House Calls and Decision Support: Increasing Access to Live Donor Transplantation

描述(由申请人提供)：虽然肾移植是成人终末期肾病(ESRD)的最佳治疗选择，但严重的种族和社会经济差异仍然存在。例如，少数族裔和低收入患者不太可能接受左肾移植(LDKT)，这会带来更好的存活率、生活质量和医疗保健。 与慢性透析或已故供者移植相比，成本结果更高。在LDKT的社会生态模型的指导下，PI开发了一种创新的出诊干预措施，已证明在克服障碍和提高黑人患者LDKT发生率方面有效。我们现在寻求通过包括其他少数族裔和社会经济弱势患者以及通过增加以患者为中心的新的决策支持部分来扩大出诊干预的覆盖范围和强度。此外，人们对干预措施对LDKT发生的影响以及干预措施是否能够缓解活体捐献中日益扩大的性别差距的影响的变量知之甚少。在这项研究中，我们将追求三个具体目标： (1)评估在House Calls干预中增加以患者为中心的决策支持部分的不同益处；(2)确定干预措施与LDKT发生之间的关系的调解人；以及(3)检查House Calls干预是否减少了活体肾脏捐赠率的性别差异。为了实现这些目标，我们将进行一项单一地点的随机对照试验，计划招募100名等待肾移植的少数族裔和低收入患者。患者将被随机分为单独接受出诊干预(HC)或出诊干预+以患者为中心的网络决策支持干预(HC+DS)。中心假设是，与单纯HC相比，HC+DS组在2年研究终点(主要结果)时将有更高比例的LDKT登记患者，并且登记的患者中至少有一次活体捐赠者询问、至少一次活体捐赠者评估以及处于LDKT行动(与考虑)阶段(次要结果)的患者比例更高。此外，我们将评估众议院呼叫干预(单独使用HC或HC+DS)是否会导致更多的捐赠者询问、评估和来自男性的实际捐赠，相对于不干预的控制组，控制患者的种族/民族、性别、年龄和家庭收入。通过为LDKT发生率历来较低的患者群体确定有效的干预措施，我们可以消除许多获取障碍，通过生产更多供移植的供体器官来减少疾病负担和降低死亡率。由于研究团队的多学科性质，以及团队在开发LDKT和活体捐赠教材、实施和评估House Call干预措施、对少数族裔和社会经济弱势患者进行LDKT研究以及产生有意义的科学和临床结果方面的专业知识和经验，我们特别为开展拟议的研究做好了充分准备。

DESCRIPTION (provided by applicant): While kidney transplantation is the best treatment option for adults with end-stage renal disease (ESRD), profound racial and socioeconomic disparities persist. Minorities and low-income patients, for instance, are less likely to receive lve donor kidney transplantation (LDKT), which yields better survival, quality of life, and health care cost outcomes than chronic dialysis or deceased donor transplantation. Guided by a socio- ecological model of LDKT, the PI developed an innovative House Calls intervention that has shown to be effective at overcoming barriers and increasing LDKT rates in Black patients. We now seek to expand the reach and intensity of the House Calls intervention by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. Also, little is known about those variables that mediate the intervention's impact on the occurrence of LDKT or whether the intervention can attenuate the growing gender disparity in living donation. In this study, we will pursue three specific aims: (1) evaluate the differential benefit of adding a patient-centered decision support component to the House Calls intervention; (2) identify mediators of the relationship between the interventions and the occurrence of LDKT; and (3) examine whether the House Calls intervention reduces the gender disparity in rates of living kidney donation. To accomplish these aims, we will conduct a single-site, randomized controlled trial with a planned enrollment of 100 minority and low income patients awaiting kidney transplantation. Patients will be randomized to receive the House Calls intervention alone (HC) or the House Calls intervention + a web-based Patient-Centered Decision Support intervention (HC+DS). The central hypothesis is that, compared to HC alone, the HC+DS group will have a higher proportion of enrolled patients with LDKT by the 2-yr study endpoint (primary outcome) and higher proportions of enrolled patients with at least one live donor inquiry, at least one live donor evaluation, and in LDKT action (vs. contemplation) stages (secondary outcomes). Also, we will evaluate whether the House Calls intervention (either HC alone or HC+DS) leads to more donor inquiries, evaluations, and actual donations from men, relative to a non-intervention control group, controlling for patient race/ethnicity, gender, age, and household income. By identifying effective interventions for patient populations with historically lower rates of LDKT, we can eliminate many barriers to access, reduce disease burden, and lower mortality rates by producing more donor organs for transplantation. We are especially well-prepared to conduct the proposed research due to the multidisciplinary nature of the research team, as well as the expertise and experience of the team in developing LDKT and living donation educational materials, implementing and evaluating the House Calls intervention, conducting LDKT research with minorities and socioeconomically disadvantaged patients, and producing meaningful scientific and clinical outcomes.