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: 9113335
• 负责人: Paul Dexter
• 金额: $ 11.19万
• 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/9113335
• 关键词: Address; Admission activity; Algorithms; Biological Markers; Businesses; Bypass; Cancer Center; Cardiology; Caring; Clinic; Clinic Visits; Clinical; Clinical Pharmacology; Community Practice; Computerized Medical Record; Data; Development; Diagnostic; Discipline of obstetrics; Drug usage; Enrollment; Environment; Gastroenterology; Genomic approach; 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; 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; personalized medicine; pharmacogenetic testing; pilot trial; prospective; safety net; treatment as usual

DESCRIPTION (provided by applicant): 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 advancs 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 innovatie 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.

描述（由申请人提供）：个性化医疗的目标是实现生物标志物药理学、分子诊断学和基因组学的进步，以改善公众健康。为了实现这门科学的全部好处，至关重要的是，将实验环境中取得的小规模科学进步扩展到社区实践，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，特别是那些服务不足的人群。许多科学进步绕过了服务不足的人群，从而导致护理不平等和成本效率低下。 2011 年，印第安纳个性化医学研究所 (IPM) 成立，作为致力于个性化医学研究的基础和临床研究人员的学术家园。 IPM 的一个具体目标是将这门科学推向临床实践。为此，本次活动的目的 提议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 每年处理超过 120 万名门诊患者和超过 15,000 名入院患者，付款人组合包括 45% 的无保险患者、26% 的医疗补助患者和 18% 的医疗保险患者。在该提案中，IPM 将与 Eskenazi Health 和 Regenstrief Institute 合作，招募新的“Eskenazi 队列”基因型患者。由临床医生和信息科学家组成的多学科小组将试点一种创新方法来实施药物基因组科学。 Regenstrief 研究所在医学信息学方面拥有良好的创新记录，并创造了评估真实临床结果的理想环境。该提案的具体目标是： 1) 检验以下假设：针对 24 种广泛使用的药物进行 CLIA 认证的基因分型测试与一年内医院和门诊经济成本的显着降低相关； 2) 测试此类药物遗传学测试是否与一年内临床结果的显着改善相关。患者将被随机分配到干预组，包括药物基因分型、将结果插入病历以及向提供者传播相关结果和决策算法（n = 2000 名患者），或分配到常规护理组（n = 4000 名患者）。该试验将在埃斯凯纳齐初级保健诊所和 6 个专科诊所实施。将前瞻性地跟踪并比较两组的经济成本和临床结果，包括就诊、住院、住院时间、药物不良反应、发病率和死亡率。为了维持这一努力，我们将把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儿童医院。这项研究的数据将首次允许根据现实世界的成本和结果开发药物基因组个性化的客观商业案例。