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.

过去 15 年来，酒精相关性肝病 (ALD) 的发病率显着上升，成为最常见的肝病。 在美国肝移植的常见适应症并产生大部分医疗保健和费用 所有肝脏疾病的负担。随着新冠病毒大流行，这些趋势进一步恶化，估计 如果不采取措施阻止这种趋势，到 2040 年，与 ALD 相关的死亡率将增加一倍。尽管数十年的医学研究 研究表明，戒酒仍然是显着降低长期 ALD 发病率的唯一干预措施 和死亡率。然而，只有 10-15% 的 ALD 患者在戒酒后的第一年接受戒酒治疗。 诊断，与男性相比，女性获得治疗的可能性更低。尽管存在这些差距，但令人惊讶的是 在酒精性肝病患者中测试过的戒酒行为干预措施很少，而且在那些患有酒精性肝病的患者中， 经过测试，综合戒酒治疗与医疗和肝病护理相结合的效果最为显着 对减少饮酒的影响。为了解决这些关键的研究差距，研究人员将进行 在 ALD 患者群体中进行的随机、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 在之前针对严重饮酒患者的随机临床试验中，显着降低了饮酒风险 紊乱）。患者将被纳入普通肝病学和多学科 ALD 诊所（其中包括 综合酒精使用治疗专业人员与肝病提供者）在两个大型三级医疗机构 中心（威斯康星大学和密歇根大学）。目标 1 将比较 CHESS 的有效性 加常规护理 (n=180) 与禁欲超过 6 个月的常规护理 (n=181)。目标 2 将评估 通过对关键患者、提供者和诊所级利益相关者进行定性访谈来实施 CHESS 使用复制有效计划框架和实施成本。我们的中学/探索性 分析将检验干预措施对健康结果的影响，包括抑郁、焦虑、失眠、AUD 治疗参与度和肝脏健康。我们将检查关键调节因素（年龄、性别、农村地区、是否存在 正式 AUD 治疗和 ALD 阶段）和中介因素（相关性、能力、自主动机） 关于结果。我们还将研究 CHESS 应用程序对慢性肝损伤测量的影响 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 在不同的酒精使用障碍人群中适应和使用 CHESS。这项研究极具创新性 三种方式：1）这是第一个经过验证的智能手机应用程序在戒酒方面的全功能有效性试验 ALD 患者，2) 将测试一种为 ALD 患者提供戒酒治疗的新护理模式，以及 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颖合作， 数字健康和实施科学。如果成功，这项研究有望提供急需的 酒精利用 ALD 患者的资源，并有可能设定新的护理标准。