Request for Applications | RFA-IMPACT-D2025

Demonstration Projects should have the following features:

• Address an area relevant to PWLD, care partners, health care providers, and/or clinical decision-making.
• Must be randomized with intervention and control/comparator arms.
• Aligned with ePCT design (NIH Stage IV effectiveness trial) as guided by the PRECIS-2 framework. Projects that do not reflect a pragmatic trial design will not be considered.
• Conduct the ePCT within one or more health care systems that have demonstrated commitment and, ideally, already have an established collaborative relationship with the applicant.
• Evaluate an intervention supported by a reasonable level of evidence demonstrating its efficacy from prior RCTs (e.g., NIH Stage II/III trial). For simple or "nudge" (versus complex) interventions, the requirement for evidence of efficacy is more relaxed.
• Evaluate an intervention with adequate data supporting the feasibility of key elements of the ePCT design including the strategies to: 1) identify and enroll participants in the intervention and control/comparator groups, 2) implement the intervention with fidelity as part of the clinical work flow, and 3) collect primary and secondary outcomes in intervention and control/comparator groups with minimal need for additional follow up, resources, or impact on usual care.
• Integrate delivery of the intervention into the clinical workflow with fidelity. Interventions that require training of providers for implementation should have established training protocols with demonstrated fidelity. Simple interventions that do not require complex implementation protocols, excessive personnel or infrastructure support, or intensive provider training to implement are particularly suitable for this mechanism.
• Include an implementation evaluation using the appropriate framework (e.g., RE-AIM).
• Employ 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 by research personnel.
  • ­Enrolls participants based on broad eligibility criteria that maximizes representation of the patient population with AD/ADRD.
  • ­Minimizes multiple stages (e.g., identification in an EHR, additional screening, contacting, acceptance of the intervention) in the intervention arm that could substantially diminish the proportion of eligible participants who will ultimately receive the intervention and cannot be feasibly replicated in a control arm. If multiple stages are necessary, pilot data must be provided to support the feasibility of the approach, and applicants should include a consort diagram illustrating the participant flow in the proposal.
• Evaluate a single primary outcome measure that is 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). Secondary clinical outcomes may be included as appropriate.
• Develop a rigorous analytic plan that specifies sample sizes and power estimates and employs analytic strategies appropriate for ePCT designs. Demonstration Projects must be powered to detect a significant difference in the primary outcome between trial arms.
• When possible and if appropriate, the 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.

The proposed Demonstration Project must be conducted in partnership with a committed health care system (HCS). Ideally, applicants would have an established productive collaboration with the HCS organization and key individuals within it who will help ensure the success of the ePCT. Effective and sustainable partnerships with health care delivery organizations and champions within systems are critical to implementation and testing interventions. It is expected that the intervention will be integrated into the clinical workflow or delivery of care. Demonstration Projects should be conducted within health care systems that have electronic health platforms as necessary to support the ePCT design. Outcomes or other metrics essential to taking a successful intervention to scale should be captured efficiently with minimal need for additional follow up, resources or impact on usual care. The HCS partner must facilitate the investigator’s access to all data sources necessary for the project, such as electronic health records, inpatient, outpatient, imaging, laboratory, pharmacy, and assessment data.

An 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 13, 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 Demonstration Project LOI application includes the following main elements (please use this description structure):

A. Objective and Rationale

B. Preliminary Data

C. Overview of ePCT Design

D. Specific Aims

E. Setting

F. Participants and the Identification and Enrollment Strategy

G. Intervention Structure and Content

H. Intervention Implementation Strategy

I. 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)
• NIH Biosketch for Principal Investigator(s)

STEP 2: Full Proposals

Applications selected for further consideration will be invited to submit a full proposal that will be due no later than Thursday, January 15, 2026, at 11:59pm ET. Invited applicants will receive an Application Guide with detailed instructions on all required components. Application decisions are anticipated in April 2026.

Full proposal applications must be submitted online through Brown University’s UFunds system: https://ufunds.brown.edu.

Applicants invited to submit a full proposal will have the opportunity to meet with an IMPACT Consultation Team during the application preparation period. The Team, comprised of experts from IMPACT Cores, is assembled specifically for each proposal. The purpose of the consultations is to help applicants prepare the strongest and most rigorous application. The applicant will submit a draft of the Specific Aims one week before the meeting. The draft Aims will be discussed during the consultation meeting, giving the applicant an opportunity to clarify points, ask questions, and receive guidance. The applicant and the project biostatistician must attend this meeting.

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 in the proposal development process. All inquiries for consultation from Cores should be addressed to the Investigator Navigator Team at IMPACTnavigator@hsl.harvard.edu.

A set of frequently asked questions (FAQ) regarding this opportunity is available here.