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

NCT05733832 | Recruiting DMC

• 2 other identifiers: TLCR01DK132390
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (5)

• 30-day hospital readmissions for patients hospitalized with complications of advanced liver disease

  The primary outcome, 30-day hospital readmission, is publicly reported by CMS, and is the benchmark measure in the Hospital Readmissions Reduction Program. It is therefore the most appropriate primary outcome.

  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

  This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).

  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

  This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).

  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

  The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.

  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

  The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.

  90 days after discharge of initial hospitalization at which the participant was enrolled in the study

Secondary Outcomes (4)

• Number of ER visits

  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

  90 days after discharge of initial hospitalization at which the participant was enrolled in the study.

• Days alive out of the hospital

  90 days after discharge of initial hospitalization at which the participant was enrolled in the study.

• Hospital readmissions

  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

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Other: Transitional Liver Clinic (TLC)

Interventions

Transitional Liver Clinic (TLC) OTHER

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

Transitional Liver Clinic (TLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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
• incarcerated
• concurrent enrollment in an interventional research study

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Eric Orman, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jake McCarty, BS

CONTACT

317-278-6305; jacmccar@iu.edu

Regina Weber, BS

CONTACT

317-278-3584; reginaw@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking; all sites will start out as control groups and all will eventually cross over to the TLC model. All sites will know into which group their and all other sites are enrolling.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 17, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)