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

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is an NHLBI (NIH) cooperative agreement funding announcement (FOA RFA-HL-21-001) that supports research studies in the inpatient (hospital) setting. The goal is to run hybrid effectiveness-implementation trials for heart, lung, blood, and sleep (HLBS) conditions.

What is the main purpose of the FOA?

The FOA is designed to close the gap between what is known to work (evidence-based practices) and what is consistently delivered in real hospital environments. Projects are expected to test implementation strategies that help proven practices get adopted and used reliably at the bedside, while also evaluating patient outcomes.

What kinds of studies does the FOA require?

The FOA explicitly requires a clinical trial that meets NIH's definition of a clinical trial. The trial should be a hybrid effectiveness-implementation trial conducted in inpatient settings.

What is meant by a "hybrid effectiveness-implementation trial" in this FOA?

In this FOA, a hybrid trial is expected to generate knowledge about both (1) patient-level effectiveness outcomes (for example, morbidity, mortality, complications, length of stay, readmissions) and (2) implementation outcomes (for example, uptake by clinical teams, adherence to protocols, time to adoption, variation across units, or cost and feasibility of implementation).

What is the primary experimental component expected to be?

The primary experimental component is expected to be an implementation strategy (or a set of strategies). The strategies are intended to increase adoption, fidelity, reach, or sustainability of one or more evidence-based practices for HLBS conditions in hospitalized patients.

Is this FOA focused on testing new clinical interventions?

The emphasis is not simply on whether a clinical intervention works. Instead, the emphasis is on how to get proven, evidence-based practices used reliably in real hospital workflows, using rigorous trial designs that evaluate both clinical and implementation outcomes.

What clinical areas are in scope?

The FOA is focused on heart, lung, blood, and sleep (HLBS) diseases and conditions, specifically in the inpatient (hospital) setting.

Does the study setting need to be inpatient?

Yes. The FOA is specifically focused on hospitalized patients and implementation in real hospital environments.

What implementation science expectations are stated in the FOA?

The implementation approach is expected to be grounded in an established implementation research framework. Applicants are expected to use a recognized conceptual model to identify barriers and facilitators, select or design strategies that address those determinants, and specify measurable implementation endpoints.

What outcomes should be measured?

The FOA signals the need to measure both clinical outcomes and implementation outcomes. Examples of clinical outcomes include morbidity, mortality, complications, length of stay, and readmissions. Examples of implementation outcomes include uptake by clinical teams, adherence to protocols, time to adoption, variation across units, and cost and feasibility of implementation.

What trial designs are anticipated for this type of work?

The FOA notes that implementation studies often use complex trial structures. Examples mentioned include cluster randomization, stepped-wedge designs, pragmatic trials, and analyses that account for provider- or unit-level effects.

What kind of research team does NHLBI expect?

The FOA strongly emphasizes a multidisciplinary team. Competitive applications are expected to include expertise in inpatient clinical research, implementation research, and biostatistics.

Why is biostatistics expertise specifically emphasized?

Because the trial structures common in implementation research can be complex (for example, cluster randomization or stepped-wedge designs), the FOA highlights the need for appropriate design, power, and analytic methods, including methods that account for provider or unit-level effects.

What is the funding mechanism?

The FOA uses a U01 cooperative agreement mechanism.

What does a U01 cooperative agreement imply for project oversight?

A U01 cooperative agreement typically means NIH expects to have substantial scientific and programmatic involvement during the conduct of the study compared with a standard research grant.

What is the stated award ceiling in the provided information?

The stated award ceiling in the provided source data is $400,000. Applicants would still need to follow the FOA's specific budgeting rules and any additional NIH policy requirements.

When was this opportunity created and when did it close?

The opportunity was created on June 15, 2020. The original closing date listed is December 9, 2020.

What organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations and includes 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; federally recognized Native American tribal governments; and other tribal organizations.

Are any specific types of institutions explicitly highlighted as eligible?

Yes. The FOA 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.

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

No. The FOA states that non-U.S. entities (foreign institutions) are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed in any form?

Yes, foreign components are allowed when they meet NIH's definition under the NIH Grants Policy Statement. This means a U.S. applicant could potentially include certain foreign elements as part of the overall project if permitted and justified under NIH policy.

Did applicants need to have participated in the earlier U34 planning grant program to apply?

No. The FOA states that applicants did not need to have participated in the earlier U34 planning grant program (referenced as RFA-HL-18-018) in order to apply.

What is the relationship to the earlier U34 planning FOA mentioned?

The earlier program referenced is a U34 planning FOA (RFA-HL-18-018), but participation in that planning grant program was not required for submission to this FOA.

What are the relevant assistance listing (CFDA) numbers associated with this opportunity?

The program falls under NIH assistance listings associated with NHLBI mission areas: 93.233, 93.837, 93.838, 93.839, and 93.840.

What is the overall expected impact of projects funded under this FOA?

The FOA aims to generate actionable, practical, and generalizable evidence on how to implement proven HLBS-related practices in hospitals, using rigorous trial methods so health systems can improve inpatient care delivery and patient outcomes.