Genetic Testing (APOL1) Decisional Support for Potential Living Kidney Donors

为潜在活体肾脏捐赠者提供基因检测 (APOL1) 决策支持

• 批准号: 10494134
• 负责人: Heather Marie Gardiner
• 金额: $ 55.53万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10494134
• 关键词: Advocate; Affect; African; African American; African American population; African Trypanosomiasis; African ancestry; Alleles; Apolipoproteins; Attitude; Award; Belief; Benefits and Risks; Cancer Model; Caring; Chronic Kidney Failure; Clinical; Communication; Consultations; Decision Making; Development; End stage renal failure; Ensure; Evaluation; Face; Family; Family member; Feedback; Financial Hardship; Focal Segmental Glomerulosclerosis; Focus Groups; Genes; Gold; Graft Rejection; Group Interviews; HIV; Health; Hypertension; Individual; Intervention; Kidney; Kidney Diseases; Kidney Transplantation; Knowledge; Latinx; Living Donors; Medical; Methodology; Methods; Modification; Outcome; Parasitic infection; Patient Care; Patients; Persons; Phase; Process; Provider; Quality of life; Randomized Controlled Clinical Trials; Recommendation; Research; Risk; Safety; Series; Social Workers; Societies; Speed; Standardization; Surveys; Testing; Transplant Recipients; Transplantation; United States; Variant; Work; base; clinical decision-making; clinical practice; cost; cultural values; design; ethnic minority; ethnic minority population; genetic testing; genetic variant; improved; living kidney donor; minority patient; nephrogenesis; non-diabetic; novel; point of care; preference; programs; randomized controlled design; response; shared decision making; support tools; tool; willingness

PROJECT SUMMARY The identification of the Apolipoprotein L-1 or APOL1 gene as an indicator of increased likelihood of developing chronic kidney disease has sparked a debate about point-of-care genetic testing for potential living kidney donors. While integrating genetic testing into the medical evaluation of potential living donors benefits patients, ensuring an informed, deliberative decision making process is paramount. The proposed study is premised on a large body of research demonstrating that traditional SDM processes and interventions fail to meet the needs of ethnic minority populations. Because SDM requires an informed patient to engage in the decision making process, novel methods are needed to assure a full, accurate understanding of risks, benefits, implications and alternate options. We propose a participatory approach to developing a decisional support tool for African American potential donors as they consider genetic testing as part of their medical evaluation. Specifically, this mixed-method study will conduct the formative research needed to develop and refine the tool. Up to 6 focus group interviews will explore potential donors' preferences for shared decision making and understanding of the risks, benefits and implications of genetic testing in the context of live kidney donation (Aim 1). The findings will inform the design of a brief quantitative survey assessing potential donors' decision-making preferences, communication style, and knowledge of and attitudes toward genetic testing, kidney transplantation and living donation. The survey (N=500) will be the first to include the Best-Worst Scaling methodology to assess the level of importance potential donors place on the risks and benefits of genetic testing as well as trade offs between risks and benefits donors are willing to make (Aim 2). A draft of the tool will be created, using the Ottowa Framwork as guide, to support African American patients and their families making decisions about both living donor kidney transplants and genetic testing in this context. Additional modifications will be made based on the findings of the focus group interviews and completed surveys. The tool will then be refined iteratively over four rounds of testing in simulated consultations with standardized providers and four rounds with a Delphi panel of transplant professionals (Aim 3). A Stakeholder Committee, comprised of transplant professionals and previous and potential living donors, will provide ongoing feedback and guidance across all study phases. In a subsequent R01, the fully-vetted, newly developed tool will be implemented and tested in clinical settings using a randomized controlled design. If successful, the tool will optimize care for the thousands of African American potential living kidney donors evaluated in the United States annually.

项目摘要 将载脂蛋白L-1或apol1基因鉴定为增加的可能性的指标 慢性肾脏疾病引发了有关潜在活肾脏的生命点基因测试的辩论 捐助者。在将基因检测整合到潜在的活捐助者的医学评估中，使患者有益于患者 确保明智的，审议的决策过程至关重要。拟议的研究以 大量研究表明，传统的SDM流程和干预措施无法满足需求 少数民族人口。因为SDM要求知情的患者参与决策 过程，需要新颖的方法来确保对风险，收益，影响和 替代选项。我们提出了一种参与式方法，以开发非洲的决策支持工具 美国潜在的捐助者将基因检测视为其医学评估的一部分。具体来说，这是 混合方法研究将进行开发和完善工具所需的形成性研究。最多6焦点 小组访谈将探讨潜在的捐助者对共同决策和理解的偏好 在现场肾脏捐赠的背景下，基因检测的风险，益处和影响（AIM 1）。发现 将告知设计简短的定量调查，以评估潜在的捐助者的决策偏好， 沟通方式，对基因测试，肾移植和生活的知识和态度 捐款。调查（n = 500）将是第一个包括评估最佳缩放方法的方法 潜在捐助者的重要性水平置于基因检测的风险和益处以及贸易折扣 风险和福利之间捐助者愿意做出的（目标2）。使用该工具的草稿将使用 渥太华的指南，以支持非洲裔美国患者及其家人做出决定 在这种情况下，活着的供体肾脏移植和基因检测。将进行其他修改 根据焦点小组访谈的发现并完成了调查。然后将该工具完善 在与标准化提供商和四回合的模拟咨询中进行了四轮测试。 与移植专业人士的Delphi小组（AIM 3）。由移植组成的利益相关者委员会 专业人士以及以前和潜在的活捐助者将在所有人中提供持续的反馈和指导 研究阶段。在随后的R01中，将在 使用随机控制设计的临床设置。如果成功，该工具将优化对 每年在美国评估成千上万的非裔美国人潜在的肾脏捐助者。