This NOSI aims to incorporate an implementation research question into Phase II and III NHLBI clinical trials that are part of phased awards (R61/R33 and UG3/UH3). The purpose of this NOSI is to strengthen the impact of findings from the parent study and prepare for ready uptake of the clinical study results into practice and real-world applications. The parent activity code of the existing award must be an NHLBI-funded R61/R33 or UG3/UH3 phased award.
The objective of this research is to increase the use and uptake of clinical trial results by incorporating tests of implementation strategies into existing NHLBI Phased II and III clinical trials. This NOSI will support applications that propose a multidisciplinary research approach in the second phase (i.e., the R33 or UH3 phase) of the bi-phasic award. Revision supplement funds will support implementation research during the full enrollment and clinical trial execution phase (R33 or UH3 phase), not to exceed the project period of the parent award.
Applicants are encouraged to form collaborations between implementation scientists and scientists with expertise in varying disciplines (e.g., behavioral economics, informatics, data science, health systems science, shared-decision making, economics, etc.). Investigators should have a strong track record of funding in related areas, such as adherence, behavioral economics, predictive analytics, health behavior, public health, health policy, decision making, health services, comparative-effectiveness, and data analytics.
By maximizing the impact of NHLBI clinical research implementation during the clinical trial execution phase (R33 or UH3), translational research will be advanced during the intervention process, rather than after an intervention is complete.
This NOSI aims to strengthen the potential for achieving impactful implementation of NHLBI clinical research studies as they transition to the R33 or UH3 phase of award. Early integration of implementation research design into clinical trials hastens and improves the subsequent implementation process. Studies may include primary or secondary data at one or more levels of analyses (i.e., patient, provider, community, organization, state, etc.). Research designs must include proven methodologies and established implementation frameworks. Qualitative and quantitative data from needs assessments, focus groups, cost data, interviews, health surveys, electronic health records, GIS, etc. are illustrative inputs. Clinical trials may choose to blend design components of clinical effectiveness and implementation research as hybrid effectiveness-implementation design studies and are of high interest.
Applications in response to this Notice must be submitted through PA-20-163, Competing Revisions to Existing NIH Grants and Cooperative Agreements (Clinical Trial Optional).
Applications for revisions in response to this Notice must follow application instructions and be submitted on the following dates: November 23, 2020; November 23, 2021; and November 23, 2022.
NOT-HL-20-795
