What side effects are associated with this type of intervention?

Common treatments for liver disease, such as antiviral therapies for chronic hepatitis C, can have side effects including flu-like symptoms, fatigue, neuropsychiatric symptoms, and hematologic effects, particularly with interferon-containing regimens. Pharmacotherapies targeting ammonia for hepatic encephalopathy may reduce blood ammonia levels but their overall clinical effects and potential harms are not well-defined. Coordinated care models like the Transitional Liver Clinic (TLC) focus on reducing hospital readmissions and improving quality of life through patient education and follow-up support, which generally do not have direct side effects but require patient adherence and engagement.

What prior FDA approvals exist?

FDA-approved treatments for liver disease that align with the coordinated care model include antiviral therapies such as sofosbuvir and daclatasvir for chronic hepatitis C, which require close monitoring and follow-up to ensure efficacy and manage side effects. Additionally, the use of ursodeoxycholic acid for primary biliary cholangitis involves regular patient education and monitoring to manage disease progression and improve outcomes. These treatments emphasize the importance of a comprehensive care approach, including patient education, regular follow-up, and coordinated care, similar to the Transitional Liver Clinic (TLC) model.

What other types of research exist?

One promising alternative to The Transitional Liver Clinic (TLC) is the use of therapeutic plasma exchange (TPE) in conjunction with conventional therapy for patients with severe liver conditions, such as Wilson's disease. This approach has shown clinical improvement in patients and may prevent further clinical deterioration. Additionally, the use of long-term antiviral therapies, such as entecavir for chronic hepatitis B, has demonstrated efficacy in viral suppression, reversal of fibrosis/cirrhosis, and continued histological improvement. These treatments, combined with coordinated care and patient education, could serve as effective alternatives to TLC.

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Transitional Care for Liver Disease (TLC Trial)

N/A

Recruiting

Led By Eric Orman, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special program called the Transitional Liver Clinic (TLC) for patients with severe liver disease. The TLC aims to reduce hospital readmissions by offering extra support and care coordination after patients leave the hospital.

Who is the study for?

This trial is for adults over 18 with advanced liver disease, either cirrhosis or acute alcoholic hepatitis. Participants must have had a recent complication from their condition and be ready to leave the hospital soon. They need to speak English or Spanish, be able to follow up after discharge, and not be in hospice care or listed for a liver transplant with a high MELD-Na score.

What is being tested?

The study tests the Transitional Liver Clinic (TLC), aiming to reduce hospital readmissions and improve quality of life for patients after they're discharged. TLC provides specialized post-discharge care tailored for individuals recovering from complications associated with advanced liver disease.

What are the potential side effects?

Since TLC involves supportive care rather than medication, side effects are minimal compared to drug treatments. However, there may still be general discomforts related to healthcare visits such as stress or anxiety about medical appointments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30-day hospital readmissions for patients hospitalized with complications of advanced liver disease

Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire

Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey

Secondary study objectives

90 day mortality

Days alive out of the hospital

Hospital readmissions

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Transitional Liver Clinic (TLC)Active Control1 Intervention

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.

Group II: Control groupActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for liver disease, particularly those similar to the Transitional Liver Clinic (TLC) model, include coordinated care, patient education, and follow-up support. Coordinated care involves a multidisciplinary team approach to manage the patient's condition comprehensively, addressing various aspects of liver disease. Patient education empowers individuals with knowledge about their condition, treatment options, and necessary lifestyle changes, leading to better self-management and adherence to treatment plans. Follow-up support ensures continuous monitoring and timely interventions, which help prevent complications, reduce hospital readmissions, and improve overall quality of life for liver disease patients.

Treatment of primary biliary cirrhosis with ursodeoxycholic acid combined with traditional Chinese medicine: A protocol for systematic review and meta analysis.Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis.Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.