Trans-America Consortium of the Health Care Systems Research Network for the Precision Medicine Initiative Cohort Program

泛美医疗保健系统研究网络联盟精准医学倡议队列计划

基本信息

批准号：
9355293
负责人：
Brian Kenneth Ahmedani
金额：
$ 189.08万
依托单位：
HENRY FORD HEALTH SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-27 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9355293
关键词：
Age Aging Alcohol or Other Drugs use American Americas Area Asthma Authorization documentation Belief Big Data Cancer Research Network Cardiovascular Diseases Caring Catchment Area Clinical Clinical Data Clinical Trials Clinical Trials Network Collection Communities Consent Data Data Set Data Sources Dementia Diabetes Mellitus Diagnosis Disease Electronic Health Record Enrollment Environmental Exposure Epidemiologic Studies Epidemiology Feedback Fostering Funding General Population Genetic Predisposition to Disease Genetic Research Geographic state Goals Health Health Personnel Health Planning Health Services Health system Healthcare Systems Human Resources Hypersensitivity Idaho Individual Informatics Informed Consent Institutes Insurance Intervention Life Style Link Location Malignant Neoplasms Massachusetts Medical Medical center Medicare/Medicaid Mental Health Michigan Minnesota Modification Movement National Institute of Drug Abuse National Institute of Mental Health North Dakota Nurses Obesity PMI cohort Participant Patient Self-Report Patient Transfer Patients Performance Philosophy Population Precision Medicine Initiative Primary Health Care Procedures Process Prospective Studies Public Health Informatics Recording of previous events Recruitment Activity Research Research Design Research Infrastructure Research Personnel Research Project Grants Research Support Resources Risk Schedule Scientist Sentinel Site Specialist Specific qualifier value Specimen Stream Structure Surveys System Testing Texas United States United States National Institutes of Health Wisconsin Work biobank case control chronic pain cohort comparative demographics empowered experience health care service utilization health record individual patient individualized medicine innovation member multi-site trial outreach patient oriented precision medicine programs prospective scale up study population systems research virtual volunteer

项目摘要

The promise of Precision Medicine in the United States can be most effectively realized on a large scale in the next decades if a research infrastructure is established and accessible to scientists across the nation and includes a large and engaged study population with comprehensive health and lifestyle histories linked to biospecimens and clinical data. Investigators from 4 integrated delivery networks (IDNs) spanning 7 states of the Health Care Systems Research Network (HCSRN, est. as HMORN in 1994), Henry Ford Health System and its partner Spectrum Health (HF-SH) in Michigan, Baylor Scott & White (BSW) in Texas, Essentia Health (EH) located in Minnesota, North Dakota, Wisconsin and Idaho, and Meyers-Fallon Primary Care Institute (MF) located in Massachusetts, have come together to form the PRECISION MEDICINE TRANS-AMERICA CONSORTIUM for the HCSRN (TACH) for the purpose of recruiting, enrolling and retaining 10,000 patient volunteers, herein designated as Patient Partners, into the Precision Medicine Initiative Cohort Program, at two of the sites in the initial 12 month period, with the potential to expand to even more HCSRN locations. The Precision Medicine Initiative (PMI) represents a major shift in the way research is conceptualized in the US. Rather than several small disease specific prospective studies, this major initiative develops the largest single prospective study involving patients and individuals with diverse sets of clinical histories, environmental exposures, demographics, genetic susceptibility, and beliefs about medical care. Furthermore, as opposed to researchers collecting data and restricting access to the outside scientific community, this study seeks to develop an open access structure whereby scientists can leverage the same data and infrastructure to make new discoveries and revolutionize medical care. Most importantly, this initiative seeks to engage participants as lifelong partners, such that by agreeing to share their data, Patient Partners will receive data and feedback on their own risk and protective factors for diseases. Finally, by combining all of these unique data sources, we can move towards tailoring treatments to patients. This, clearly, represents a new age of research, and our TACH network fully-supports and embraces this movement. We not only share the important philosophy of the NIH and the PMI, but have demonstrated this philosophy in our prior work. As we will describe, we have the resources, network, and experience to become a successful Regional Medical Center Healthcare Provider Organization (RMC-HPO) network in the PMI Cohort Program (PMI-CP). Our proposed TACH network draws upon the strengths of the HCSRN, a consortium of 18 large IDNs serving the vast majority of U.S. states. Our proposed network involves four HCSRN sites (HF-SH, BSW, EH, and MF). All participating HCSRN sites have a standard Virtual Data Warehouse (VDW), which has extensive clinical and demographic information for all members. This data infrastructure is extremely innovative for multisite studies. The VDW includes a combination of electronic health records (EHR) and insurance claims data, which allows the capture of nearly all health care utilization (~99%) within and outside of the system. Data on demographics, encounters, prescriptions, diagnoses, procedures, and enrollment are organized into uniform datasets using standardized variables and definitions across sites. The participating IDNs are all using the Epic EHR system, which is the largest and most commonly used EHR across the US – over 52% of Americans now have an Epic health record. Epic employs a Care Everywhere feature, which allows systems to access EHR data from any Epic-using facility, with patient permission. All HCSRN sites are leading IDNs with affiliated health plans (Commercial, Medicaid, Medicare plans) and academic research centers. They have all collaborated for decades on multi-site research projects (see Past Performance Section), and are supported by federal infrastructure support, including (but not limited to) the NCI-funded Cancer Research Network (U24CA171524), NIMH-funded Mental Health Research Network (U19MH092201), Health Systems Node of the NIDA Clinical Trials Network (UG1DA040314), FDA-funded Mini-Sentinel, and NIA-funded AGING Initiative (R24AG045050), among many others. Populations vary by health system, but the demographic make-up is diverse and broadly representative of their local state’s general populations. Each site has experienced investigators, coordinators, informatics specialists, nurses, recruiters, medical and lab associates, statisticians, and other staff already in place and available to participate in the PMI-CP project immediately. This is essential, given that this project requires rapid recruitment and scale-up. The IDNs all manage many NIH projects, including numerous multi-site prospective studies and clinical trials. Over 100 multi-site trials and prospective studies have been externally funded across the HCSRN. As demonstrated in the ‘Key Personnel Section,’ investigators have vast expertise in a diverse range of disease areas (e.g., cardiovascular disease, cancer, diabetes, allergy, asthma, mental health, substance use, obesity, chronic pain, dementia) and research designs (e.g., experimental, prospective, case control, observational, and big-data EHR epidemiological studies) as well as in patient engagement, health informatics, and genetic research. All TACH sites employ NIH-funded investigators with extensive experience in recruiting and retaining sizeable numbers of research participants, in collecting biospecimens and self-report survey data, using electronic health record (EHR) data, e-consenting, coordinating multi-site data streams, and in collaborating with other health provider organizations and national centralized research cores. These IDN HPOs in the TACH network together provide comprehensive health services to over 9 million diverse patients each year. We will capitalize on our experience in recruiting and retaining large numbers of participants in epidemiological and clinical cohorts along with our patient-centered and process improvement approaches and expertise in managing multi-site EHR data, to efficiently maximize recruitment and retention, and foster true partnerships with the TACH PMI-CP Patient Partners, as well as nimbly identify and solve project problems as they arise, or make needed modifications.

在美国，精确医学的承诺可以在大规模上最有效地实现接下来的几十年是否建立了研究基础设施，全国各地的科学家都可以访问包括一个庞大而敬业的研究人群，具有全面的健康和生活方式历史生物测量和临床数据。来自4个综合交付网络（IDN）的调查人员跨越了7个状态卫生保健系统研究网络（HCSRN，Est。1994年的HMorn），亨利·福特卫生系统及其合作伙伴Spectrum Health（HF-SH）位于密歇根州，贝勒·斯科特（Baylor Scott＆White）（BSW），德克萨斯州的Essentia Health （EH）位于明尼苏达州，北达科他州，威斯康星州和爱达荷州，以及Meyers-Fallon初级保健研究所（MF）位于马萨诸塞州，已经聚集在一起形成精密医学跨美国 HCSRN（TACH）的财团，目的是招募，招募和保留10,000名患者此处被指定为患者合作伙伴的志愿者进入了精密医学倡议队列计划，在最初的12个月期间，其中两个站点有可能扩展到更多的HCSRN位置。精确医学计划（PMI）代表了研究方式的重大转变美国。这项主要倡议不是多个小疾病的特定前瞻性研究，而是发展最大的单一前瞻性研究涉及患者和具有临床历史的潜水员组的患者环境暴露，人口统计，遗传敏感性，并相信医疗。此外，与收集数据并限制访问外部科学界的研究人员相反，本研究试图开发开放访问结构，科学家可以利用相同的数据和基础架构做出新发现并彻底改变医疗服务。最重要的是，该计划试图参与作为终身合作伙伴的参与者，通过同意共享数据，患者合作伙伴将收到数据以及关于自身风险和疾病保护因素的反馈。最后，通过结合所有这些独特数据源，我们可以朝着为患者裁缝。这显然代表了一个新时代研究以及我们的TACH网络充分支持并包含这一运动。我们不仅分享重要的 NIH和PMI的哲学，但在我们先前的工作中证明了这一哲学。我们会的描述，我们拥有成为成功的区域医疗中心的资源，网络和经验 PMI队列计划（PMI-CP）中的医疗保健提供商组织（RMC-HPO）网络。我们提出的TACH网络借鉴了HCSRN的优势，该联盟由18个大型IDN组成为美国绝大多数州服务。我们提出的网络涉及四个HCSRN站点（HF-SH，BSW，EH，，和MF）。所有参与的HCSRN站点都有一个标准的虚拟数据仓库（VDW），它具有广泛的所有成员的临床和人口统计信息。对于多站点，此数据基础架构非常创新研究。 VDW包括电子健康记录（EHR）和保险索赔数据的组合，这允许捕获系统内部和外部几乎所有医疗保健利用率（〜99％）。数据上人口统计，遭遇，处方，诊断，程序和入学率均匀数据集使用跨站点的标准变量和定义。参与的IDN都在使用史诗 EHR系统是美国最大，最常用的EHR - 现在超过52％的美国人拥有史诗般的健康记录。 Epic员工到处都有护理功能，该功能允许系统访问EHR 在患者许可的情况下，来自任何史诗般的设施的数据。所有HCSRN站点都在带有会员的IDN领导健康计划（商业，医疗补助，医疗保险计划）和学术研究中心。他们有全部在多站点研究项目（请参阅过去的绩效部分）上合作数十年，并得到联邦基础设施支持，包括（但不限于）NCI资助的癌症研究网络（U24CA171524），NIMH资助的心理健康研究网络（U19MH092201），卫生系统节点 NIDA临床试验网络（UG1DA040314），FDA资助的迷你赛和NIA资助的老化倡议（R24AG045050），等等。人群因卫生系统而异，但人口构成是潜水员并广泛地代表其当地国家的一般人口。每个网站都有经历调查人员，协调员，信息专家，护士，招聘人员，医疗和实验室员工，统计学家，还有其他工作人员已经到位，可以立即参加PMI-CP项目。这是鉴于该项目需要快速招募和扩大规模。 IDN都管理了许多NIH 项目，包括许多多站点的前瞻性研究和临床试验。超过100次多站点试验和前瞻性研究已在整个HCSRN上资助。如“关键人员” 一节，研究人员在潜水区域的疾病领域（例如心血管疾病，癌症，糖尿病，过敏，哮喘，心理健康，药物使用，肥胖，慢性疼痛，痴呆）和研究设计（例如，实验，前瞻性，案例控制，观察性和大数据EHR流行病学研究）以及患者参与，健康信息和遗传研究。所有TACH网站员工NIH资助的调查员都有丰富的招聘和保留经验大量研究参与者，在收集生物测量和自我报告调查数据时，使用电子健康记录（EHR）数据，电子一致，协调的多站点数据流以及合作与其他健康提供者组织和国家集中研究核心。这些IDN HPO TACH网络每年共同为超过900万潜水员患者提供全面的卫生服务。我们将利用我们在招募和保留大量参与者的经验以及临床人群以及我们以患者为中心的过程改进方法和专业知识管理多站点EHR数据，有效地最大化招聘和保留率，并促进真正的合作伙伴关系与TACH PMI-CP患者合作伙伴一起，以及在出现的项目问题或解决项目问题的情况下或进行所需的修改。