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

NCT ID: NCT05733832

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2028-06-30

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.

Detailed Description

This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; <6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control.

In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC.

All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Transitional Liver Clinic (TLC)

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Eric Orman

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Orman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

University of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

Site Status: RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jake McCarty, BS

Role: CONTACT

jacmccar@iu.edu

317-278-6305

Regina Weber, BS

Role: CONTACT

reginaw@iu.edu

317-278-3584

Facility Contacts

Michael Charleton, MD

Role: primary

mcharlton@medicine.bsd.uchicago.edu

773-702-1234

Regina Weber, BS, RRT

Role: primary

reginaw@iu.edu

317-278-3584

Eric Orman, MD

Role: backup

esorman@iu.edu

317-278-1630

Elliott Tapper, MD

Role: primary

etapper@umich.edu

734- 936-9250

Victor Navarro, MD

Role: primary

navarrov@einstein.edu

215-456-8242

Other Identifiers

R01DK132390

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TLC

Identifier Type: -

Identifier Source: org_study_id