Chronic PainGAP-421NCT07451587
Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy
A study testing GAP-421 Personalized Care Management Model in people with Chronic Pain and Chronic Non-cancer Pain, run by Universidad Autonoma de Madrid at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Chronic Non-cancer Pain, Care Coordination
- What is being tested?
- GAP-421 Personalized Care Management Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
CS Valleaguado
Coslada, Madrid
Patricia Moreno-Carrero, +34 617 77 90 96, pmcarrero@salud.madrid.org
Centro de Salud Buenos Aires - Physiotherapy Unit
Madrid, Madrid
Raqueñ Blázquez-Cembellin, +34 651 95 59 14, raquel.blazquezcem@salud.madrid.org
Raquel Blázquez-Cembellin
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Pain, Chronic Non-cancer Pain, Care Coordination, Primary Health Care, Musculoskeletal Pain
- Being tested
- GAP-421 Personalized Care Management Model
- Keywords
- Physiotherapy Management, Chronic Pain, Primary Care, Care Coordination, Invisible Work, Organizational Model, Mixed Methods
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAP-421 Personalized Care Management ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GAP-421 Personalized Care Management Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 weeks plus 30 days post-closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter pre-post single-arm pilot study with convergent mixed-methods design. Three primary care health centers (clusters) implement the GAP-421 organizational model in a staggered fashion over a 7-month inclusion period. Each patient receives the 6-week GAP-421 intervention window with 3-month follow-up. No randomization is performed as this is a feasibility pilot study; all centers receive the intervention.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
- Investigators
- Raúl Ferrer-Peña, Dr, Principal investigator, Gerencia Asistencial de Atención Primaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451587
- Sponsor's protocol ID
- GAP-421-MM-2026
- Acronym
- GAP-421
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 24279835Proctor 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.
PubMed 20957426May 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.
PubMed 19460163May 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.
PubMed 24969758Treede 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.
PubMed 30586067Raja 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.
PubMed 32694387
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07451587
- Acronym / sponsor ID
- GAP-421 / GAP-421-MM-2026
- Conditions
- Chronic Pain, Chronic Non-cancer Pain, Care Coordination, Primary Health Care, Musculoskeletal Pain
- Keywords
- Physiotherapy Management, Chronic Pain, Primary Care, Care Coordination, Invisible Work, Organizational Model, Mixed Methods
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter pre-post single-arm pilot study with convergent mixed-methods design. Three primary care health centers (clusters) implement the GAP-421 organizational model in a staggered fashion over a 7-month inclusion period. Each patient receives the 6-week GAP-421 intervention window with 3-month follow-up. No randomization is performed as this is a feasibility pilot study; all centers receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| GAP-421 Intervention | Experimental | Other: GAP-421 Personalized Care Management ModelAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAP-421 Personalized Care Management ModelIt 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. | Other | GAP-421 Intervention |
Primary outcome
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.
9 secondary outcomes
Plan Comprehension - Patient Reported Experience Measure
Time frame: End of GAP window at 6 weeks (T1), 3 months post-closure (T2)
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)
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)
Pain Intensity (Numerical Rating Scale - NRS)
Time frame: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Functional Limitation Scale
Time frame: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)
Coordination Burden (Professional Activity Diary)
Time frame: Continuous during 6-week GAP window, summarized at T1
Interprofessional Role Clarity - Assessment of Interprofessional Team Collaboration Scale II (AITCS-II)
Time frame: Baseline, end of GAP window at 6 weeks (T1)
Avoidable Re-consultations
Time frame: 30 and 60 days post-closure of GAP window
Emergency Department Use for Chronic Pain
Time frame: 6 weeks plus 30 days post-closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 24279835Fetters 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.
- Background: PubMed 20957426Proctor 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.
- Background: PubMed 19460163May 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.
- Background: PubMed 24969758May 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.
- Background: PubMed 30586067Treede 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.
- Background: PubMed 32694387Raja 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raúl Ferrer-Peña, Dr principal investigator
Gerencia Asistencial de Atención Primaria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAP-421 Personalized Care Management Model in people with Chronic Pain and Chronic Non-cancer Pain, run by Universidad Autonoma de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raúl Ferrer-Peña, Dr (+34607712148, raul.ferrer@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Perceived Care Coordination (Coordination PREM) (time frame: Baseline (T0), end of GAP window at 6 weeks (T1), 3 months post-closure (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07451587, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.