Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System (ADD-RHD 2B)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Rheumatic Heart Disease

Treatments: Other: Secondary Assessment Phase; Other: Primary Training Phase; Other: Primary Assessment Phase; Other: Secondary Training Phase; Other: Secondary Screening Phase; Other: Primary Screening Phase

Study type: Interventional

Funder types: Other

Identifiers

NCT05668611

2022-0312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,628 patients

Sex: All

Ages: 5 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,628 participants in 2 patient groups

Primary Training

Experimental group

Description:

4 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

Treatment:

Other: Primary Assessment Phase

Other: Primary Training Phase

Other: Primary Screening Phase

Secondary Training

Experimental group

Description:

The 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.

Treatment:

Other: Secondary Training Phase

Other: Secondary Screening Phase

Other: Secondary Assessment Phase