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

描述（由申请人提供）：虽然肾移植是终末期肾病（ESRD）成人的最佳治疗选择，但严重的种族和社会经济差异仍然存在。例如，少数民族和低收入患者不太可能接受lve供体肾移植（LDKT），这可以带来更好的生存率，生活质量和医疗保健 比慢性透析或死亡供体移植的成本结果。在LDKT的社会生态模型的指导下，PI开发了一种创新的家访干预措施，该干预措施已被证明在克服障碍和提高黑人患者的LDKT率方面有效。我们现在寻求通过包括其他少数民族和社会经济上处于不利地位的患者，并通过增加一个新的以患者为中心的决策支持组件，扩大上门服务干预的范围和强度。此外，很少有人知道这些变量介导的干预措施的影响，发生LDKT或干预措施是否可以减轻日益增长的性别差距，在活体捐赠。在这项研究中，我们将追求三个具体目标： (1)评估在上门服务干预中增加以患者为中心的决策支持组件的差异效益;（2）确定干预与LDKT发生之间关系的中介;（3）检查上门服务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，我们将进行一项单中心随机对照试验，计划招募100名等待肾移植的少数民族和低收入患者。患者将随机接受单独出诊干预（HC）或出诊干预+基于网络的以患者为中心的决策支持干预（HC+DS）。中心假设是，与HC单独治疗相比，HC+DS组在2年研究终点（主要结局）时LDKT的入组患者比例更高，并且至少有一次活体供体询问、至少有一次活体供体评价和处于LDKT行动（与预期）阶段（次要结局）的入组患者比例更高。此外，我们将评估上门拜访干预（单独HC或HC+DS）是否导致更多的男性捐赠者询问、评估和实际捐赠，相对于非干预对照组，控制患者种族/民族、性别、年龄和家庭收入。通过为历史上LDKT率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，减少疾病负担，并通过生产更多的供体器官用于移植来降低死亡率。由于研究团队的多学科性质，以及团队在开发LDKT和活体捐赠教育材料，实施和评估家访干预，与少数民族和社会经济弱势患者进行LDKT研究方面的专业知识和经验，我们特别准备好进行拟议的研究，并产生有意义的科学和临床成果。 公共卫生相关性：某些少数民族和低收入患者不成比例地受到慢性肾脏疾病的影响。虽然肾移植提供了长期存活和降低发病率的最佳选择，但少数群体和社会经济弱势群体等待肾移植的时间更长，他们接受活体肾移植的可能性要小得多。虽然教育工作有助于提高对LDKT的必要性和益处的认识，但很少有人尝试系统地研究在少数民族和低收入患者中增加LDKT的策略。拟议的研究是创新的，因为它进一步评估了唯一的医疗支持的干预措施之一，以减少LDKT种族差异的相对有效性。具体 将扩大干预的范围，包括更多的少数群体，低收入患者和一个新的以患者为中心的决策支持组件。这项研究的结果有可能通过确定有效的教育和干预措施来缩小健康差距。 肾移植中心可用于增加少数民族和低收入患者的LDKT的策略。

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. PUBLIC HEALTH RELEVANCE: Certain minorities and low-income patients are disproportionately affected by chronic kidney disease. While kidney transplantation offers the best option for long-term survival and reduced morbidity, minorities and the socioeconomically disadvantaged wait longer for kidney transplantation and they are far less likely to receive live donor kidney transplantation (LDKT). While educational efforts have helped to expand awareness about the need for and benefits of LDKT, there have been very few attempts to systematically examine strategies for increasing LDKT in minority and low-income patients. The proposed research is innovative because it further evaluates the relative effectiveness of one of the only empirically-supported interventions to reduce racial disparities in LDKT. Specifically, it will expand the reach of the intervention to include more minority groups, low-income patients, and a novel patient-centered decision support component. Findings from this study have the potential to close the health disparity gap by identifying effective educational and interventional strategies that can be used by kidney transplant centers to increase LDKT in minority and low-income patients.