Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System
Condition: Rheumatic Heart Disease
MeSH terms: Rheumatic Heart Disease; Rheumatic Diseases; Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): Primary Training Phase; Primary Assessment Phase; Primary Screening Phase; Secondary Training Phase; Secondary Assessment Phase; Secondary Screening Phase
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): 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.; 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.; 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.; Each Primary Trained MOH Nurse will train 3 other nurses from their Health Center using pre-recorded PowerPoints.; The secondarily trained nurses will be assessed and certified by the nurse trainer.; 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.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
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.
Masking: None (Open Label)
Primary purpose: Health Services Research