Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

通过在印第安纳州不同且服务不足的人群中进行实用试验来实施基因组医学。

• 批准号: 10365343
• 负责人: Paul Dexter
• 金额: $ 15.85万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-19 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10365343
• 关键词: Adverse event; Antidepressive Agents; Area; Bioethics; CYP2C19 gene; CYP2D6 gene; Caring; Clinical; Clinical Medicine; Computerized Medical Record; Control Groups; Dangerousness; Development; Dose; Drug Prescriptions; Effectiveness; Enrollment; Ethics; Funding; Future; General Practices; Genes; Genomic medicine; Genomics; Goals; Guidelines; Health Personnel; Healthcare; Indiana; Institution; Interview; Knowledge; Lead; Learning; Letters; Life; Materials Testing; Measures; Medical; Medicine; Mental Depression; Methods; Minority Groups; Mission; National Human Genome Research Institute; Opioid; Pain; Participant; Patient Care; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacogenetics; Pharmacogenomics; Population Heterogeneity; Postoperative Pain; Practice Guidelines; Provider; Public Health; Randomized; Research; Resources; Sampling; Site; Telephone Interviews; Test Result; Testing; Underserved Population; Universities; Work; chronic pain; evidence base; genetic technology; health care service utilization; improved; innovation; interest; pragmatic trial; routine care; socioeconomics; usability

Pharmacogenomics can only be effectively and ethically implemented into routine care if patients are informed about the results of their pharmacogenomic testing, so they can understand changes made to their medications and inform future providers about relevant findings. There are significant challenges to educating patients in this area. Detailed explanations may be confusing and lead to dangerous mistakes, such as stopping a medicine incorrectly without asking a healthcare provider. Materials that have been used to explain pharmacogenomic results have not been tested in diverse groups of patients and in real-life clinical situations. The ADOPT PGx trial (A Depression and Opioid Pragmatic Trial in Pharmacogenetics), funded by the Implementing Genomics in Practice (IGNITE) network of NHGRI, provides an excellent opportunity to learn more about how to adequately inform patients about their pharmacogenomic results. The trial will enroll 4500 patients with depression, chronic pain, or expected post-operative pain. Half will be randomized to undergo pharmacogenomic testing for two genes, CYP2C19 and CYP2D6, and results will be entered in the electronic medical record to guide prescription of anti-depressants and pain medicines. After completing participation, all patients will be sent a letter informing them of their pharmacogenomic test results. For the proposed supplement, we will conduct telephone interviews with 150 participants total from all sites after they receive their pharmacogenomic test results (120 with actionable results and 30 with non-actionable results). Our long- term goal is to support the ethical and effective use of pharmacogenomics in clinical medicine. The main objectives of the project are to leverage a large study to (a) explore patients’ perspectives on how they learned their pharmacogenomics results, (b) determine the usability and acceptability of a letter disclosing those results, and (c) determine patients’ objective understanding of those results. Previous studies have measured patients’ subjective understanding (how they feel about their level of knowledge) without measuring objective understanding (how they perform on a knowledge test). Our Aims are to: 1: Assess how patients learned about their pharmacogenomic test results and determine the acceptability and usability of written materials disclosing those test results. 2: Determine patients’ understanding of their results of pharmacogenomics testing and implications for future healthcare, including their intentions to discuss results with future providers. Our project is innovative because we will identify patients’ perspectives and understanding of pharmacogenomic test results in a diverse population who underwent testing in a range of real-life clinical settings. The project will produce a significant advance by providing evidence about return pharmacogenomic results that will inform development of practice guidelines and will create resources for future bioethics research. Achieving our aims will further NHGRI’s mission of integrating genomics into medical care in a particularly important area, since pharmacogenomics will likely be one of the first genetic technologies to be used widely in general practice.

药物基因组学只有在患者知情的情况下才能有效和道德地实施到常规护理中 关于他们的药物基因组学测试的结果，这样他们就可以了解他们的药物基因组学测试结果的变化。 药物，并告知未来的供应商有关的调查结果。教育面临着巨大的挑战， 病人在这个领域。详细的解释可能会令人困惑，并导致危险的错误，例如 在没有询问医疗保健提供者的情况下错误地停药。这些材料被用来解释 药物基因组学结果尚未在不同的患者组和现实生活中的临床情况下进行测试。 ADOPT PGx试验（药物遗传学中的抑郁症和阿片类药物实用性试验），由 实施NHGRI的基因组学实践（IGNITE）网络，提供了一个很好的学习机会 更多关于如何充分告知患者其药物基因组学结果。该试验将招募4500名 抑郁、慢性疼痛或预期术后疼痛的患者。一半将随机接受 对两种基因（CYP 2C 19和CYP 2D 6）进行药物基因组学检测，并将结果输入电子 医疗记录指导抗抑郁药和止痛药的处方。完成参与后，所有 将向患者发送一封信，告知他们的药物基因组学测试结果。拟议 作为补充，我们将在所有研究中心的150名参与者收到 他们的药物基因组学检测结果（120例具有可采取行动的结果，30例具有不可采取行动的结果）。我们长久以来- 长期目标是支持药物基因组学在临床医学中的伦理和有效使用。主要 该项目的目标是利用一项大型研究来（a）探索患者对他们如何学习的观点 他们的药物基因组学结果，（B）确定披露这些结果的信函的可用性和可接受性 结果，以及（c）确定患者对这些结果的客观理解。以前的研究测量了 患者的主观理解（他们对自己知识水平的感受），而不测量客观 了解他们如何在知识测试中表现。我们的目标是：1：评估患者如何学习 药物基因组学试验结果，并确定书面材料的可接受性和可用性 披露这些测试结果。2：确定患者对其药物基因组学检测结果的理解 以及对未来医疗保健的影响，包括他们与未来提供者讨论结果的意图。我们 项目是创新的，因为我们将确定患者的观点和药物基因组学的理解 测试结果在一个不同的人群谁经历了测试在一系列现实生活中的临床设置。该项目将 通过提供有关返回药物基因组学结果的证据， 制定实践指南，并将为未来的生物伦理学研究创造资源。实现我们的目标 将进一步推进NHGRI的使命，将基因组学整合到医疗保健中的一个特别重要的领域，因为 药物基因组学将可能是第一批广泛用于一般实践的遗传技术之一。