NCT05733832 A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
| NCT ID | NCT05733832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Liver Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-09-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Eric Orman, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05733832 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05733832 currently recruiting?
Yes, NCT05733832 is actively recruiting participants. Contact the research team at jacmccar@iu.edu for enrollment information.
Where is the NCT05733832 trial being conducted?
This trial is being conducted at Chicago, United States, Indianapolis, United States, Ann Arbor, United States, Philadelphia, United States.
Who is sponsoring the NCT05733832 clinical trial?
NCT05733832 is sponsored by Indiana University. The principal investigator is Eric Orman, MD at Indiana University. The trial plans to enroll 1,000 participants.