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

Primary Purpose

Rheumatic Heart Disease

Status
Active
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Primary Training Phase
Primary Assessment Phase
Primary Screening Phase
Secondary Training Phase
Secondary Assessment Phase
Secondary Screening Phase
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatic Heart Disease

Eligibility Criteria

5 Years - 40 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Uganda Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary Training

Secondary Training

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knowledge Assessment
Questionnaire to test compare pre and post training knowledge about Rheumatic Heart Disease administered to nurse trainees.
Computer Based Testing
Computer based testing designed to determine positive and negative screening referrals of patients with RHD and other cardiac diseases
Rapid Competency assessment
This assessment will be administered post training to nurse trainees. It is an observation- based assessment designed to assess correct use of the technology, basic image acquisition proficiency, diagnostic accuracy and image quality.
Provider satisfaction
Surveys questions on training and screening experience along with guided discussions on the training and screening experiences will be administered to nurse trainees
Longitudinal Image Quality
Expert Echocardiographers will access each image acquired by nurses using the ACEP scale. A scale of 1-5 (1) being no recognizable structure and (5) being excellent image quality of all structures. A score of 3 and above will be considered diagnostic.
Provider confidence
Nurses will subjectively report their level of confidence regarding image quality. The levels of confidence will be assessed. (1) Very confident, image quality is good and adequate for diagnosis. (2) Fairly confident, image is good but confirmation of diagnosis by expert trainer needed, (3) Not confident, image quality not adequate.
Diagnostic performance for other common categories of cardiac diseases
Assess nurse's ability to accurately identify left ventricular dysfunction and pericardial effusion as compared to the same standard applied by an expert.
Time to certification
Determine the time from the first day of training to certification for participants including remediation time.

Full Information

First Posted
October 26, 2022
Last Updated
January 27, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Uganda Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05668611
Brief Title
Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System
Acronym
ADD-RHD 2B
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Uganda Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Training
Arm Type
Experimental
Arm 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
Arm Title
Secondary Training
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Primary Training Phase
Intervention Description
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
Intervention Name(s)
Primary Assessment Phase
Intervention Description
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
Intervention Name(s)
Primary Screening Phase
Intervention Description
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
Intervention Name(s)
Secondary Training Phase
Intervention Description
Each Primary Trained MOH Nurse will train 3 other nurses from their Health Center using pre-recorded PowerPoints.
Intervention Type
Other
Intervention Name(s)
Secondary Assessment Phase
Intervention Description
The secondarily trained nurses will be assessed and certified by the nurse trainer.
Intervention Type
Other
Intervention Name(s)
Secondary Screening Phase
Intervention Description
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.
Primary Outcome Measure Information:
Title
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses
Description
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
Time Frame
2 months after completion of training
Secondary Outcome Measure Information:
Title
Knowledge Assessment
Description
Questionnaire to test compare pre and post training knowledge about Rheumatic Heart Disease administered to nurse trainees.
Time Frame
Immediately before the training session and immediately after completion of training
Title
Computer Based Testing
Description
Computer based testing designed to determine positive and negative screening referrals of patients with RHD and other cardiac diseases
Time Frame
Immediately following training
Title
Rapid Competency assessment
Description
This assessment will be administered post training to nurse trainees. It is an observation- based assessment designed to assess correct use of the technology, basic image acquisition proficiency, diagnostic accuracy and image quality.
Time Frame
Immediately following training
Title
Provider satisfaction
Description
Surveys questions on training and screening experience along with guided discussions on the training and screening experiences will be administered to nurse trainees
Time Frame
Immediately post training
Title
Longitudinal Image Quality
Description
Expert Echocardiographers will access each image acquired by nurses using the ACEP scale. A scale of 1-5 (1) being no recognizable structure and (5) being excellent image quality of all structures. A score of 3 and above will be considered diagnostic.
Time Frame
Daily assessment for 1 month
Title
Provider confidence
Description
Nurses will subjectively report their level of confidence regarding image quality. The levels of confidence will be assessed. (1) Very confident, image quality is good and adequate for diagnosis. (2) Fairly confident, image is good but confirmation of diagnosis by expert trainer needed, (3) Not confident, image quality not adequate.
Time Frame
Daily assessment for 1 month
Title
Diagnostic performance for other common categories of cardiac diseases
Description
Assess nurse's ability to accurately identify left ventricular dysfunction and pericardial effusion as compared to the same standard applied by an expert.
Time Frame
Through completion of screening phase, average of 1 month
Title
Time to certification
Description
Determine the time from the first day of training to certification for participants including remediation time.
Time Frame
Trough first day of training to study completion, average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Z Beaton
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uganda Heart Institute
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No

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

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