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）：在美国，肾脏短缺每年近10,000人死亡。增加可用肾脏数量的一种策略是提供肾脏移植（KT）候选肾脏，该肾脏具有增加人类免疫缺陷病毒（HIV），丙型肝炎（HBV）和C（HBV）和C（HCV）的风险（IR），使用1994年美国公共卫生服务（PHS）指南定义的，以预防感染性疾病。 IR捐赠者被定义为那些从事与艾滋病毒和HCV传播风险增加的行为相关的行为的人，占美国所有死者器官捐赠者的约9％。但是，在2007年将艾滋病毒和HCV意外传播给了4名接收者之后，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肾脏的接受者要求获得知情同意。尽管需要具体知情同意，但OPTN和CMS均未提供有关如何或哪些信息向潜在接收者披露的指导。结果，当前的知情同意程序提供了有关IR捐赠者的不同水平。此外，已经发现KT候选人误解了IR捐助者是什么，并且希望有关IR捐赠肾脏的更多信息。 KT候选者的识字水平低可能会限制他们对IR供体肾脏的理解。 这项研究的目的是提高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，我们将开发一种基于网络的工具，该工具对当前知情同意程序进行教育和评估候选人的理解（IGETIR）。然后，我们将进行RCT，以比较当前知情同意程序（控制）与Igetir补充的当前同意过程的有效性。该工具将利用健康信息技术向候选人提供有关通过基于Web的应用程序使用IR肾脏的定义，风险，福利和替代方案的信息。我们将通过将传染性风险数据转换为易于使用成人学习理论，健康沟通最佳实践和健康素养普遍预防措施的信息来开发教育材料。作为此创新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，以提高理解力。 鉴于Optn和CMS的任务，移植社区的优先事项是开发教育工具以改善当前知情同意过程，我们不知道任何解决此需求的干预措施。由于移植护士在患者教育的多学科方法中起着核心作用，并为KT提供了知情同意程序，因此本研究建议通过补充当前知情同意程序来利用其知识和专业知识。 公共卫生相关性：拟议的研究将开发一种基于网络的工具，该工具对肾脏移植候选者对增加风险供体肾脏（IGETIR）的理解。然后，我们将比较Igetir补充的当前知情同意过程的有效性，仅目前的同意程序用于肾脏移植候选者。标准化和个性化的知情同意程序将改善肾脏移植候选者的理解力并增强自主决策，同时帮助移植中心符合当前的OPTN和CMS授权，以实现患者教育和知情同意，特别是为了增加风险供体肾脏的肾脏。