Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)
Barcelona, Catalonia, 08009, Spain
NCT Number: NCT07339007
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.
Interested in participating?
Request Info15 year and older
All sexes
Observational
Barcelona, Catalonia, 08009, Spain
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:
Secondary Hypotheses:
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for professionals in the training program are:
The inclusion criteria for patients are:
Exclusion criteria
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.
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)
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).
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).
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).
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).
Time frame: Programme completion (2027)
Satisfaction scores (1-5 Likert scale) from patients, GPs, and cardiologists regarding FoCUS programme acceptability and usability (Objective 7).
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
Other
Acronym: HEART-CAMFiC
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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