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).

项目概要 酒精相关性肝病（ALD），包括酒精相关性肝硬化（AAC）和酒精相关性肝硬化（AAC） 相关性肝炎（AH）目前是美国肝移植（LT）的主要适应症。早期 LT (eLT)、 LT 定义为禁酒 6 个月以内的 LT 评估，与可接受的 AH 结果相关 在回顾性研究中。然而，包括生物心理社会因素在内的前瞻性多中心数据对 eLT 的影响 种族、文化和社会经济多样化人群中缺乏所有晚期 ALD。据了解 戒酒是影响 ALD 患者生存的最重要因素，而综合性酒精使用障碍 (AUD)/ALD 护理对于帮助患者实现戒酒至关重要，但护理整合的程度以及如何做到这一点 LT 后结果的影响尚未得到系统研究。 ALD 的 eLT 知识差距包括：a) 关于谁被转介接受 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) 除了 LT 提供商之外，利益相关者的参与最少。有紧急情况 需要（1）定义影响 eLT 转诊的因素，（2）开发以患者为中心的关键风险预测模型 结果，(3) 将经过验证的生物心理社会测量纳入模型中，以及 (4) 评估 对 eLT 后结果的综合护理。例如，INTEGRATE 协作，包括 来自德克萨斯大学西南医学中心的多元化、多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威尔康奈尔医学院是理想的选择 旨在解决这些紧迫的研究需求。我们共同培养了一位独特的调查员 团队在以下方面具有多样性：(1) 职业阶段 (2) 性别和种族/民族，(3) 临床和方法学专业知识 ALD、AUD、LT、行为研究、风险建模、数据协调、健康差异、因果推理、 和混合方法研究，以及 (4) 记录 NIH 在 LT 获取、器官分配、 LT 结果和医疗保健差异，以及 NIAAA 对 ALD/AUD 的资助。我们的大容量移植中心 将针对 ALD 的 eLT 方案应用于高度多样化的人群，将有助于实现以下目标： 1) 描述和开发机会有限的患者的无移植生存风险预测模型 LT 确定最需要 eLT 转介和列表的人群； 2) 评估转介的障碍和促进因素 用于 ALD 中的 eLT； 3）对观察数据应用因果推理方法来评估生物心理社会因素 并开发风险模型来预测 ALD 的 eLT 关键时间点的结果； 4）定义利益相关者 对 ALD eLT 的选择和结果的看法和偏好； 5) 评估综合护理如何 流程影响 ALD 的 eLT 结果。在这项工作结束时，我们将合作：（1） 确定 ALD 中 eLT 转诊和候补的因素（选择），(2) 确定哪些生物心理社会因素 因素是因果相关的，并且可以预测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 的 eLT（管理）中与利益相关者相关的结果。