Primary Care-Based Screening Tool and Intervention Development for the Detection and Prevention of Abuse and Neglect in Older and Vulnerable Adults With, or at Risk for, Mild Cognitive Impairment and AD/ADRD (R61/R33 Clinical Trial Required) | RFA AG 24 048

Frequently Asked Questions (FAQs) - RFA-AG-24-048

What is RFA-AG-24-048?

RFA-AG-24-048 is a discretionary NIH funding opportunity focused on moving the field toward practical, evidence-based approaches that help primary care settings detect, prevent, and respond to abuse and neglect affecting older and other vulnerable adults with mild cognitive impairment (MCI), Alzheimer's disease (AD), Alzheimer's disease-related dementias (AD/ADRD), and people at risk for these conditions.

What is the main goal of this funding opportunity?

The main goal is to support research that develops primary care-based screening tools and behavioral interventions that can be used in real-world clinical environments to identify abuse and neglect early, reduce harm, and improve safety for patients and families.

Why is primary care the focus of this opportunity?

The opportunity is built on the idea that primary care is often the most consistent point of contact for patients and families. At the same time, clinicians may lack validated tools and workflow-ready interventions to recognize abuse early and act in ways that reduce risk and harm, particularly when cognitive impairment complicates detection and reporting.

What types of projects does the NOFO support?

The NOFO supports research aimed at developing (or adapting) screening approaches and behavioral intervention strategies designed for primary care, with an emphasis on feasibility, acceptability, and readiness for use in real clinical workflows. Projects are expected to address what happens after a positive screen, such as safety planning, caregiver support, referral coordination, and follow-up.

What is the required award mechanism for this opportunity?

The award mechanism is the R61/R33 phased innovation model.

What does the R61/R33 phased innovation model mean in practice?

It generally supports a two-stage pathway. The first phase (R61) is milestone-driven and focuses on early development and feasibility work. The second phase (R33) supports more rigorous testing and refinement after the predefined milestones are met. Applicants typically propose a development-to-evaluation plan that starts with creating or adapting a screening tool and an intervention, then progresses to testing them for feasibility and acceptability and positioning them to be effective in primary care practice.

Is a clinical trial required?

Yes. The opportunity states that a clinical trial is required.

What populations are intended to benefit from this research?

The intended populations include older and other vulnerable adults who have MCI, AD, or AD/ADRD, as well as individuals who are at risk for these conditions. The focus is on abuse and neglect risk in the context of cognitive impairment and dementia.

What kinds of abuse and neglect challenges are projects expected to address?

Projects are expected to grapple with complexities that arise when cognitive impairment is present, such as identifying abuse when a patient may have limited ability to report, distinguishing neglect from disease-related functional decline, recognizing caregiver stress and burden as contributors to risk, and designing responses that protect autonomy while addressing safety.

Does the opportunity emphasize caregivers and family context?

Yes. The opportunity highlights the family context and signals interest in approaches that consider caregivers and family systems, not only the patient, when designing screening workflows and prevention strategies.

What kinds of settings should the screening tools and interventions fit into?

The tools and interventions are intended for primary care settings and should be usable in real-world clinical environments. Competitive projects typically account for implementation realities such as time constraints in clinics, staff training needs, referral pathways, patient privacy, caregiver involvement, and coordination with social services and protective systems.

What makes a project "primary care-ready" under this opportunity?

Based on the description, "primary care-ready" products are those that clinicians and care teams can reliably use within routine workflows. This typically implies attention to practical deployment issues (like training and time burden) and having a clear plan for next steps after screening identifies potential abuse or neglect.

Who is the administering agency?

The administering agency is the National Institutes of Health (NIH).

What is the activity category and Assistance Listing (CFDA) number?

The activity category is health research, and the Assistance Listing (CFDA) number is 93.866.

When was the NOFO created and what is the listed closing date?

The NOFO was created on 2023-07-05, and the original closing date listed is 2023-10-20.

Does the provided information include an award ceiling or expected number of awards?

No. The source information does not provide an award ceiling or the expected number of awards.

Where should applicants look for budget guidance and project period limits?

Applicants would need to consult the full announcement for budget guidance, project period limits, and any institute-specific constraints, because those details are not provided in the summary information.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations, including state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses.

Are specific institution types and community organizations explicitly included?

Yes. The NOFO explicitly includes Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; regional organizations; and U.S. territories or possessions.

Are foreign (non-U.S.) organizations eligible?

Yes. The eligibility list explicitly includes non-domestic (non-U.S.) entities (foreign organizations).

Does this opportunity suggest interest in diverse communities and settings?

Yes. The breadth of eligible applicant types and the explicit inclusion of multiple institution categories and community-based settings suggests interest in solutions that can be tested across diverse populations, geographies, and health system contexts, including communities that are underserved or face barriers to care and protection services.

What outcomes are projects expected to work toward?

The opportunity is aimed at producing concrete products and approaches that improve detection of potential abuse and neglect and reduce risk and harm. It also emphasizes the importance of defining measurable outcomes and connecting primary care realities to those outcomes, while incorporating clear milestones across the R61/R33 phases.

What should applicants plan for after a positive screen?

The description indicates that strong concepts typically build in pathways for what happens after a positive screen, such as safety planning, caregiver support, referral coordination, and follow-up, while accounting for legal, ethical, and cultural considerations when abuse is suspected in patients with cognitive impairment.

What kinds of implementation considerations are relevant to competitiveness?

Competitive projects usually emphasize workflow and real-world constraints, including clinic time limitations, staff training needs, patient privacy concerns, caregiver involvement, referral pathways, and coordination with social services and protective systems.