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

Mayo Clinic

Status: Completed

Conditions: Cirrhosis

Treatments: Device: ACE (AI-Cirrhosis-ECG) 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT05782283

22-009726

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 279 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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279 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

Primary care providers will treat subject per standard of care

Electrocardiogram AI Group

Experimental group

Description:

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.

Treatment:

Device: ACE (AI-Cirrhosis-ECG) 2.0