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New treatment option for Liver Diseases
Official title A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
ClinicalTrials.gov ID: NCT05733832
What this study is testing
- What it's testing
- 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.
- Time commitment: about 45 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female age ≥18
- Diagnosis of advanced liver disease, defined as either (must meet either a or b)
- cirrhosis based on (either i or ii):
- biopsy
- characteristic clinical, laboratory, and imaging findings
You likely can't join if
- discharge under hospice
- listed for liver transplant with MELD-Na ≥ 35
- unable or unwilling to participate in post-discharge follow-up either in-person or virtually
- unable to speak or understand English and/or Spanish
- low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
- lack of access to a telephone
See the full eligibility criteria
- Male or female age ≥18
- Diagnosis of advanced liver disease, defined as either (must meet either a or b)
- cirrhosis based on (either i or ii):
- biopsy
- characteristic clinical, laboratory, and imaging findings
- 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
- Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
- ascites requiring diuretics or paracentesis
- hepatic encephalopathy requiring lactulose or rifaximin
- gastrointestinal bleeding due to portal hypertension
- jaundice
- Has planned discharge alive to home or a facility within 72 hours of informed consent
- Able and willing to provide informed consent
- discharge under hospice
- listed for liver transplant with MELD-Na ≥ 35
- unable or unwilling to participate in post-discharge follow-up either in-person or virtually
- unable to speak or understand English and/or Spanish
- low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
- lack of access to a telephone
- incarcerated
- concurrent enrollment in an treatment research study
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Ann Arbor, Michigan, United States
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 45 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Indianapolis, Indiana, United States; Ann Arbor, Michigan, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.