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

• 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
• 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

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：制定活体捐献者后续行动和参与的稳健战略 美国有超过15万名活体肾脏捐赠者，新捐赠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 移植和支持知情同意和尊重利他行为的道德要求。这 需要收集捐献者的细粒度随访数据，并与健康的非捐献者进行比较。到目前为止， 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 作为一名捐赠者，我非常清楚捐赠后监测的深刻和系统性失败， 捐助者和卫生系统两个层面。2013年，一项国家政策要求移植中心满足 执行了活体捐献者后续行动标准，但事实证明， 移植中心，只有不到50%的人成功地满足了这一要求。 与移植中心的持续接触不仅可以更好地科学地了解 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 (such如高血压），并在这些成为主要不良后果之前进行干预。此外，一个适当的 健康的非供体队列从未被成功捕获和研究。为了改善这种持续的 2017年，我们在10个肾移植中心启动了试点活体捐赠者集体（LDC）， 移植受体科学登记处（Scientific Registry of Transplant Recipients，SRTR） 为了以系统、科学的方式改善活体供者的后续行动， 在全国各地的中心，我们将采取重要的第一步，评估如何10个试点移植 中心和SRTR实施了LDC，并利用这些信息来规划这一重要项目的下一次迭代 奋进。由于在美国的273个移植中心中，只有10个中心参与了试点，因此至关重要的是， 了解移植中心各种特征的实施障碍。指导 实施科学框架和混合方法的方法，我们的目标是：（1）了解LDC 在试点中心和SRTR之间实施，（2）进行形成性评估并评估移植 中心的准备和能力，以参与整个美国的最不发达国家，（3）创建一个实施 完善和扩大最不发达国家的战略。 本研究将提供对实施挑战、成功和失败的全面了解 一个活体捐献者追踪的集中项目。这为美国所有移植中心提供了基础 参与，解决了历史上无法解决和尴尬的卫生系统的挑战，是必要的， 准备未来的R01，以在全国范围内制定和实施集中的活体供者后续行动。