The IMPACT Collaboratory is a nationwide infrastructure funded through a cooperative agreement from the National Institute on Aging that promotes the conduct of embedded pragmatic clinical trials (ePCTs) evaluating non-pharmacological approaches to care for people living with dementia (PLWD) and their caregivers within health care systems. Click here to learn more.
Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life routine practice conditions, whereas explanatory clinical trials aim to test whether interventions work under optimal conditions. An ePCT tests an intervention that is “embedded” into routine care practices of a healthcare system, agency or organization, or other non-healthcare based organizations.
The NIH Health Care Systems Research Collaboratory Living Textbook of Pragmatic Trials is a helpful resource to learn more about ePCTs.
Interventions must be non-pharmacologic in nature and involve people living with dementia or their caregivers. The intervention (or components thereof) should have some level of evidence supporting its efficacy, and a high potential for implementation in “real world” settings. Pragmatic trials generate results that can be generalized and applied in routing care settings.
Investigators can use the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for ePCTs. The PRECIS-2 model (original paper, model website) can help you to assess your study design and consider aspects that can be designed more pragmatically.
Requests for applications are solicited annually for pilot studies for ePCTs of non-pharmacologic interventions involving people living with dementia and/or their caregivers. All funding opportunities will be posted on the pilot grant funding page.