Transitional care for patients with chronic liver disease after hospital discharge
A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
This study tests a new follow-up care program for people with advanced liver disease after they leave the hospital to see if it helps them stay healthier and reduces the need for readmissions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT05733832 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a Transitional Liver Clinic (TLC) model aimed at improving outcomes for patients with advanced liver disease after hospital discharge. It is a stepped-wedge randomized trial involving 1,000 patients across four high-volume medical centers over 45 months. Initially, all sites provide standard care, and then they will transition to the TLC model in a staggered manner. The study aims to reduce hospital readmissions and enhance the quality of life and patient experience through structured follow-up and support.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with advanced liver disease and experiencing complications during hospitalization.
Not a fit: Patients without advanced liver disease or those not experiencing complications during hospitalization may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for patients with chronic liver disease.
How similar studies have performed: Other studies have shown promise in transitional care models for chronic conditions, suggesting potential success for this approach in liver disease management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 3 other locations
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Indiana University Division of Gastroenterolgy and Hepatology — Indianapolis, Indiana, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Eric Orman, MD — Indiana University
- Study coordinator: Jake McCarty, BS
- Email: jacmccar@iu.edu
- Phone: 317-278-6305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.