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: 9486384
• 负责人: Paul Dexter
• 金额: $ 8万
• 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 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9486384
• 关键词: Address; Admission activity; Algorithms; Biological Markers; Businesses; Bypass; CLIA certified; Cancer Center; Cardiology; Caring; Clinic; Clinic Visits; Clinical; Clinical Pharmacology; Community Practice; Community of Practice; Computerized Medical Record; Data; Development; 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; International; Intervention; Laboratories; Length of Stay; Measures; Medicaid; Medical Informatics; Medical Records; Medicare; Modeling; Morbidity - disease rate; Nephrology; Outcome; Outpatients; Patient-Focused Outcomes; 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; System; Testing; Time; Underserved Population; Uninsured; Universities; Visit; aging brain; arm; base; clinical care; clinical practice; cohort; cost; digital; economic cost; evidence base; experience; genomic platform; genotyped patients; healthy aging; improved; inner city; innovation; medical specialties; molecular diagnostics; mortality; multidisciplinary; personalized medicine; pharmacogenetic testing; pilot trial; prospective; public health relevance; 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）：个性化医学的目标是实施生物标志物药理学，分子诊断和基因组学的进步，以改善公共卫生。为了实现这项科学的全部好处，至关重要的是，在实验环境中和小规模上取得的科学进步将扩展到社区实践，并且可以做出商业案例来支持这种传播。重要的是要将关键创新扩展到各个医院环境中，尤其是包括服务不足的人群的医疗保健系统。许多科学进步绕过了服务不足的人群，因此护理和成本效率低下的不平等现象。 2011年，创建了印第安纳州个性化医学研究所（IPM），以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住所。 IPM的一个具体目标是将该科学转向临床实践。为此，目的 建议是在大型安全网保健系统中试行基因组平台，并衡量这样做的经济成本和临床结果。埃斯凯纳济（Eskenazi Health）每年处理超过120万个门诊就诊和> 15,000次入院，付款人组合包括45％未保险，26％的医疗补助和18％的Medicare患者。在此提案中，IPM将与埃斯基纳济卫生健康和雷金斯研究所合作，招募新的基因分型患者“埃斯基纳济同志”。跨学科的临床医生和信息科学家小组将尝试采用创新方法来实施药物基因组学科学。 Regenstrief Institute拥有医学信息学创新的可靠记录，并创造了一个理想的环境，以评估实际临床结果。该提案的具体目的是：1）检验以下假设：CLIA认证的基因分型测试针对24种使用的药物，与医院的大幅降低和1年以内的门诊经济成本大幅降低有关； 2）测试这种药物遗传学测试是否与1年内临床结局的显着改善有关。患者将被随机分为干预臂，涉及药物基型，在病历中插入结果以及相关结果的传播和对提供者的决策算法（n = 2000名患者）或通常的护理（n = 4000名患者）。该试验将在埃斯凯纳济初级保健诊所和6家专科诊所实施。经济成本和临床成果，包括诊所就诊，住院，住院时间，不良药物反应，发病率和死亡率，并将在两组之间进行比较。为了维持这一努力，我们将将对这项测试的访问范围扩展到IU Health，以及隶属的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基于现实世界成本和成果的药物基因组个性化的客观业务案例开发。