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: 8504539
• 负责人: Elisa J Gordon
• 金额: $ 18.39万
• 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 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8504539
• 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; eighth grade; 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.

描述（由申请人提供）：美国每年因 KT 肾脏短缺导致近 10,000 人死亡。增加可用肾脏数量的一项策略是为肾移植 (KT) 候选者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 (IR) 较高的肾脏，定义如下： 1994 年美国公共卫生服务 (PHS) 预防传染病传播指南。 IR 捐献者被定义为那些从事与 HIV 和 HCV 传播风险增加相关行为的人，约占美国所有已故器官捐献者的 9%。然而，2007 年，在 IR 已故捐赠者意外将 HIV 和 HCV 传播给 4 名接受者之后，OPTN 政策和医疗保险和医疗补助服务中心 (CMS) 的参与条件强制要求接受 IR 肾脏的接受者必须知情同意。尽管有特定知情同意的要求，但 OPTN 和 CMS 均未提供有关如何向潜在接收者披露信息或应向潜在接收者披露哪些信息的指导。因此，当前的知情同意流程提供了有关 IR 捐助者的不同级别的信息。此外，KT 候选者被发现误解了 IR 供体的含义，并希望获得比所提供的更多有关 IR 供体肾脏的信息。 KT 候选者的文化水平较低可能会限制他们对 IR 供体肾脏的了解。 本研究的目的是提高 KT 候选人对 IR 肾脏的理解，这是提供知情同意所必需的。为了实现这一目标，我们将开发一个基于网络的工具，用于教育和评估候选人的理解力（iGetIR），作为当前知情同意流程的补充。然后，我们将进行随机对照试验，以比较当前知情同意流程（控制）与由 iGetIR 补充的当前同意流程的有效性。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。作为这一创新知情同意流程的一部分，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对信息进行个性化，以提高理解力。 鉴于 OPTN 和 CMS 的授权，移植界的首要任务是开发教育工具以改进当前的知情同意流程，并且我们不知道有任何干预措施可以满足这一需求。由于移植护士在患者教育和 KT 知情同意流程的多学科方法中发挥着核心作用，因此本研究建议通过补充当前的知情同意流程来利用他们的知识和专业知识。

项目成果

Effect of a Mobile Web App on Kidney Transplant Candidates' Knowledge About Increased Risk Donor Kidneys: A Randomized Controlled Trial.

• DOI: 10.1097/tp.0000000000001273
• 发表时间: 2017-06
• 期刊: Transplantation
• 影响因子: 6.2
• 作者: Gordon EJ;Sohn MW;Chang CH;McNatt G;Vera K;Beauvais N;Warren E;Mannon RB;Ison MG
• 通讯作者: Ison MG