ePCT Planning Grant Program

ePCT Planning Grant Program

Program Overview

The goal of this 12-month Embedded Pragmatic Clinical Trials (ePCT) Planning Grant is to support the activities required to collaboratively plan and develop a feasible, fully specified protocol for a Stage IV effectiveness ePCT in dementia care. Projects must be conducted in partnership with a nursing home organization and include at least two nursing home sites (either within a single organization or across multiple organizations).

This mechanism is intended for Stage IV effectiveness trials (based on the NIH Stage Model). It does not support early-stage intervention development (Stages 0-I) or protocol development for efficacy trials (Stages II-III).

This award emphasizes strong partnerships among investigators, nursing home partners, and an advisory board of residents, care partners, and other caregivers. By working together, this opportunity is to ensure the intervention and its implementation align with real-world operational contexts, are feasible, and are ready for future testing in an ePCT.

By the end of the award period, awardees are expected to produce a fully specified trial protocol for either a pilot or full-scale ePCT. The protocol should incorporate core design components, including the level of randomization, an approach to participant identification and enrollment, intervention structure and implementation, specification of clinical outcomes, and plans for data access and transfer.

With a well-developed protocol in place, awardees are expected to be strongly positioned to pursue subsequent funding to conduct either a pilot ePCT (e.g., IMPACT Pilot Grant, NIH R21, R34) or a full-scale ePCT (e.g., IMPACT Demonstration Project Grant, R01, or equivalent).

Funding Opportunity Description

This is a focused planning grant for a Stage IV ePCT in nursing home settings. Please review the full RFA to determine whether this opportunity is a fit for your work.

The IMPACT Collaboratory will fund up to two 12-month awards for up to $150,000 (total direct costs). Applicants must partner with a nursing home organization, with participation from at least two nursing homes (within a single organization or across multiple organizations) and include a resident-care partner advisory board.

This funding opportunity supports planning activities necessary to design trial protocols for ePCTs (Stage IV on the NIH Stage Model) that will evaluate the effectiveness of non-pharmacological interventions to improve the management of behavioral and psychological symptoms of dementia (BPSD) in nursing home settings. Proposed projects must emphasize nursing home-level approaches suitable for evaluation in future pilot or full-scale ePCTs.

The award is structured to provide sufficient resources to support meaningful engagement with nursing home partners, the resident-care partner advisory board, and other engaged partners, including relationship-building and collaborative planning for developing and finalizing the ePCT protocol, intervention and implementation strategy, participant and outcome selection, and plans for data access and transfer. The planning activities should ensure that the ePCT protocol is well-aligned with the operational workflows, staffing, and care delivery needs and constraints.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this funding opportunity.