Lt-Care (Liver Transplant-Community Access for Referral Equity) Applied

Investigating Fairness in Liver Transplant Referrals

L
Lauren Nephew

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase N/A
25 participants needed
2 Locations

Brief description of study

A previous study (25857) focused on developing a multilevel intervention addressing health related variables and other social/structural barriers faced by patients as the most prominent way to acknowledge and improve LT referral equity. The LT-CARE intervention has been designed and as a part of this protocol, will be delivered to and assessed by patients and health care providers.

Recruitment for providers: Prospective Provider participants will be from among those who are a GI provider in the state of Indiana. A member of the study staff will call the prospective participant to explain the study in appropriate language.
 
Recruitment for patients: Prospective participants will be referred from their provider or will self-refer from a recruitment flier. A member of the study staff will call the prospective participant to explain the study in appropriate language. At IU Health and Eskenazi sites, prospective participants will be recruited from among those seen in clinic by a Hepatology care provider and will be contacted in person during their clinic appointment.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

The long-term goal of LT-CARE (Liver Transplant–Community Access for Referral Equity) is to develop and test a multicomponent referral intervention that addresses health system, provider, and patient-level barriers to improve equity in liver transplant referral. Building on formative work completed in Aim 1. Aims 2 (implementation) and 3 (assessment) will focus on piloting LT-CARE in real-world community gastroenterology (GI) settings and evaluating its implementation and effectiveness.
We will implement LT-CARE in five community GI practices that serve patients experiencing disparities in transplant referral, such as those located in rural areas, serving predominantly racial/ethnic minority populations, or with low waitlisting-to-death ratios. Findings will inform iterative refinements to the intervention and provide preliminary data on the effectiveness of the intervention.

LT-CARE will be implemented over 12 months and includes components delivered at the provider and patient level. Implementation strategies were informed by stakeholder input (previously completed in Aim 1) and align with Implementation Mapping and the NIMHD Health Disparities Research Framework.

Objectives:

1.    Implement and Pilot LT-CARE in Community GI Practices. 
2.    Evaluate Implementation and Preliminary Effectiveness Outcomes

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatocellular carcinoma (HCC), Liver diease, Cancer
  • Age: 18 years - 75 years
  • Gender: All

Inclusion Criteria
Patients:
•    Age between 18 and 75 years
•    Referral from one of the five participating community GI practices
•    Inpatient or outpatient
•    One of the following clinical criteria:
o    Hepatocellular carcinoma (HCC) within UCSF criteria
o    MELD 3.0 score >15 
o    Presence of two or more complications of liver disease, including:
    Ascites requiring paracentesis
    Hepatic encephalopathy (requiring lactulose)
    Jaundice with total bilirubin >3.0 mg/dL
    Esophageal variceal bleeding
 

Community GI Practice / Provider must:
•    Be one of five Indiana-based community GI practices selected for participation
•    Deliver care to patients with decompensated cirrhosis or other indications for liver transplantation, as determined by the provider
 

Exclusion Criteria
Patients will be excluded if they:
•    Are older than 75 years of age
•    Obvious medical contraindications to liver transplantation including:
o    Metastatic cancer
o    Ejection fraction less than 40%
o    BMI over 50
o    Bed bound
o    Study team will review active alcohol use for eligibility for early LT pathway. 
 

Community GI Practices / Providers will be excluded if they:
•    Do not routinely care for patients with liver disease who may be candidates for transplantation

This study investigates how to improve fairness in liver transplant referrals. The purpose is to develop and test a program called LT-CARE, which aims to address barriers faced by patients, healthcare providers, and the health system. The study will be conducted in five community gastroenterology practices that serve groups experiencing disparities, such as those in rural areas or serving minority populations.

Participants will be involved in a program over 12 months. This includes activities for both healthcare providers and patients to help understand and improve the referral process for liver transplants. The study will measure how well the program works and how it can be improved based on feedback from those involved.

  • Who can participate: Adults aged 18 to 75 who are referred from participating community GI practices can join. They must meet certain health criteria, such as having specific liver conditions. Providers must be from selected Indiana-based practices.
  • Study details: Participants will take part in activities designed to improve the liver transplant referral process. Healthcare providers and patients will work together to identify and overcome barriers. The study will use feedback to refine the program and measure how well it works.
  • Study timelines: The study will last 12 months.
Updated on 23 Dec 2025. Study ID: GI-IIR-LT-CARE-APPLIED, 28252
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only