A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Indiana University
Summary
Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.
Description
This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; \<6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control. In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female age ≥18 2. Diagnosis of advanced liver disease, defined as either (must meet either a or b) 1. cirrhosis based on (either i or ii): * biopsy * characteristic clinical, laboratory, and imaging findings 2. acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as * onset of jaundice (serum bilirubin \>3.0 mg/dL) in prior 8 weeks * consumption of \>40 (female) or 60 (male) g alcohol/day for ≥6 months, with \<60 days abstinence before jaundice onset, * AST\>50 IU/L, AST/ALT\>1.5, and both values \<400…
Interventions
- OtherTransitional Liver Clinic (TLC)
Participants in this intervention receive additional attention from their Hepatology providers in terms of an additional call/telemedicine visit and more specific/additional attention from their Hepatology APP (advanced practice provider) based on individual patient needs
Locations (4)
- University of ChicagoChicago, Illinois
- Indiana University Division of Gastroenterolgy and HepatologyIndianapolis, Indiana
- University of MichiganAnn Arbor, Michigan
- Albert Einstein Healthcare NetworkPhiladelphia, Pennsylvania