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）：个性化医疗的目标是实施生物标志物药理学，分子诊断学和基因组学的进步，以改善公众健康。为了实现这一科学的全部利益，至关重要的是，在实验环境中取得的科学进步和小规模扩大到社区实践，并可以提出一个商业案例来支持这种传播。重要的是，关键创新要从单个医院环境扩展到大型医疗保健系统，特别是那些包括服务不足人群的系统。许多科学进步绕过了服务不足的人群，结果造成了护理不平等和成本效率低下。2011年，印第安纳州个性化医学研究所（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。为此目的， 该提案的目的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每年处理超过120万次门诊就诊，每年超过15，000次入院，其中包括45%的无保险患者，26%的医疗补助患者和18%的医疗保险患者。在这项提案中，IPM将与Eskenazi Health和Regenstrief Institute合作，招募一个新的基因型患者“Eskenazi队列”。一个由临床医生和信息科学家组成的多学科小组将试行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，并为评估真实的临床结果创造了理想的环境。本提案的具体目的是：1）检验针对24种广泛使用药物的CLIA认证基因分型检测与1年内发生的医院和门诊经济成本显著降低相关的假设; 2）检验此类药物遗传学检测是否与1年内临床结局的显著改善相关。患者将被随机分配至干预组，包括药物基因分型、在病历中插入结果并向提供者传播相关结果和决策算法（n=2000例患者），或接受常规治疗（n=4000例患者）。本试验将在Eskenazi初级保健诊所和6个专科诊所实施。将前瞻性随访两组的经济成本和临床结局，包括门诊访视、住院、住院时间、药物不良反应、发病率和死亡率，并进行比较。为了维持这一努力，我们将把这项测试的范围扩大到IU Health，以及附属的NCI西蒙癌症中心和莱利儿童医院。本研究的数据将首次允许基于真实的世界成本和结果开发药物基因组学个性化的客观商业案例。