Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05733832

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

Led by Indiana University · Updated on 2025-10-24

1000

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a transitional care model called the Transitional Liver Clinic (TLC) on patients with advanced liver disease who face challenges after hospital discharge. This trial seeks to reduce early hospital readmissions, improve quality of life, and enhance patient experience during this vulnerable period. The study is designed as a stepped-wedge randomized trial conducted across four large centers over 45 months, including about 1,000 patients with advanced liver disease. Participants will receive either usual care or the TLC intervention. Those in usual care will be followed by their regular providers based on discharge recommendations. Patients in the TLC group will get a phone call from TLC staff within two business days after discharge and an in-person or telehealth clinic visit with a hepatology advanced practice provider within 14 days. Additional care tailored to individual patient needs is provided during the 30-day transitional period. Each site transitions from usual care to TLC sequentially during the study periods. Participants are followed up by phone at 30 and 90 days after discharge to assess outcomes. The study measures include 30-day hospital readmission rates, quality of life using the Promis 29+2 survey, and patient satisfaction via the PSQ 18 questionnaire. Secondary outcomes include emergency room visits, mortality at 90 days, days alive outside the hospital, and hospital readmissions at 30 and 90 days. The total participation spans the hospitalization and follow-up periods, with close monitoring of patient health and experience.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female age 18 years or older
  • Diagnosis of advanced liver disease defined as cirrhosis confirmed by biopsy or clinical findings, or acute alcoholic hepatitis meeting specific criteria
  • At least one complication from advanced liver disease during hospitalization, such as ascites, hepatic encephalopathy, gastrointestinal bleeding, or jaundice
  • Planned discharge alive to home or a facility within 72 hours of informed consent
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Discharge under hospice care
  • Listed for liver transplant with MELD-Na score 35 or higher
  • Unable or unwilling to participate in post-discharge follow-up in person or virtually
  • Unable to speak or understand English or Spanish
  • Low hearing or communication ability interfering with study participation
  • Lack of access to a telephone
  • Currently incarcerated
  • Enrolled in another interventional research study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 72 hours before hospital discharge

Participants are screened for eligibility to participate in the trial.

1 screening visit (in-person during hospitalization)

Treatment

Duration - 30 days post-discharge

Participants receive either usual care or Transitional Liver Clinic (TLC) post-discharge support involving phone calls and clinic visits to manage advanced liver disease.

1 phone call within 2 business days of discharge and 1 in-person or telehealth clinic visit within 14 days of discharge

Follow-up

Duration - Up to 90 days post-discharge

Participants are followed up by telephone to assess health status and outcomes after the treatment period.

2 telephone follow-up calls at 30 and 90 days post-discharge

Trial Site Locations

Total: 4 locations

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

2

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States, 46202

Actively Recruiting

3

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

4

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States, 19141

Actively Recruiting

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Research Team

J

Jake McCarty, BS

R

Regina Weber, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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