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

Description

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

Liver Diseases

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Liver Diseases
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Indianapolis

Indiana University Division of Gastroenterolgy and Hepatology, Indianapolis, Indiana, United States, 46202

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Philadelphia

Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, United States, 19141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Eric Orman, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2028-06-30