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

January 7, 2026 updated by: Monica Solanes Cabus, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08009
        • Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Diagnostic agreement assessment in real-world clinical practice following training completion (2024-2027 recruitment period).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Training completion (6-8 months post-enrolment)
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).
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.
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).
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
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).
Real-world implementation (2024-2027)
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).
Programme completion (2027)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

Investigators

  • Study Director: Antoni Sisó-Almirall, Ph.D., IDIBAPS. CAMFiC.
  • Study Director: Laura Conangla-Ferrín, Ph.D., Institut Catlà de la Salut. CAMFiC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEART-CAMFiC FoCUS Study Group

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will be collected in a pseudonymised format in REDCap, a secure platform for clinical research data management. Access to the dataset will be restricted to authorised members of the research team and used solely to address the study objectives. Data handling will comply with applicable data protection regulations, safeguarding confidentiality throughout the study and subsequent analyses. There is no plan to share individual participant data (IPD) outside the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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