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

测试将酒精使用治疗与肝病护理相结合的移动医疗系统，以治疗酒精相关性肝病患者

• 批准号: 10818885
• 负责人: Randall T Brown
• 金额: $ 63.06万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10818885
• 关键词: Abstinence; Address; Adoption; Age; Alcohol consumption; Alcoholic Hepatitis; Alcoholic Liver Diseases; Alcohols; Anxiety; Behavior Therapy; Behavioral; Blood Tests; COVID-19 pandemic; Caring; Cessation of life; Chronic; Cirrhosis; Clinic; Collaborations; Competence; Computerized Medical Record; Cost Effectiveness Analysis; Cost Measures; Counseling; Critical Care; Data; Decision Making; Diagnosis; Diagnostic; Disease; Effectiveness; Engineering; Enrollment; Goals; Health; Health Care Costs; Health Sciences; Health Services Accessibility; Healthcare; Heavy Drinking; Hepatology; Hybrids; Impairment; Intervention; Interview; Liver; Liver diseases; Measurement; Measures; Mediator; Medical; Medical Research; Medical center; Mental Depression; Mental Health; Michigan; Mobile Health Application; Modeling; Monitor; Morbidity - disease rate; Motivation; National Institute on Alcohol Abuse and Alcoholism; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Persons; Pharmacotherapy; Population; Prognosis; Provider; Quality-Adjusted Life Years; Randomized; Randomized, Controlled Trials; Replicating Effective Programs; Research; Research Personnel; Resources; Self Management; Sleeplessness; Sodium; Specialist; Strategic Planning; Substance Use Disorder; Substance abuse problem; System; Testing; United States; Universities; Wisconsin; Woman; Work; alcohol abstinence; alcohol abuse therapy; alcohol availability; alcohol intervention; alcohol testing; alcohol use disorder; behavior change; compare effectiveness; cost comparison; digital health; effectiveness evaluation; effectiveness trial; effectiveness/implementation trial; end stage liver disease; evidence base; high risk drinking; implementation cost; implementation evaluation; implementation science; improved; improved outcome; innovation; intervention effect; liver transplantation; mHealth; men; mortality; multidisciplinary; novel; pandemic disease; patient engagement; patient population; peer support; primary outcome; public health emergency; randomized, clinical trials; reduced alcohol use; routine provider; rurality; sex; smartphone application; standard of care; stem; tertiary care; treatment as usual; treatment comparison; trend

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.

在过去的15年中，与酒精相关的肝病（ALD）率显着提高，成为最多的 在美国肝移植的常见指示，并产生大部分医疗保健和成本 所有肝病的负担。随着共同大流行的影响，这些趋势恶化了，估计 那，如果没有采取任何措施来阻止潮流，与ALD相关的死亡率将在2040年增加一倍。尽管有数十年的医疗 研究，酒精戒烟仍然是唯一大大降低长期ALD发病率的干预措施 和死亡率。但是，只有10-15％的ALD患者在他们的第一年获得酒精治疗 诊断，与男性相比，女性接受治疗的可能性更低。尽管存在这些差距，但令人惊讶的是 在ALD患者中，几乎没有对酒精戒烟的行为干预措施，并且有 经过测试，与医疗和肝病护理同时进行的综合酒精戒烟治疗最多 减少饮酒的影响。为了解决这些关键的研究差距，调查人员将执行 ALD患者人群中的随机，受控，1型混合实施效应试验 评估国际象棋健康连接的有效性（用于酒精戒烟的智能手机应用 严重饮酒患者的先前随机临床试验中，大大降低了风险饮酒 紊乱）。患者将在一般肝病学和多学科ALD诊所中注册（其中包括 在两个大三级护理中，综合酒精使用治疗专业人员与肝病学提供者一起 中心（威斯康星大学和密歇根大学）。 AIM 1将比较国际象棋的有效性 加上在6个月内禁欲的日子里，通常的护理（n = 180）与通常的护理（n = 181）。 AIM 2将评估 通过对关键患者，提供者和诊所级别利益相关者的定性访谈实施国际象棋 使用复制有效的程序框架和实施成本。我们的次要/探索性 分析将检查对抑郁症，焦虑，失眠，AUD等健康结果的干预影响 治疗参与和肝脏健康。我们将检查关键主持人（年龄，性别，乡村，存在 正式的AUD治疗以及ALD的阶段）和调解人（相关性，能力，自动动机） 关于结果。我们还将检查国际象棋应用程序对慢性肝脏损害措施的影响 使用该模型进行终末期肝病钠评分。这项研究将基于十多年的工作 适应和在各种酒精使用障碍的人群中使用国际象棋。这项研究具有高度创新性 三种方式：1）这是一项经过验证的智能手机应用程序的首次全力效力试验 ALD患者，2）它将测试一种新的护理模型，用于为ALD患者提供酒精戒烟治疗，并 3）它将利用具有ALD专业知识的系统工程和医学研究人员的新型合作， 数字健康和实施科学。如果成功，这项研究将有望提供急需的 酒精资源用于ALD患者，并有可能树立新的护理标准。