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

Overview

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.

Interventions

• Other Transitional Liver Clinic (TLC)
  Participants in this intervention receive additional attention from their Hepatology providers in terms of an additional call/telemedicine visit and more specific/additional attention from their Hepatology APP (advanced practice provider) based on individual patient needs

Primary outcome measures

• 30-day hospital readmissions for patients hospitalized with complications of advanced liver disease [Time frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.]
• Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey [Time frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.]
• Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey [Time frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study]
• Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire [Time frame: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study]
• Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire [Time frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study]

Secondary outcome measures (4)

• Number of ER visits [Time frame: 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]
• 90 day mortality [Time frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.]
• Days alive out of the hospital [Time frame: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.]
• Hospital readmissions [Time frame: 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]

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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 interventional research study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• University of Chicago — Chicago
• Indiana University Division of Gastroenterolgy and Hepatology — Indianapolis
• University of Michigan — Ann Arbor
• Albert Einstein Healthcare Network — Philadelphia

Identifiers

NCT: NCT05733832 · TLC · R01DK132390

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗