Live Donor Champion Program for Liver Disease

(LLDC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Age less than 18, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals awaiting a liver transplant by teaching them and a supporter how to identify potential live donors. Participants will attend sessions on key topics such as living liver donation, communication skills, and success stories. The goal is to evaluate the effectiveness of the "Live Donor Champion" program in expanding access to live donor liver transplants. Suitable candidates for this trial include those currently on the liver transplant waitlist without potential living donors and who have not undergone a previous transplant. As an unphased trial, this study provides a unique opportunity to acquire skills that could significantly enhance the chances of finding a live donor.

Do I need to stop my current medications for this trial?

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 Liver Live Donor Champion Program is safe?

Research has shown that living donor programs, such as the Liver Live Donor Champion Program, are generally safe. These programs involve surgeries with risks like bleeding, infections, or allergic reactions to anesthesia. However, these risks are similar to those of other surgeries and are usually manageable. More research is needed to fully assess the safety of living donor programs. So far, participants in similar situations have generally tolerated them well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Liver Live Donor Champion Program because it offers a fresh approach to educating and empowering potential liver donors. Unlike traditional methods that focus mainly on medical aspects and logistics, this program actively involves participants through interactive sessions that include storytelling, group discussions, and role-playing. By building communication skills and exploring social networks, the program aims to make the donor process more accessible and less intimidating, potentially increasing the number of successful living liver donations.

What evidence suggests that the Liver Live Donor Champion Program is effective for expanding access to live donor liver transplantation?

Research has shown that the Liver Live Donor Champion Program, the only educational intervention in this trial, can significantly improve the chances of finding a living donor. Studies indicate that 56.7% of participants in similar programs identified at least one potential living donor, more than four times the previous rate. The program provides education about severe liver disease, teaches communication skills, and shares real-life success stories. It aims to empower participants by enhancing their knowledge and social connections to aid in finding a donor. These findings suggest that the program could effectively increase access to living donor liver transplants. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth A King, MD PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English, are mentally able to consent, and are on the liver transplant waitlist without any current living donors. It's not for those under 18, non-English speakers, anyone with potential live donors already identified, or patients who have had a previous liver transplant or need multiple organs.

Inclusion Criteria

I am on the waiting list for a liver transplant.

Be English speaking

I am mentally capable of understanding and agreeing to the trial's procedures.

Exclusion Criteria

I have had a liver transplant.

I am on the waiting list for multiple organ transplants.

Has potential live donor candidates

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Advocacy Training

Participants and their Live Donor Champions receive education and advocacy training through the Liver Live Donor Champion program, consisting of 2 or 3 monthly sessions.

2-3 months

2 or 3 sessions (in-person)

Follow-up

Participants are monitored for live donor inquiries and transplantation outcomes, as well as knowledge and comfort with live donation.

6 months

Long-term Follow-up

Participants are monitored for live donor inquiries and transplantation outcomes over a longer period.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Liver Live Donor Champion Program

Trial Overview The study tests an educational and advocacy program called the Liver Live Donor Champion Program. This pilot will evaluate two versions of the program to see how well they help expand access to live donor liver transplants by training 'Live Donor Champions' alongside transplant candidates.

How Is the Trial Designed?

Group I: Liver Live Donor Champion Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Living donor liver transplantation (LDLT) significantly reduces waitlist mortality and offers excellent long-term outcomes for patients with end-stage liver disease, yet its use in the US remains limited.

A consensus conference identified cultural beliefs and behaviors as major barriers to expanding LDLT, emphasizing the need for education and engagement to shift perceptions and promote LDLT as the preferred option for liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living donor liver transplantation: A multi-disciplinary collaboration towards growth, consensus, and a change in culture. Liapakis, A., Jesse, MT., Pillai, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03580629

Pilot Study of the Liver Live Donor Champion Program ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257956/

Living-Donor Liver Transplantation in the United States There were acceptable outcomes (88-89% one-year graft survival) observed at an average preceding frequency of 3 to 20 LDLTs per year. While ...

3. uwmedicine.org uwmedicine.org/specialties/transplant/living-donor-liver-transplant/donor-champion-toolkit

Living Liver Donor Champion We developed this toolkit to teach living liver donor champions about living liver donation and to provide guidance to living donor champions on how to ...

4. atcmeetingabstracts.com atcmeetingabstracts.com/abstract/live-donor-champion-program-time-to-redefine-living-liver-donation/

Live Donor Champion Program: Time to Redefine Living ... Data shows that 56.7 % of LDC participant identified at least one potential living donor, which represents an increase of more than 4 fold (or 474%) the number ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37635282/

Living Donor Liver Transplantation for Adults With High Model ... Outcomes after living-donor liver transplantation (LDLT) at high Model for End-stage Liver Disease (MELD) scores are not well characterized in the United ...

6. upmc.com upmc.com/services/transplant/liver/living-donor/benefits-risks

Living-Donor Liver Transplant Benefits and Risks What Are the Risks for Living Donors? · Bile leakage — this occurs in a small subset of living-liver donors and most often resolves itself. · Infection — some ...

7. hopkinsmedicine.org hopkinsmedicine.org/transplant/programs/liver/living-donor-liver-transplant/what-to-expect

What to Expect as a Liver Donor Risks Associated with Liver Donation · Possible allergic reaction to anesthesia · Pain and discomfort · Nausea · Wound infection · Bleeding that may require ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10653593/

Current status and challenges of living donor liver ... Living donor champion programs, where recipients are paired with an advocate ... Prospective studies on safety are needed to guide donor risk assessment.

9. liverfoundation.org liverfoundation.org/liver-diseases/treatment/living-donor-liver-transplant-information-center/a-donors-guide-to-living-donor-liver-transplant/

Living Donor Liver Transplant: Benefits & Risks Allergic reaction to anesthesia · Injury to tissue or other organs · Infection · Blood clots · Bleeding · Pneumonia · Death (in rare cases).

10. uchealth.com uchealth.com/en/treatments-and-procedures/living-liver-donation

Living Liver Donor | UC Health Transplant While living liver donation is generally safe, potential risks include: Surgical Complications: As with any surgery, there are risks such as bleeding, infection ...