Observational Study to Validate a Family Physician Echocardiography Training Programme

NCT07339007 | Enrolling By Invitation

• 1 other identifier: HEART-CAMFiC FoCUS Study Group
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Primary Health Care; Echocardiography; Family Practice; Ultrasound Training; Ultrasonography; Education, Medical

Outcome Measures

Primary Outcomes (1)

• Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography.

  Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography on key cardiac parameters: left ventricular systolic function (preserved vs. reduced), cavity sizes (normal vs. dilated), and significant valve abnormalities (none vs. moderate-severe). Additional parameters include pericardial effusion and IVC dilation. Measured by weighted kappa coefficient comparing blinded independent interpretations of the same patients. Higher κ = better agreement. Clinical competency threshold κ ≥ 0.6 (substantial agreement). Unit of measure: Weighted kappa coefficient (0-1)

  Diagnostic agreement assessment in real-world clinical practice following training completion (2024-2027 recruitment period).

Secondary Outcomes (5)

• GPs knowledge and competence after FoCUS training

  Training completion (6-8 months post-enrolment)

• FoCUS routine integration in clinical practice

  Following completion of recruitment (December 2027), a survey will be conducted among the 46 family physicians who have participated in this training program to assess the proportion regularly applying FoCUS (≥1/week) in routine primary care consultation

• FoCUS indications and abnormalities documented.

  Documentation analysis of FoCUS performed during study period for clinical indications and documented key abnormalities: first half of 2028 (January-June 2028), following recruitment completion and REDCap data extraction.

• Time from FoCUS triage to specialist care

  Real-world implementation (2024-2027)

• Programme acceptability and satisfaction

  Programme completion (2027)

Study Arms (2)

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.

Other: Cohort of GPs: Training program

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.

Diagnostic Test: Cohort of patients

Interventions

Cohort of GPs: Training program 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 GPs

Cohort of patients 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.

Cohort of Patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of: * GPs who meet the eligibility criteria and complete the FoCUS training programme, regardless of workplace setting. * Patients aged \>15 years receiving routine care at sites where participating GPs work, in whom a FoCUS assessment is clinically indicated, and who provide written informed consent for inclusion in the paired FoCUS-comprehensive echocardiography agreemnt study.

You may not qualify if:

• 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.
• Refusal to participate (no written informed consent)
• Severe mental illness
• Significant cognitive impairment preventing informed consent.

Sponsors & Collaborators

• Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC): lead
• University of Barcelona: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator

Study Sites (1)

Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)

Barcelona, Catalonia, 08009, Spain

Location

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MeSH Terms

Conditions

Heart Failure; Heart Valve Diseases; Atrial Fibrillation; Hypertension; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Antoni Sisó-Almirall, Ph.D.

  IDIBAPS. CAMFiC.

  STUDY DIRECTOR

• Laura Conangla-Ferrín, Ph.D.

  Institut Catlà de la Salut. CAMFiC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Societat Catalana de Medicina Familiar i Comunitaria (CAMFiC)

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 14, 2026
• Study Start: September 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)