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

Liver Diseases Clinical Trial

— TLC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733832
• Other study ID #: TLC
• Secondary ID: R01DK132390
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: Jake McCarty, BS
• Phone: 317-278-6305
• Email: jacmccar[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2028
• Est. primary completion date: February 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Chicago	Chicago	Illinois
United States	Indiana University Division of Gastroenterolgy and Hepatology	Indianapolis	Indiana
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eric Orman	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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	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.	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
Secondary	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.	90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Secondary	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.	90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Secondary	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	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