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 new approach to assist people with advanced liver disease after hospital discharge. The goal is to determine if a special clinic, the Transitional Liver Clinic (TLC), can reduce hospital readmissions, enhance quality of life, and improve patient satisfaction with care. The TLC team will check in with patients shortly after discharge and provide additional support as needed. Suitable candidates have advanced liver disease, face challenges like fluid buildup or mental confusion, and are about to leave the hospital. As an unphased trial, this study offers patients a unique opportunity to receive personalized support and potentially improve their quality of life post-hospitalization.

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 prior data suggests that the Transitional Liver Clinic (TLC) is safe for patients with advanced liver disease?

Research shows that the Transitional Liver Clinic (TLC) effectively supports patients with liver disease after hospital discharge. Studies have found that patients visiting a TLC are less likely to return to the hospital within 30 days, indicating the care model's effectiveness during a crucial time.

The TLC provides follow-up care led by healthcare professionals such as nurse practitioners or physician assistants. This care is manageable for patients, as it doesn't involve new medications or invasive procedures. Instead, it focuses on advice and monitoring to help manage ongoing health needs.

Since the TLC model aims to improve post-hospital care, no specific side effects or negative events are linked to the program itself. It uses existing resources more effectively to enhance patient outcomes. Overall, research supports the TLC's safety and potential benefits for patients transitioning from hospital to home care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transitional Liver Clinic (TLC) approach because it offers a proactive and personalized follow-up care system for patients recently discharged with liver disease. Unlike traditional treatment options that rely on standard follow-up visits with usual providers, TLC ensures patients receive a phone call from specialized staff within two business days of discharge and an in-person or telehealth visit with a hepatology specialist within 14 days. This tailored approach aims to address individual patient needs more effectively during the crucial 30-day transitional period, potentially reducing readmission rates and improving overall patient outcomes.

What evidence suggests that the Transitional Liver Clinic (TLC) is effective for reducing hospital re-admissions in liver disease patients?

This trial will compare the Transitional Liver Clinic (TLC) with standard care. Studies have shown that the TLC can help reduce hospital readmissions for patients with liver disease. Specifically, patients who visit a TLC have fewer hospital readmissions within 30 days. A similar program led by nurse practitioners also effectively lowers the risk of returning to the hospital. These findings suggest that the TLC model may improve outcomes for people with advanced liver disease by providing extra support after hospital discharge. ^{2 6 7 8 9}

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

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

Able and willing to provide informed consent

I have advanced liver disease with complications like fluid buildup, confusion, bleeding, or jaundice.

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

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12269276/

Nurse Practitioner-Led Transitional Care for Liver Disease A nurse practitioner-led transitional care program could be effective in reducing the risk of readmission for patients with liver disease.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05733832?term=AREA%5BBasicSearch%5D(TLC%20clinic)&rank=3

A Trial of Post-Discharge Transitional Care for Patients ... This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic ( TLC ), in reducing hospital re-admissions, improving ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002934321006471

Attendance at a Transitional Liver Clinic May Be ... Patients with liver disease seen in a PA-led TLC may have a significant reduction in the 30-day readmission rate. Randomized trials are needed to establish the ...

4. amjmed.com amjmed.com/article/S0002-9343(21)00647-1/abstract

Attendance at a Transitional Liver Clinic May Be ... Patients with liver disease seen in a PA-led TLC may have a significant reduction in the 30-day readmission rate. Randomized trials are needed ...

5. researchgate.net researchgate.net/publication/387237469_Evaluation_of_a_nurse_practitioner-led_post-discharge_transitional_care_program_for_patients_with_liver_disease_A_retrospective_cohort_study

Evaluation of a nurse practitioner-led post-discharge ... Conclusions A nurse practitioner-led transitional care program could be effective in reducing the risk of readmission for patients with liver disease. Future ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05733832

A Trial of Post-Discharge Transitional Care for Patients ... This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8840978/

Attendance at a Transitional Liver Clinic May Be ... Patients with liver disease seen in a PA-led TLC may have a significant reduction in the 30-day readmission rate.

8. aasld.confex.com aasld.confex.com/aasld/2020/meetingapp.cgi/Paper/23436

A POST-DISCHARGE TRANSITION CLINIC FOR ... Of these, 120 (20%) were seen in TC after a mean of 13 days (SD 9) following discharge, with 75% of TC visits occurring within 14 days. Patients seen in TC were ...

9. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-025-03189-4

Effectiveness of transitional care interventions in patients with ... Transitional care interventions can improve quality of life and symptoms, although based on low or very low certainty of evidence.