Transforming Curiosity Into Donation: Validating a Risk Prediction Index to Detect and Prevent Drop-Out in Potential Living Kidney Donors Who Are Racial/Ethnic Minorities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduce Risk of Drop-Out
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential living kidney donor flagged as higher risk for drop-out
- •Previous living kidney donors.
排除标准
- •Ruled out from donating by a transplant center
- •High (≥ 35) or low (≤ 18) body mass index (BMI)
- •High blood pressure
- •Concern for undiagnosed kidney disease
- •Age ≤ 18 years
研究组 & 干预措施
Potential Living Kidney Donors
干预措施: Living Kidney Donor Support (Behavioral)
Pre-Donation Experience
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.
Index Validation
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.
结局指标
主要结局
Reduce Risk of Drop-Out
时间窗: From initial donor evaluation through the following six months
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.
次要结局
未报告次要终点