Testing an mHealth System for Integrating Alcohol Use Treatment with Hepatology Care for Patients with Alcohol-associated Liver Disease

在过去的15年里，与酒精相关的肝病(ALD)的发病率显著上升，成为 肝移植在美国的常见适应症和产生的大部分医疗保健和成本 在所有肝病中负担最重。随着新冠肺炎的流行，这些趋势已经恶化，据估计 如果不采取任何措施遏制这一趋势，到2040年，与ALD相关的死亡率将翻一番。尽管几十年来的医疗 研究表明，戒酒仍然是显著降低长期ALD发病率的唯一干预措施 和死亡率。然而，只有10%-15%的ALD患者在接受酒精治疗后的第一年接受酒精治疗 与男性相比，女性获得治疗的可能性更小。尽管存在这些差距，但令人惊讶的是 在ALD患者中，几乎没有对戒酒的行为干预进行测试，在那些已经戒酒的患者中 经过测试，戒酒治疗与医疗和肝病护理相结合的效果最好 对减少酒精使用的影响。为了解决这些关键的研究差距，调查人员将进行一项 在ALD患者人群中进行的随机对照1型混合实施-有效性试验 评估Chess Health Connections(一款戒酒智能手机应用程序)的有效性 在先前对严重饮酒患者进行的随机临床试验中，显著减少危险饮酒 无序)。患者将同时参加普通肝科和多学科ALD诊所(包括 综合酒精使用治疗专业人员和肝病提供者)在两个大型三级护理 中心(威斯康星大学和密歇根大学)。目标1将比较国际象棋的有效性 禁欲超过6个月的天数，加常规护理(n=180)与常规护理(n=181)。目标2将评估 通过对关键患者、提供者和临床级别的利益相关者进行定性访谈来实施CHESS 使用复制有效的方案框架和实施成本。我们的次要/探索性 分析将检查干预对健康结果的影响，包括抑郁、焦虑、失眠、AUD 治疗参与度和肝脏健康。我们将检查主要的主持人(年龄、性别、乡村、是否存在 正式的AUD治疗，以及ALD的阶段)和中介(关联性、能力、自主动机) 关于结果的。我们还将研究国际象棋应用程序对慢性肝损伤指标的影响。 使用终末期肝病模型-钠评分。这项研究将建立在十多年的工作基础上 在不同酒精使用障碍人群中适应和使用国际象棋。本研究在以下方面具有很高的创新性 三种方式：1)这是经过验证的戒酒智能手机应用程序的第一个全功率有效性试验 ALD患者，2)将测试一种向ALD患者提供戒酒治疗的新护理模式，以及 3)它将利用系统工程和具有ALD专业知识的医学研究人员的新合作， 数字健康和实施科学。如果成功，这项研究有望提供急需的 酒精使用资源给ALD患者，并可能设定一个新的护理标准。

Alcohol-associated liver disease (ALD) rates have risen markedly over the past 15 years, becoming the most common indication for liver transplantation in the U.S. and generating the majority of healthcare and cost burden among all liver diseases. With the COVID pandemic, these trends have worsened, and it is estimated that, if nothing is done to stem the tide, ALD-related mortality will double by 2040. Despite decades of medical research, alcohol cessation remains the only intervention that substantially decreases long-term ALD morbidity and mortality. However, only 10-15% of ALD patients access alcohol use treatment in the first year after their diagnosis, with women even less likely to access treatment compared to men. Despite these gaps, surprisingly few behavioral interventions for alcohol cessation have been tested in ALD patients, and, of those that have been tested, integrated alcohol cessation treatment alongside medical and hepatology care has had the most impact at reducing alcohol use. To address these critical research gaps, the investigators will perform a randomized, controlled, Type 1 hybrid implementation-effectiveness trial in a population of ALD patients to evaluate the effectiveness of CHESS Health Connections (a smartphone app for alcohol cessation shown to significantly reduce risky drinking in a prior randomized clinical trial of patients with severe alcohol use disorder). Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin and University of Michigan). Aim 1 will compare the effectiveness of CHESS plus usual care (n=180) versus usual care (n=181) on days of abstinence over 6 months. Aim 2 will assess implementation of CHESS through qualitative interviews of key patient, provider, and clinic-level stakeholders using the Replicating Effective Programs framework and implementation costs. Our secondary/exploratory analyses will examine intervention effects on health outcomes including depression, anxiety, insomnia, AUD treatment engagement, and liver health. We will examine key moderators (age, sex, rurality, presence of formal AUD treatment, and stage of ALD) and mediators (relatedness, competence, autonomous motivation) on outcomes. We will also examine the impact of the CHESS app on measures of chronic liver impairment using the Model for End-Stage Liver Disease-Sodium score. This study will build on over a decade of work in adapting and using CHESS in various populations with alcohol use disorder. This study is highly innovative in three ways: 1) it is the first fully powered effectiveness trial of a proven smartphone app for alcohol cessation in ALD patients, 2) it will test a new model of care for delivering alcohol cessation treatment to ALD patients, and 3) it will utilize a novel collaboration of systems engineering and medical researchers with expertise in ALD, digital health, and implementation science. If successful, this study holds promise to provide critically needed alcohol use resources to ALD patients and potentially set a new standard of care.