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

NCT ID: NCT05668611

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-12-20

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.

Conditions

Rheumatic Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Primary Training

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

Group Type: EXPERIMENTAL

Primary Training Phase

Intervention Type: 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 Assessment Phase

Intervention Type: 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 Screening Phase

Intervention Type: 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.

Secondary Training

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.

Group Type: EXPERIMENTAL

Secondary Training Phase

Intervention Type: OTHER

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

Secondary Assessment Phase

Intervention Type: OTHER

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

Secondary Screening Phase

Intervention Type: 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.

Interventions

Primary Training Phase

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.

Intervention Type: OTHER

Primary Assessment Phase

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.

Intervention Type: OTHER

Primary Screening Phase

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.

Intervention Type: OTHER

Secondary Training Phase

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

Intervention Type: OTHER

Secondary Assessment Phase

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

Intervention Type: OTHER

Secondary Screening Phase

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uganda Heart Institute

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Z Beaton

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Uganda Heart Institute

Kampala, , Uganda

Countries

Uganda

Other Identifiers

2022-0312

Identifier Type: -

Identifier Source: org_study_id