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)

This milestone-driven Funding Opportunity Announcement (FOA) invites applications for single-site, biphasic, late-stage implementation and translation (T4) research trials to identify and test pragmatic and sustainable implementation strategies that will increase the use of evidence-based practices (EBP), i.e., evidence-based guidelines or other well-accepted evidence-based interventions, for preventing and/or managing heart, lung, and blood diseases and/or sleep (HLBS) disorders. Clinical trials for this FOA must meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applicants will be expected to 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. During the planning phase awardees will be expected to: finalize selection of the EBP; recruit participating organization(s); prepare the implementation protocol; develop milestones and a project timeline; and develop plans for data collection and management, and participant recruitment and retention. Robust plans for the implementation research clinical trial and the supporting implementation strategy dissemination package are required for the R33 phase of the application. Upon administrative review by the NHLBI, only meritorious R61 projects that meet the predetermined scientific milestones will be selected to transition to the R33 phase.

Investigators with expertise in T4 clinical trials and hybrid studies for heart, lung, blood, or sleep conditions are expected to be part of the research team. In addition, applications proposing collaborative investigative teams combining expertise in qualitative methods, administration of T4 implementation clinical trials as appropriate at various levels (e.g., individual, clinical practice, facility, etc.), quality improvement, health economics, implementation of skills development programs, and robust experience in the adaptation and implementation of other established EBP will be encouraged. Personnel involved in the proposed strategy, e.g., nurse practitioners, patient, family members, respiratory therapists, pharmacists, hospital intensivists, etc., should be meaningfully engaged in the conceptualization and the planned execution of the proposed project.

Applications proposing to establish a new EBP are not within the scope of this FOA.

For additional information, view the funding announcement.