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.

个性化医学的目的是实施生物标志物药理学的进步 诊断和基因组学以改善公共卫生。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，可以做出商业案例来支持这种传播。重要的是 关键的创新将扩展到个人医院环境之外，尤其是那些 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，作为一个 导致护理和成本效率低下的不平等现象。 2011年，印第安纳州个性化医学研究所 （IPM）是为了作为致力于研究的基础和临床研究人员的学术住所 个性化医学。 IPM的一个具体目标是将该科学转向临床实践。为此， 该建议的目的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。埃斯基纳济卫生处理超过120万 每年门诊就诊，每年> 15,000次入院，付款人组合包括45％未保险，26％ 医疗补助和18％的医疗保险患者。在此提案中，IPM将与Eskenazi Health合作 RegeStrief Institute招募了基因分型患者的新“ Eskenazi队列”。一个多学科的群体 临床医生和信息科学家将尝试实施创新的方法 药物基础科学。 Regenstrief Institute拥有医学创新的可靠记录 信息学，并创造了一个理想的环境，以评估实际临床结果。具体 该提案的目的是：1）检验以下假设：CLIA认证的基因分型测试针对24 广泛使用的药物与医院的大幅降低和门诊经济成本有关 超过1年； 2）测试这种药物遗传学测试是否与显着改善有关 在1年以上的临床结果中。患者将被随机分为干预臂，涉及 药物基因分型，在病历中插入结果以及相关结果的传播 提供者的决策算法（n = 2000名患者）或通常的护理（n = 4000名患者）。这个审判将是 在埃斯基纳济初级保健诊所和6家专科诊所中实施。经济成本和临床 结局包括诊所就诊，住院，住院时间，不良药物反应，发病率和 死亡率将前瞻性遵循并在两组之间进行比较。为了维持这一努力，我们将 将对此测试的访问扩展到IU Health，以及隶属于NCI Simon Cancer Center和Riley医院 孩子们。这项研究的数据将首次允许开发目标业务案例 基于现实世界成本和结果的药物基因组个性化。