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临床试验/NCT07451587
NCT07451587
尚未招募
不适用

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

Universidad Autonoma de Madrid2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年9月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
2
主要终点
Patient-Perceived Care Coordination (Coordination PREM)

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

盲法说明

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).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: GAP-421 Personalized Care Management Model (Other)

结局指标

主要结局

Patient-Perceived Care Coordination (Coordination PREM)

时间窗: 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.

次要结局

  • 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))
  • Coordination Burden (Professional Activity Diary)(Continuous during 6-week GAP window, summarized at T1)
  • Interprofessional Role Clarity - Assessment of Interprofessional Team Collaboration Scale II (AITCS-II)(Baseline, end of GAP window at 6 weeks (T1))
  • Avoidable Re-consultations(30 and 60 days post-closure of GAP window)
  • Emergency Department Use for Chronic Pain(6 weeks plus 30 days post-closure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raúl Ferrer-Peña

Professor

Universidad Autonoma de Madrid

研究点 (2)

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