MedPath

Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System

Not Applicable
Completed
Conditions
Rheumatic Heart Disease
Interventions
Other: Secondary Training Phase
Other: Primary Training Phase
Other: Secondary Assessment Phase
Other: Primary Assessment Phase
Other: Primary Screening Phase
Other: Secondary Screening Phase
Registration Number
NCT05668611
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1628
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Secondary TrainingSecondary Assessment PhaseThe 4 Ministry of Health nurses trained in Aim 1 will then train and certify 3 other nurses from their clinics in focused echocardiography acquisition interpretation.
Secondary TrainingSecondary Training PhaseThe 4 Ministry of Health nurses trained in Aim 1 will then train and certify 3 other nurses from their clinics in focused echocardiography acquisition interpretation.
Primary TrainingPrimary Training Phase4 Ministry of Health nurses will be trained by expert trainers to become certified in focused echocardiography acquisition and interpretation in order to screen patients for rheumatic heart diseases
Primary TrainingPrimary Screening Phase4 Ministry of Health nurses will be trained by expert trainers to become certified in focused echocardiography acquisition and interpretation in order to screen patients for rheumatic heart diseases
Primary TrainingPrimary Assessment Phase4 Ministry of Health nurses will be trained by expert trainers to become certified in focused echocardiography acquisition and interpretation in order to screen patients for rheumatic heart diseases
Secondary TrainingSecondary Screening PhaseThe 4 Ministry of Health nurses trained in Aim 1 will then train and certify 3 other nurses from their clinics in focused echocardiography acquisition interpretation.
Primary Outcome Measures
NameTimeMethod
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses2 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 Outcome Measures
NameTimeMethod
Computer Based TestingImmediately following training

Computer based testing designed to determine positive and negative screening referrals of patients with RHD and other cardiac diseases

Knowledge AssessmentImmediately before the training session and immediately after completion of training

Questionnaire to test compare pre and post training knowledge about Rheumatic Heart Disease administered to nurse trainees.

Rapid Competency assessmentImmediately following training

This assessment will be administered post training to nurse trainees. It is an observation- based assessment designed to assess correct use of the technology, basic image acquisition proficiency, diagnostic accuracy and image quality.

Longitudinal Image QualityDaily assessment for 1 month

Expert Echocardiographers will access each image acquired by nurses using the ACEP scale. A scale of 1-5 (1) being no recognizable structure and (5) being excellent image quality of all structures. A score of 3 and above will be considered diagnostic.

Provider confidenceDaily assessment for 1 month

Nurses will subjectively report their level of confidence regarding image quality. The levels of confidence will be assessed. (1) Very confident, image quality is good and adequate for diagnosis. (2) Fairly confident, image is good but confirmation of diagnosis by expert trainer needed, (3) Not confident, image quality not adequate.

Diagnostic performance for other common categories of cardiac diseasesThrough completion of screening phase, average of 1 month

Assess nurse's ability to accurately identify left ventricular dysfunction and pericardial effusion as compared to the same standard applied by an expert.

Time to certificationTrough first day of training to study completion, average of 1 year

Determine the time from the first day of training to certification for participants including remediation time.

Provider satisfactionImmediately post training

Surveys questions on training and screening experience along with guided discussions on the training and screening experiences will be administered to nurse trainees

Trial Locations

Locations (1)

Uganda Heart Institute

🇺🇬

Kampala, Uganda

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