Transitional Care for Liver Disease

(TLC Trial)

Recruiting at 3 trial locations

Overseen By Regina Weber, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hospice, Liver transplant, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

1000 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{2 6 7 8 9}

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. ^{2 4 10 11 12}

Who Is on the Research Team?

Eric Orman, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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.

Has planned discharge alive to home or a facility within 72 hours of informed consent

Able and willing to provide informed consent

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Transitional Liver Clinic (TLC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Transitional Liver Clinic (TLC) Active Control 1 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 group Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eric Orman

Lead Sponsor

Trials

1

Recruited

1,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study of 498 liver disease patients showed that those who attended a Physician Assistant-led Transitional Liver Clinic (TLC) had a significantly lower 30-day hospital readmission rate of 12% compared to 22% for those who did not attend, indicating the potential effectiveness of this intervention.

The TLC attendance was associated with a reduced risk of readmission even after adjusting for other factors, suggesting that this model of post-discharge care could be beneficial, particularly for women and patients without chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attendance at a Transitional Liver Clinic May Be Associated with Reduced Readmissions for Patients with Liver Disease. Yoder, L., Mladenovic, A., Pike, F., et al.[2023]

The Transitional Care (TLC) Partners program significantly reduced the number of emergency department visits and rehospitalizations among older veterans compared to those not enrolled in the program, indicating its effectiveness in supporting hospital-to-home transitions.

Despite the positive outcomes in reducing hospital visits, the preparedness and burden scores for caregivers remained largely unchanged, suggesting that while patient outcomes improved, caregiver experiences may need further support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional Care Partners: a hospital-to-home support for older adults and their caregivers. Hendrix, C., Tepfer, S., Forest, S., et al.[2021]

A national study called Project ACHIEVE identified eight essential components of effective transitional care (TC) for vulnerable Medicare beneficiaries, including patient and caregiver engagement, medication management, and care continuity.

The study emphasizes that addressing all identified TC components is crucial for improving health outcomes and meeting the needs of patients and caregivers, highlighting the importance of a patient-centered approach in healthcare transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components of Comprehensive and Effective Transitional Care. Naylor, MD., Shaid, EC., Carpenter, D., et al.[2018]

The transitional care program led by clinical nurse specialists (CNS) significantly reduced emergency department visits and hospitalizations in patients with chronic diseases, demonstrating its efficacy in improving post-hospitalization outcomes.

The palliative care program showed a significant reduction in hospitalizations but not in emergency department visits, indicating that different transitional care models may have varying impacts depending on patient populations and healthcare provider focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Preventable Hospitalizations With Two Models of Transitional Care. Morrison, J., Palumbo, MV., Rambur, B.[2018]

Cirrhotic patients who received outpatient telephonic transitional care (OTTC) after hospital discharge had a significantly higher 6-month survival rate (84.2%) compared to those who did not receive OTTC (68.8%), indicating that this intervention may improve long-term outcomes.

Despite the improved survival, the readmission rates at 1, 3, and 6 months were similar between the OTTC group and the control group, suggesting that readmission rates may not be a reliable measure of the quality of care or the effectiveness of transitional care programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. Rao, BB., Sobotka, A., Lopez, R., et al.[2020]

Transitions of care are critical for improving healthcare quality and patient safety, yet studies show that over half of these transitions have significant lapses, such as missing clinical information and medication errors, leading to adverse outcomes in 15-25% of patients.

Implementing effective transitional care interventions, including both less intensive coaching and more intensive case management, can significantly reduce re-hospitalization rates, with reductions of up to one-third in less intensive models and over half in more intensive approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care transitions and home health care. Boling, PA.[2013]

The Trauma Transitional Care Coordination (TTCC) program effectively reduced 30-day readmission rates for high-risk trauma patients, with significant reductions observed in specific groups such as those with lower-extremity injuries and complicated procedures.

Out of 475 patients enrolled, the TTCC program led to a 6 to 16 percentage point decrease in readmission rates for targeted conditions, resulting in over one million dollars in savings for the hospital annually through improved quality-based reimbursement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma transitional care coordination: A mature system at work. Hall, EC., Tyrrell, RL., Doyle, KE., et al.[2019]

In a study of 32 pediatric liver transplant recipients transitioning to adult care, 28% experienced mortality after the transfer, highlighting a concerning trend in patient survival during this vulnerable period.

Post-transfer, there was a significant drop in adherence to office visits and indications of worsening health outcomes, such as increased liver enzyme levels and higher rates of hospital admissions, suggesting that the transition may negatively impact overall health and increase healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, Medical Outcomes, and Health Care Costs in Adolescents/Young Adults Following Pediatric Liver Transplantation. Lawrence, ZE., Martinez, M., Lobritto, S., et al.[2021]

A new transitional cancer care program was developed in Iran, focusing on continuity of care for patients moving from hospital to home, which is crucial for reducing unnecessary hospital admissions and complications.

The program, validated by expert feedback with a content validity of 98.7% and feasibility of 95.8%, includes integrated services, holistic care, and the use of telemedicine, structured in three phases: pre-discharge, post-discharge, and transitional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional Cancer Care Program from Hospital to Home in the Health Care System of Iran. Alizadeh, Z., Rohani, C., Rassouli, M., et al.[2021]

Young adult liver transplant recipients face higher rates of rejection, graft loss, and medical complications when transitioning from pediatric to adult care, highlighting the need for effective transition programs.

A structured, multidisciplinary approach to health care transition is essential for helping these young adults develop independent health care skills and ensuring a smooth transfer to adult providers, but it requires support from governing organizations to be widely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Transition: A Time of Increased Vulnerability for Pediatric Liver Transplant Recipients. Vittorio, J.[2021]

In a study involving 199 participants aged over 60 with multiple health issues, the Mayo Clinic Care Transitions (MCCT) program did not show a significant improvement in quality of life (QoL) compared to usual care after one year.

While 74% of MCCT participants reported good-to-excellent QoL at baseline, this dropped to 64% after one year, indicating a potential decline in QoL that may be due to the progression of chronic diseases rather than the effectiveness of the MCCT program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. Faucher, J., Rosedahl, J., Finnie, D., et al.[2020]

Pediatric liver transplant patients face significant health risks after transitioning to adult care, with many experiencing increased morbidity and mortality due to issues like medical non-adherence, which is linked to higher rates of rejection and graft loss.

Transplant programs that implement formal transition processes tend to achieve better patient outcomes, highlighting the importance of individualized transition programs tailored to specific transplant centers, although more comprehensive multi-site studies are needed to strengthen these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TRANSITION of Pediatric Liver Transplant Patients to Adult Care: a Review. Stevens, JP., Hall, L., Gupta, NA.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Attendance at a Transitional Liver Clinic May Be Associated with Reduced Readmissions for Patients with Liver Disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Transitional Care Partners: a hospital-to-home support for older adults and their caregivers. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Components of Comprehensive and Effective Transitional Care. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Reducing Preventable Hospitalizations With Two Models of Transitional Care. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Care transitions and home health care. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Trauma transitional care coordination: A mature system at work. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Adherence, Medical Outcomes, and Health Care Costs in Adolescents/Young Adults Following Pediatric Liver Transplantation. [2021]

9. Thailand pubmed.ncbi.nlm.nih.gov

Transitional Cancer Care Program from Hospital to Home in the Health Care System of Iran. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Health Care Transition: A Time of Increased Vulnerability for Pediatric Liver Transplant Recipients. [2021]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

TRANSITION of Pediatric Liver Transplant Patients to Adult Care: a Review. [2021]