This 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.
The overall goal of the NIH Health Care Systems (HCS) Research Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations and patients as research partners. The NIH HCS Research Collaboratory Program established a Collaboratory Coordinating Center (CCC) led by Duke University in 2012 (https://rethinkingclinicaltrials.org/about-nih-collaboratory/) that is providing national leadership and technical expertise. Since 2012, the CCC has facilitated the successful planning and conduct of 19 full-scale Pragmatic Clinical Trials launched in the NIH HCS Research Collaboratory Program. Awardees from this FOA will work with the NIH and CCC for both the planning and conduct of their pragmatic clinical trial or implementation trial. All Projects should conduct research studies in partnership with at least three health care delivery systems, some of the participating Institutes and Centers will give high priority to studies that address care in populations with health disparities (see Institute and Center priorities below). Projects will work with the NIH and the CCC to ultimately make available data, tools, resources and lessons learned from Collaboratory research projects to facilitate a broadened base of research partnerships with HCS.
The aim of the HCS Research Collaboratory program is to provide a framework of implementation methods and best practices that will enable the participation of many HCS in pragmatic and implementation research, not to support a defined health care research network. Health care systems have interest in participating in studies that may potentially impact the care they deliver, including pragmatic and implementation trials addressing the uptake of new interventions or technologies into routine care. Research conducted in partnership with health care systems is essential to strengthen the relevance of research results to ‘real world’ health practice. Successful approaches and best practices established through this initiative to create research partnerships with HCS should have a major impact on clinical research in the US. The Collaboratory is also well-suited for testing how practice guidelines can be implemented in HCS, and for assessing outcomes of implementation across a broad range of HCS serving various patient sub-groups. The Collaboratory could also leverage existing efforts, such as those of the US Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/BrowseRec/Index/browse-recommendations), for generating evidence regarding screenings, counseling services and preventive medications and services to improve the health of Americans.
The increased adoption of health information technology tools is not only changing how care is delivered but also providing opportunities for expanded participation of health care delivery organizations in research. The current COVID-19 pandemic has precipitated a marked shift from in-person patient care to virtual clinician-patient interactions, which may produce sustained alterations in US health care delivery. Evolution of care delivery during the pandemic provides an opportunity to understand the impacts of these changes on access to care, particularly for patient populations with health disparities.
Although the importance of engaging health care delivery organizations for expanding informative biomedical research programs is clear, many challenges exist, both cultural and practical. Many ethical and regulatory issues must be addressed to perform research in the health care delivery setting. Technical challenges to accessing and aggregating quality-controlled data from HCS in understandable ways are not trivial. Research studies frequently use endpoints that are not part of the normal evaluation of patients during a routine visit or monitor the fidelity of intervention delivery in ways that are difficult to translate to most care delivery settings, which may limit external validity. Education and engagement of providers and patients on the value of research in the care setting, and of researchers on the relevance of their work to health systems, are urgently needed for optimizing the medical care for all people in the US. The NIH HCS Research Collaboratory program created a broad framework to tackle some of these major challenges and will continue to further address these issues.
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