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A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease

RECRUITINGN/ASponsored by Indiana University
Actively Recruiting
PhaseN/A
SponsorIndiana University
Started2023-09-01
Est. completion2028-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Liver DiseaseLiver Diseases

Locations4 sites

Illinois

1 site
University of Chicago
Chicago, Illinois, 60637
Michael Charleton, MD773-702-1234mcharlton@medicine.bsd.uchicago.edu

Indiana

1 site
Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana, 46202
Regina Weber, BS, RRT317-278-3584reginaw@iu.edu

Michigan

1 site
University of Michigan
Ann Arbor, Michigan, 48109
Elliott Tapper, MD734- 936-9250etapper@umich.edu

Pennsylvania

1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Victor Navarro, MD215-456-8242navarrov@einstein.edu

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