Pilot Study of the Liver Live Donor Champion Program

Study Overview
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Brief Summary
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In this pilot study, investigators plan to enroll liver transplant candidates and a Live Donor Champion for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.

Detailed Description
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In the United States, more than 13,000 patients are on the waiting list to receive a liver transplant. Although more than 6,000 liver transplants are performed every year, at least 1,700 patients die each year while on the waiting list. Livers are allocated to patients based on how sick the participants are, with sicker patients receiving priority. Living donation offers patients the option of transplant before patients get very sick, significantly decreasing the time patients wait for a liver. Livers from living donors are usually of excellent quality because donors are evaluated extensively and only allowed to donate if patients are in very good health. Living donation not only saves the life of the liver transplant candidate but also frees up a liver for a patient on the waiting list who does not have that option. A number of studies have attempted to understand barriers to finding a living donor. Multiple surveys have suggested that the educational needs are not met for both transplant candidates and potential donors. Furthermore, lack of knowledge and understanding of the consequences of donation may aggravate candidate fear of donor risks, contributing to candidate reluctance in allowing friends or family to donate. Finally, having an inadequate communication skill set in how to ask someone to donate is one of the most prevalent barriers reported by transplant candidates. A Live Donor Champion (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in participants' pursuit of living donation. Investigators' center has previously developed a six-month program that provides education and advocacy training to kidney transplant candidates and participants' LDCs; however, no program currently exists for liver transplant candidates. The instrumental support provided by the LDC from investigators' kidney program bridges a critical link between education and action. In pilot studies, candidates with an LDC were more likely to undergo live donor kidney transplantation than matched controls. In this pilot study, investigators plan to enroll liver transplant candidates and participants' LDCs for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.

Official Title
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Pilot Study of the Liver Live Donor Champion Program

Conditions
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End Stage Liver Disease

Intervention / Treatment
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* Behavioral: Liver Live Donor Champion Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active candidate on the liver transplant waitlist. Have no potential living donors at the time of study enrollment. Have not had a previous transplant be 18 years or older be English speaking Mentally capable of providing informed consent Exclusion Criteria: Age less than 18 years old Has potential live donor candidates non-English speaking Previous liver transplant Listed for multiple organs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver Live Donor Champion<br>The Liver Live Donor Champion program (LLDC) is the sole educational intervention for this trial. LLDC consists of 2 or 3 monthly sessions (depending on cohort) of approximately 2 or 3 hours each. Each LLDC session is led by a transplant physician or clinical coordinator. The sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LLDC session topics are as follows: 1) education about End-Stage Liver Disease (ESLD), liver transplantation, and living donation 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) surgeon and hepatologist panel 6) Program Recap. | Behavioral: Liver Live Donor Champion Program<br>* Even with adequate education of live donation, many liver transplant candidates still feel ill equipped to ask others to consider donating. Friends and family are often eager to help and may not be able to serve as donors themselves, but might be able to provide instrumental support. A Live Donor Champion (LDC) is a friend or family member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed the Liver Live Donor Champion program to provide education and advocacy training to waitlist candidates and their LDCs. The support provided by the LDC bridges a critical link between education and action. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm.<br>* Other names: LLDC program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Donor Inquiries | Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical system. | within 2 year of enrollment | 
| Live Donor Liver Transplantation | Live Donor Liver Transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system. | within 2 year of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of live donation and liver transplantation | Knowledge of live donation and liver transplantation will be collected during participant surveys. | within 6 months of enrollment | 
| Comfort initiating conversations | Comfort initiating conversations with others about live donation will be collected during participant surveys. | within 6 months of enrollment | 
| Feasibility - Implementation Outcome | Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Feasibility will be assessed qualitatively by recording reflections of the implementing study team. | within 2 year of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Live Donor Liver Transplant, Education, Advocacy, Live Donor Champion