Actively Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Led by Indiana University · Updated on 2025-10-24
1000
Participants Needed
4
Research Sites
252 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Male or female age ≥18
-
Diagnosis of advanced liver disease, defined as either (must meet either a or b)
-
cirrhosis based on (either i or ii):
- biopsy
- characteristic clinical, laboratory, and imaging findings
-
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 IU/L
- liver biopsy confirmation in patients with confounding factors
-
-
Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
- ascites requiring diuretics or paracentesis
- hepatic encephalopathy requiring lactulose or rifaximin
- gastrointestinal bleeding due to portal hypertension
- jaundice
-
Has planned discharge alive to home or a facility within 72 hours of informed consent
-
Able and willing to provide informed consent
You will not qualify if you...
- discharge under hospice
- listed for liver transplant with MELD-Na ≥ 35
- unable or unwilling to participate in post-discharge follow-up either in-person or virtually
- unable to speak or understand English and/or Spanish
- low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
- lack of access to a telephone
- incarcerated
- concurrent enrollment in an interventional research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
Research Team
J
Jake McCarty, BS
CONTACT
R
Regina Weber, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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