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).

项目总结