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

Indiana University

Status: Enrolling

Conditions: Liver Diseases

Treatments: Other: Transitional Liver Clinic (TLC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05733832

TLC

R01DK132390 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; <6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control.

In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC.

All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Control group

No Intervention group

Description:

Patients in the usual care arm will receive standard follow-up care from their usual providers based on recommendations made by inpatient providers at the time of discharge from the hospital.

Transitional Liver Clinic (TLC)

Active Comparator group

Description:

Enrolled patients discharged during the experimental TLC intervention implementation period will receive a phone call from TLC staff within 2 business days of discharge followed by an in-person or video telehealth clinic visit with a hepatology APP within 14 days of discharge. TLC staff will provide additional care based on individual patient needs during the 30-day transitional period.

Treatment:

Other: Transitional Liver Clinic (TLC)