Table 1.

Functions of the NIA IMPACT Collaboratory’s^a Key Organizational Elements

Element	Function (s)
Leadership
NIA project office	Oversees all activities in cooperation with the two principal investigators.
External advisory panel	Reviews key milestones every 6 months and advises on strategies to ensure markers of success are being achieved.
Steering committee	Reviews the day-to-day activities every month and deliberates on current approaches and need for alternative strategies.
Administration and management core teams
Grants administration	Coordinates overall budget including about 40 subcontracts.
Organization and logistics	Coordinates all meetings/communication within the collaboratory.
Data sharing and standards	Implements a data-sharing plan for all collaboratory projects and centralized data capture system for pilot projects.
Investigator navigation	Coordinates assistance from collaboratory experts for IMPACT pilot project and Career Development Award recipients, as well as other NIA-funded investigators conducting ePCTs in dementia care.
Communication/Knowledge dissemination	Manages public website, knowledge repository, collaboratory intranet, social and news media, grand rounds and podcasts, and dissemination of all products created by the collaboratory community.
IRB and regulation	Oversees single IRB submissions, adherence to data use agreement standards, and serves as a liaison to the Data Safety Monitoring Board.
Working group cores and teams
Technical and data	Leverages electronic health records and administrative data sources to conduct ePCTs.
Pilot studies	Leads a nationwide competitive pilot award program for pilot studies for ePCTs (about 40 awards over 5 years).
Patient- and caregiver-reported outcomes	Develops and supports use of patient- and caregiver-reported outcomes relevant to PLWD in the design and conduct of ePCT.
Regulation and ethics	Clarifies the balance among the competing priorities of conducting ePCTs to protect the interests of participants and assure healthcare systems that regulatory issues are addressed.
Health equity	Develops and implements strategies to address health equity in the conduct of ePCTs.
Design and statistics	Focuses on the statistical methods needed to design, conduct, and analyze ePCTs.
Training	Trains investigators to become experts in conducting of ePCTs through workshops, career development awards (about eight over 5 years).
Dissemination and implementation	Focuses on implementing and disseminating dementia care interventions in ePCTs and optimizing the potential for integration into healthcare systems.
Healthcare systems	Focuses on engaging the varied healthcare systems providing dementia care in the conduct of ePCTs.
Stakeholder engagement	Focuses on engaging key stakeholders in the conduct of ePCTs.

^aNational Institute on Aging Imbedded Pragmatic Alzheimer’s disease (AD) or an AD-related dementia (AD/ADRD) Clinical Trials (IMPACT) Collaboratory.

Abbreviations: ePCT, embedded pragmatic clinical trial; IRB, institutional review board; NIA, National Institute on Aging.