3/4-The INTEGRATE Study: Evaluating INTEGRATEd Care to Improve Biopsychosocial Outcomes of Early Liver Transplantation for Alcohol-Associated Liver Disease

3/4-综合研究：评估综合护理以改善酒精相关性肝病早期肝移植的生物心理社会结果

• 批准号: 10710924
• 负责人: David Seth Goldberg
• 金额: $ 38.64万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2030-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10710924
• 关键词: Abstinence; Address; Alcohol consumption; Alcoholic Hepatitis; Alcoholic Liver Diseases; Alcohols; Behavioral Research; Biological Factors; Caregivers; Caring; Cirrhosis; Clinical; Communication; County Hospitals; Data; Ethnic Origin; Evaluation; Family; Focus Groups; Funding; Geographic Locations; Hepatitis; Interview; Knowledge; Liver diseases; Longitudinal cohort; Measures; Medical; Medical Care Team; Medical center; Medicine; Mental Health; Methodology; Methods; Michigan; Modeling; National Institute on Alcohol Abuse and Alcoholism; Organ Donor; Organ Procurements; Outcome; Pathway interactions; Patient Care; Patient-Focused Outcomes; Patients; Perception; Population; Population Heterogeneity; Positioning Attribute; Process; Protocols documentation; Provider; Psychological Factors; Qualitative Evaluations; Race; Recurrence; Research; Research Methodology; Research Personnel; Resource Allocation; Resources; Retrospective Studies; Risk; Sodium Chloride; Standardization; Surveys; Techniques; Texas; Time; Transplantation; Underinsured; United States National Institutes of Health; Universities; Waiting Lists; Work; access disparities; alcohol abstinence; alcohol use disorder; biopsychosocial; biopsychosocial factor; candidate selection; career; cohort; data harmonization; design; ethnic diversity; health care disparity; health disparity; improved; innovation; integrated care; liver transplantation; member; multidisciplinary; novel; organ allocation; outcome prediction; patient population; preference; prospective; racial diversity; risk prediction model; sex; social health determinants; socioeconomics; stakeholder perspectives; substance use; survival prediction; transplant centers; transplant model; virtual

PROJECT SUMMARY Alcohol-associated liver disease (ALD), which includes alcohol-associated cirrhosis (AAC) and alcohol- associated hepatitis (AH), is now the leading indication for liver transplant (LT) in the US. Early LT (eLT), defined as LT evaluation with <6 months of alcohol abstinence, is associated with acceptable outcomes for AH in retrospective studies. However, prospective, multi-center data including biopsychosocial factors on eLT for all advanced ALD in racially, culturally, and socioeconomically diverse populations are lacking. It is known that alcohol cessation is the most important factor influencing survival in ALD, and integrated alcohol use disorder (AUD)/ALD care is critical to help patients achieve abstinence, yet the degree of care integration and how this influences post-LT outcomes has not been systematically studied. Knowledge gaps in eLT for ALD include: a) limited data on who gets referred for eLT and referral barriers; b) lack of standardized biopsychosocial measures and outcomes; and c) minimal stakeholder involvement beyond LT providers. There is an urgent need to (1) define factors influencing eLT referral, (2) develop risk prediction models of key patient-centered outcomes, (3) incorporate validated biopsychosocial measures into models, and (4) evaluate the impact of integrated care on outcomes following eLT. For example, The INTEGRATE collaborative, comprised of diverse, multidisciplinary clinicians and researchers from the University of Texas Southwestern Medical Center, University of Michigan, University of Miami, and Columbia University-Weill Cornell Medicine, is ideally positioned to address these urgent research needs. Collectively, we have developed a distinctive investigator team with diversity in: (1) career stage (2) sex and race/ethnicity, (3) clinical and methodological expertise in ALD, AUD, LT, behavioral research, risk modeling, data harmonization, health disparities, causal inference, and mixed-methods research, and (4) documented track record of NIH funding in LT access, organ allocation, LT outcomes and healthcare disparities, and NIAAA funding in ALD/AUD. Our large volume transplant centers with established protocols for eLT for ALD applied to highly diverse populations will facilitate the following aims: 1) characterize and develop risk prediction models for transplant-free survival among those with limited access to LT to define those in greatest need of eLT referral and listing; 2) evaluate barriers and facilitators to referral for eLT in ALD; 3) apply causal inference approaches to observational data to evaluate biopsychosocial factors and develop risk models predictive of outcomes at key timepoints in eLT for ALD; 4) define stakeholder perceptions and preferences for selection and outcomes in eLT for ALD; and 5) evaluate how integrated care processes influence outcomes in eLT for ALD. At the conclusion of this work, we will have collaboratively: (1) defined factors for referral and waitlisting for eLT in ALD (selection), (2) identified which biopsychosocial factors are causally related and predictive of outcomes most important to stakeholders (outcomes) and (3) determined how integrated care influences stakeholder-relevant outcomes in eLT for ALD (management).

项目摘要 酒精相关肝病（ALD），包括酒精相关的肝硬化（AAC）和酒精 - 相关的肝炎（AH）现在是美国肝移植（LT）的主要指示。早期LT（ELT）， 定义为LT评估，戒酒<6个月，与AH的可接受结果有关 在回顾性研究中。但是，前瞻性，多中心数据，包括ELT的生物心理社会因素 缺乏种族，文化和社会经济多样性的所有先进的ALD。众所周知 饮酒是影响ALD生存的最重要因素，综合酒精使用障碍 （AUD）/ALD护理对于帮助患者的戒酒至关重要，但是护理整合程度以及如何 影响LT后结果尚未系统地研究。 ALD ELT中的知识差距包括：a） 关于谁被转介的ELT和转介障碍的数据有限； b）缺乏标准化的生物心理社会 措施和结果； c）LT提供商以外的最小利益相关者参与。有紧急 需要（1）定义影响ELT推荐的因素，（2）开发以患者为中心的关键的风险预测模型 结果，（3）将经过验证的生物心理社会措施纳入模型，（4）评估 ELT之后的结果综合护理。例如，集成协作，包括 来自德克萨斯大学西南医学中心的多元学科临床医生和研究人员， 密歇根大学，迈阿密大学和哥伦比亚大学 - 韦尔康奈尔大学医学是理想情况下 定位以满足这些紧急研究需求。总体而言，我们开发了一个独特的研究者 具有多样性的团队：（1）职业阶段（2）性别和种族/种族，（3）临床和方法论专业知识 ALD，AUD，LT，行为研究，风险建模，数据协调，健康差异，因果推断， 和混合方法研究，以及（4）记录了LT访问，器官分配中NIH资金的记录记录 LT成果和医疗保健差异以及ALD/AUD的NIAAA资金。我们的大量移植中心 使用已建立的ELT方案用于ALD，适用于高度多样化的人群，将有助于以下目的： 1）表征和开发有限访问权限的人的无移植生存的风险预测模型 LT定义最需要ELT推荐和上市的人； 2）评估障碍和促进者转介 为Ald的Elt； 3）将因果推理方法应用于观察数据以评估生物心理社会因素 并开发风险模型，以预测ALD的ELT关键时点的结果； 4）定义利益相关者 ALD的ELT选择和结果的感知和偏好； 5）评估综合护理如何 过程影响ALD ELT的结果。在这项工作结束时，我们将进行协作：（1） ALD（选择）中ELT的转诊和等待列表的定义因素（2），确定了哪些生物心理社会 因素与因果关系和预测对利益相关者最重要的结果（结果）和（3）的结果有效。 确定综合护理如何影响ALD（管理）ELT中利益相关者的结果。