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Clinical Trials/NCT05668611
NCT05668611
Completed
Not Applicable

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 site in 1 country1,628 target enrollmentJanuary 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatic Heart Disease
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
1628
Locations
1
Primary Endpoint
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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. Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated. 4 MOH trainees will use pre-recorded PowerPoint presentations to conduct hands-on training for phase 2 (secondary) nurses. Objective 2: Similar to Phase 1 with just a few exceptions. 12 MOH nurses will be trained and certified by MOH nurse trainers from phase 1 to acquire and interpret RHD focused screening echocardiograms using a novel AI guided software. Screening will be integrated into routine care for 2 months and diagnostic performance assessed.

Registry
clinicaltrials.gov
Start Date
January 3, 2023
End Date
December 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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