Observational Study to Validate a Family Physician Echocardiography Training Programme

NCT ID: NCT07339007

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-12

Study Completion Date

2027-12-31

Brief Summary

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Observational Study on the Validation of Family Doctors' Training in Echocardiography

The Catalan Society of Family and Community Medicine (CAMFiC) developed a structured training program for Family Physicians in focused cardiac ultrasound (FoCUS). This study evaluates GP FoCUS performance against comprehensive echocardiography and assesses training competence.

Developed between September 2023 and November 2025 (92 hours total, including 70 hours supervised practice), participants perform FoCUS on patients with suspected cardiac pathology. The study measures concordance between GP FoCUS and cardiologist echocardiography, and evaluates FoCUS integration into primary care pathways to enhance diagnostic capacity for common cardiac conditions.

Detailed Description

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ACKGROUND \& JUSTIFICATION Cardiovascular disease generates long cardiology waiting lists in Spain (\>90 days echocardiography). Elderly patients discharged from hospital require cardiac follow-up in primary care, but Family Medicine residency (MIR) excludes point-of-care ultrasound (POCUS) training. This gap limits GP triage capacity for common cardiac pathology.

The Catalan Society of Family and Community Medicine (CAMFiC), in collaboration with the Catalan Society of Cardiology (SCC), developed a structured FoCUS training program (2022, 92 hours total: 18h theory + 4h workshop for cardiac views + 70h supervised hospital practice) to empower primary care physicians.

HYPOTHESIS

Primary Hypotheses:

1. Structured FoCUS training enables GPs to achieve competency across ≥6/7 predefined domains (standard views, LVEF estimation, RV/volume assessment, valvular disease detection, pericardial effusion, LVH recognition, theoretical knowledge).
2. This training program achieves ≥80% concordance between GP-performed FoCUS and cardiologist-performed standard echocardiography on predefined cardiac parameters (κ≥0.6).

Secondary Hypotheses:
3. Trained GP will be able to integrate this technique into routine practice (≥1 scan/week).
4. FoCUS enables documentation of key cardiac pathologies (LVEF impairment, RV dilation, significant valve disease, pericardial effusion) among primary care scans performed for clinical indications (dyspnea, heart murmur, suspected HF, arrhythmia).
5. FoCUS plus clinical data identifies ≥3 distinct patient profiles among primary care patients assessed.
6. FoCUS in primary care achieves appropriate triage of patients requiring formal echocardiography.
7. The programme will be acceptable to stakeholders, with high satisfaction reported by patients, family doctors, and cardiologists participating in the programme.
8. FoCUS in primary care will increase identification of suspected heart failure among assessed patients and may reduce time to appropriate management.

STUDY OVERVIEW Prospective observational study (CEIm IDIAP 23/072-P). 46 CAMFiC GPs perform FoCUS on consecutive adult patients (\>18 years) with clinical cardiac indication during primary care visits, followed by cardiologist echocardiography confirmation. Data captured via REDCap eCRF.

See Outcomes, Eligibility Criteria, and Arms/Interventions for specific measures, criteria, and procedures.

PHASES

* Phase 0: Preparation (2022)
* Phase 1: Training (2022-2025)
* Phase 2: Data collection (2024-2027)
* Phase 3: Analysis (kappa/ICC/Bland-Altman, mixed models) (2027-2028)
* Phase 4: Dissemination (PhD thesis, peer-reviewed publications) (2028)

CLINICAL IMPACT Reduces time-to-diagnosis, shortens cardiology waiting lists, enables primary care triage of common cardiac conditions, cost-effective, scalable model.

PROTOCOL AVAILABILITY Full protocol available upon request from IDIAP Jordi Gol Primary Care Research Institute.

See structured sections (Outcomes, Eligibility Criteria, Arms/Interventions) for specific measures, criteria, and procedures.

Conditions

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Heart Failure Valvular Heart Diseases Atrial Fibrillation (AF) Arterial Hypertension Cardiomyopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of GPs

Cohort of GPs:

Board-certified Family and Community Medicine specialists in Catalonia who will complete a structured FoCUS training programme and participate in a validation study.

Intervention of interest: FoCUS training (online theory + supervised hands-on practice, including simulator assessment) followed by routine FoCUS use in primary care with data capture in REDCap and paired comparison with cardiologist echocardiography.

Inclusion criteria: Family and Community Medicine specialist; CAMFiC member; workplace access to an ultrasound device suitable for FoCUS; commitment to complete the programme.

Exclusion criteria: Not meeting any inclusion criterion.

Cohort of GPs: Training program

Intervention Type OTHER

1. Accredited curriculum: 18 hours of online theory (2.7 CCFCPS credits) with a mandatory 20-item MCQ assessing knowledge and image interpretation.
2. Structured, supervised scanning volume: 4-hour hands-on introductory session on core cardiac views using healthy volunteers, followed by 70 hours of supervised clinical training with a hospital cardiologist, including a predefinied target of 60 FoCUS examinations per GP.

Cohort of Patients

Cohort of Patients:

Individuals aged \>18 years who require cardiac imaging for any clinical indication in routine care at a site where a participating GP works.

Intervention of interest: A FoCUS assessment performed by the trained GP as part of usual clinical care; no additional study tests or follow-up visits.

Sampling: Non-random, consecutive/clinician-driven recruitment based on routine clinical need and medical judgment.

Exclusion criteria: Refusal to participate (no written informed consent) and severe mental illness or significant cognitive impairment preventing informed consent.

Cohort of patients

Intervention Type DIAGNOSTIC_TEST

Eligible patients are those seen in routine primary care by participating GPs who, based on usual clinical judgment, need an echocardiographic assessment. In these cases, the GP will perform a FoCUS scan as part of the consultation and record a standard set of variables in the study eCRF. When the patient subsequently undergoes a comprehensive echocardiography in cardiology, both assessments (GP FoCUS and cardiology echocardiography) will be paired to evaluate agreement. No additional tests or extra study visits are required beyond usual care.

Interventions

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Cohort of GPs: Training program

1. Accredited curriculum: 18 hours of online theory (2.7 CCFCPS credits) with a mandatory 20-item MCQ assessing knowledge and image interpretation.
2. Structured, supervised scanning volume: 4-hour hands-on introductory session on core cardiac views using healthy volunteers, followed by 70 hours of supervised clinical training with a hospital cardiologist, including a predefinied target of 60 FoCUS examinations per GP.

Intervention Type OTHER

Cohort of patients

Eligible patients are those seen in routine primary care by participating GPs who, based on usual clinical judgment, need an echocardiographic assessment. In these cases, the GP will perform a FoCUS scan as part of the consultation and record a standard set of variables in the study eCRF. When the patient subsequently undergoes a comprehensive echocardiography in cardiology, both assessments (GP FoCUS and cardiology echocardiography) will be paired to evaluate agreement. No additional tests or extra study visits are required beyond usual care.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Board-certified specialist in Family and Community Medicine.
* Member of the Catalan Society of Family and Community Medicine (CAMFiC).
* Access at the workplace to an ultrasound device suitable for FoCUS.

* Age over 18 years old.
* Clinical indication for FoCUS/echocardiographic assessment in routine care.
* Attended at a site where a participating GP provides care.
* Able to provide written informed consent.

Exclusion Criteria

* Refusal to participate (no written informed consent)
* Severe mental illness
* Significant cognitive impairment preventing informed consent.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role collaborator

Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)

OTHER

Sponsor Role lead

Responsible Party

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Monica Solanes Cabus

Vice President, Societat Catalana de Medicina Familiar i Comunitaria (CAMFiC)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoni Sisó-Almirall, Ph.D.

Role: STUDY_DIRECTOR

IDIBAPS. CAMFiC.

Laura Conangla-Ferrín, Ph.D.

Role: STUDY_DIRECTOR

Institut Catlà de la Salut. CAMFiC

Locations

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Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEART-CAMFiC FoCUS Study Group

Identifier Type: -

Identifier Source: org_study_id

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