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Pilot Study of the Liver Live Donor Champion Program (LLDC)

Primary Purpose

End Stage Liver Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liver Live Donor Champion Program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Liver Disease focused on measuring Live Donor Liver Transplant, Education, Advocacy, Live Donor Champion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver Live Donor Champion

Arm Description

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.

Outcomes

Primary Outcome Measures

Live Donor Inquiries
Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical system.
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.

Secondary Outcome Measures

Knowledge of live donation and liver transplantation
Knowledge of live donation and liver transplantation will be collected during participant surveys.
Comfort initiating conversations
Comfort initiating conversations with others about live donation will be collected during participant surveys.
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.

Full Information

First Posted
June 26, 2018
Last Updated
August 8, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03580629
Brief Title
Pilot Study of the Liver Live Donor Champion Program
Acronym
LLDC
Official Title
Pilot Study of the Liver Live Donor Champion Program
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
Keywords
Live Donor Liver Transplant, Education, Advocacy, Live Donor Champion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver Live Donor Champion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Liver Live Donor Champion Program
Other Intervention Name(s)
LLDC program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live Donor Inquiries
Description
Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical system.
Time Frame
within 2 year of enrollment
Title
Live Donor Liver Transplantation
Description
Live Donor Liver Transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system.
Time Frame
within 2 year of enrollment
Secondary Outcome Measure Information:
Title
Knowledge of live donation and liver transplantation
Description
Knowledge of live donation and liver transplantation will be collected during participant surveys.
Time Frame
within 6 months of enrollment
Title
Comfort initiating conversations
Description
Comfort initiating conversations with others about live donation will be collected during participant surveys.
Time Frame
within 6 months of enrollment
Title
Feasibility - Implementation Outcome
Description
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.
Time Frame
within 2 year of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A King, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of the Liver Live Donor Champion Program

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