The purpose of this study is to assess a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of cardiac amyloidosis (CA).
This pragmatic trial will be the first study to prospectively evaluate the use of the AI ECG dashboard along with an augmented report in everyday practice. The findings will also guide future implementation strategies and inform the translation of many of the current and future AI algorithms into the clinical setting. The participants are the providers. Basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. Patient health information will be collected on their patients using a HIPPA waiver. There will be no patient contact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
20,143
Artificial intelligence enabled electrocardiogram screening tool used to identify the predictive model that best differentiates those at greatest risk for an amyloidosis diagnosis
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, United States
To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis
The number of patients diagnosed with cardiac amyloidosis in cardiology and hematology practices will be compared between those providers undergoing the AI ECG intervention to those randomized to standard practice arm
Time frame: 1 year
To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata)
Performance of AI ECG intervention across cardiology and hematology practices and between community and tertiary facilities will be analyzed by measuring rates of cardiac amyloidosis diagnosis across these strata
Time frame: 1 year
To assess provider satisfaction with the AI ECG intervention
For a screening tool to be effective, it has to be user friendly. The providers randomized to the AI ECG intervention arm will be surveyed to understand their experience. This endpoint will be descriptive. Providers will answer a 6 question using a 5-point Likert scale (higher number is more favorable).
Time frame: 1 year
To assess differential costs between the intervention arm and the standard of care arm
Upon trial completion, the difference in clinical expenditures between the intervention and standard of care arms will be compared. To this end, the rates of test ordering will be counted and compared between the interventional arm and the standard of care arm. A cost will be assigned to each test to calculate expenditures per correct diagnosis. The test of interest will include: NT-proBNP, troponin, protein electrophoresis with isotyping, serum immunoglobulin free light chains, 24-hour urinary protein with immunofixation, cardiac magnetic resonance imaging, echocardiogram, technetium pyrophosphate nuclear cardiac scintigraphy , endomyocardial biopsy, and fat aspirate.
Time frame: 1 year
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