An observational study in Kidney Transplant, Kidney Donor and Drop Out, sponsored by The Methodist Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by The Methodist Hospital Research Institute · Observational
This is a multi-step study that will first create a preliminary living donor drop-out risk index (LD-DROP) by retrospectively identifying factors that contribute to the discontinuation of living donor evaluation. Investigators will then validate the LD-DROP index by prospectively tracking the progress of a large group of individuals presenting for living kidney donor evaluation.
In parallel, investigators will conduct focus groups with previous donors and individual qualitative interviews with potential living donors who vary by race, gender, and level of risk for drop-out, to explore barriers affecting their donation decision-making, and the most helpful interventions for overcoming these barriers.
Finally, using data gathered from the LD-DROP index and individual interviews, investigators will pilot an intervention with potential donors identified to be at a modifiable high risk of drop-out.
To reduce disparities in living donation and increase living kidney donor transplant (LKDT), investigators propose to:
Aim 1a: Retrospectively identify clinical factors, social determinants of health, and other modifiable factors that are correlated with discontinuation of the donor candidate's evaluation to develop a living donor drop-out risk prediction index, LD-DROP. Subgroup analyses will examine issues specific to racial and ethnic minorities and potential donors of lower socioeconomic status (SES) independently to determine if socioeconomic factors differentially impact donation in minority populations.
Aim 1b: Prospectively validate the LD-DROP index for predicting drop-out during evaluation. Potential donors (n=2000) who initiate referral in the respective electronic medical record will be followed for a 2-year period after initiation to assess final donation outcomes.
Aim 2: Conduct community-engaged research with previous donors (n=12) from the NKF PEERS mentoring program, and potential donors (n=100) from Houston Methodist Hospital Transplant Center (HMH-TC) and Cooperman Barnabas Transplant Center (CB-TC) to better understand how to support potential living donors at high risk for drop-out during evaluation who are Black, Hispanic, have lower SES, and/or are entering the evaluation process at varying levels of readiness.
Aim 3: Pilot an intervention with potential donors (n=73) from HMH-TC and the NKF PEERS mentoring program to support potential donors identified as being at high risk of dropping out from evaluation.
The study population will be recruited from Houston Methodist Hospital, Cooperman Barnabas Medical Center, and the National Kidney Foundation (NKF) network.
Exclusion Criteria:
Behavioral: Living Kidney Donor Support
Investigators will develop and pilot an interview guide with living donors and conduct a mixed methods pre-donation experience study with previous donors and potential living donors to better understand barriers affecting potential donors' decision-making, and what types of support from transplant providers and peer supporters could be most beneficial.
Investigators will follow potential donors who initiate referral in the respective electronic medical record for a 2-year period after initiation of evaluation and evaluate final donation outcomes at the conclusion of that time. Each potential donor will be categorized by their ultimate donation outcome (i.e., donor outcome pending, successfully donated, donor discontinuation, medical/surgical contraindication to donation, recipient reason for non-donation) and compared across risk category (low-, moderate-, or high-risk) as designated by the LD-DROP index.
This intervention is a relational, educational support pilot designed to improve the living donor evaluation experience. It is delivered by educators and conducted primarily by telephone or video conferencing over a six-month period. Potential donors are offered optional monthly touchpoints focused on supporting informed and values aligned decision making, regardless of whether they choose to proceed with donation. During each interaction, educators assess donor experience and readiness, document changes over time, respond to questions and concerns, and provide information about available resources to reduce stress and donor associated financial burden. Participants also receive monthly emailed video digital stories from the Living Donor Storytelling program and are offered the opportunity to connect with a National Kidney Foundation peer mentor. Educators document participant engagement, questions raised, and responses to the supports offered across all touchpoints.
Reduce Risk of Drop-Out
As a pilot study, participants will not be randomized. Investigators will measure the proportion of potential living kidney donors who remain eligible donor candidates six months after initial donation request. This observed proportion will be compared with an estimated proportion based on LD-DROP (Living Donor Drop-Out Index, derived from patient-reported characteristics and beliefs). For each participant, an expected risk adjusted probability of donor drop-out will be calculated using the LD-DROP score. The observed drop-out rate at six months will be compared with this score to generate an observed to expected ratio. The pilot will be considered successful if the observed dropout rate is at least 25% lower than expected. Time to donor drop out will also be summarized using Kaplan Meier curves that display the proportion of donors remaining active candidates over the six month follow up period.
Time frame: From initial donor evaluation through the following six months
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The Methodist Hospital Research Institute