Clinical trial NCT03580629: Pilot Study of the Liver Live Donor Champion Program
Official title: Pilot Study of the Liver Live Donor Champion Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End Stage Liver Disease
Keywords: Live Donor Liver Transplant
Education
Advocacy
Live Donor Champion
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Live Donor Inquiries
timeFrame: within 2 year of enrollment
measure: Live Donor Liver Transplantation
timeFrame: within 2 year of enrollment
Secondary outcomes:
measure: Knowledge of live donation and liver transplantation
timeFrame: within 6 months of enrollment
measure: Comfort initiating conversations
timeFrame: within 6 months of enrollment
measure: Feasibility - Implementation Outcome
timeFrame: within 2 year of enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elizabeth A King, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: