Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors

描述（由申请人提供）：在美国，用于KT的肾脏短缺导致每年近10,000人死亡。增加可用肾脏数量的一种策略是提供人类免疫缺陷病毒（HIV）、乙型肝炎（HBV）和丙型肝炎（HCV）传播风险增加（IR）的肾移植（KT）候选肾脏，根据1994年美国公共卫生服务（PHS）预防传染病传播指南的定义。IR献血者被定义为那些从事与HIV和HCV传播风险增加相关的行为的人，约占美国所有已故器官献血者的9%。然而，在2007年，一名已故IR供体意外将HIV和HCV传播给4名受者后，OPTN政策和医疗保险和医疗补助服务中心（CMS）的参与条件要求接受IR肾脏的受者知情同意。尽管有具体知情同意的要求，但OPTN和CMS都没有就如何或应向潜在接收者披露哪些信息提供指导。因此，目前的知情同意程序提供了不同程度的IR捐助者信息。此外，发现KT候选人误解了IR供体是什么，并希望获得更多关于IR供体肾脏的信息。KT候选人的低文化水平可能限制他们对IR供体肾脏的了解。本研究的目的是提高KT候选人对提供知情同意所需的IR肾脏的理解。为了实现这一目标，我们将开发一个基于网络的工具来教育和评估候选人的理解（iGetIR），作为当前知情同意流程的补充。然后，我们将进行一项随机对照试验，比较当前知情同意流程（对照）与当前由iGetIR补充的同意流程的有效性。该工具将利用卫生信息技术，通过基于网络的应用程序向候选人提供有关使用IR肾脏的定义、风险、益处和替代方案的信息。我们将利用成人学习理论、健康沟通最佳做法和健康素养普遍预防措施，将感染风险数据转化为易于理解的信息，从而编写教育材料。作为这一创新的知情同意过程的一部分，计算机自适应学习将根据每个候选人在互动章节中的理解水平个性化信息，以增加理解。鉴于OPTN和CMS的授权，开发教育工具来改善目前的知情同意程序是移植社区的优先事项，我们不知道有任何针对这一需求的干预措施。由于移植护士在KT患者教育和知情同意过程的多学科方法中发挥核心作用，本研究建议通过补充当前的知情同意过程来利用他们的知识和专业知识。

DESCRIPTION (provided by applicant): The shortage of kidneys for KT results in almost 10,000 deaths per year in the United States. One strategy to increase the number of available kidneys is to offer kidney transplant (KT) candidates kidneys at increased risk (IR) of transmission of human immunodeficiency virus (HIV), hepatitis B (HBV) and C (HCV), as defined using the 1994 US Public Health Service (PHS) guidelines for preventing infectious disease transmissions. IR donors are defined as those who have engaged in behaviors associated with an increased risk of HIV and HCV transmissions, and comprise approximately 9 percent of all US deceased organ donors. However, following an unexpected transmission of HIV and HCV from an IR deceased donor to 4 recipients in 2007, OPTN policy and Center for Medicare and Medicaid Services (CMS) conditions of participation mandated informed consent from recipients who accept IR kidneys. Despite the requirements for specific informed consent, neither OPTN nor CMS offer guidance about how or what information should be disclosed to potential recipients. As a result, the current informed consent processes provide varying levels of information about IR donors. Further, KT candidates have been found to misunderstand what IR donors are and desire more information about IR donor kidneys than provided. Low literacy levels of KT candidates may limit their understanding of IR donor kidneys. The objective of this study is to increase KT candidates' comprehension about IR kidneys necessary for providing informed consent. To accomplish this objective, we will develop a web-based tool that educates and assesses candidates' comprehension (iGetIR), as a supplement to current informed consent processes. We will then conduct an RCT to compare the effectiveness of the current informed consent processes (controls) with the current consent processes supplemented by iGetIR. The tool will utilize health information technology to deliver information to candidates about the definition of, risks, benefits, and alternatives to using IR kidneys via a web-based application. We will develop educational materials by transforming infectious risk data into easy to comprehend information using adult learning theory, health communication best practices, and health literacy universal precautions. As part of this innovative informed consent process, computer adaptive learning will personalize information according to each candidate's comprehension levels in interactive chapters to increase comprehension. Given OPTN's and CMS's mandate, it is a priority of the transplant community to develop educational tools to improve the current informed consent process, and we are unaware of any interventions that address this need. Because transplant nurses play a central role in the multidisciplinary approach to the patient education and informed consent processes for KT, this study proposes to capitalize on their knowledge and expertise by supplementing the current informed consent processes. PUBLIC HEALTH RELEVANCE: The proposed study will develop a web-based tool that educates and assesses kidney transplant candidates' comprehension of increased risk donor kidneys (iGetIR). We will then compare the effectiveness of the current informed consent processes supplemented by iGetIR, with the current consent processes alone for kidney transplant candidates. A standardized and personalized informed consent process will improve kidney transplant candidates' comprehension and enhance autonomous decision-making, while helping transplant centers meet current OPTN and CMS mandates for patient education and informed consent, specifically for increased risk donor kidneys.