Access to Genetic Information Leveraging Innovative Technology (AGILITY) Study

利用创新技术获取遗传信息（AGILITY）研究

• 批准号: 10492770
• 负责人: Jessica Ezzell Hunter
• 金额: $ 49.25万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10492770
• 关键词: Academy; Address; Adult; American; Cardiovascular system; Caring; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Clinical Trials; Clinical assessments; Communities; Complement; Conflict (Psychology); Counseling; Data; Decision Making; Distress; Enrollment; Ensure; Familial Hypercholesterolemia; Florida; Genes; Genetic; Genetic Counseling; Genomic medicine; Genomics; Gold; Health; Health system; Hereditary Breast and Ovarian Cancer Syndrome; Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndromes; Hereditary Nonpolyposis Colorectal Neoplasms; Hybrids; Individual; Inherited; International; Intervention; Interview; Lead; Learning; Machine Learning; Malignant Neoplasms; Medical Genetics; Medicine; Notification; Outcome; Participant; Pathogenicity; Patient Care; Patients; Persons; Population; Positioning Attribute; Prevalence; Preventive; Primary Health Care; Provider; Randomized; Randomized Controlled Trials; Readiness; Recommendation; Regrets; Research; Research Personnel; Resources; Services; Sum; Target Populations; Test Result; Testing; Training; Translating; Universities; Variant; Work; arm; base; cancer risk; care providers; chatbot; clinical care; comparative efficacy; computer program; cost; digital; follow-up; genetic counselor; genetic information; genetic testing; genetic variant; genomic predictors; hereditary risk; high risk; hybrid type 1 trial; implementation evaluation; implementation outcomes; implementation science; information technology workforce; innovative technologies; interest; medical schools; novel; population based; precision medicine; primary care setting; primary outcome; racial and ethnic; racial diversity; randomized trial; recruit; retention rate; screening; secondary outcome; service delivery; socioeconomics; standard care; standard of care; success; testing uptake; therapy development; tool; usability; virtual

PROJECT SUMMARY/ABSTRACT The AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) trial will assess layered challenges in realizing precision medicine. This includes a limited genetic counseling workforce to facilitate test decisions, and existing inequities in access to genetic testing. To address these challenges, we will conduct a Type1 Hybrid Trial that includes three specific aims. The first aim is to take an existing clinical genetics chatbot and tailor it for use in population screening of gene variants that can lead to Hereditary Breast and Ovarian Cancer syndromes, Lynch Syndrome, and Familial Hypercholesterolemia. Due to the prevalence of the variants and options for taking actions to reduce negative outcomes, 10 genes have been endorsed for population screening by the National Academy of Medicine and the American College of Medical Genetics. To validate the chatbot for the target population, we will use data from interviews with primary care patients and providers to learn the informational needs to achieve informed test decisions. Once the chatbot is validated, the second aim is to conduct a virtually-implemented randomized controlled trial with primary care patients from a variety of backgrounds. We will test non-inferiority of the chatbot in comparison to standard genetic counseling. We plan to enroll 2,400 adult participants from five racially, ethnically and socioeconomically diverse primary care clinics at the University of Florida Health System. Patients will be eligible to enroll in the trial if they have no higher risks for the screening conditions. [Those with higher risks will be offered the opportunity to undergo targeted genetic testing as is standard of care, and followed as a descriptive study arm.] Participants will be randomized to learn about testing via a clinical chatbot or a genetic counselor. Our primary outcome is informed choice about undergoing genetic testing. As such, those who decline testing are as informative as those who accept. Secondary outcomes include test-related distress, decisional conflict, and testing uptake. Informed choice will be assessed immediately following the decision, after receipt of results for those who accept testing, and 3 and 6 months later for all participants. To ensure success of the AGILITY Trial, investigators at RTI International will work with the Senior Associate Dean of Research, primary care providers, patients and the community advisory board at the University of Florida Health System to develop recruitment, engagement, and retention strategies. The third aim is to conduct an implementation assessment of the clinical chatbot as an intervention to optimize genetic counseling without compromising informed decision-making and to facilitate population screening. To do so, we will analyze interviews with participants, genetic counselors, and primary care providers participating in the trial, using recognized approaches to inform implementation. The AGILITY study will provide evidence in support of workable solutions to address the critical issue of how to provide robust and scalable genetic counseling around predictive genomics in routine clinical care.

项目概要/摘要 AGILITY（利用创新技术获取遗传信息）试验将评估分层 实现精准医疗的挑战。这包括有限的遗传咨询人员，以促进 测试决定以及在获得基因测试方面存在的不平等。为了应对这些挑战，我们将 进行 Type1 混合试验，其中包括三个具体目标。第一个目标是利用现有的临床 遗传学聊天机器人，并将其定制用于可导致遗传性遗传的基因变异的群体筛查 乳腺癌和卵巢癌综合征、林奇综合征和家族性高胆固醇血症。由于 变异的普遍性以及采取行动减少负面结果的选择，已对 10 个基因进行了研究 经美国国家医学院和美国医学院认可用于人群筛查 遗传学。为了验证目标人群的聊天机器人，我们将使用初级保健访谈的数据 患者和提供者了解信息需求以做出明智的测试决策。一旦聊天机器人 得到验证后，第二个目标是进行一项虚拟实施的随机对照试验 照顾来自不同背景的患者。我们将测试聊天机器人与 标准遗传咨询。我们计划招收 2,400 名来自五个种族、族裔和 佛罗里达大学卫生系统的社会经济多元化初级保健诊所。患者将会 如果他们在筛选条件下没有更高的风险，则有资格参加试验。 【风险较高者 将有机会按照护理标准进行有针对性的基因检测，并作为后续检查 描述性研究组。] 参与者将被随机分配，以了解通过临床聊天机器人或遗传测试进行的测试 顾问。我们的主要结果是对接受基因检测的知情选择。因此，那些 拒绝测试与接受测试一样提供信息。次要结果包括与测试相关的痛苦， 决策冲突和测试采用情况。知情选择将在做出决定后立即进行评估， 接受测试的人在收到结果后，所有参与者在 3 个月和 6 个月后。为确保 AGILITY 试验取得成功后，RTI International 的研究人员将与该项目的高级副院长合作 佛罗里达大学的研究、初级保健提供者、患者和社区咨询委员会 卫生系统制定招募、参与和保留策略。第三个目标是开展 临床聊天机器人的实施评估作为优化遗传咨询的干预措施，无需 损害知情决策并促进人群筛查。为此，我们将分析 采访参与试验的参与者、遗传咨询师和初级保健提供者，使用 为实施提供信息的公认方法。 AGILITY 研究将提供证据支持 解决如何提供稳健且可扩展的遗传咨询这一关键问题的可行解决方案 围绕常规临床护理中的预测基因组学。