Transitional Care for Liver Disease
(TLC Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Hospice, Liver transplant, Incarcerated, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Transitional Liver Clinic (TLC) and Transitional Care Model for liver disease?
Research suggests that attending a Transitional Liver Clinic (TLC) may help reduce hospital readmissions for patients with liver disease. Additionally, transitional care programs, which include follow-up after hospital discharge, have been shown to reduce hospitalizations and improve outcomes in various patient populations.
12345Is transitional care for liver disease safe for humans?
Transitional care models, including those for liver disease, have been studied for their effectiveness in improving health outcomes and reducing hospital readmissions. While specific safety data for liver disease is not detailed, these models generally focus on improving care transitions, which can enhance patient safety by reducing medication errors and ensuring better continuity of care.
23678How is the Transitional Liver Clinic (TLC) treatment different from other treatments for liver disease?
The Transitional Liver Clinic (TLC) treatment is unique because it focuses on providing continuous care as patients move from the hospital to home, aiming to reduce complications and hospital readmissions. This approach is particularly important for young adults transitioning from pediatric to adult care, ensuring they receive consistent support and education to manage their health independently.
29101112Eligibility Criteria
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.Inclusion Criteria
I have advanced liver disease with complications like fluid buildup, confusion, bleeding, or jaundice.
I am 18 years old or older.
Has planned discharge alive to home or a facility within 72 hours of informed consent
+2 more
Exclusion Criteria
I cannot speak or understand English or Spanish.
I am currently under hospice care.
I am on the liver transplant list with a MELD-Na score of 35 or higher.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Control Phase
Participants receive usual care during the initial 9-month enrollment interval
9 months
Standard follow-up care from usual providers
Transitional Liver Clinic (TLC) Phase
Participants receive a phone call from TLC staff within 2 business days of discharge followed by an in-person or video telehealth clinic visit within 14 days of discharge. Additional care is provided based on individual patient needs during the 30-day transitional period.
9 months
1 phone call, 1 in-person or video telehealth visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
90 days
Follow-up by telephone at 30 and 90 days after discharge
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Albert Einstein Healthcare NetworkPhiladelphia, PA
Indiana University Division of Gastroenterolgy and HepatologyIndianapolis, IN
University of MichiganAnn Arbor, MI
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
Eric OrmanLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Attendance at a Transitional Liver Clinic May Be Associated with Reduced Readmissions for Patients with Liver Disease. [2023]Patients with liver disease have high rates of early hospital readmission, but there are no studies of effective, scalable interventions to reduce this risk. In this study, we examined the impact of a Physician Assistant (PA)-led post-discharge Transitional Liver Clinic (TLC) on hospital readmissions.
Transitional Care Partners: a hospital-to-home support for older adults and their caregivers. [2021]To describe the development, implementation, and preliminary results of the Transitional Care (TLC) Partners, a clinical demonstration program that supports the transition from hospital to home of older veterans.
Components of Comprehensive and Effective Transitional Care. [2018]Transitional care (TC) has received widespread attention from researchers, health system leaders, clinicians, and policy makers as they attempt to improve health outcomes and reduce preventable hospital readmissions, yet little is known about the critical elements of effective TC and how they relate to patients' and caregivers' needs and experiences. To address this gap, the Patient-Centered Outcomes Research Institute (PCORI) funded a national study, Achieving patient-centered Care and optimized Health In care transitions by Evaluating the Value of Evidence (Project ACHIEVE). A primary aim of the study is the identification of TC components that yield desired patient and caregiver outcomes. Project ACHIEVE established a multistakeholder workgroup to recommend essential TC components for vulnerable Medicare beneficiaries. Guided by a review of published evidence, the workgroup identified and defined a preliminary set of components and then analyzed how well the set aligned with real-world patients' and caregivers' experiences. Through this process, the workgroup identified eight TC components: patient engagement, caregiver engagement, complexity and medication management, patient education, caregiver education, patients' and caregivers' well-being, care continuity, and accountability. Although the degree of attention given to each component will vary based on the specific needs of patients and caregivers, workgroup members agree that health systems need to address all components to ensure optimal TC for all Medicare beneficiaries.
Reducing Preventable Hospitalizations With Two Models of Transitional Care. [2018]Transitional care is an emerging model of health care designed to decrease preventable adverse events and associated utilization of health care through temporary follow-up after hospital discharge. This study describes the approaches and outcomes of two distinct transitional care programs serving different populations: one is provided by master's-prepared clinical nurse specialists (CNS) with a chronic disease self-management focus, another by physicians specializing in palliative care (PPCs). Existing research has shown that transitional care programs with intensive follow-up reduce hospitalizations, emergency department (ED) visits, and costs. Few studies, however, have included side-by-side descriptions of the efficacy of transitional care programs varying by healthcare providers or program focus.
Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. [2020]Intervention to improve outcomes in cirrhotic patients (CP) after hospital discharge often focus on 30 d readmission rate (RR). However, recent studies suggest dissociation between RR and survival. At our center, CP are now offered outpatient telephonic transitional care (OTTC) by a care coordinator for 30 d after hospital discharge.
Care transitions and home health care. [2013]Transitions of care are becoming recognized as an important area for improvement in health care quality and patient safety. Yet there remains consistent evidence from multiple studies in varied settings of failures to complete safe, effective hand-offs from one location of care to the next. Major lapses include absent or limited clinical information and care plan content, plus errors related to medications. There are identifiable problems with half or more of the transitions that occur between care settings, and adverse consequences occur in 15 to 25 percent of patients. Undoubtedly these lapses contribute to the rates of re-hospitalization in post-acute care which affect 20 to 30 percent of patients within 60 days after hospital discharge. This article reviews models of transitional care intervention that have been tested and shown to be effective including less intensive coaching or guided care approaches, and more intensive case management strategies. Effective transitional care processes, linked with strong home care programs can reduce re-hospitalization by a third in some less intensive models and by half or more in some more intensive models.
Trauma transitional care coordination: A mature system at work. [2019]We have previously demonstrated effectiveness of a Trauma Transitional Care Coordination (TTCC) Program in reducing 30-day readmission rates for trauma patients most at risk. With program maturation, we achieved improved readmission rates for specific patient populations.
Adherence, Medical Outcomes, and Health Care Costs in Adolescents/Young Adults Following Pediatric Liver Transplantation. [2021]Improved outcomes after pediatric liver transplantation (LT) have led to increasing numbers of adolescent and young adult recipients entering into adult health care systems. The aim of this study was to evaluate the impact of transition from pediatric to adult health care models on medical outcomes, measures of adherence, and health care utilization for pediatric LT recipients.
Transitional Cancer Care Program from Hospital to Home in the Health Care System of Iran. [2021]Transitional care program refers to the health care continuity during transferring from one health care setting to another or to home. This is an essential program for cancer patients and reduces the risk of unnecessary hospital admissions as well as the complications of the disease. The aim of this study was to develop a transitional cancer care program from hospital to home in the health care system of Iran.
Health Care Transition: A Time of Increased Vulnerability for Pediatric Liver Transplant Recipients. [2021]Improvements in pediatric liver transplantation (LT) have led to an increased number of patients reaching young adulthood. Young adult LT recipients transferring from pediatric to adult models of care have increased rates of rejection, graft loss, and medical complications. The goal of a health care transition program is to optimize health and assist youth in reaching their full potential. The means to achieve this goal requires an organized transition process to support youth in acquiring independent health care skills, preparing for an adult model of care, and transferring to new providers without disruption in treatment. This can only be achieved through a multidisciplinary approach to transition planning. This is often a labor and resource-intensive undertaking, which may not receive the necessary support from local institutions. Widespread implementation requires the assistance and endorsement from governing organizations at the national and international level.
Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. [2020]Transitional care programs are common interventions aimed at reducing medical complications and associated readmissions for patients recently discharged from the hospital. While organizations strive to reduce readmissions, another important related metric is patient quality of life (QoL).
TRANSITION of Pediatric Liver Transplant Patients to Adult Care: a Review. [2021]Many pediatric liver transplant patients are surviving to adulthood, and providers have come to recognize the importance of effectively transitioning these patients to an adult hepatologist. The review aims to analyze the most recent literature regarding patient outcomes after transition, barriers to successful transition, recommendations from clinicians and medical societies regarding transition programs, and to provide personal insights from our experience in transitioning liver transplant recipients.