Early Detection of Advanced Liver Disease Via Artificial Intelligence-Enabled Electrocardiogram (Advance): A Pragmatic, Cluster-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 279
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 6 months
Number of participants with new diagnosis of advanced liver disease as assessed by a novel electrocardiogram-enabled convoluted neural network (CNN) compared to standard of care at 6 months.
次要结局
- The secondary objective is to assess barriers for adoption of an AI-enabled algorithm for detection of liver disease in routine community clinical practice.(6 months)
研究者
Douglas (Doug) A. Simonetto
Principal Investigator
Mayo Clinic