Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (R61/R33 - Clinical Trial Required) | PAR 18 585

FAQs: NIH PAR-18-585 Pragmatic Clinical Trials to Improve Dementia Care in LTSS

What is NIH PAR-18-585?

PAR-18-585 is a National Institutes of Health (NIH) funding opportunity that supports pragmatic, comparative clinical trials designed to improve dementia care for people with Alzheimer's disease (AD) and Alzheimer's disease and related dementias (AD/ADRD) who receive services in Long-term Services and Support (LTSS) settings.

What is the main purpose of this funding opportunity?

The main purpose is to fund real-world studies that answer practical questions that matter to people living with dementia, clinicians, and caregivers (both paid staff and unpaid family caregivers). The focus is on generating evidence that can be adopted quickly by providers, organizations, patients, and caregivers in LTSS.

What makes these trials "pragmatic"?

These projects are expected to run in everyday care environments rather than tightly controlled research settings. They should reflect routine conditions in LTSS, use broad eligibility criteria, and be structured so that findings are directly usable in practice.

Are these studies required to be comparative?

Yes. A key expectation is that proposed trials are comparative and pragmatic, meaning they test interventions, care strategies, or implementation approaches under routine conditions and compare meaningful alternatives in real-world LTSS contexts.

Is a clinical trial required under this announcement?

Yes. The opportunity is labeled a "clinical trial required" announcement, meaning funded projects must include a clinical trial component consistent with NIH definitions and expectations for trial conduct, oversight, and reporting.

What settings are considered LTSS for this opportunity?

The announcement targets Long-term Services and Support (LTSS) settings. The provided information emphasizes that these are real-world care environments where staffing patterns, workflows, and patient needs can vary widely.

Who is the intended population for the interventions studied?

The intended population includes people with Alzheimer's disease (AD) and Alzheimer's disease and related dementias (AD/ADRD) who receive services in LTSS settings.

Does the FOA emphasize enrolling diverse populations?

Yes. Applications are expected to enroll diverse populations and reflect the realities of LTSS, supporting the goal of producing evidence that is broadly relevant and adoptable.

What outcomes does NIH want these trials to improve?

The FOA emphasizes outcomes that improve the lives of people with dementia and those who care for them. Projects should be positioned to do one or more of the following: improve quality of care for persons with dementia; improve quality of life for persons with dementia and their informal caregivers; deliver more patient-centered and cost-effective care within LTSS; and/or reduce disparities in LTSS dementia care.

What kinds of interventions or approaches fit this funding opportunity?

The opportunity can include interventions or approaches that can realistically be integrated into LTSS operations. Examples mentioned include improvements to care processes, communication, symptom management, caregiver support, staff training, and care coordination, as well as other practical approaches that work within routine LTSS workflows.

How is this award structured (R61/R33)?

This opportunity uses a phased award structure (R61/R33). The first phase supports pilot and feasibility work. If predefined Go/No-Go milestones are met, the project can transition to the second phase to conduct the larger full-scale pragmatic trial.

What happens during the R61 (pilot/feasibility) phase?

During the initial phase, applicants are expected to test whether the LTSS intervention can be implemented, integrated, and sustained in targeted real-world settings. This includes establishing that recruitment, delivery, fidelity, data collection, and operational fit are workable, and refining procedures needed for the larger trial.

Is transition from R61 to R33 automatic?

No. Progression to the second phase is not automatic. Transition depends on meeting predefined Go/No-Go milestones and criteria set for the early phase, with the transition governed by administrative review of milestone completion.

What is the R33 phase intended to support?

If Go/No-Go criteria are achieved, the project can transition to the R33 phase to conduct the full-scale pragmatic clinical trial in LTSS settings.

What does "Go/No-Go milestones" mean in this FOA?

In this context, Go/No-Go milestones are predefined feasibility and performance criteria for the early phase. Meeting them demonstrates the intervention and trial procedures can work in real-world LTSS operations and supports moving forward to the larger pragmatic trial phase.

What is the funding mechanism and activity category?

The funding mechanism is a grant, and the activity category is health. The CFDA listing provided is 93.866.

Is there an award ceiling listed?

The source data lists an award ceiling of $500,000. The FOA also describes a phased structure that supports pilot feasibility work followed by a larger pragmatic trial phase, with transition governed by milestone completion and administrative review.

Who is eligible to apply?

Eligibility is broad and includes many types of organizations involved in LTSS and dementia care. Eligible applicants include state, county, city, township, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses); and other entities.

Are specific institution types explicitly highlighted as eligible?

Yes. The FOA explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. (foreign) organizations.

Can for-profit organizations apply?

Yes. For-profit organizations, including small businesses, are listed as eligible applicants.

Can tribal governments and tribal organizations apply?

Yes. Federally recognized tribal governments and other tribal organizations are listed as eligible applicants, and the FOA also highlights TCCUs and other serving institutions.

Can non-U.S. (foreign) organizations apply?

Yes. Non-U.S. (foreign) organizations are explicitly included among eligible applicants in the information provided.

Why does the FOA emphasize real-world implementation in LTSS?

Because the goal is to produce evidence that is directly adoptable and can be translated rapidly into practice. LTSS environments vary widely in staffing patterns, workflows, and patient needs, and the FOA aims to fund studies designed around those real constraints.

What kinds of stakeholders should the research be relevant to?

The trials are expected to address questions that matter to people living with dementia, clinicians, and caregivers, including both paid staff caregivers and unpaid family caregivers.

What is the overall aim of PAR-18-585?

Overall, PAR-18-585 is geared toward producing actionable evidence on dementia care in LTSS by funding pragmatic, inclusive, real-world clinical trials that can be adopted quickly, using a phased feasibility-to-trial structure with milestone-driven progression.