his Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve health and care delivery, with a particular focus on health care systems (HCS) with less historical involvement in research studies focused on improving health outcomes for US patient populations. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a trial conduct phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.
The overall goal of this initiative is to support the "real world" assessment of health care strategies and clinical practices and procedures in health care systems (HCS) that lead to improved care for populations in a variety of healthcare contexts, with a strong focus on populations with health disparities. Results from the pragmatic studies supported by this FOA should inform policy makers, payers, doctors and patients across diverse patient care settings. This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings. Studies can propose to integrate multi-modal or multiple interventions that have demonstrated efficacy into HCS; or implement HCS changes to improve adherence to evidence-based guidelines. Trials should be conducted across three or more health care systems (HCS) that provide care to patient populations and will become part of and work with the NIH HCS Research Collaboratory. The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. Awarded applicants will work with the HCS CCC (https://rethinkingclinicaltrials.org/) to facilitate further planning and refinement of the proposed study.