Patient-Perceived Care Coordination (Coordination PREM)

    Time frame: 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

  1. Plan Comprehension - Patient Reported Experience Measure

    Time frame: 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.

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

    Time frame: 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

  3. Chronic Pain Magnitude (Graded Chronic Pain Scale - GCPS)

    Time frame: 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.

  4. Pain Intensity (Numerical Rating Scale - NRS)

    Time frame: 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.

  5. Functional Limitation Scale

    Time frame: 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.

  6. Coordination Burden (Professional Activity Diary)

    Time frame: 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.

  7. Interprofessional Role Clarity - Assessment of Interprofessional Team Collaboration Scale II (AITCS-II)

    Time frame: 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.

  8. Avoidable Re-consultations

    Time frame: 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).

  9. Emergency Department Use for Chronic Pain

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raúl Ferrer-Peña, Dr

CONTACT

[email protected]

+34607712148

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Collaborators

  • Colegio de Fisioterapeutas de la Comunidad de Madrid

Registry information

Official study title

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

Acronym: GAP-421

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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