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

4/4：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

基本信息

批准号：
10710711
负责人：
Anne Christie Fernandez
金额：
$ 40.95万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-16 至 2030-07-31
项目状态：
未结题

项目摘要

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).

项目总结酒精性肝病(ALD)，包括酒精性肝硬变(AAC)和酒精性肝病相关性肝炎(AH)，现在是美国肝移植(LT)的主要适应症。早期LT(ELT)，被定义为LT评估并戒酒6个月，与AH的可接受结果相关在回顾研究中。然而，包括生物、心理和社会因素在内的前瞻性多中心数据显示，在种族、文化和社会经济多样化的人群中，所有先进的ALD都是缺乏的。众所周知，戒酒是影响ALD和综合酒精使用障碍患者生存的最重要因素 (AUD)/ALD护理对于帮助患者实现禁欲至关重要，然而护理整合的程度以及如何做到这一点对肝移植术后结局的影响还没有系统的研究。ALD英语教学中的知识差距包括：a) 关于谁被推荐参加英语学习和推荐障碍的数据有限；b)缺乏标准化的生物心理社会措施和结果；以及c)除LT提供者之外的最低限度的利益相关者参与。有一件急事需要(1)确定影响ELT转诊的因素，(2)开发以关键患者为中心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，以及(4)评估综合护理对ELT后结果的影响。例如，集成协作，由以下部分组成德克萨斯大学西南医学中心的不同的、多学科的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威尔·康奈尔医学院是理想的定位于满足这些紧迫的研究需求。总体而言，我们培养了一位与众不同的调查员在以下方面具有多样性的团队：(1)职业阶段(2)性别和种族/族裔，(3)临床和方法方面的专长 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)NIH在移植获取、器官分配、 LT结果和医疗保健差异，以及NIAAA在ALD/AUD方面的资金。我们的大容量移植中心建立了ALD的ELT方案，适用于高度多样化的人群，将有助于实现以下目标： 1)描述和开发那些获得有限机会的人的无移植存活的风险预测模型向LT确定哪些人最需要英语培训推荐和名单；2)评估推荐的障碍和促进者对于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为ALD开发预测ELT关键时间点结果的风险模型；4)定义利益相关者对ALD ELT的选择和结果的看法和偏好；以及5)评估综合护理如何治疗过程影响ALD的ELT治疗结果。在本工作结束时，我们将协作：(1) ALD中ELT转介和等待名单的定义因素(选择)，(2)确定哪些生物心理社会因素是因果关系的，对利益相关者最重要的结果(结果)和(3) 确定综合护理如何影响ALD(管理)ELT中与利益相关者相关的结果。