Stimulating T4 Implementation Research to Optimize Integration of Proven-effective Interventions for Heart, Lung, and Blood Diseases and Sleep Disorders into Practice (STIMULATE-2) (R61/R33 Clinical Trial Required) | RFA HL 21 011

Frequently Asked Questions (FAQs)

What is the STIMULATE-2 grant opportunity?

STIMULATE-2 is an NIH discretionary grant opportunity titled "Stimulating T4 Implementation Research to Optimize Integration of Proven-effective Interventions for Heart, Lung, and Blood Diseases and Sleep Disorders into Practice." It is identified by Funding Opportunity Number (FON) RFA-HL-21-011.

What problem is this funding opportunity trying to solve?

The program targets a persistent "translation gap" where proven, evidence-based interventions are not adopted broadly, implemented well, or sustained over time in routine clinical care, public health, or community settings, even when strong evidence already exists.

What health areas does STIMULATE-2 focus on?

The focus is on heart, lung, and blood diseases and sleep disorders, often abbreviated as HLBS.

What type of research does this FOA support?

This FOA supports late-stage translation and implementation research described as T4 research. The focus is on integrating interventions that are already proven effective into real-world practice, rather than generating more efficacy evidence under controlled conditions.

What does T4 implementation research mean in this context?

In this FOA, T4 is about achieving sustainable uptake and routine use of proven-effective interventions in real-world settings. The emphasis is on the practical "how" of rolling out an evidence-based practice (EBP) so it is adopted, implemented consistently, and maintained over time.

Is this FOA about testing whether an intervention works clinically?

No. The FOA is designed to push beyond generating additional efficacy data. The emphasis is on implementation strategies that help proven-effective interventions get integrated into everyday practice and reach more people.

What is meant by an evidence-based practice (EBP) in this FOA?

An EBP, as described here, is an intervention that is already proven effective through strong clinical or public health evidence. The research focus is on improving delivery and sustained use of that proven intervention in real-world systems.

What is an implementation strategy in the context of this opportunity?

An implementation strategy is the approach used to increase adoption, improve implementation quality, and support long-term sustainment of a proven-effective EBP. The FOA emphasizes studying the strategy (the rollout approach), not re-proving the clinical efficacy of the EBP itself.

Are applicants expected to use implementation science frameworks?

Yes. Applicants are expected to use established implementation science frameworks to design, refine, and test implementation strategies.

What does the FOA mean by "adaptable" implementation strategies?

"Adaptable" strategies are approaches that can be adjusted to fit local context (such as staffing, workflows, patient populations, technology, and resource levels) while preserving the core elements needed to succeed. The goal is to produce strategies that are useful beyond the original study site.

What is the overall goal for implementation strategies under STIMULATE-2?

The FOA aims to identify and test adaptable implementation strategies that increase scale-up and sustainable use of EBPs for preventing and/or managing HLBS conditions.

What kind of project design does this FOA encourage?

The FOA supports pragmatic, milestone-driven projects that are single-site and biphasic using the R61/R33 mechanism. Projects are described as late-stage implementation research intended to be practical and decision-relevant for real-world systems.

What does "single-site" mean for this FOA?

Based on the information provided, the projects are intended to be conducted at a single site (rather than multi-site), while still producing strategies and products that can be reused or adapted elsewhere.

What is the R61/R33 funding mechanism?

R61/R33 is a biphasic funding mechanism. The first phase (R61) typically focuses on planning, preparation, and achieving defined milestones. The second phase (R33) focuses on executing and evaluating the implementation approach after the R61 milestones are met.

How do milestones affect the transition from R61 to R33?

The R61 phase is milestone-driven, and moving into the R33 phase is tied to achieving the defined milestones. The R33 phase proceeds once those milestones are achieved.

Does the FOA require a clinical trial?

Yes. The funding opportunity explicitly requires a clinical trial, meaning the proposed research must include a prospective, systematic evaluation consistent with NIH clinical trial definitions. In this FOA, the "intervention" being evaluated is typically the implementation strategy (or strategies) used to improve adoption and sustained use of an already proven EBP.

If a clinical trial is required, what is being tested?

The clinical trial component generally evaluates the implementation strategy (the method for improving adoption, integration, and sustainment), rather than re-testing whether the underlying EBP is clinically effective.

What does "pragmatic" mean in the way this FOA uses the term?

"Pragmatic" indicates the research is intended to be practical and decision-relevant for real-world systems like clinics, health systems, public health organizations, and community settings, rather than optimized for highly controlled research environments.

What does the FOA emphasize about sustainability after the grant ends?

The FOA emphasizes strategies that can last beyond the life of the research grant and are not dependent on temporary outside resources.

What does the FOA say about scalability and broader usefulness?

The FOA prioritizes strategies that can be transferred or adapted by other organizations and stakeholder groups. The intent is to generate approaches that can be scaled up and used sustainably in diverse settings, not only at the original site.

Are applicants expected to create tools or materials others can reuse?

Yes. The FOA values developing and disseminating an implementation strategy plan that others can reuse. It describes producing practical tools such as playbooks, protocols, and potentially reusable infrastructure to help future adopters replicate success.

Does the FOA mention any examples of reusable infrastructure?

Yes. An example given is reusable infrastructure such as national standards for data extraction and interoperability, reflecting interest in solutions that improve implementation efficiency through better data systems, measurement, and information exchange.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations and government entities. Examples include 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; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are community-centered institutions and specific organization types included in eligibility?

Yes. The FOA also calls out Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

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

No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply.

Can a U.S. applicant include foreign components?

No. While U.S. organizations may include non-domestic components, the FOA states that "foreign components" (as defined in the NIH Grants Policy Statement) are not allowed. This limits conducting substantive project elements abroad.

Which agency is offering this opportunity?

The opportunity is offered by the National Institutes of Health (NIH).

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840, reflecting NIH programs spanning heart and vascular, lung, blood, and sleep-related research portfolios.

When was this FOA created and what was the original closing date?

The FOA was created on 2019-11-19 and had an original closing date of 2020-07-01.

What is the award ceiling listed in the opportunity summary?

The listed award ceiling is $485,000, indicating the maximum award amount referenced in the opportunity summary. Applicants are typically expected to verify detailed budget limits and project period rules in the full FOA text.

Does the excerpt specify how many awards NIH expects to make?

No. Expected awards are not specified in the provided information.

What makes a strong application based on the FOA description provided?

Based on the description provided, strong applications would focus on framework-guided implementation strategies that are adaptable to local context, can be sustained beyond the grant period, are evaluated pragmatically through a clinical trial of the implementation strategy, and produce reusable products (such as plans, tools, playbooks, protocols, or infrastructure) that other organizations can use to replicate and scale successful implementation.