Observational Study to Validate a Family Physician Echocardiography Training Programme
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion/
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cohort of GPs: Training program (Other)
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.
干预措施: Cohort of patients (Diagnostic Test)
结局指标
主要结局
Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography.
时间窗: 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)
次要结局
- 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))
研究者
Monica Solanes Cabus
Vice President, Societat Catalana de Medicina Familiar i Comunitaria (CAMFiC)
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)