Integrating a culturally competent APOL1 genetic testing program into living donor evaluation

将具有文化能力的 APOL1 基因检测计划纳入活体捐赠者评估中

• 批准号: 10180256
• 负责人: Elisa J Gordon
• 金额: $ 71.46万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10180256
• 关键词: Address; Adopted; Adoption; African; African American; Alleles; Altruism; Apolipoproteins; Artificial Intelligence; Bioethics; Chicago; Clinical; Clinical Practice Guideline; Communities; Conflict (Psychology); Counseling; Data; Decision Making; Dialysis procedure; Effectiveness of Interventions; End stage renal failure; Ensure; Ethics; Evaluation; Family; Friends; Fright; Future; Genetic; Genetic Counseling; Genomics; Genotype; Health; Health Personnel; Hospitals; Informed Consent; Intervention; Kidney Transplantation; Knowledge; Living Donors; Medical; Medical Genetics; Medicine; Modeling; Outcome; Patients; Physicians; Population; Populations at Risk; Prevalence; Quality of life; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Renal function; Reporting; Risk; Safety; Testing; Time; Training Programs; Transplantation; United States National Institutes of Health; Universities; Variant; Washington; Work; chatbot; clinical practice; cultural competence; design; effectiveness evaluation; genetic counselor; genetic information; genetic testing; health disparity; high risk; implementation intervention; implementation outcomes; implementation science; improved; literacy; living kidney donor; mobile application; novel; optimal treatments; programs; risk variant; satisfaction; scale up; shared decision making; skills; success; transplant centers; willingness

PROJECT SUMMARY/ABSTRACT Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates’ decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs’ widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates’ safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical “chatbots,” mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians’ time, can improve informed treatment decisions and reduce decisional conflict. The chatbot “Gia,” created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists’ genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates’ decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs’ satisfaction with informed consent. The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.

项目摘要/摘要 活体供肾移植是终末期肾病患者的最佳治疗方法 (ESKD)。然而，LDS本身承担着未来ESKD的更高风险。非裔美国人(AA)LD有一种 捐献后患ESKD的风险甚至是白色LDS的3.3倍。因为有证据表明 载脂蛋白L1(APOL1)风险变异导致这种更大的风险，移植肾病学家越来越多地 使用APOL1测试评估非洲血统的LD考生。然而，肾病学家并不一致 由于缺乏以下方面的知识和技能，与LD考生进行关于APOL1的遗传咨询 关于APOL1的咨询。如果没有适当的咨询，APOL1测试将放大学习障碍考生的决定 关于捐赠的冲突，危及他们的知情同意。考虑到他们捐献后ESRD的风险增加， 以及AA对基因测试的广泛文化担忧，保护AA LD考生的伦理至关重要 通过APOL1检测以一种有文化能力的方式提高安全性，以改善有关捐赠的明智决定。 没有一个移植项目将APOL1测试以一种符合文化能力的方式整合到LD评估中。 临床“聊天机器人”，使用人工智能向患者提供遗传信息的移动应用程序 缓解对临床医生时间的限制，可以改善知情的治疗决策，减少决策冲突。 由一家医学遗传学公司开发的聊天机器人“Gia”可以适应任何条件。然而，没有 APOL1上的聊天机器人目前可用。没有为肾脏科医生提供咨询培训计划来 以一种有文化能力的方式，就APOL1和捐赠向AA LDS提供咨询。考虑到遗传基因的短缺 咨询师们，提高肾科医生的遗传素养是将基因检测应用于实践的关键。 这项研究的目的是在文化上适应和评估APOL1测试的有效性 在两个移植中心为大量AA LD人群(芝加哥、伊利诺伊州和华盛顿州)提供AA LD计划 DC)。APOL1测试计划将评估文化能力测试、聊天机器人和 就AA LD考生关于捐赠的决策冲突、决策准备、 自愿捐献，并对知情同意感到满意。具体目标是： 1.将GIA和移植咨询改编为APOL1，用于常规临床实践 2.评估这种干预在决策冲突、准备和意愿方面的有效性 以发布前的设计进行捐赠 3.通过使用RE-AIM框架评估该干预措施在临床实践中的实施情况 纵向评估肾病医生的咨询实践和LDS对知情同意的满意度。 这项研究的影响将是为AA LDS的APOL1测试创建一个模型，然后可以 通过实施科学方法在全国范围内实施。APOL1将作为集成的模型 在移植和其他实践中进行具有文化能力的基因测试，以改善患者的知情同意。