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(申请人提供)：个性化医学的目标是实现生物标记物药理学、分子诊断学和基因组学的进步，以改善公众健康。为了充分实现这一科学的好处，至关重要的是将在实验环境中取得的科学进步和小规模的科学进步推广到社区实践中，并提供商业案例来支持这种传播。重要的是，关键创新必须从个别医院扩展到大型医疗保健系统，特别是那些包括未得到充分服务的人群的系统。许多科学进步绕过了服务不足的人群，结果导致了医疗保健的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之家。IPM的一个具体目标是将这门科学推向临床实践。为此，这样做的目的是 建议是在一个大型安全网医疗保健系统中试行一个基因组平台，并衡量这样做的经济成本和临床结果。Eskenazi Health每年处理120多万次门诊和15,000次住院，付费组合包括45%的未参保、26%的医疗补助和18%的医疗保险患者。在这项提案中，IPM将与Eskenazi Health和Regenstrief Institute合作，招募一批新的Eskenazi基因分型患者。一个由临床医生和信息科学家组成的多学科小组将试验一种创新的方法来实施药物基因组学。Regenstrief研究所在医学信息学创新方面有着良好的记录，并创造了一个评估真实临床结果的理想环境。这项建议的具体目的将是：1)测试CLIA认证的针对24种广泛使用的药物的基因分型测试与一年内住院和门诊经济成本显著降低相关的假设；以及2)测试这种药物遗传学测试是否与一年内临床结果的显著改善相关。患者将被随机分配到干预组，包括药物基因分型、将结果插入医疗记录并将相关结果和决策算法传播给提供者(n=2000名患者)，或接受常规护理(n=4000名患者)。这项试验将在Eskenazi初级保健诊所和6家专科诊所实施。前瞻性地跟踪两组的经济成本和临床结果，包括诊所就诊、住院时间、药物不良反应、发病率和死亡率，并进行比较。为了保持这一努力，我们将把这项测试的机会扩大到IU Health，以及附属的NCI Simon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为药物基因组个性化开发一个客观的商业案例。