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Implementation of the Live Donor Champion Program (LDC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435510
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
End-stage Renal Disease Behavioral: Live Donor Champion Program Not Applicable

Detailed Description:

Live Donor Champion Concept: Even with adequate education of live donation, many kidney 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 substantial instrumental support. A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed a six-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. In pilot studies, candidates with an LDC were more likely to undergo Live Donor Kidney Transplant (LDKT) than matched controls. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm, including support from United Network for Organ Sharing.

Live Donor Champions (LDCs) as Instrumental Support for Transplant Candidates. Approaching potential donors is a daunting and overwhelming experience for Kidney Transplant (KT) candidates. Current educational programs address the medical aspects of dialysis, KT, and donation, but neglect the health communication skills to discuss transplantation and to spread awareness through their various social networks. While transplant candidates are hesitant to engage others in conversations about End Stage Renal Disease (ESRD) and live donation, friends, family members, or community members are eager to spread awareness and provide advocacy for the patient. In pilot studies, this intervention improved knowledge regarding LDKT and provided instrumental support to the transplant candidates. Understanding what factors are associated with the successful implementation of this program will enable its eventual dissemination at transplant centers nationwide ultimately improving nationwide education and awareness of LDKT. In order to successfully do so, a scientifically rigorous implementation study is necessary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implementation of the Live Donor Champion Program
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Live Donor Champion
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
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.
Other Name: LDC Program




Primary Outcome Measures :
  1. Acceptability - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  2. Adoption - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  3. Appropriateness - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  4. Cost - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  5. Feasibility - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  6. Fidelity - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  7. Penetration - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.

  8. Sustainability - Implementation Outcome [ Time Frame: within 2 years of enrollment ]
    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.


Secondary Outcome Measures :
  1. Live donor kidney transplantation [ Time Frame: within 1 year of enrollment ]
    Live donor kidney transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system.

  2. Live Donor Inquiries [ Time Frame: within 1 year of enrollment ]
    Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical record system.

  3. Knowledge of live donation and kidney transplantation [ Time Frame: within 6 months of enrollment ]
    Knowledge of live donation of transplant candidates will be collected during the survey.

  4. Comfort initiating conversations [ Time Frame: within 6 months of enrollment ]
    Comfort initiating conversations with others about live donation will be collected during the survey.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Waitlist Candidates

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Candidates with live donors currently under evaluation for donation will be excluded.
  • Those with a previous kidney transplant will be excluded

Live Donor Champions Inclusion Criteria

  • aged≥18
  • English-speaking
  • Be a "Live Donor Champion" (a friend, family member or community member willing to advocate for the wait-listed patient).

Exclusion Criteria

  • <18, not English-speaking

LDC Administrators Inclusion Criteria

  • aged≥18
  • English-speaking
  • Performed tasks related to implementing the LDC program

Exclusion Criteria

  • <18, not English-speaking, and no affiliation with implementing the LDC program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435510


Locations
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United States, Missouri
Washington University in Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jacqueline M Garonzik Wang, MD PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03435510    
Other Study ID Numbers: IRB00157440
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Live Donor Kidney Transplant
Education
Advocacy
Live Donor
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency