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

基本信息

批准号：
10617640
负责人：
Akansha Agrawal
金额：
$ 66.28万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
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/10617640
关键词：
Address Adopted Adoption African American African ancestry Alleles Altruism Apolipoproteins Artificial Intelligence Bioethics Chicago Clinical Clinical Practice Guideline Communities Conflict (Psychology)Counseling Data Decision Making Dialysis procedure Donor person 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 evaluation 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

项目摘要

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.

项目概要/摘要活体肾移植（LD）是终末期肾病患者的治疗方法 (ESKD)。但是，非裔美国人 (AA) LD 本身面临更高的 ESKD 风险。捐赠后患 ESKD 的风险是白人 LD 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 测试来评估非洲血统的 LD 候选者然而，肾脏病学家的看法并不一致。由于缺乏相关知识和技能，对 LD 候选人进行有关 APOL1 的遗传咨询有关 APOL1 的咨询如果没有适当的咨询，APOL1 测试将放大 LD 候选人的决策。捐赠方面的冲突，危及他们的知情同意，因为他们在捐赠后患 ESRD 的风险较高，以及 AA 对基因检测普遍存在的文化担忧，保护 AA LD 候选人在道德上至关重要通过以符合文化的方式进行 APOL1 测试来提高捐献的知情决策的安全性。没有移植项目以文化上可行的方式将 APOL1 测试整合到 LD 评估中。临床“聊天机器人”是使用人工智能向患者和患者提供遗传信息的移动应用程序缓解人群时间限制，可以改善明智的治疗决策并减少决策冲突。一家医学遗传学公司创建的聊天机器人“Gia”可以适应任何情况，但事实并非如此。目前，APOL1 上的聊天机器人尚无可供肾脏科医生使用的咨询培训计划。鉴于遗传资源的短缺，以文化上合适的方式向 AA LD 提供关于 APOL1 和捐赠的咨询。咨询师们，提高肾脏科医生的基因素养对于将基因检测融入实践至关重要。本研究的目的是在文化上适应并评估 APOL1 测试的有效性两个移植中心的 AA LD 计划，为大量 AA LD 人群提供服务（芝加哥、伊利诺伊州和华盛顿州） DC）APOL1 测试程序将评估文化能力测试、聊天机器人和的效果。就 AA LD 候选人关于捐赠的决策冲突、决策准备、捐赠意愿和知情同意满意度具体目标是： 1. 将 Gia 和移植咨询调整为 APOL1 以用于常规临床实践 2. 评估该干预措施对决策冲突、准备情况和意愿的有效性捐赠前期设计 3. 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专家的咨询实践和 LD 对知情同意的满意度。这项研究的影响将是创建一个用于 AA LD 的 APOL1 测试模型，然后可以将其通过实施科学方法在全国范围内实施 APOL1 将作为整合的模型。对移植和其他实践进行具有文化背景的基因检测，以提高患者的知情同意。