Background
The National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory was established in 2019 to meet the urgent public health need to deliver high quality, evidence-based care to people living with dementia (PLWD) and their care partners within the healthcare systems (HCS) that serve them.
Over six million Americans are living with AD/ADRD. PLWD are particularly vulnerable to receiving uncoordinated and poor quality care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. Strategies to improve their care must be informed by high-quality evidence. While prior research has elucidated opportunities for improvement, the adoption of promising interventions has been stymied by the lack of research evaluating their effectiveness when implemented under “real-world” conditions.
Chart created by the Alzheimer's Association
Context
Over 6 million Americans are living with AD/ADRD. PLWD are particularly vulnerable to receiving uncoordinated and poor quality care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. Strategies to improve their care must be informed by high-quality evidence.
ePCTs Bridge Research and Clinical Care
Embedded pragmatic clinical trials have the potential to accelerate the translation of evidence-based interventions into clinical practice. Since its inception in 2012, the NIH Common Fund HCS Research Collaboratory (NIH Collaboratory) has accomplished foundational work towards strengthening the national capacity to conduct ePCTs in a broad array of medical disciplines and healthcare systems.
With this foundation, the NIA IMPACT Collaboratory is motivated by the recognition that conducting ePCTs among PLWD and their caregivers merits special focus. PLWD are served by a variety of unique HCS that employ distinct electronic health records (EHRs), registries, and administrative datasets. Novel approaches and standards are needed to identify PLWD and capture relevant outcomes using these data sources. There are also distinct ethical and regulatory considerations for involving vulnerable PLWD in ePCTs, an array of interested parties that must be engaged, and the need to address diversity and inclusion in all aspects of ePCTs conducted.
ePCTs in Dementia Require Special Focus
The NIA IMPACT Collaboratory brings together a multidisciplinary group of over 60 investigators representing approximately 31 academic institutions with expertise in AD/ADRD, HCS, EHR and administrative data, design and analysis of ePCTs, ethics and regulatory issues specific to dementia, implementation science, research mentorship, diversity and inclusion, and community engagement. The NIA IMPACT Collaboratory provides the infrastructure for these experts to partner with industry leaders and other interested parties from across the nation. Together, the NIA IMPACT Collaboratory is building the nation’s capacity to conduct ePCTs among PLWD and their caregivers by developing and disseminating best practice research methods, supporting the design and conduct of ePCTs, building investigator capacity, and ensuring the research includes culturally-tailored interventions and people from diverse and under-represented backgrounds.