# 1/4-The INTEGRATE  Study: Evaluating INTEGRATEd Care to Improve Biopsychosocial Outcomes of Early  Liver Transplantation for Alcohol-Associated Liver Disease

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 2024 · $424,668

## Abstract

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...

## Key facts

- **NIH application ID:** 10893472
- **Project number:** 5R01AA030956-02
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Lisa B VanWagner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $424,668
- **Award type:** 5
- **Project period:** 2023-08-01 → 2030-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10893472

## Citation

> US National Institutes of Health, RePORTER application 10893472, 1/4-The INTEGRATE  Study: Evaluating INTEGRATEd Care to Improve Biopsychosocial Outcomes of Early  Liver Transplantation for Alcohol-Associated Liver Disease (5R01AA030956-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10893472. Licensed CC0.

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