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: 10377408
• 负责人: Akansha Agrawal
• 金额: $ 68.07万
• 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/10377408
• 关键词: Address; Adopted; Adoption; African; African American; African ancestry; 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 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

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 活体供体（LD）肾脏移植是终末期肾脏疾病患者的最佳治疗方法 （ESKD）。但是，LD会承担更高的未来ESKD风险。非裔美国人（AA）LDS有一个 与白色LDS持续后，ESKD的风险更大，3.3倍。因为有证据表明 载脂蛋白L1（APOL1）风险变体有助于这种更大的风险，移植肾病学家越来越多 使用APOL1测试评估非洲血统的LD候选者。但是，肾脏科医生并非一致 由于缺乏知识和技能，与LD候选人一起进行遗传咨询 有关apol1的咨询。没有适当的咨询，APOL1测试将放大LD候选人的决策 关于捐赠的冲突，危害他们的知情同意。鉴于他们升高后的ESRD风险， AAS对基因检测的广泛文化关注，在道德上，保护AA LD候选人至关重要 通过APOL1测试以具有文化胜任的方式进行安全性，以改善有关捐赠的明智决定。 没有移植程序以具有文化胜任的方式将APOL1测试集成到LD评估中。 临床“聊天机器人”，使用人工智能为患者提供遗传信息的移动应用程序 减轻对临床医生时间的限制，可以改善明智的治疗决策并减少决策冲突。 由医学遗传公司创建的聊天机器人“ GIA”可以适应任何条件。但是，不 聊天机器人当前可用。肾脏科医生没有咨询培训计划可用于 咨询AA LDS关于APOL1和以文化优势的方式捐赠。鉴于通用短缺 肾病学家的遗传学素养增加对于将基因检测纳入实践至关重要。 这项研究的目的是在文化上适应和评估APOL1测试的有效性 为大量AA LD人群（芝加哥，伊利诺伊州和华盛顿， DC）。 APOL1测试计划将评估具有文化胜任的测试，聊天机器人和 咨询AA LD候选人关于捐赠，准备决策的决策冲突， 愿意捐赠和满足知情同意。具体目的是： 1。适应GIA和移植咨询到APOL1用于常规临床实践 2。评估这种干预对决策冲突，准备和意愿的有效性 在前设计中捐款 3。通过使用RE-AIM框架来评估这种干预措施对临床实践的实施 纵向评估肾脏科医生咨询实践和LDS对知情同意的满意。 这项研究的影响将是创建用于AA LDS的APOL1测试的模型，然后可以是 通过实施科学方法在全国实施。 APOL1将作为集成的模型 具有文化胜任的基因检测对移植和其他实践，以改善患者知情同意。