Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
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)
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
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here