Administrative Core

行政核心

• 批准号: 10443663
• 负责人: Vincent Mor
• 金额: $ 368.55万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10443663
• 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; Dementia; Development; Doctor of Philosophy; Elements; Ensure; Funding; Grant; Healthcare Systems; Home; Human Resources; Infrastructure; Institutes; Institution; Institutional Review Boards; K-Series Research Career Programs; Knowledge; Lead; Leadership; Life; Life Cycle Stages; Link; Logistics; Maintenance; National Institute on Aging; Office of Administrative Management; Persons; Pilot Projects; Pragmatic clinical trial; Preparation; Principal Investigator; 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; cohesion; 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.

项目概要 美国国家老龄化研究所 (NIA) 阿尔茨海默病 (AD) 和 AD 相关痴呆 (AD/ADRD) 合作实验室将作为国家资源，促进嵌入式务实研究的发展和开展 旨在改善痴呆症患者 (PWD) 及其护理人员的护理和结果的临床试验 (ePCT)， 与提供护理服务的各个医疗保健系统 (HCS) 建立伙伴关系。为了实现这一目标， 协作必须不仅仅是各个部分的总和。这一范围的倡议不仅要求每个人 组成部分拥有必要的基础设施和资源，而且活动是协同整合的 跨组件。为此，需要卓越的行政和管理核心。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 合作；目标 2. 协调对试点项目和 NIA 资助的研究人员进行的支持和指导 来自工作组核心和管理团队的 PWD 中的 ePCT；目标 3. 协调 开发和传播所有产品、指导材料以及关键方面的培训机会 对残疾人及其护理人员进行 ePCT。有几个因素将使核心能够完成其艰巨的任务。 首先，它将受益于多个主要研究者 (MPI) 经验丰富且富有凝聚力的领导， 博士。 Vincent Mor（布朗大学公共卫生学院）和 Susan Mitchell（希伯来高级生命研究所） 衰老研究（HSL IFAR））。第二行政职责将得到丰富研究的支持 其机构的基础设施具有悠久的合作历史。两位卓有成就的高管 董事将领导每个站点的团队； Rosa Baier MPH（布朗）和 Ellen McCarthy 博士（HSL IFAR）。第三， 行政职能将由八个小组（每个地点四个）组织如下： 1. 赠款管理 （棕色的）; 2. 组织和后勤（棕色）； 3. 机构审查委员会 (IRB)/监管机构（布朗），4. 数据 共享和标准（棕色），5. 研究者导航 (HSL IFAR)，6. 沟通和知识 传播 (HSL IFAR)、7. 利益相关者参与 (HSL IFAR) 和 8. 多元化和包容性 (HSL IFAR)。 最后，专业服务提供商将参与管理可以完成更多工作的大型关键任务 高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：组织积极的项目支持、协调 强制性 sIRB，托管一个通用的 REDCap 数据库，以及一个专门的团队来确保与 ePCT 设计的各个方面都满足多样性和包容性。影响：拟议的 AD/ADRD 合作实验室 拥有成功的所有必要要素：强有力的领导、充足的资源、领导工作的专家 集团核心和团队，以及极具影响力的议程。然而，所有这些要素都必须得到支持并且 为合作实验室进行整合，以改变残疾人及其患者的护理服务的提供、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着关键作用。