Observational Study to Validate a Family Physician Echocardiography Training Programme (HEART-CAMFiC)

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

Status: Invitation-only

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

Treatments: Other: Cohort of GPs: Training program; Diagnostic Test: Cohort of patients

Study type: Observational

Funder types: Other

Identifiers

NCT07339007

HEART-CAMFiC FoCUS Study Group

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion/Exclusion Criteria for Professionals:

Inclusion criteria for professionals in the training program are:

• 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.

• Willing and able to complete all training and study procedures. Exclusion criteria: Not meeting any inclusion criterion.

  • Inclusion/Exclusion Criteria for Patients:

The inclusion criteria for patients are:

• 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.

Trial design

500 participants in 2 patient groups

Cohort of GPs

Description:

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.

Treatment:

Other: Cohort of GPs: Training program

Cohort of Patients

Description:

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.

Treatment:

Diagnostic Test: Cohort of patients