Liver DiseasesTLCNCT05733832
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
A study testing Transitional Liver Clinic (TLC) in people with Liver Diseases, run by Indiana University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Transitional Liver Clinic (TLC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Elliott Tapper, MD, 734- 936-9250, etapper@umich.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Michael Charleton, MD, 773-702-1234, mcharlton@medicine.bsd.uchicago.edu
- Recruiting
Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana, 46202
Regina Weber, BS, RRT, 317-278-3584, reginaw@iu.edu
Eric Orman, MD, 317-278-1630, esorman@iu.edu
- Recruiting
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Victor Navarro, MD, 215-456-8242, navarrov@einstein.edu
About this study
Official title: A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
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.
Read the 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.
- Conditions
- Liver Diseases
- Being tested
- Transitional Liver Clinic (TLC)
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transitional Liver Clinic (TLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Secondary outcomes (4)
Number of ER visits
Recognizing the limitations on CMS data, the number of ER visits for each participant will be taken from the medical record and will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Measured: 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
Recognizing the limitations on CMS data, 90 day mortality will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Measured: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Days alive out of the hospital
Recognizing the limitations on CMS data, number of days alive out of the hospital will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Measured: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Hospital readmissions
Participants will self report or data will be obtained from local institutional medical records the number of times, if any, they were admitted to the hospital during their time of participation in this study
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Orman, Indiana University
- Investigators
- Eric Orman, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733832
- Sponsor's protocol ID
- TLC
- Other IDs
- R01DK132390
- Acronym
- TLC
- Status last verified
- Nov 2026
- First submitted
- 18 Jan 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05733832
- Acronym / sponsor ID
- TLC / TLC
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Transitional Liver Clinic (TLC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female age ≥18
- Diagnosis of advanced liver disease, defined as either (must meet either a or b)
- Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
- Has planned discharge alive to home or a facility within 72 hours of informed consent
- Able and willing to provide informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Transitional Liver Clinic (TLC) |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Orman, MD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Liver Clinic (TLC) in people with Liver Diseases, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jake McCarty, BS (317-278-6305, jacmccar@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.