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

NCT05668611 | Completed

• 1 other identifier: 2022-0312
• Study Type: interventional
• Target: 1,628
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses

  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

  2 months after completion of training

Secondary Outcomes (8)

• Knowledge Assessment

  Immediately before the training session and immediately after completion of training

• Computer Based Testing

  Immediately following training

• Rapid Competency assessment

  Immediately following training

• Provider satisfaction

  Immediately post training

• Longitudinal Image Quality

  Daily assessment for 1 month

Study Arms (2)

Primary Training

EXPERIMENTAL

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

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

Secondary Training

EXPERIMENTAL

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.

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

Interventions

Primary Training Phase OTHER

A four-day training program taken over the course of two weekends will include materials on RHD and RHD echocardiographic screening using focused artificial intelligence navigational guided echocardiographic acquisition to identify patients who are screen positive or screen negative for RHD. The echo protocol will be limited to the parasternal long axis-view (2D and color Doppler) focusing on mitral and aortic valve morphology and function and a single 2D apical 4 chamber view for auto EF. The curriculum package will include online modules, instructor delivered PowerPoint presentations, and hands on practice on volunteers with and without RHD.

Primary Training

Primary Assessment Phase OTHER

A pre- and post-training test on RHD knowledge and diagnosis will be administered. A rapid competency assessment, including obtaining imaging on volunteers with or without RHD and an online test with pre-recorded cases of RHD, LV dysfunction and Pericardial effusions, will be utilized at the end of the 4-day training sessions. Trainees will be monitored by trained study personnel and at the end of the practicum training, the expert users will blindly review and assess the quality of each study using the standardized scale and competency scorecard provided below. Additionally, they will be asked to pass the knowledge quiz (80% or better). If competency is not achieved, an additional weekend of training can be added.

Primary Training

Primary Screening Phase OTHER

Following certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care. Screening will be done daily over a period of one month. A minimum total of 400 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants (at least 5 participants per day). At the end of each screen, the trainees will interpret the screen as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo. At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks.

Primary Training

Secondary Training Phase OTHER

Each Primary Trained MOH Nurse will train 3 other nurses from their Health Center using pre-recorded PowerPoints.

Secondary Training

Secondary Assessment Phase OTHER

The secondarily trained nurses will be assessed and certified by the nurse trainer.

Secondary Training

Secondary Screening Phase OTHER

Following certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care. Screening will be done daily over a period of two months. A minimum total of 1200 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants. At the end of each screen, the trainees will interpret the study as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo. At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks.

Secondary Training

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Uganda Heart Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Z Beaton

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 30, 2022
• Study Start: January 3, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)