A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2025-09-01

Brief Summary

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The overall objectives of this study are to determine the effectiveness of ACE 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an AI-enabled algorithm for prediction of liver disease in primary care.

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Detailed Description

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A pragmatic, cluster randomized trial in 45 Mayo Clinic primary care practices will be conducted over a period of 6 months with 6 months of follow up. Care teams will be randomized 1:1 to intervention or usual care, stratified by region and patient volume. In the intervention arm, the DULCE score will be used to alert consenting providers to the likelihood of advanced liver disease with a recommendation for a FibroTest-ActiTest. The primary endpoint will be detection of advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests and hepatology referral within 180 days of ECG, new diagnosis of liver disease stratified by etiology (nonalcoholic fatty liver disease, alcohol-associated liver disease, hepatitis C, and others) and severity (compensated with and without clinically-significant portal hypertension, and decompensated disease), initiation of prophylactic nonselective beta-blockers and imaging for hepatocellular carcinoma surveillance, according to published society guidelines. Post-study surveys to participating clinicians will be applied.

Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Usual Care Group

Primary care providers will treat subject per standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Electrocardiogram AI Group

The ACE (AI-Cirrhosis-ECG) 2.0 will be used to alert primary care providers to the likelihood of advanced liver disease with a recommendation for laboratory tests.

Group Type EXPERIMENTAL

ACE (AI-Cirrhosis-ECG) 2.0

Intervention Type DEVICE

An electrocardiogram (ECG) based artificial intelligence (AI) powered tool for detection of undiagnosed cirrhosis in primary care practices. And email alert is sent to providers which will display whether the ACE 2.0 result is positive or negative for the likelihood of advanced liver disease.

Interventions

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ACE (AI-Cirrhosis-ECG) 2.0

An electrocardiogram (ECG) based artificial intelligence (AI) powered tool for detection of undiagnosed cirrhosis in primary care practices. And email alert is sent to providers which will display whether the ACE 2.0 result is positive or negative for the likelihood of advanced liver disease.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary care clinicians (physicians, nurse practitioners, and physician assistants).
* Part of a team that cares for adult patients (≥18 years).
* Have the ability to order ECG.
* Consent will be obtained from primary care clinicians.
* Patients' data will be collected from electronic medical records (EMR).
* Adult patients (≥ 18 years) undergoing an ECG for any indication over a period of 6 months will be included.

Exclusion Criteria

* Patients with known cirrhosis based on noninvasive fibrosis assessment tests, liver biopsy or complications of decompensated disease, or with a documented history of cirrhosis identified by clinical notes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No