RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-01

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05733832

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Jake McCarty, BS

CONTACT

317-278-6305

jacmccar@iu.edu

Regina Weber, BS

CONTACT

317-278-3584

reginaw@iu.edu

Principal Investigator

Eric Orman, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141

United States

Collaborators and Investigators

Sponsor: Indiana University

Eric Orman, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Liver Diseases