Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required) | RFA HL 21 001

Opportunity Information: Apply for RFA HL 21 001

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), offered this cooperative agreement opportunity to fund hybrid effectiveness-implementation trials focused on heart, lung, blood, and sleep (HLBS) diseases specifically in the inpatient (hospital) setting. The central idea is not simply to test whether a clinical intervention works, but to test how best to get proven, evidence-based practices used reliably in real hospital environments. In other words, the research emphasis is on closing the gap between what is known to work and what is consistently delivered at the bedside, using rigorous trial designs that evaluate both clinical outcomes and implementation outcomes.

This FOA (RFA-HL-21-001) calls for applications that propose a clinical trial in which the primary experimental component is an implementation strategy, or a set of strategies, intended to increase adoption, fidelity, reach, or sustainability of one or more evidence-based practices for HLBS conditions in hospitalized patients. Importantly, the implementation approach is expected to be grounded in an established implementation research framework, meaning applicants should use a recognized conceptual model to identify barriers and facilitators, select or design strategies that address those determinants, and specify measurable implementation endpoints. The focus on hybrid effectiveness-implementation trials signals that projects should generate practical, generalizable knowledge about both patient-level effectiveness (for example, morbidity, mortality, complications, length of stay, readmissions) and the real-world implementation process (for example, uptake by clinical teams, adherence to protocols, time to adoption, variation across units, or cost and feasibility of implementation).

Because these studies sit at the intersection of inpatient clinical research and implementation science, the FOA strongly emphasizes the need for a multidisciplinary research team. NHLBI indicates that competitive applications should include expertise in inpatient clinical research (to ensure the clinical problem, workflow, and patient population are well understood), implementation research (to ensure the strategy selection and evaluation are theory-informed and methodologically sound), and biostatistics (to ensure appropriate design, power, and analytic methods for complex trial structures common in implementation studies, such as cluster randomization, stepped-wedge designs, pragmatic trials, or analyses that account for provider or unit-level effects).

The funding mechanism is a U01 cooperative agreement, which typically means NIH expects to have substantial scientific and programmatic involvement during the conduct of the study compared with a standard research grant. The FOA explicitly requires clinical trials, so applications must include a trial that meets NIH’s definition of a clinical trial. The stated award ceiling in the provided source data is $400,000 (noting that applicants would still need to follow the FOA’s specific budgeting rules and any additional NIH policy requirements). The original closing date listed is December 9, 2020, and the opportunity was created on June 15, 2020. The program falls under NIH assistance listings associated with NHLBI’s mission areas (CFDA/assistance listing numbers 93.233, 93.837, 93.838, 93.839, and 93.840).

Eligibility is broad across U.S.-based organizations and includes many common applicant types: state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments and other tribal organizations. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), regional organizations, and Indian/Native American tribal governments that are not federally recognized. At the same time, the FOA makes clear that non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components are allowed when they meet NIH’s definition under the NIH Grants Policy Statement, meaning a U.S. applicant could potentially include certain foreign elements as part of the overall project if permitted and justified.

A key practical point is that applicants did not need to have participated in the earlier planning grant program (the U34 planning FOA referenced as RFA-HL-18-018) to apply. Any applicant proposing a trial that meets this FOA’s requirements could submit, regardless of whether they had received planning support. Overall, the opportunity is aimed at generating actionable evidence on how to implement proven HLBS-related practices in hospitals, using rigorous trial methods to produce results that can be used by health systems to improve care delivery and patient outcomes in inpatient settings.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2020-06-15.
• Applicants must submit their applications by 2020-12-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $400,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 21 001

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