Implementation of the Live Donor Champion Program

NCT03435510 | Completed

• 1 other identifier: IRB00161951
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

The Live Donor Champion Program is a clinical education program offered to patients placed on the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. The goal of the program is to increase patient knowledge regarding end stage renal disease, kidney transplantation, and live kidney donation and to help patients identify potential live kidney donors. Patients are encouraged to bring family and friends to participate in the program and act as advocates on their behalf. These friends and family members are labeled "live donor champions" and work to assist the patient in spreading awareness about end stage renal disease, kidney transplantation, and live kidney donation. The objectives of this project are to pilot-test and optimize strategies for the dissemination of the Live Donor Champion program in the clinical transplant center setting. The goals of the study are to develop an implementation protocol for centers who want to establish a live donor champion program at their institution.

Conditions

End-stage Renal Disease

Keywords

Live Donor Kidney Transplant; Education; Advocacy; Live Donor

Outcome Measures

Primary Outcomes (8)

• Acceptability - Implementation Outcome

  Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Acceptability will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

• Adoption - Implementation Outcome

  Adoption is defined as the intention or action to employ an innovation or practice. Adoption will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

• Appropriateness - Implementation Outcome

  Appropriateness is a qualitative measure of the perceived fit, relevance, or compatibility of the innovation for a given setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue. We will measure program appropriateness using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

• Cost - Implementation Outcome

  Cost (incremental or implementation cost) is the cost impact of an implementation effort. Implementation cost will be assessed by estimations made during observational sessions of the intervention.

  within 2 years 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 using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

• Fidelity - Implementation Outcome

  Fidelity is defined as the degree to which an intervention was implemented as prescribed in the original protocol or as it was intended by the developers. Fidelity will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

• Penetration - Implementation Outcome

  Penetration is the integration of a practice within a setting or subsystem. Penetration of the LDC program within our two sites will be measured by calculating the number of eligible persons who use a service, divided by the total number of eligible.

  within 2 years of enrollment

• Sustainability - Implementation Outcome

  Sustainability is defined as the extent to which a newly implemented treatment is maintained or institutionalized within a service setting's ongoing, stable operations. Sustainability will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.

  within 2 years of enrollment

Secondary Outcomes (4)

• Live donor kidney transplantation

  within 1 year of enrollment

• Live Donor Inquiries

  within 1 year of enrollment

• Knowledge of live donation and kidney transplantation

  within 6 months of enrollment

• Comfort initiating conversations

  within 6 months of enrollment

Study Arms (1)

Live Donor Champion

OTHER

The Live Donor Champion program is the sole educational intervention for this trial. LDC consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy 6) Program Recap.

Behavioral: Live Donor Champion Program

Interventions

Live Donor Champion Program BEHAVIORAL

Even with adequate education of live donation, many KT 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 substantial instrumental support. An 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 a 6-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental 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.

Also known as: LDC Program

Live Donor Champion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
• If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
• Participants at University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.

You may not qualify if:

• Candidates with live donors currently under evaluation for donation will be excluded.
• Those with a previous kidney transplant will be excluded
• aged≥18
• English-speaking
• Be a "Live Donor Champion" (a friend, family member or community member willing to advocate for the wait-listed patient).
• \<18, not English-speaking
• aged≥18
• English-speaking
• Performed tasks related to implementing the LDC program
• \<18, not English-speaking, and no affiliation with implementing the LDC program

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth King, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 19, 2018
• Study Start: May 30, 2018
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)