Opportunity Information: Apply for RFA HL 18 018
Preparing for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01) is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity issued by the U.S. Department of Health and Human Services through the National Institutes of Health. The grant mechanism is a U01 cooperative agreement, which typically means the project is supported through a more hands-on partnership with NIH staff than a standard research grant, with substantial programmatic involvement during the life of the award. The core aim is to help research teams get ready for a later, larger hybrid effectiveness-implementation clinical trial focused on inpatient care for heart, lung, blood, and sleep (HLBS) conditions.
The scientific focus is not to run the definitive effectiveness trial yet, but to do the preparatory implementation research that makes a later hybrid trial feasible and rigorous. Applicants are expected to start with an evidence-based practice (or set of practices) relevant to inpatient HLBS care and then systematically study why that practice is not consistently or effectively used in real hospital settings. The work centers on identifying barriers and facilitators to implementation, meaning investigators should examine practical, organizational, behavioral, workflow, and contextual factors that either prevent adoption of the evidence-based practice or make it easier to integrate into routine inpatient care. This could include issues such as staffing, clinical workflow, training and competency, competing priorities, documentation systems, local policies, leadership support, resource constraints, patient-level factors, and the culture of specific inpatient units.
A defining expectation of the FOA is the use of an implementation research framework to guide the project. Rather than relying on informal observations, teams are meant to use established implementation science approaches to structure the assessment of context and determinants and to design implementation strategies in a way that is theory-informed and measurable. The deliverable is an implementation strategy, or potentially multiple strategies, that are well-specified and ready to be tested in a subsequent hybrid effectiveness-implementation trial. In practical terms, this means the project should move beyond simply describing problems and should produce a concrete plan for what will be implemented, who will carry it out, how it will be integrated into inpatient workflows, what supports or training will be provided, how fidelity will be assessed, and which implementation outcomes will be tracked.
During the U01 period, investigators are also expected to measure baseline practice, sometimes described as the usual-care state, with respect to the targeted evidence-based practice(s). This baseline measurement is meant to clarify how care is currently delivered in the participating inpatient settings, quantify gaps between usual care and recommended care, and document variation across units or hospitals. These baseline data help justify the need for an implementation intervention, inform the selection and tailoring of strategies, and provide essential planning inputs for the next-stage hybrid trial, such as feasible outcome measures, data sources, recruitment and enrollment processes, and realistic effect-size assumptions.
The FOA emphasizes team composition and the need for multidisciplinary expertise. Competitive applications are expected to bring together inpatient clinical research expertise (people who understand hospital-based HLBS care and clinical outcomes) and implementation research expertise (people trained in implementation science methods, frameworks, and evaluation). This reflects the program’s intent to bridge clinical evidence and real-world delivery, ensuring that the eventual trial is both clinically meaningful and operationally feasible in inpatient environments.
From a program pathway standpoint, this U01 is positioned as a stepping-stone. At the end of the award, successful teams should be prepared to apply to a separate NHLBI funding opportunity to conduct the actual hybrid effectiveness-implementation trial, referenced in the notice NOT-HL-17-493. In other words, this FOA is designed to build the foundation for a subsequent trial by clarifying what needs to change in inpatient practice, how to change it, and how to test the change using a hybrid design that examines both patient/clinical effectiveness and implementation success.
Administratively, the opportunity is listed as RFA-HL-18-018 and falls under the Health funding activity category. It uses the cooperative agreement instrument, with an award ceiling of $350,000 and an anticipated total of about 7 awards. The original application closing date was December 4, 2017, and the opportunity was created July 14, 2017. Eligible applicants are broad and include many types of organizations that could plausibly support inpatient implementation research, including state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and additional categories referenced in the eligibility clarifications. The CFDA program numbers associated with the opportunity include 93.233 and 93.837 through 93.840, reflecting the NHLBI program areas that commonly support research in heart, lung, blood, and sleep domains.
Overall, the grant supports a practical and methodical preparation phase: determine what prevents consistent use of proven inpatient HLBS practices, identify what enables success, use implementation science to design one or more strategies that fit real inpatient conditions, document the baseline care environment, and produce a strong, trial-ready plan for a later hybrid effectiveness-implementation study backed by NHLBI.Apply for RFA HL 18 018
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Preparing for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01)" 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 Jul 14, 2017.
- Applicants must submit their applications by Dec 04, 2017. (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 $350,000.00 in funding.
- The number of recipients for this funding is limited to 7 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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