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: 7581433
• 负责人: LAURA A. SIMINOFF
• 金额: $ 54.63万
• 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/7581433
• 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; Randomized Controlled Clinical Trials; 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; 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.

说明（由申请人提供）：死者捐赠仍是器官的主要来源。尽管公众表达了对器官捐赠的热情，但捐赠同意率仍然相对较低。在美国，不超过60%的符合捐赠条件的家庭同意捐赠。提高已故捐献家庭的同意率是减缓供需差距扩大的关键手段。这项为期五年的研究，将测试采用两阶段的早期转介及申请方法，在器官采购机构提出申请时，提高死者家属对实体器官捐赠的同意率。重建局包括以医院为基础的评估评估系统和沟通干预。它针对的两个关键因素可能对器官捐赠的同意产生影响：1)医院将潜在的捐赠患者转介到OPO的时间敏感；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。重建局的干预措施是基于对器官捐赠障碍领域15年的前期研究，并以最近的一项研究结果为基础。我们将采用实验设计，在两种条件下（自主和辅助）测试重地重建干预的两个要素的整体功效，以确定重地重建实施的最佳实践。重建局的第一个模块是医院捐赠采购障碍快速评估（Rapid）。第二个模块是关于捐赠的有效沟通（CEaD），教给OPO请求者沟通技巧，旨在提高他们向符合捐赠条件的家庭提出请求的有效性。位于美国各地的8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（n=80）参与研究。该建议有以下具体目标：目标1。测试快速方案的有效性，以便通过医院通知opo来增加对潜在捐助者的及时识别，以及快速方案和可持续发展方案培训模块对同意率的影响。目标2。在两种条件下测试快速和CEaD模块的OPO实现。需要测试的两个实施条件是：a)完全自主的条件，OPO不使用任何外部协助来实施模块；b)辅助方法，由经过培训的外部顾问在实施模块中发挥作用。公共卫生相关性：有超过96,000名患者在移植等待名单上，但在任何一年，这些患者中接受器官移植的不超过一小部分。本研究提出一种有助于提高器官捐献率和缓解器官短缺的干预措施。