Development of a Robust Strategy for Living Kidney Donor Follow-up and Engagement

制定活体肾脏捐赠者随访和参与的稳健策略

基本信息

批准号：
10426492
负责人：
Macey Leigh Levan
金额：
$ 12.71万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10426492
关键词：
Altruism Awareness Characteristics Collection Consensus Country Data Databases Development Dimensions Donor person Electronic Mail Ethics Failure Foundations Future Goals Health Status Health system Healthcare Systems Hypertension Individual Informed Consent Infrastructure Intake Interview Investigation Kidney Kidney Transplantation Lead Leadership Living Donors Living Standards Medical Methods Patients Physiological Policies Process Reach Effectiveness Adoption Implementation and Maintenance Readiness Research Proposals Resources Risk Surveys System Time TimeLine Training Transplant Recipients Transplantation Work adverse outcome base cohort comparison group data exchange design follow-up formative assessment implementation barriers implementation evaluation implementation framework implementation strategy improved interest living kidney donor meetings member operation patient engagement programs success transplant centers transplant registry

项目摘要

Project Summary: Developing a Robust Strategy for Living Donor Follow-up and Engagement There are more than 150,00 living kidney donors in the US, and the number of new donors is increasing yearly. Understanding the risks and sequelae of donation is a practical requirement for expanding live donor kidney transplantation and an ethical requirement for supporting informed consent and honoring an altruistic act. This requires the collection of granular follow-up data in donors, and a comparison to healthy non-donors. To date, national efforts at kidney donor follow-up and long-term engagement have failed. As a living kidney donor myself, I am intimately aware of the profound and systemic failures in post-donation surveillance from both the donor-level and the health system-level. In 2013 a national policy mandating transplant centers meet standards for living donor follow-up was implemented, yet this policy has proven nearly impossible for transplant centers, with fewer than 50% successful in meeting the mandate. Continued engagement with transplant centers not only allows a better scientific understanding of the implications of donation, but also allows careful surveillance of donors to identify early physiologic changes (such as hypertension) and intervene before these become major adverse outcomes. Furthermore, a proper healthy non-donor cohort has never been successfully captured and studied. To improve this ongoing failure, in 2017 we launched a pilot Living Donor Collective (LDC) at 10 kidney transplant centers, centralized though the Scientific Registry of Transplant Recipients (SRTR). In an effort to improve living donor follow-up in a systematic, scientific manner that can be disseminated to centers across the country, we will take the important first steps of evaluating how the 10 pilot transplant centers and the SRTR implemented the LDC and use this information to plan the next iteration of this important endeavor. Since only 10 centers participated in the pilot, out of 273 transplant centers in the US, it is critical to understand barriers to implementation across a wide spectrum of transplant center characteristics. Guided by an implementation science framework and a mixed methods approach, we aim: (1) to understand LDC implementation among pilot centers and SRTR, (2) conduct a formative evaluation and assess transplant center readiness and capacity for participation in the LDC across the US, and (3) create an implementation strategy to refine and expand the LDC. This study will provide a comprehensive understanding of implementation challenges, successes, and failures of a centralized program for living donor follow-up. This provides the foundation for all U.S. transplant centers to participate, solves a historically unsolvable and embarrassing health system challenge, and is necessary to prepare a future R01 to develop and implement centralized living donor follow-up nationally.

项目摘要：为活体捐赠者的后续和参与制定强有力的策略美国有超过15万名活体肾脏捐献者，并且新捐献者的数量每年都在增加。了解捐献的风险和后遗症是扩大活体供肾的现实要求移植以及支持知情同意和尊重利他行为的道德要求。这需要收集捐赠者的详细随访数据，并与健康的非捐赠者进行比较。迄今为止，国家在肾脏捐赠者后续行动和长期参与方面的努力失败了。作为一个活肾作为捐赠者本人，我非常清楚捐赠后监测方面存在深刻的系统性失败捐助者层面和卫生系统层面。 2013年国家政策强制移植中心召开活体捐献者后续标准已经实施，但事实证明，这一政策对于移植中心，只有不到 50% 成功完成任务。与移植中心的持续接触不仅可以更好地科学理解移植中心捐赠的影响，但也允许仔细监测捐赠者以确定早期的生理变化（如高血压）并在这些成为主要不良后果之前进行干预。此外，适当的健康的非捐赠者队列从未被成功捕获和研究。为了改善这一持续由于失败，我们于 2017 年在 10 个肾移植中心启动了活体捐赠者集体 (LDC) 试点，通过移植受者科学登记处 (SRTR) 进行集中管理。努力以系统、科学的方式改善活体捐献者的后续工作，并将其传播给在全国各地的中心，我们将采取重要的第一步，评估 10 个试点移植的情况中心和 SRTR 实施了 LDC，并使用此信息来规划这一重要的下一次迭代努力。由于美国 273 个移植中心中只有 10 个中心参与了试点，因此至关重要了解各种移植中心特征的实施障碍。指导者一个实施科学框架和混合方法方法，我们的目标是：（1）了解 LDC 在试点中心和 SRTR 之间实施，(2) 进行形成性评价和评估移植中心参与全美最不发达国家 (LDC) 的准备情况和能力，以及 (3) 制定实施方案完善和扩大最不发达国家的战略。这项研究将提供对实施挑战、成功和失败的全面了解活体捐赠者后续集中计划的制定。这为所有美国移植中心奠定了基础参与，解决历史上无法解决且令人尴尬的卫生系统挑战，并且有必要准备未来的 R01，以在全国范围内制定和实施集中的活体捐赠者后续行动。