Clinical trial NCT05733832: A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Official title: A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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.
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: 30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
timeFrame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
measure: Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
timeFrame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
measure: Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
timeFrame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
measure: Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
timeFrame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study
measure: Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
timeFrame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Secondary outcomes:
measure: Number of ER visits
timeFrame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
measure: 90 day mortality
timeFrame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
measure: Days alive out of the hospital
timeFrame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
measure: Hospital readmissions
timeFrame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Division of Gastroenterolgy and Hepatology
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Indiana University
name: Eric Orman, MD
role: PRINCIPAL_INVESTIGATOR
References: