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.
