Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01)

This Funding Opportunity Announcement (FOA) solicits applications for grant funding to conduct Large Health Services Research Projects (R01) focused on Combating Antibiotic-Resistant Bacteria (CARB) in the following ways: by promoting appropriate antibiotic use, reducing the transmission of resistant bacteria, and preventing healthcare-associated infections (HAIs) in the first place. Background Antibiotic resistance (AR), which has been noted since soon after the discovery of penicillin, has become a national and international threat. The Centers for Disease Control and Prevention (CDC) estimates that more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. In 2014, the White House called for a national effort for Combating Antibiotic-Resistant Bacteria (CARB). The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) was released in March 2015, and in 2020, the CARB NAP was updated for 2020-2025 (available at: https://www.hhs.gov/sites/default/files/carb-national-action-plan-2020-2025.pdf). The first and third goals of the CARB NAP are particularly relevant to AHRQ's mission. The first goal of the CARB NAP focuses on slowing the emergence of resistant bacteria and preventing the spread of resistant infections, and the third goal of the NAP includes improving the use of diagnostic tests in clinical care directed to potential resistant infections. The Department has also published the National Action Plan to Prevent Healthcare-Associated Infections (HAI NAP), which is available at: http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html. AHRQ’s CARB-related activities contribute significantly to achieving the goals of both the CARB NAP and the HAI NAP. A complementary FOA (PA-22-048) highlights the research areas of interest for R18 applications related to CARB. Research Objectives AHRQ is interested in supporting AR research in all settings targeted in the CARB NAP and the HAI NAP, including acute care hospitals, long-term care, and ambulatory care settings, as well as transitions between care settings. AHRQ notes that methods of combating AR and conducting antibiotic stewardship are less-well-developed in long-term care and ambulatory settings than in the inpatient hospital setting. Additional research in these areas is especially needed. AHRQ aims to support research in all three settings. It should be noted that AR blurs the distinction between community-acquired infections and HAIs since AR bacteria that emerge in the community tend to be transmitted in due time to healthcare settings. AR is not confined to specific healthcare settings. Factors that contribute to AR in one setting affect others as well, whether through inappropriate use of antibiotics across settings or transmission of resistant infections from one setting to another. Consistent with AHRQ’s mission to improve the delivery of healthcare, AHRQ will fund grants that address AR, in the following areas of research interest: Promoting appropriate antibiotic use. Areas of interest include but are not limited to: Improving the appropriateness of antibiotic selection and use in all healthcare settings, including but not limited to identifying and modifying factors influencing prescriber decisions about the use and choice of antibiotics. The role of new and existing diagnostics, including rapid diagnostics, in improving antibiotic use, including how diagnostics should be integrated into clinicians decision making about antibiotic use. The role of the patient’s perceptions and preferences and patient engagement in influencing antibiotic use. Developing improved methods for conducting antibiotic stewardship, particularly in ambulatory and long-term care settings, including multidisciplinary approaches to antibiotic stewardship Developing electronic health record-based approaches to antibiotic stewardship in and across various settings. Promoting the implementation of antibiotic stewardship programs in long-term care, ambulatory, and hospital settings, including but not limited to identifying and overcoming barriers to implementation. Reducing the transmission of resistant organisms. Areas of interest include but are not limited to: Approaches to preventing the transmission of AR organisms, including regional approaches that span hospital, long-term care, and ambulatory care. Developing new methods, improving existing methods, and improving implementation of decolonization with or without screening. Reducing transmission of Clostridioides difficile (C. diff) and multidrug-resistant organisms (MDROs). Preventing HAIs in the first place. Combating C. diff and MDROs, including but not limited to carbapenem-resistant Enterobacteriaceae (CRE)/Klebsiella pneumoniae carbapenemase (KPC), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and extended spectrum beta-lactamase-producing organisms (ESBLs). See also PA-21-265 the basic R01 funding announcement focused on prevention of HAIs. Funding This FOA announces the availability of funds to support Large Research Projects, using the R01 mechanism, that address the following aspects of the CARB research areas noted above: Determination of the clinical efficacy and effectiveness of CARB-related interventions, including unintended adverse consequences. Characterization and assessment of relevant epidemiological aspects related to improving antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated infections. A companion FOA (PA-22-048) announces the availability of funds to support Large Health Services Research Demonstration and Dissemination Projects, using the R18 mechanism, in the following broad areas of CARB research: Demonstration, dissemination, and evaluation of strategies and approaches focused on promoting appropriate antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated infections. Research regarding adoption and implementation (including sustainment and spread/scale-up) of evidence-based approaches for promoting appropriate antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated infections. In AHRQ’s research funding framework, R01 projects on CARB are intended to produce evidence to determine the effectiveness of interventions that are CARB-related or to identify epidemiological factors, whereas R18 projects on CARB are intended to take interventions that have been shown to be effective on a small scale or in a particular setting and to demonstrate and disseminate their application more widely or to explore issues of implementation and adoption. It should be noted that, in addition to the CARB FOAs for R01 and R18 applications, AHRQ has published a set of FOAs that solicit R01 and R18 applications focused on preventing HAIs. Applications for proposed projects that are primarily focused on CARB issues should be submitted in response to the CARB FOAs. Applications that are primarily focused on HAI prevention should be submitted in response to the HAI FOAs. It will be helpful for applicants to follow this guidance. However, because prevention of HAIs is intimately connected to achieving the aims of the CARB NAP, AHRQ will consider applications on HAI prevention and/or CARB issues responsive if submitted to either set of FOAs. Promoting equity is an important societal goal. AHRQ intends that research funded by the agency contribute to this goal by addressing equity. AHRQ encourages applicants responding to this FOA to consider whether there are equity issues in their proposed projects and, where relevant, to address these issues in the proposed research plan. Pursuant to its authorizing legislation, see 42 U.S.C. 299(c), AHRQ conducts and supports research for AHRQ priority populations (see Section IV.7 for a list of priority populations). AHRQ is interested in CARB research that includes a focus on priority populations such that meaningful subgroup analysis can be conducted and results stratified by priority population can be produced. Recipients of awards under this FOA must provide annual and final reports of performance in achieving the FOA objective to support large research grants for combating antibiotic-resistant bacteria (see section VI.3. Reporting). See Section VIII. Other Information for award authorities and regulations.