RecruitingNot ApplicableNCT05733832

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

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


Sponsor

Indiana University

Enrollment

1,000 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria17

  • 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

Exclusion Criteria8

  • 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

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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 Chicago

Chicago, Illinois, United States

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

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NCT05733832


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