An interventional study of GAP-421 Personalized Care Management Model in Chronic Pain, Chronic Non-cancer Pain and Care Coordination, sponsored by Universidad Autonoma de Madrid. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Universidad Autonoma de Madrid · Not applicable, Interventional, and Health services research
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.
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:
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 6 weeks plus 30 days post-closure
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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