A Randomized Trial of the ERRA Intervention to Increase Consent to Organ Donation

ERRA 干预措施提高器官捐献意愿的随机试验

• 批准号: 7753209
• 负责人: LAURA A. SIMINOFF
• 金额: $ 54.06万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-01 至 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7753209
• 关键词: Adult; Affect; American; Area; Artificial Heart; Communication; Consent; Dialysis procedure; Educational process of instructing; Effectiveness; Elements; End stage renal failure; Evaluation; Experimental Designs; Family; Geographic Locations; Health; Healthcare; Heart; Hospital Referrals; Hospitals; Individual; Intervention; Kidney Failure; Kidney Transplantation; Learning; Left; Literature; Liver; Liver Failure; Lung; Methods; Notification; Organ; Organ Donations; Organ Procurements; Organ Transplantation; Organ failure; Outcome; Participant; Patients; Play; Professional Education; Quality of life; Renal dialysis; Research; Role; Site; Solid; Source; System; Techniques; Testing; Therapeutic; Time; Training; Transplant Recipients; Transplantation; United States; Waiting Lists; base; communication theory; cost; cost effective; design; end-stage organ failure; hospital organization; improved; programs; public health relevance; randomized trial; skills; therapy design; ventricular assist device

DESCRIPTION (provided by applicant): Deceased donation remains the major source of organs. Despite the public's stated enthusiasm for organ donation, donation consent rates have remained relatively low. In the U.S. no more than 60% of the families of donation-eligible individuals consent. Improving the rates of consent from deceased donor families is a pivotal means for slowing the rise of the supply-demand gap. The proposed five-year study will test the use of a two-part Early Referral and Request Approach (ERRA) intervention to raise consent rates to solid organ donation from the families of deceased patients at the point where requests are made by Organ Procurement Organizations (OPOs). The ERRA consists of a hospital-based evaluation assessment system and a communication intervention. It targets two key factors that can make a difference to consent to organ donation: 1) time-sensitive referrals by hospitals of potential donor patients to the OPO; and 2) use of effective communication techniques by OPO requesters to discuss organ donation with donation-eligible patients' families. The ERRA intervention is based on 15 years of prior research in the area of obstacles to organ donation and is grounded in the results of a recent study. We will use an experimental design to test the overall efficacy of both elements of the ERRA intervention under two conditions (autonomous and assisted) to ascertain best practices for ERRA implementation. The first module of the ERRA is the Rapid Assessment of Hospital Procurement barriers in Donation (RAPiD). The second module is the Communicating Effectively about Donation (CEaD) that teaches OPO requesters communication skills designed to improve the effectiveness of their requests to donor-eligible families. Eight OPOs, located around the United States, and their OPO coordinators who request organ donation, will participate as study sites and participants (n=80). The proposal has the following specific aims: Aim 1. Test the effectiveness of the RAPiD to increase timely identification of potential donors through hospital notification of OPOs and the affect of the RAPiD and CEaD training modules on consent rates. Aim 2. Test OPO implementation of the RAPiD and CEaD modules under two conditions. The two implementation conditions to be tested are: a) a completely autonomous condition in which an OPO does not employ any outside assistance to implement the module, and b) an assisted method whereby trained outside consultants play a role in implementing the modules. PUBLIC HEALTH RELEVANCE: There are over 96,000 patients on the transplantation waiting list but no more than a fraction of these patients will receive an organ transplant in any given year. This study proposes an intervention to help increase the rates of organ donation and alleviate the organ shortage.

描述（由申请人提供）：死者捐献仍然是器官的主要来源。尽管公众对器官捐献热情高涨，但捐献同意率仍然相对较低。在美国，只有 60% 的符合捐赠资格的个人家庭同意。提高已故捐献者家属的同意率是减缓供需缺口扩大的关键手段。拟议的五年研究将测试使用两部分早期转诊和请求方法（ERRA）干预措施，以提高已故患者家属在器官采购组织提出请求时对实体器官捐赠的同意率（ OPO）。 ERRA由基于医院的评估评估系统和沟通干预组成。它针对两个可能影响器官捐献同意的关键因素：1）医院及时将潜在捐献患者转介给 OPO； 2) OPO 请求者使用有效的沟通技巧与符合捐赠资格的患者家属讨论器官捐赠问题。 ERRA 干预措施基于 15 年之前在器官捐献障碍领域的研究，并以最近的一项研究结果为基础。我们将使用实验设计来测试 ERRA 干预的两个要素在两种条件（自主和辅助）下的总体功效，以确定 ERRA 实施的最佳实践。 ERRA 的第一个模块是医院采购捐赠障碍的快速评估 (RAPiD)。第二个模块是关于捐赠的有效沟通 (CEaD)，教授 OPO 请求者的沟通技巧，旨在提高他们向符合捐赠资格的家庭提出请求的有效性。位于美国各地的八个 OPO 及其请求器官捐赠的 OPO 协调员将作为研究地点和参与者参与 (n=80)。该提案有以下具体目标： 目标 1. 测试 RAPiD 的有效性，以通过医院 OPO 通知来及时识别潜在捐赠者，以及 RAPiD 和 CEaD 培训模块对同意率的影响。目标 2. 在两种条件下测试 RAPiD 和 CEaD 模块的 OPO 实现。要测试的两种实施条件是：a) 完全自主的条件，其中 OPO 不使用任何外部援助来实施模块；b) 受过培训的外部顾问在实施模块中发挥作用的辅助方法。公共卫生相关性：移植等待名单上有超过 96,000 名患者，但这些患者中在任何一年接受器官移植的人都不超过一小部分。这项研究提出了一种干预措施，以帮助提高器官捐献率并缓解器官短缺。