Back to resultsA Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease (TLC)
Primary Purpose
Liver Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transitional Liver Clinic (TLC)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Diseases
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
Sites / Locations
- University of ChicagoRecruiting
- Indiana University Division of Gastroenterolgy and HepatologyRecruiting
- University of MichiganRecruiting
- Albert Einstein Healthcare NetworkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control group
Transitional Liver Clinic (TLC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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).
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT05733832
First Posted
January 18, 2023
Last Updated
September 19, 2023
Sponsor
Eric Orman
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05733832
Brief Title
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Acronym
TLC
Official Title
A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
February 28, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Orman
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Transitional Liver Clinic (TLC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transitional Liver Clinic (TLC)
Intervention Description
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 Measure Information:
Title
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
Description
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.
Time Frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Title
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
Description
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).
Time Frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Title
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
Description
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).
Time Frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Title
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
Description
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.
Time Frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study
Title
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
Description
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.
Time Frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Secondary Outcome Measure Information:
Title
Number of ER visits
Description
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.
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
Title
90 day mortality
Description
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.
Time Frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Title
Days alive out of the hospital
Description
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.
Time Frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Title
Hospital readmissions
Description
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jake McCarty, BS
Phone
317-278-6305
Email
jacmccar@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Weber, BS
Phone
317-278-3584
Email
reginaw@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Orman, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Charleton, MD
Phone
773-702-1234
Email
mcharlton@medicine.bsd.uchicago.edu
Facility Name
Indiana University Division of Gastroenterolgy and Hepatology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Weber, BS, RRT
Phone
317-278-3584
Email
reginaw@iu.edu
First Name & Middle Initial & Last Name & Degree
Eric Orman, MD
Phone
317-278-1630
Email
esorman@iu.edu
First Name & Middle Initial & Last Name & Degree
Eric Orman, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elliott Tapper, MD
Phone
734-936-9250
Email
etapper@umich.edu
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Navarro, MD
Phone
215-456-8242
Email
navarrov@einstein.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
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