Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC): A Randomized Pragmatic 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
- 145
- 试验地点
- 2
- 主要终点
- Median delta MELD-3.0 from baseline to end of study.
研究概览
简要总结
The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.
The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.
详细描述
This will be a pilot study with a pragmatic trial design wherein all hepatology providers at the Mayo Clinic in Rochester, MN and Scottsdale, AZ will be invited to participate in the study. Consented providers will be randomized to the Digital ALD/AUD Clinic (DALC) arm or standard of care. Provides randomized to standard of care arm will continue to enroll their patients with ALD in the Interactive Care Plan (ICP), a nursing led program started at Mayo in 2021 for longitudinal remote care of patients with compensated and decompensated cirrhosis. All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state). Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care.
The target sample size will be 40 providers (20 providers per arm) and the investigators anticipate 150 patients with ALD will be seen during the study period across both arms. The number of ICP eligible patients seen versus the number of ICP referred patients will be recorded for all providers. Clinically relevant outcomes including hepatic decompensation, MELD 3.0 score, liver chemistries, alcohol use or relapse, liver-related hospitalizations, medication compliance, and mortality will be recorded as part of current ICP program, in both arms. Data will be collected retrospectively from the available medical records at the end of the study period, and no research contact will be made with the patients after initial consent for those patients being offered the DALC. The study duration will be 6 months after the initial Hepatology appointment. At study enrollment and completion, providers will be asked to fill out a survey regarding their satisfaction with ALD/AUD treatment. Consented providers will be informed that they may drop out of the study at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
- •Patient-Age ≥ 18 y.o.
- •Patient-Alcohol-associated liver disease
排除标准
- •Provider-Providers in other divisions
- •Patient-Inability to provide consent
研究组 & 干预措施
Digital Clinic Arm
The Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet.
干预措施: DALC Digital Clinic (Other)
Standard of Care Arm
Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program.
结局指标
主要结局
Median delta MELD-3.0 from baseline to end of study.
时间窗: 6 months
The primary aim of this study is to improve clinical outcomes in patients with ALD as defined as median delta MELD-3.0 from baseline to the end of the study.
次要结局
- Sustained alcohol abstinence(6 months)
- Reduction of Number of hospitalizations(6 months)
- Greater provider satisfaction in DALC arm(6 months)
研究者
Douglas (Doug) A. Simonetto
Principal Investigator
Mayo Clinic