A Multicenter Pragmatic Implementation Study of AI-ECG-Based Clinical Decision Support Software to Identify Low LVEF

Study Overview
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Brief Summary
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A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (AI-ECG) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting. The objective of this study is to evaluate the impacts of an AI-ECG algorithm to detect low LVEF and an associated clinical decision support software when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

Detailed Description
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The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA. Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes. Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a 6 week feasibility phase followed by a 3-month initial observation period and up to 2x 3 month follow-up periods. Data will be collected after the completion of each 3 month follow-up period. At the completion of the 6 week feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s). Primary endpoints and exploratory endpoints will be assessed at each timepoint.

Official Title
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A Prospective Pragmatic Cluster-Randomized Care-as-Usual Controlled Study to Evaluate the Impact of an ECG-Based AI Algorithm to Detect Low Left Ventricular Ejection Fraction on Diagnosis Rates of LVEF ≤40% in the Outpatient Setting

Conditions
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Ventricular Ejection Fraction

Intervention / Treatment
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* Device: Anumana Low EF AI-ECG Algorithm
* Other: Care-as-Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years or older Digital 10 second, 12 Lead ECG captured or available in EHR or ECG data store for AI-ECG analysis at point-of-care Exclusion Criteria: Known history of LVEF ≤ 40% Known history of heart failure Opted out of electronic health record-based research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinicians in primary care practice groups will be consented for enrollment into the study. Practice groups that decide to participate in the study will be randomized to have the software available or to provide care as usual without the software.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anumana Low EF AI-ECG Algorithm<br> | Device: Anumana Low EF AI-ECG Algorithm<br>* Clinician will have access to the Anumana Low EF AI-ECG algorithm via a link in the patient's electronic health record which will display results applied to patients' ECGs, as well as supporting information. Using the results of the algorithm, combined with the clinician's knowledge of patient-specific risk factors, the clinician will determine whether further evaluation is warranted.<br>|
| Other: Care-as-Usual<br> | Other: Care-as-Usual<br>* Clinicians will not have access to the Anumana Low EF AI-ECG algorithm and will provide care-as-usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual |  | 90 days |