NCT05733832 · Indiana University
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
(TLC)
What this study is 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.
View original scientific description
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.
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.
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.
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.
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).
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
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).
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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):
- 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
- 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
Where
- Chicago, Illinois
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Philadelphia, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 24, 2025 · Source of record for eligibility and locations