Request for Applications | RFA-IMPACT-P2025

Applications to the Pilot Grant Program must propose pilot ePCTs that have the following design features:

• Propose a pilot ePCT to assess the feasibility of a full-scale ePCT evaluating a non-pharmacological intervention targeting PLWD and/or their care partners.
• Address an area relevant to PLWD, care partners, or the health care providers caring for them.
• Evaluate an intervention with a reasonable level of evidence demonstrating its efficacy from prior randomized clinical trials (e.g., NIH Stage II/III trial). The level of evidence of efficacy is less stringent for simple or “nudge” (versus complex) interventions.
• Randomization is NOT required for pilot ePCTs, though in some cases it may be useful to assess the feasibility of a randomization scheme.
• Include settings with two or more health care systems or sites within health care systems (e.g., nursing homes, hospitals, health care provider practices).
• When possible and if appropriate, the pilot ePCT should be designed to qualify for a waiver or alteration of informed consent in accordance with Federal regulation 45 CFR §46.116(f)(3)(i.-v.). Informed consent may be needed for ancillary activities, such as qualitative interviews with participants.
• Evaluate the feasibility of a participant identification and enrollment strategy that aligns with an ePCT design, i.e., typically leverages real-world or existing data sources with no active screening or recruitment by research personnel.
• Evaluate an intervention that can be implemented with fidelity in a health care system using strategies that align with an ePCT design, i.e., typically implemented in the course of usual care (e.g., by providers) with no involvement by research personnel.
• Specify and evaluate the feasibility of collecting a single primary clinical outcome that will ultimately be used to evaluate the effectiveness of the intervention in a future full-scale ePCT. The primary clinical outcome should be 1) clinically relevant to PLWD, their care partners and/or their health care providers, and 2) efficiently captured with minimal need for additional follow up, resources, or impact on usual care (i.e., in alignment with an ePCT design).
• Specify quantitative feasibility endpoints indicating the success of the strategies proposed to 1) identify/enroll participants, 2) implement the intervention, and 3) collect the primary clinical outcome. Demonstrating that each of these strategies are successful in a pilot ePCT supports the feasibility of a full-scale ePCT.
• Address biologic variable of sex as it relates to populations and outcomes.

This informational webinar provides investigators with an overview of application details.

Interested applicants are required to submit a Letter of Intent (LOI) through the Brown University UFunds system at: https://ufunds.brown.edu. LOIs may be submitted no later than Thursday, November 6, 2025, at 11:59pm ET.

Access to UFunds: UFunds can be accessed either with a Brown University email address or with a Gmail address that has been granted rights to the system. The PI may request Gmail access, or someone else may request permission to submit on behalf of a PI. UFunds is not a multi-user environment. If the PI needs more than one person to work on the application in UFunds, contact Faye_Dvorchak@brown.edu to discuss a possible workaround prior to requesting access to UFunds.

Investigators who were previously granted access to UFunds may use their credentials. New users are required to request access to the UFunds system using a Gmail address via https://tinyurl.com/UFundsAccess. Upon approval, an invitation will be issued to the Gmail address provided. Please note that the registration process may require up to 2 business days; applicants are advised to initiate their request as early as possible.

There is a competitive two-step application process:

STEP 1:  Letter of Intent

• The LOI application for the Pilot ePCT includes the following main elements. (Please use this template)
  • A. Rationale
    B. Overview of Pragmatic Pilot ePCT Design
    C. Specific Aims
    D. Setting(s) (types and names of health care systems)
    E. Participants including the Identification and Enrollment Strategy
    F. Intervention Structure and Content
    G. Intervention Implementation Strategy, and
    H. Clinical Outcome Definitions and Collection Strategy
• Bibliography and References Cited (up to 10 and no more than 1-page; not included in the 2-page limit above)
• Attestation in UFunds that Principal Investigator has read:
  • ­   RAPT Model: Describes if the intervention is READY for an ePCT
  • ­   PRECIS-2 Framework: Describes key DESIGN elements in an ePCT
• NIH Biosketches for Principal Investigator(s)

STEP 2:  Full Proposals by Invitation Only

• Applications selected for further consideration will be invited to submit a full proposal that will be due no later than Thursday, February 12, 2026, at 11:59pm ET. Invited applicants will receive an Application Guide with detailed instructions on all required components.
• Applications that are not aligned with an ePCT design will be administratively triaged prior to review. Pilot ePCTs for intervention generation/refinement (i.e., Stage I on NIH Stage Model) or efficacy trials (i.e., Stage II/III on NIH Stage Model) will NOT be considered.

Applicants invited to submit a full proposal will have two one-hour meetings with an IMPACT Consultation Team during the application preparation period. The Team is comprised of experts from IMPACT Cores and is assembled specifically for each proposal. The purpose of the consultations is to help applicants prepare the strongest and most rigorous application. The applicant and the project biostatistician must attend both meetings.

Prior to the first meeting, the Consultation Team Lead will provide a form with structured feedback based on the LOI. This form will be discussed during the first consultation meeting. The applicant will have an opportunity to ask questions and receive guidance.

One week before the second meeting, the applicant will submit a draft of the Specific Aims. These draft aims will be discussed at the second consultation meeting, offering a further opportunity for feedback and guidance.

The IMPACT Investigator Navigator Team can facilitate additional one-on-one individual consultations between the applicant and experts from specific IMPACT Cores (e.g., Design and Statistics, Implementation) at any time during the proposal preparation period. All inquiries for consultation from Cores should be addressed to the Investigator Navigator Team at IMPACTnavigator@hsl.harvard.edu.

Investigators interested in conducting a pilot ePCT in the long-term care setting who do not already have an established relationship with a provider group are encouraged to explore opportunities with the Long-Term Care Data Cooperative (LTCDC). Additional information about the LTCDC is available through the informational video series.

Investigators seeking to explore whether their pilot ePCT aligns with the interests of facilities participating in the LTCDC should contact the Investigator Navigator Team at IMPACTnavigator@hsl.harvard.edu. Applicants considering using the LTCDC for their pilot ePCT should be aware that additional time will be required to submit a separate application to LTCDC and receive the required approvals to use this resource.

A set of frequently asked questions can be found on this page: Pilot Grant FAQ.