Observational Study to Validate a Family Physician Echocardiography Training Programme

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Диагностический тест 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 e

Первичные конечные точки

• Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography. [Срок оценки: Diagnostic agreement assessment in real-world clinical practice following training completion (2024-2027 recruitment period).]

Вторичные конечные точки (5)

• GPs knowledge and competence after FoCUS training [Срок оценки: Training completion (6-8 months post-enrolment)]
• FoCUS routine integration in clinical practice [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Real-world implementation (2024-2027)]
• Programme acceptability and satisfaction [Срок оценки: Programme completion (2027)]

Критерии участия

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Societat Catalana de Medicina Familiar i Comunitària (CAMFiC) — Barcelona

Публикации

• Solanes-Cabús M, Pujol-Salud J, Alonso-Aliaga J, Mayench-Ariza F, Marsal-Mora JR, Sabaté-Navarro A, et al. Inter-rater agreement and reliability among general practitioners and radiologists on ultrasound examinations after a specialized training program [Internet]. Journal of Primary Health Care & General Practice. 2019;3(1):026 [cited 2025 Oct 25]. Available from: https://www.scribd.com/document/
• Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4. PMID 31749019
• British Medical Ultrasound Society; Royal College of Radiologists. Recommendations for specialists practising ultrasound independently of radiology departments: safety, governance and education [Internet]. London: Royal College of Radiologists; 2023 Apr [cited 2025 Oct 26]. Available from: https://www.rcr.ac.uk/publication/recommendations-for-specialists-practising-ultrasound-independently-of-radi
• Conangla-Ferrin L, Guirado-Vila P, Solanes-Cabus M, Teixido-Gimeno D, Diez-Garcia L, Pujol-Salud J, Evangelista-Robleda L, Bertran-Culla J, Ortega-Vila Y, Canal-Casals V, Siso-Almirall A. Ultrasound in primary care: Consensus recommendations on its applications and training. Results of a 3-round Delphi study. Eur J Gen Pract. 2022 Dec;28(1):253-259. doi: 10.1080/13814788.2022.2150163. PMID 36503353
• Homar V, Gale ZK, Lainscak M, Svab I. Knowledge and skills required to perform point-of-care ultrasonography in family practice - a modified Delphi study among family physicians in Slovenia. BMC Fam Pract. 2020 Mar 26;21(1):56. doi: 10.1186/s12875-020-01130-z. PMID 32216753
• Diaz-Gomez JL, Mayo PH, Koenig SJ. Point-of-Care Ultrasonography. N Engl J Med. 2021 Oct 21;385(17):1593-1602. doi: 10.1056/NEJMra1916062. No abstract available. PMID 34670045
• Andersen CA, Lundbye-Christensen S, Riis A, Mehnert U, Lokkegaard T, Mengel-Jorgensen T, Rasmussen LD, Soll N, Stork B, Andersen SK, Pil L, Stjernebjerg C, Graumann O, Jensen MB. General practitioners' scanning competence following tailored ultrasound training: a hybrid effectiveness-implementation study. BMC Med Educ. 2025 May 20;25(1):733. doi: 10.1186/s12909-025-07356-8. PMID 40394656
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007 Oct 20;335(7624):806-8. doi: 10.1136/bmj.39335.541782.AD. PMID 17947786

Идентификаторы

NCT: NCT07339007 · HEART-CAMFiC FoCUS Study Group

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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