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临床试验/NCT05668611
NCT05668611已完成不适用

Design and Evaluation of a Train the Trainer Curriculum to Scale Up Automated Intelligence Supported Echocardiography for Rheumatic Heart Disease Screening in a Public Health Care System

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 1,628 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,628
试验地点
1
主要终点
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses

研究概览

简要总结

The first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease. The second primary objective is to determine the diagnostic performance (sensitivity and specificity) of secondary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by MOH nurse trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease.

详细描述

Objective 1:

4 ultrasound naïve nurses (Primary) employed at the HCIII/IVs participating in ADD-RHD Part 1 (SOMREC REF 2021-61) in Lira, will be trained and certified by experts in echocardiography for RHD on focused RHD echocardiographic screening examination and interpretation using a novel AI guided software.

Focused RHD screening echocardiograms by the 4 nurses will be integrated into routine clinical practice at their assigned HCIII/IVs for 1 month.

Screen positive patients will be referred to LRRH for confirmatory echocardiogram using a Standard echocardiographic machine under the National RHD registry (SOMREC REF 2014-137).

All echocardiograms will be uploaded to a secure cloud-based server and over-read by a cardiologist with in one - two (1 - 2) weeks to ensure patient safety and to determine trainee performance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
5 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Attend same HCIII/IV sites that the MOH nurses work at
  • Agree to participate via the study's informed consent

排除标准

  • Very sick participants requiring transfer to higher level facility or inpatient care

结局指标

主要结局

RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses

时间窗: 2 months after completion of training

Diagnostic performance of MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers will be assessed. Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated to determine diagnostic performance of MOH nurses who have completed certification on focused echocardiography acquisition and interpretation. The ability of trainees to correctly identify screen positive and negative patients for RHD using known expert diagnosis as the reference. Correct determination of RHD screen positive/negative in at least 80% of cases is the benchmark

次要结局

  • Computer Based Testing(Immediately following training)
  • Knowledge Assessment(Immediately before the training session and immediately after completion of training)
  • Rapid Competency assessment(Immediately following training)
  • Longitudinal Image Quality(Daily assessment for 1 month)
  • Provider confidence(Daily assessment for 1 month)
  • Diagnostic performance for other common categories of cardiac diseases(Through completion of screening phase, average of 1 month)
  • Time to certification(Trough first day of training to study completion, average of 1 year)
  • Provider satisfaction(Immediately post training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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