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Enrolling by Invitation

NCT Number: NCT07339007

Observational Study to Validate a Family Physician Echocardiography Training Programme

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)

Barcelona, Catalonia, 08009, Spain

About this study

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:

  • 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).
  • This training program achieves ≥80% concordance between GP-performed FoCUS and cardiologist-performed standard echocardiography on predefined cardiac parameters (κ≥0.6).

Secondary Hypotheses:

  • Trained GP will be able to integrate this technique into routine practice (≥1 scan/week).
  • 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).
  • FoCUS plus clinical data identifies ≥3 distinct patient profiles among primary care patients assessed.
  • FoCUS in primary care achieves appropriate triage of patients requiring formal echocardiography.
  • The programme will be acceptable to stakeholders, with high satisfaction reported by patients, family doctors, and cardiologists participating in the programme.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Cohort of GPs: Training program

Other
  • Accredited curriculum: 18 hours of online theory (2.7 CCFCPS credits) with a mandatory 20-item MCQ assessing knowledge and image interpretation.
  • 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

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.

Primary outcomes

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

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

    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)

Secondary outcomes

  1. GPs knowledge and competence after FoCUS training

    Time frame: Training completion (6-8 months post-enrolment)

    Change from baseline in 20-item MCQ knowledge score + % practical competencies checklist + simulator pass rate, assessing FoCUS training effectiveness for GPs (Objective 1).

  2. FoCUS routine integration in clinical practice

    Time frame: 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

    Proportion of trained GPs regularly using FoCUS (≥1/week) in primary care consultations, assessed by participant survey at end of recruitment (Objective 3).

  3. FoCUS indications and abnormalities documented.

    Time frame: 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.

    Frequency of predefined indications (dyspnea, heart murmur, suspected heart failure, cardiac arrhythmia) and key abnormalities documented during routine FoCUS use (Objective 4).

  4. Time from FoCUS triage to specialist care

    Time frame: Real-world implementation (2024-2027)

    Time elapsed from the detection of significant cardiac findings using FoCUS to care by a specialist/echocardiography in general practitioners trained in FoCUS versus standard care, evaluating the benefits of triage and accelerated care pathways (hypothesis 6+8).

  5. Programme acceptability and satisfaction

    Time frame: Programme completion (2027)

    Satisfaction scores (1-5 Likert scale) from patients, GPs, and cardiologists regarding FoCUS programme acceptability and usability (Objective 7).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • University of Barcelona

Registry information

Acronym: HEART-CAMFiC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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