Embedding Pharmacogenotyping in an Integrated Health System for the Underserved

将药物基因分型嵌入到服务欠缺的综合卫生系统中

• 批准号: 8703229
• 负责人: Paul Dexter
• 金额: $ 75万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-05 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8703229
• 关键词: Address; Admission activity; Algorithms; Biological Markers; Businesses; Bypass; Cancer Center; Cardiology; Caring; Clinic; Clinic Visits; Clinical; Clinical Pharmacology; Commit; Community Practice; Computerized Medical Record; Data; Development; Diagnostic; Discipline of obstetrics; Drug usage; Enrollment; Environment; Gastroenterology; Genomics; Genotype; Goals; HIV; Health; Health Care Costs; Health system; Healthcare Systems; Home environment; Hospitals; Indiana; Individual; Inequality; Informatics; Institutes; Intervention; Laboratories; Learning; Length of Stay; Measures; Medicaid; Medical Informatics; Medical Records; Medicare; Medicine; Modeling; Molecular; Morbidity - disease rate; Nephrology; Outcome; Outpatients; Patients; Pediatric Hospitals; Pharmaceutical Preparations; Pharmacogenomics; Pharmacology; Primary Health Care; Provider; Public Health; Randomized; Reaction; Recruitment Activity; Research; Research Personnel; Science; Scientific Advances and Accomplishments; Scientist; Solutions; System; Testing; Time; Underserved Population; Uninsured; Universities; Visit; aging brain; arm; base; clinical care; clinical practice; cohort; cost; digital; economic cost; evidence base; experience; improved; inner city; innovation; medical specialties; mortality; multidisciplinary; pharmacogenetic testing; pilot trial; prospective; public health relevance; safety net; treatment as usual

The goal of Personalized Medicine is to implement advances in biomarker pharmacology, molecular diagnostics and genomics to improve public health. For the full benefits of this science to be realized, it is critical that scientific advances made in experimental settings and on a small scale be extended to community practice and that a business case can be made to support such dissemination. It is important that key innovations be extended beyond individual hospital settings to large health care systems, especially those that include underserved populations. Many scientific advances bypass underserved populations, and as a result inequalities of care and cost inefficiencies result. In 2011, the Indiana Institute for Personalized Medicine (IPM) was created to serve as an academic home for basic and clinical researchers committed to research in personalized medicine. A specific goal of the IPM is to move this science towards clinical practice. To that end, the purpose of this proposal is to pilot a genomic platform in a large safety-net health care system, and to measure the economic costs and clinical outcomes of doing so. Eskenazi Health handles over 1.2 million outpatient visits per year and > 15,000 admissions annually, with a payer mix that include 45% uninsured, 26% Medicaid and 18% Medicare patients. In this proposal, the IPM will partner with Eskenazi Health and the Regenstrief Institute to recruit a new "Eskenazi cohort" of genotyped patients. A multidisciplinary group of clinicians and information scientists will pilot an innovative approach to the implementation of pharmacogenomic science. The Regenstrief Institute has a proven track record of innovation in medical informatics, and has created an ideal environment in which to assess real clinical outcomes. The specific aims of this proposal will be: 1) To test the hypothesis that a CLIA certified genotyping test targeted at 24 widely used drugs is associated with significant reductions in hospital and outpatient economic costs incurred over 1 year; and 2) To test whether such pharmacogenetic testing is associated with significant improvements in clinical outcomes over 1 year. Patients will be randomized either to an intervention arm, involving pharmacogenotyping, insertion of results in the medical record and dissemination of relevant results and decision algorithms to providers (n=2000 patients), or to usual care (n=4000 patients). This trial will be implemented in Eskenazi primary care clinics and 6 specialty clinics. Economic costs and clinical outcomes including clinic visits, hospital admissions, length of stay, adverse drug reactions, morbidity and mortality, will be followed prospectively and compared between the two groups. To sustain this effort, we will extend access to this testing to IU Health, and the affiliated NCI Simon Cancer Center and Riley Hospital for Children. Data from this study will allow for the first time the development of an objective business case for pharmacogenomic personalization based on real world costs and outcomes.

个性化医疗的目标是实现生物标志物药理学、分子生物学的进步 诊断和基因组学以改善公共卫生。为了充分发挥这门科学的优势， 至关重要的是，将实验环境和小规模取得的科学进步推广到 社区实践，并且可以制定商业案例来支持这种传播。重要的是 关键创新应从单个医院环境扩展到大型医疗保健系统，特别是那些 其中包括服务不足的人群。许多科学进步绕过了服务不足的人群，并且作为 结果导致护理不平等和成本效率低下。 2011年，印第安纳个性化医疗研究所 (IPM) 的创建是为了作为致力于研究的基础和临床研究人员的学术家园 个性化医疗。 IPM 的一个具体目标是将这门科学推向临床实践。为此， 该提案的目的是在大型安全网医疗保健系统中试点基因组平台，并 衡量这样做的经济成本和临床结果。 Eskenazi Health 处理超过 120 万人 每年门诊量超过 15,000 人次，付款人组合包括 45% 没有保险，26% 医疗补助和 18% 医疗保险患者。在该提案中，IPM 将与 Eskenazi Health 和 Regenstrief 研究所将招募一个新的基因分型患者“Eskenazi 队列”。一个多学科小组 临床医生和信息科学家将试验一种创新的实施方法 药物基因组学。 Regenstrief Institute 在医疗创新方面拥有良好的记录 信息学，并创造了一个评估真实临床结果的理想环境。具体的 该提案的目的是： 1) 检验 CLIA 认证的基因分型测试针对 24 广泛使用的药物可显着降低医院和门诊患者的经济成本 1年以上； 2) 测试此类药物遗传学测试是否与显着改善相关 超过一年的临床结果。患者将被随机分配到干预组，包括 药物基因分型、将结果插入病历并传播相关结果和 向提供者（n=2000 名患者）或常规护理（n=4000 名患者）提供决策算法。此次审判将 在埃斯凯纳齐初级保健诊所和 6 个专科诊所实施。经济成本和临床 结果包括就诊、入院、住院时间、药物不良反应、发病率和 死亡率，将进行前瞻性跟踪并比较两组之间的情况。为了维持这一努力，我们将 将这项检测的范围扩大到 IU Health 以及附属的 NCI 西蒙癌症中心和莱利医院 孩子们。这项研究的数据将首次为以下领域制定客观的商业案例： 基于现实世界成本和结果的药物基因组个性化。