Yes. Multiple principal investigators (MPIs) are allowed for Demonstration Projects.

An embedded pragmatic clinical trial (ePCT) is a trial based on implementing an intervention that can be “embedded” within routine care provided within a healthcare system, agency or organization, or other non-healthcare based organizations. The intervention is implemented in a “real-world” environment by practicing clinicians or non-clinical staff, not interventionists. A core component is that the intervention can be maintained for real-world use and sustained beyond the scope of a trial. ePCTs use a variety of systematic research methods to test the effectiveness of the intervention. Randomization for a full scale ePCT generally occurs at the level of an organization, care team or unit rather than at an individual level, though this is not a hard and fast rule. Most ePCTs utilize data available from electronic health records, administrative data, or claims data to assess effectiveness outcomes.

The NIH Health Care Systems Research Collaboratory Living Textbook of Pragmatic Trials is a helpful resource to learn more about ePCTs. Additional resources include the State of the Science for pragmatic trials for non-pharmacological interventions to improve outcomes among people living with dementia and their caregivers; lessons learned from the NIH Health Care Systems Research Collaboratory; and the process of embedding PCTs in health care systems.

We strongly encourage investigators to use the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for ePCTs.

Applications for Demonstration Projects must demonstrate a substantially pragmatic design. Applications that are not designed to be pragmatic will be administratively triaged prior to review. Thus, it is important to pay special attention to the specific requirements specified in the Request for Applications (RFA). Scientific review of applications will focus on the degree to which the study design represents a pragmatic approach based on the PRECIS-2 framework.

Yes, you may use two or more sites within the same healthcare organization, but you must provide the rationale for site selection. You should also address how data from sites within a single organization will directly inform the scalability of the intervention to involve implementation in multiple organizations.

Interventions must be non-pharmacologic in nature and involve people living with dementia or their care partners. Ideally the intervention (or components thereof) should have a reasonable level of evidence supporting its efficacy as described in the Readiness Assessment for Pragmatic Trials (RAPT) Model paper, and a high potential for implementation in “real world” settings. It may be helpful to consider PCORI Methodology Standards of Complex Interventions.

This funding mechanism follows NIH guidelines in regard to allowable costs and activities.

No. Demonstration Project applications may budget up to $500,000 in direct costs. Indirect costs may be budgeted at your institution's negotiated facilities and administrative rate.

Subaward indirect costs will be excluded from the direct cost limit of $500,000. This mechanism may have up to two Subawards.

No. You do not need to include costs for the IRB in your budget. These costs will be supported by the IMPACT Collaboratory.

Yes. You will need to include costs for the PI's travel and accommodation to one in-person IMPACT Collaboratory Meeting in Bethesda, MD during each year of the project period.

You will be asked to attend and present at a future IMPACT Scientific Meeting in Bethesda, MD, but travel and accommodations for this will be supported by the IMPACT Collaboratory. You do not need to include this in your budget, as it will occur after your project has ended.

Yes. Each subaward (cannot exceed 2) must have a separate budget and budget justification, at least one Key Personnel, and a Unique Entity Identifier (UEI). The UEI Number has replaced the DUNS Number as the primary means of entity identification for Federal awards government-wide.

Whenever appropriate, purchase of services and consulting agreements are encouraged.  Service and consulting agreements do not count towards the number of subawards. Federal regulations providing guidance for making an accurate determination are available at 2 CFR 200.331. Purchase of services and consulting agreements should be listed within the PI’s main budget. Subaward indirect costs will be excluded from the direct cost limit of $500,000.

The table below may help to determine whether to use a Subaward or a Consultant/Contractor. Whenever feasible, purchase of services and/or consultant agreements are strongly preferred.