Integrated, Individualized, Intelligent Prescribing (I3P)

集成、个体化、智能处方（I3P）

• 批准号: 8700883
• 负责人: Joshua C. Denny
• 金额: $ 75.07万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8700883
• 关键词: Academic Medical Centers; Algorithms; Area; Attitude; Behavior; Boxing; Cardiac; Caring; Clinical; Colorectal Cancer; Community Health Networks; Community Health Systems; Computerized Medical Record; DNA; Data; Decision Making; Diagnosis; Drug Prescriptions; Ecosystem; Electronic Health Record; Environment; Evaluation; Future; Gene Mutation; General Hospitals; Genes; Genetic; Genetic Markers; Genetic screening method; Genomics; Genotype; Health; Healthcare; Healthcare Systems; Historically Black Colleges and Universities; Hospitals; Human Genome Project; Individual; Informatics; Institution; Internet; Label; Laboratories; Leadership; Link; Malignant Neoplasms; Malignant neoplasm of lung; Mediator of activation protein; Medical center; Medicine; Methods; Metric; Military Personnel; Mission; Morbidity - disease rate; Mutation; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacogenomics; Physicians; Population; Preventive; Probability; Procedures; Process; Provider; Reaction; Recommendation; Relative (related person); Reporting; Research; Research Infrastructure; Resources; Role; Simvastatin; Site; Structure; Surveys; System; Test Result; Testing; Therapeutic; Time; Toxic effect; Translations; Underrepresented Minority; United States Food and Drug Administration; Variant; Veterans; Vision; Warfarin; Wisconsin; Work; base; biobank; clinical practice; clinically significant; clopidogrel; computerized; improved; knowledge base; knowledge translation; lung melanoma; malignant breast neoplasm; medical schools; meetings; melanoma; mortality; programs; public health relevance; response; social stigma; tool; treatment program; tumor

A widely-held vision arising from the Human Genome Project is use of newly available genetic information to guide preventive and therapeutic decision making in individual patients. One therapeutic area that seems particularly ripe to test this concept is pharmacogenomics, the idea that variability in therapeutic response includes a genomic component. Common variation in both germline and somatic tumor genes is an increasingly well-recognized contributor to variability in drug response, and as a result, recommendations for genotype-guided therapy are being promulgated. Through leadership in multiple genomic networks, Vanderbilt has been at the forefront of pharmacogenomic discovery and translation of this knowledge into clinical practice locally. However, few institutions or practitioners have the procedures and tools in place to incorporate genetic data into routine drug prescribing. In this proposal, we move toward this practice by establishing a program for integrating genomic medicine in diverse healthcare settings. The purpose of the Integrated, Individualized, and Intelligent Prescribing (I3P) project is to perform a multi-site demonstration that integrating genetic data within electronic health records (EHRs) can improve healthcare. We will establish the processes and infrastructure necessary to disseminate clinical genetic testing, results reporting, and decision support into diverse hospital and EHR environments. This application focuses on pharmacogenomics, given the role of adverse drug reactions (ADRs) as major causes of morbidity and mortality, the increasing number of recognized variants included in US Food and Drug Administration (FDA) labels as mediators of both efficacy and toxicity, and the relative lack of stigma attached to carriers of variants in "pharmacogenes." The project will build on two ongoing, clinical genotyping efforts at Vanderbilt: 1) the Pharmacogenomic Resource for Enhanced Decisions In Care and Treatment (PREDICT) program, which prospectively tests patients for 184 high-value germline pharmacogenomic variants including those associated with clopidogrel, warfarin and simvastatin; and 2) the Personal Cancer Medicine Initiative (PCMI), which routinely performs multiplex tumor gene mutation testing in lung cancer and melanoma to direct therapy. I3P will leverage the existing expertise, informatics, and laboratory infrastructure and resources at Vanderbilt to implement genomic medicine in three diverse healthcare systems at "early adopter" sites. These healthcare systems include underserved, minority populations (Nashville General Hospital at Meharry Medical College), military populations (Nashville Veterans Affairs Medical Center), and a community health system (Aurora Health Care).

人类基因组计划产生的一个广泛持有的愿景是利用新近可用的基因 指导个体患者的预防和治疗决策的信息。一 测试这一概念的治疗领域似乎特别成熟，那就是药物基因组学，这个想法 治疗反应的变异性包括基因组成分。常见的变异 种系肿瘤基因和体细胞肿瘤基因都日益被认为是导致肿瘤发生的重要因素。 药物反应的变异性，因此，基因型指导治疗的建议是 正在颁布。通过在多个基因组网络中的领导地位，范德比尔特一直在 药物基因组学发现的前沿并将这些知识转化为临床 本地练习。然而，很少有机构或从业者拥有适当的程序和工具 将遗传数据纳入常规药物处方中。在本提案中，我们朝着这个方向迈进 通过建立将基因组医学整合到多元化医疗保健中的计划来进行实践 设置。综合、个性化和智能处方 (I3P) 项目的目的是 进行多站点演示，将遗传数据整合到电子健康中 记录（EHR）可以改善医疗保健。我们将建立流程和基础设施 向公众传播临床基因检测、结果报告和决策支持所必需的 多样化的医院和​​ EHR 环境。该应用程序侧重于药物基因组学，考虑到 药物不良反应（ADR）作为发病率和死亡率的主要原因， 美国食品和药物管理局 (FDA) 纳入的认可变体数量不断增加 标签为功效和毒性的介质，并且相对缺乏耻辱感 “药物基因”变异体的携带者。该项目将建立在两个正在进行的临床 范德堡大学的基因分型工作：1) 用于增强决策的药物基因组资源 护理和治疗 (PREDICT) 计划，前瞻性地测试患者的 184 项高价值 种系药物基因组变异，包括与氯吡格雷、华法林和 辛伐他汀； 2) 个人癌症医学倡议 (PCMI)，该倡议定期执行 对肺癌和黑色素瘤进行多重肿瘤基因突变检测以指导治疗。 I3P将 利用现有的专业知识、信息学以及实验室基础设施和资源 范德比尔特大学将在“早期”在三个不同的医疗保健系统中实施基因组医学 采用者”网站。这些医疗保健系统包括服务不足的少数民族人口（纳什维尔 梅哈里医学院总医院）、军人（纳什维尔退伍军人事务部 医疗中心）和社区卫生系统（Aurora Health Care）。