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

出诊和决策支持：增加活体捐赠者移植的机会

• 批准号: 8500744
• 负责人: James R Rodrigue
• 金额: $ 29.9万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-24 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8500744
• 关键词: Activities of Daily Living; Acute; Adult; Affect; Age; Attenuated; Awareness; Cessation of life; Chronic; Chronic Kidney Failure; Clinic; Clinical; Control Groups; Decision Making; Dialysis procedure; Disadvantaged; Discrimination; Education; Educational Materials; Effectiveness; End stage renal failure; Enrollment; Ethnic Origin; Evaluation; Exposure to; Facilities and Administrative Costs; Failure; Feedback; Gender; Health Care Costs; Health Educators; Healthcare; Hispanics; Home environment; House Call; Household; Income; Intervention; Kidney; Kidney Transplantation; Knowledge; Life; Living Donors; Low Income Population; Low income; Mediating; Mediator of activation protein; Minority; Minority Groups; Modeling; Morbidity - disease rate; Nature; Online Systems; Organ Transplantation; Outcome; Participant; Patients; Quality of life; Race; Randomized; Randomized Controlled Trials; Readiness; Relative (related person); Research; Sampling; Self Efficacy; Site; Social Network; Staging; Study Section; Survival Rate; Time; Transplantation; United States; Woman; base; burden of illness; effective intervention; experience; functional status; health disparity; improved; innovation; male; member; men; mortality; multidisciplinary; novel; patient oriented; patient population; peer; primary outcome; programs; secondary outcome; socioeconomics; success; therapy design; willingness

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.

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，但深刻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接受活体肾移植 (LDKT) 的可能性较小，而活体肾移植可带来更好的生存率、生活质量和医疗保健 比慢性透析或死者供体移植的成本结果。在 LDKT 社会生态模型的指导下，PI 开发了一种创新的上门干预措施，该干预措施已被证明可以有效克服障碍并提高黑人患者的 LDKT 率。我们现在寻求扩大出诊干预的范围和强度，包括其他少数族裔和社会经济弱势患者，并添加新的以患者为中心的决策支持部分。此外，对于那些调节干预措施对 LDKT 发生影响的变量，或者干预措施是否可以减弱活体捐赠中日益扩大的性别差异，人们知之甚少。在这项研究中，我们将追求三个具体目标： (1) 评估在出诊干预中添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发生之间关系的中介因素； (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。患者将被随机分配接受单独上门干预 (HC) 或上门干预 + 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，与单独的 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 入组患者，并且至少进行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）的入组患者比例更高。此外，我们将评估相对于非干预对照组，在控制患者种族/民族、性别、年龄和家庭收入的情况下，出诊干预（单独 HC 或 HC+DS）是否会导致更多的捐赠者询问、评估和男性的实际捐赠。通过为历来 LDKT 发生率较低的患者群体确定有效的干预措施，我们可以通过生产更多的供移植器官来消除许多获取障碍，减轻疾病负担并降低死亡率。由于研究团队的多学科性质，以及该团队在开发 LDKT 和活体捐赠教育材料、实施和评估上门干预、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，我们为开展拟议的研究做好了充分的准备。 公共卫生相关性：某些少数族裔和低收入患者受慢性肾脏病的影响尤为严重。虽然肾移植提供了长期生存和降低发病率的最佳选择，但少数族裔和社会经济弱势群体等待肾移植的时间更长，而且他们接受活体肾移植（LDKT）的可能性要小得多。虽然教育工作有助于提高人们对 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族裔和低收入患者中增加 LDKT 的策略。拟议的研究具有创新性，因为它进一步评估了唯一有经验支持的干预措施之一的相对有效性，以减少 LDKT 的种族差异。具体来说，它 将扩大干预的范围，以包括更多的少数群体、低收入患者和以患者为中心的新型决策支持部分。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 肾移植中心可采用的策略来增加少数族裔和低收入患者的 LDKT。