Administrative Core

行政核心

• 批准号: 10673657
• 负责人: Vincent Mor
• 金额: $ 468.65万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673657
• 关键词: Aging; Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; Caregivers; Caring; Clinical Trials; Clinical Trials Design; Collaborations; Committee Members; Communication; Complex; Data; Databases; Dedications; Dementia; Development; Doctor of Philosophy; Elements; Ensure; Funding; Grant; Healthcare Systems; Home; Human Resources; Infrastructure; Institution; Institutional Review Boards; K-Series Research Career Programs; Knowledge; Leadership; Life; Life Cycle Stages; Link; Logistics; Maintenance; National Institute on Aging; Outcome; Persons; Pilot Projects; Pragmatic clinical trial; Preparation; Principal Investigator; Productivity; Public Health Schools; Recording of previous events; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Scientist; Services; Site; Structure; Sum; United States National Institutes of Health; Universities; care outcomes; care systems; career development; collaboratory; data enclave; data sharing; data standards; design; diversity and inclusion; experience; improved; innovation; service providers; success; systems research; training opportunity; web site; working group

PROJECT SUMMARY The National Institute on Aging (NIA) Alzheimer's disease (AD) and AD-related dementia (AD/ADRD) Collaboratory will serve as a national resource to promote the development and conduct of embedded pragmatic clinical trials (ePCTs) to improve care and outcomes for persons with dementia (PWD) and their caregivers, in partnership with the various healthcare systems (HCS) that deliver their care. To achieve this objective, the Collaboratory must be more than just a sum of its parts. An initiative of this scope requires not only that each component has the requisite infrastructure and resources, but also that activities are synergistically integrated across components. To do so will require an exceptional Administration and Management Core. The Core’s Specific Aims are to: Aim 1. Administer, manage, and integrate all the components of the AD/ADRD Collaboratory; Aim 2. Coordinate support and guidance for pilot project and NIA-funded investigators conducting ePCTs in PWD from the Working Group Cores and Administration Teams; and Aim 3. Coordinate the development and dissemination of all products, guidance materials, and training opportunities for key aspects of conducting ePCTs in PWD and their caregivers. Several factors will enable the Core to meet its formidable task. First, it will benefit from the experienced and cohesive leadership of the Multiple Principal Investigators (MPIs), Drs. Vincent Mor (Brown University School of Public Health) and Susan Mitchell (Hebrew Senior Life Institute for Aging Research (HSL IFAR)). Second administrative responsibilities will be supported by the rich research infrastructures of their institutions which have a long history of collaboration. Two highly-accomplished Executive Directors will lead the teams at each site; Rosa Baier MPH (Brown) and Ellen McCarthy PhD (HSL IFAR). Third, administrative functions will be organized across eight Teams (four per site) as follows: 1. Grants Administration (Brown); 2. Organization and Logistics (Brown); 3. Institutional Review Board (IRB)/Regulatory (Brown), 4. Data Sharing and Standards (Brown), 5. Investigator Navigation (HSL IFAR), 6. Communication and Knowledge Dissemination (HSL IFAR), 7. Stakeholder Engagement (HSL IFAR), and 8. Diversity and Inclusion (HSL IFAR). Finally, specialized service providers will be engaged to manage large, critical tasks that can be done more efficiently with their expertise (e.g. website creation and maintenance, single Institutional Review Board (sIRB)). Particularly innovative functions of the Core include: organizing proactive project support, coordinating the mandatory sIRB, hosting a common REDCap database, and a dedicated Team to ensure issues related to diversity and inclusion are met in all aspects of ePCT design. IMPACT: The proposed AD/ADRD Collaboratory has all the necessary ingredients for success: strong leadership, ample resources, experts leading the Working Group Cores and Teams, and a highly-impactful agenda. However, all these elements must be supported and integrated for the Collaboratory to transform the delivery, quality, and outcomes of care for PWD and their caregivers. The Administration and Management Core serves a critical role in achieving that objective.

项目总结 国家老龄研究所(NIA)、阿尔茨海默病(AD)和AD相关痴呆(AD/ADRD) 协作室将作为国家资源，促进嵌入式语用的发展和开展 临床试验(EPCT)，以改善痴呆症患者(PWD)及其照顾者的护理和预后 与提供医疗服务的各种医疗系统(HCS)建立合作伙伴关系。为了实现这一目标， 合作必须不仅仅是其组成部分的总和。这种规模的倡议不仅要求每个 这一组成部分不仅拥有必要的基础设施和资源，而且各项活动也是协同整合的 跨组件。要做到这一点，将需要一个特殊的行政和管理核心。核心的 具体目标是：目标1.管理、管理和集成AD/ADRD的所有组件 协作；目标2.协调对试点项目和NIA资助的调查人员进行的支持和指导 工作组核心和行政小组在PWD中的ePCT；以及目标3.协调 开发和传播所有产品、指导材料和关键方面的培训机会 在残障人士及其照顾者中进行ePCT。有几个因素将使核心能够完成其艰巨的任务。 首先，它将受益于多个首席调查员富有经验和凝聚力的领导， 文森特·莫尔博士(布朗大学公共卫生学院)和苏珊·米切尔博士(希伯来老年生活研究所 老龄化研究(HSL IFAR))。第二，行政责任将得到丰富的研究支持 他们机构的基础设施有很长的合作历史。两位成就卓著的高管 董事将领导每个地点的团队；罗莎·拜尔(Rosa Baier)公共卫生硕士(Brown)和艾伦·麦卡锡博士(HSL IFAR)。第三, 行政职能将由八个小组(每个地点四个)组成，具体如下：1.赠款管理 (布朗)；2.组织和后勤(布朗)；3.机构审查委员会(IRB)/监管(布朗)，4.数据 共享和标准(布朗)，5.调查员导航(HSL IFAR)，6.交流和知识 传播(HSL IFAR)、7.利益攸关方参与(HSL IFAR)和8.多样性和包容性(HSL IFAR)。 最后，将聘请专门的服务提供商来管理可以完成更多任务的大型关键任务 有效地利用他们的专业知识(例如网站创建和维护、单一机构审查委员会(SIRB))。 核心的特别创新职能包括：组织积极主动的项目支助，协调 强制性sirB，托管一个公共的RedCap数据库，以及一个专门的团队，以确保与以下相关的问题 EPCT设计的各个方面都满足多样性和包容性的要求。影响：拟议的AD/ADRD合作实验室 具备成功的所有必备要素：强大的领导力、充足的资源、专家领导工作 集团核心和团队，以及极具影响力的议程。但是，所有这些元素都必须得到支持，并且 为合作实验室整合，以改变对PWD及其患者的护理的交付、质量和结果 照顾者。行政和管理核心在实现这一目标方面发挥了关键作用。