Clinical trial NCT05782283: A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram
Official title: Early Detection of Advanced Liver Disease Via Artificial Intelligence-Enabled Electrocardiogram (Advance): a Pragmatic, Cluster-Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The primary objective of this pragmatic trial is to validate a deep learning-based artificial intelligence (AI) model for early detection of cirrhosis-associated signals on digitized ECG.
timeFrame: 6 months
Secondary outcomes:
measure: The secondary objective is to assess barriers for adoption of an AI-enabled algorithm for detection of liver disease in routine community clinical practice.
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Douglas Simonetto, MD
role: PRINCIPAL_INVESTIGATOR
References: