Clinical trial NCT05668611: Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Heart Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Uganda Heart Institute
First posted: 2022-12-30
Enrollment: 1628
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a two-phase cohort study that will determine the ability of MOH nurses to accurately integrate echocardiographic screening for rheumatic heart disease into primary healthcare clinics in Uganda.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses
timeFrame: 2 months after completion of training
Secondary outcomes:
measure: Knowledge Assessment
timeFrame: Immediately before the training session and immediately after completion of training
measure: Computer Based Testing
timeFrame: Immediately following training
measure: Rapid Competency assessment
timeFrame: Immediately following training
measure: Provider satisfaction
timeFrame: Immediately post training
measure: Longitudinal Image Quality
timeFrame: Daily assessment for 1 month
measure: Provider confidence
timeFrame: Daily assessment for 1 month
measure: Diagnostic performance for other common categories of cardiac diseases
timeFrame: Through completion of screening phase, average of 1 month
measure: Time to certification
timeFrame: Trough first day of training to study completion, average of 1 year
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Heart Institute
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrea Z Beaton
role: PRINCIPAL_INVESTIGATOR
References: