Transitional care for patients with chronic liver disease after hospital discharge

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a Transitional Liver Clinic (TLC) model aimed at improving outcomes for patients with advanced liver disease after hospital discharge. It is a stepped-wedge randomized trial involving 1,000 patients across four high-volume medical centers over 45 months. Initially, all sites provide standard care, and then they will transition to the TLC model in a staggered manner. The study aims to reduce hospital readmissions and enhance the quality of life and patient experience through structured follow-up and support.

Why it matters

Who can join: the full rules

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 IU/L
      * liver biopsy confirmation in patients with confounding factors
3. Has at least one of the following complications due to advanced liver disease occurring during hospitalization:

   1. ascites requiring diuretics or paracentesis
   2. hepatic encephalopathy requiring lactulose or rifaximin
   3. gastrointestinal bleeding due to portal hypertension
   4. jaundice
4. Has planned discharge alive to home or a facility within 72 hours of informed consent
5. Able and willing to provide informed consent

Exclusion Criteria:

1. discharge under hospice
2. listed for liver transplant with MELD-Na ≥ 35
3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually
4. unable to speak or understand English and/or Spanish
5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
6. lack of access to a telephone
7. incarcerated
8. concurrent enrollment in an interventional research study

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting
• Indiana University Division of Gastroenterolgy and Hepatology
  Indianapolis, Indiana, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Albert Einstein Healthcare Network
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Eric Orman, MD — Indiana University
• Study coordinator: Jake McCarty, BS
• Email: jacmccar@iu.edu
• Phone: 317-278-6305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.