Notice of Intent to Publish an NHLBI Funding Opportunity Announcement for STIMULATE-2 (R61/R33 – Clinical Trial Required)

Notice Number: NOT-HL-19-715

Key Dates

Release Date: August 07, 2019
Estimated Publication Date of Funding Opportunity Announcement: December 31, 2019
First Estimated Application Due Date: May 01, 2020
Earliest Estimated Award Date: March 31, 2021
Earliest Estimated Start Date: May 03, 2021

Related Announcements
RFA-HL-19-014

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The NHLBI intends to publish a new milestone-driven Funding Opportunity Announcement (FOA) to invite applications for single-site, biphasic, late-stage translation (T4) research projects which will identify and test pragmatic and sustainable multi-level implementation strategies that will increase the use of evidence-based guidelines and/or proven effective interventions for preventing and/or managing heart, lung, blood diseases and/or sleep (HLBS) disorders. This anticipated FOA, Stimulating T4 Implementation Research to Optimize Integration of Proven-effective Interventions for Heart, Lung, and Blood Diseases and Sleep Disorders into Practice -2 (STIMULATE -2), is intended to complement the late-stage research portfolio for the STIMULATE-1 FOA, RFA-HL-19-014Stimulating T4 Implementation Research to Optimize Integration of Proven-effective Interventions for Heart, Lung, and Blood Diseases and Sleep Disorders into Practice (STIMULATE) (R01 Clinical Trial Not Allowed).

STIMULATE-2 applicants would address a planning phase (R61) of up to one year, and an implementation research phase (R33) of up to four years for the clinical trial. The R61 planning phase would be expected to address an approach for selecting and planning an adaptation of the evidence-based guideline or multi-level proven-effective intervention, data collection and management, a recruitment and retention plan, milestones, and a project timeline. A robust plan for the implementation research (R33) phase of the application would also be required. Upon administrative review by the NHLBI, only the meritorious R61 projects that meet the predetermined scientific milestones of the planning phase will be selected to transition to the R33 phase.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in winter 2020 with an expected application due date in spring 2021.

This FOA will utilize the R61/R33 Clinical Trial Required activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of T4 implementation research for heart, lung, blood, or sleep conditions to consider applying for this new FOA.

In addition, applications proposing collaborative investigations combining expertise in qualitative methods, administration of T4 implementation clinical trials at various levels (e.g., individual, clinical practice, facility, etc.), quality improvement, health economics, development in training programs, and robust experience in the adaptation and implementation of evidence-based guidelines developed by others will be encouraged . Personnel involved in the implementation strategy, e.g., nurse practitioner, patient, family members, respiratory therapist, pharmacist, hospital intensivists, etc., should be meaningfully engaged in the conceptualization and the planned execution of the research project

STIMULATE-2 implementation research projects would plan to develop context-informed strategies for optimized adoption, scale-up, and sustainable utilization of proven-effective interventions for one or more HLBS conditions. Applications would need to meet the NIH definition of a clinical trial (NOT-OD-15-015). The primary outcome metrics would be implementation science outcome measures. For applicants considering health economics analyses, we recommend that you review the NIH’s Notice, Clarifying NIH Priorities for Health Economics, (NOT-OD-16-025). Clinical measures could be used as secondary outcome metrics. The single-site clinical trial may enroll participants from multiple locations/clinics, yet, all participants would be required to receive an intervention or undergo clinical outcome assessments under the direction and oversight of a research team at the same investigational site.

Applications proposing to develop and test the effectiveness of a new intervention would be identified as non-responsive and returned without review.

Funding Information

Estimated Total Funding $3,685,000 first year total cost
Expected Number of Awards 5
Estimated Award Ceiling $485,000 direct costs/ $737,000 total costs
Primary CFDA Numbers 93.840

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Rebecca A. Roper, MS, MPH
National Heart, Lung, and Blood Institute (NHLBI)
301-496-1051
rebecca.roper@nih.gov



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