Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors

优化肾移植患者对风险增加的捐赠者的知情同意

• 批准号: 8341357
• 负责人: Elisa J Gordon
• 金额: $ 24万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-04 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8341357
• 关键词: Address; Adult; Algorithms; Behavior; Benefits and Risks; Cessation of life; Communicable Diseases; Communities; Comprehension; Computer software; Computers; Conflict (Psychology); Consent; Control Groups; Data; Decision Making; Disclosure; Educational Materials; Ensure; Evaluation; Guidelines; HIV; Health Communication; Hepatitis B; Hepatitis B Virus; Hepatitis C Transmission; Hepatitis C virus; Informed Consent; Intervention; Kidney; Kidney Transplantation; Knowledge; Learning; Nurses; Online Systems; Organ; Organ Donor; Patient Education; Patients; Play; Policies; Process; Provider; Publishing; Randomized Controlled Trials; Risk; Role; Testing; Time; Transplant Nursing; Transplant Recipients; Transplantation; United States; United States Centers for Medicare and Medicaid Services; United States Public Health Service; Universal Precautions; Variant; compare effectiveness; computerized; disease transmission; health information technology; health literacy; improved; innovation; interactive multimedia; interdisciplinary approach; literacy; meetings; prevent; response; satisfaction; theories; tool; transmission process; usability

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.

描述（由申请人提供）：用于KT的肾脏短缺导致美国每年近10，000人死亡。增加可用肾脏数量的一种策略是提供具有增加的人类免疫缺陷病毒（HIV）、乙型肝炎B（HBV）和丙型肝炎（HCV）传播风险（IR）的肾移植（KT）候选者的肾脏，如使用1994年美国公共卫生服务（PHS）预防传染病传播指南所定义的。IR捐献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捐献者的9%。然而，在2007年从一名IR已故捐赠者向4名接受者意外传播HIV和HCV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肾脏的接受者知情同意。尽管有具体的知情同意要求，OPTN和CMS都没有提供关于如何或哪些信息应该披露给潜在接收者的指导。因此，目前的知情同意程序提供了关于IR捐助者的不同程度的信息。此外，已经发现KT候选人误解了IR供体是什么，并且希望获得比所提供的更多的关于IR供体肾的信息。KT候选人的低文化水平可能会限制他们对IR供体肾脏的理解。 本研究的目的是增加KT候选人对IR肾脏的理解，这是提供知情同意书所必需的。为了实现这一目标，我们将开发一个基于网络的工具，教育和评估候选人的理解（iGetIR），作为目前知情同意程序的补充。然后，我们将进行一项RCT，以比较当前知情同意过程（对照）与iGetIR补充的当前知情同意过程的有效性。该工具将利用健康信息技术，通过基于网络的应用程序向候选人提供有关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、健康传播最佳实践和健康素养普遍预防措施，将传染风险数据转化为易于理解的信息，从而开发教育材料。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来个性化信息，以提高理解能力。 鉴于OPTN和CMS的任务，移植界的优先事项是开发教育工具以改善当前的知情同意过程，我们不知道有任何干预措施可以满足这一需求。由于移植护士在KT的患者教育和知情同意过程的多学科方法中发挥着核心作用，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。 公共卫生关系：这项拟议的研究将开发一种基于网络的工具，用于教育和评估肾移植候选人对高风险供体肾（iGetIR）的理解。然后，我们将比较iGetIR补充的当前知情同意过程与当前仅用于肾移植候选人的同意过程的有效性。标准化和个性化的知情同意过程将提高肾移植候选人的理解力并增强自主决策，同时帮助移植中心满足当前OPTN和CMS对患者教育和知情同意的要求，特别是针对风险增加的供体肾脏。