Recruiting

Transitional Care

Sponsor:

Indiana University

Code:

NCT05733832

Conditions

Liver Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transitional Liver Clinic (TLC)

Study Details

Brief 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.

Conditions

Liver Diseases

Study ID

NCT05733832

Start date

Sep 1, 2023

Status verified date

Oct, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control group

Patients in the usual care arm will receive standard follow-up care from their usual providers based on recommendations made by inpatient providers at the time of discharge from the hospital.

active comparator: Transitional Liver Clinic (TLC)

Enrolled patients discharged during the experimental TLC intervention implementation period will receive a phone call from TLC staff within 2 business days of discharge followed by an in-person or video telehealth clinic visit with a hepatology APP within 14 days of discharge. TLC staff will provide additional care based on individual patient needs during the 30-day transitional period.

Interventions

Transitional 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

Primary outcome measure

  • 30-day hospital readmissions for patients hospitalized with complications of advanced liver disease [ Time Frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study. ]
  • Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey [ Time Frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study. ]
  • Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey [ Time Frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study ]
  • Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire [ Time Frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study ]
  • Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire [ Time Frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study ]

Central Contacts and Locations

Central contacts

Jake McCarty, BS

317-278-6305jacmccar@iu.edu

Regina Weber, BS

317-278-3584reginaw@iu.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Michael Charleton, MD

773-702-1234mcharlton@medicine.bsd.uchicago.edu

Indiana University Division of Gastroenterolgy and Hepatology

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Regina Weber, BS, RRT

317-278-3584reginaw@iu.edu

Eric Orman, MD

317-278-1630esorman@iu.edu

Principal Investigator:

Eric Orman, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Elliott Tapper, MD

734- 936-9250etapper@umich.edu

Albert Einstein Healthcare Network

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Victor Navarro, MD

215-456-8242navarrov@einstein.edu

More Information

Sponsor

Indiana University

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2025-10-24.