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Technical, Data and Health Care Systems Core (TDHCS) (B)

$4,318,310U54FY2025AGNIH

Brown University, Providence RI

Investigators

Linked publications & trials

Abstract

Conducting embedded pragmatic clinical trials (ePCTs) requires willing and committed health care systems (HCS) which recognize the importance of meeting the needs of PLWD and their care partners (CPs). Equally as important are investigators who are able to work with HCS partners at all levels to successfully implement interventions into the clinical workflow and master the HCS data systems to identify ePCT participants and extract outcomes from real world data (RWD) sources, such as electronic health records (EHR). Without harmonizing these elements, the successful conduct of ePCTs and ultimate dissemination of effective interventions to improve dementia care are unlikely. The Technical and Data (TDC) and HCS Cores from the first cycle of the IMbedded Pragmatic Alzheimer's disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory will be combined in the renewal period to become the Technical, Data, and Health Care Systems (TDHCS) Core, as the accomplishments of these Cores advanced the field to the point where their functions and goals have merged. The TDC validated algorithms to identify individuals at risk for and with a diagnosis of dementia using RWD (e.g., EHRs, Medicare claims), and created resources that used nationwide Medicare data to generate characteristics (e.g., demographics) of beneficiaries with dementia to inform HCS site selection and sample size estimates. The HCS Core established Learning Communities of HCS representing 4 care settings to understand their priorities for serving PLWD. Finally, IMPACT established several HCS consortia willing to host ePCTs and created shared data platforms for researchers to conduct them, such as the Long- Term Care Data Cooperative. Building on this foundation, the over-riding goal of the TDHCS Core is to provide the opportunity, conceptual foundations, technical expertise, and research resources for investigators and HCS to partner to design and conduct rigorous, feasible and highly impactful ePCTs of interventions to improve the care of PLWD and their CPs. The AIMS are: Aim 1. Support the design and conduct of ePCTs among PLWD and their CPs by providing guidance and consultation to investigators, Aim 2. Support the design and conduct of ePCTs by establishing and maintaining partnerships with HCS caring for PLWD prepared to host ePCTs, Aim 3. Enhance investigator capacity by providing training on the use of RWD and partnering with HCS to conduct dementia care ePCTs, and Aim 4. Develop and disseminate knowledge to advance methodologies for using RWD and partnering with HCS to conduct ePCTs for PLWD. IMPACT: A committed partnership between investigators and HCS is essential for successful and impactful ePCTs. The TDHCS Core will provide the platform and resources for such partnerships from the very inception of an ePCT, thus serving an essential role in realizing IMPACT’s mission to be a national infrastructure to build the nation’s capacity to conduct ePCTs of interventions within HCS for PLWD and their CPs.

View original record on NIH RePORTER →