Transitional Liver Clinic (TLC) - A Randomized Trial of Post-Discharge Transitional Care for Patients with Chronic Liver Disease
Enrolling:No - Anticipated in 2023
What is TLC?The TLC is an APP-centric post-hospital discharge Transitional Care Management program. It includes a telephone call within 2 business days of discharge followed by a face-to-face or virtual visit within14days with an APP. Context-sensitive and protocolized care is provided during the 30-day transitional care period.
This is a 45-month stepped wedge cluster randomized trial in which, every 9 months, one randomly chosen site is crossed over from usual care to the TLC intervention. All sites begin the trial using usual care and all sites end the trial using TLC. All sites recruit participants for the entire 45 months.
Unique Aspects of the Project: Patients with the complications of advanced liver disease often have difficulties after hospital discharge that result in early readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This project aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), led by APPs, in reducing readmissions, improving quality of life, and improving patient experience.
Duration of Participation: Each patient will participate for 90-days post-hospital discharge with follow-up phone calls at 30-days and 90-days.
Duration of Study: 5 years after anticipated start of enrollment in 2023.
Objectives: To assess the effect of TLC versus usual care on 30-day readmission rate, QoL, and patient satisfaction for patients with advanced liver disease after hospital discharge:
Specific Aim 1To test the effect of the TLC compared to usual care on 30-day readmissions for patients hospitalized with complications of advanced liver disease. Secondary outcomes will include preventable readmissions, 90-day readmissions and 30- and 90-day emergency room visits, mortality, and days alive out of the hospital.
Specific Aim 2 To test the effect of the TLC compared to usual care on quality of life for patients hospitalized with complications of advanced liver disease. Quality of life will be assessed at 30- and 90-days post-discharge using the PROMIS-29+2 Profile.
Specific Aim 3 To test the effect of the TLC compared to usual care on patient satisfaction for patients hospitalized with complications of advanced liver.
Treatment:Protocolized post-hospital comprehensive discharge care (Transitional Liver Clinic [TLC]) run by Advanced Practice Providers (NPs/PAs) for patients with decompensated liver disease versus standard of care after hospital discharge.
Patient Population:Participants will be aged 18 and greater who haveadvanced liver disease and are soon to be discharged from the hospital.
Anticipated Enrollment: 1,000 patients.
Current Participating Sites:
Indiana University, Indianapolis, IN
University of Michigan, Ann Arbor, MI
Albert Einstein Health Network, Philadelphia, PA
University of Chicago, Chicago, IL
Sponsor and Funding Support: NIDDK and NIH R01.
Interested in this study? Please contact the project leader: