Erin F Barreto1,2, Andrew D Rule3,4, Mohammad H Alshaer5,6, Jason A Roberts7, Mohd Hafiz Abdul Aziz7, Marc H Scheetz8,9, Kristin C Mara10, Paul J Jannetto11, Ognjen Gajic12, John C O'Horo12,13, Kasey R Boehmer14. 1. Department of Pharmacy, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. Barreto.erin@mayo.edu. 2. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. Barreto.erin@mayo.edu. 3. Division of Epidemiology, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 4. Division of Nephrology and Hypertension, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 5. Infectious Disease Pharmacokinetics Lab, Emerging Pathogens Institute, University of Florida, 1600 SW Archer Rd, Gainesville, FL, 32610, USA. 6. Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 1600 SW Archer Rd, Gainesville, FL, 32610, USA. 7. University of Queensland Centre for Clinical Research (UQCCR), Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, QLD, 4029, USA. 8. Department of Pharmacy Practice, Chicago College of Pharmacy, Midwestern University, 555 31st St, Downers Grove, IL, 60515, USA. 9. Pharmacometrics Center of Excellence, Midwestern University, 555 31st St, Downers Grove, IL, 60515, USA. 10. Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 11. Department of Laboratory Medicine & Pathology, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 12. Division of Pulmonary and Critical Care Medicine, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 13. Division of Infectious Diseases, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. 14. Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Abstract
BACKGROUND: Beta-lactams (i.e., penicillins, cephalosporins, carbapenems, monobactams) are the most widely used class of antibiotics in critically ill patients. There is substantial interpatient variability in beta-lactam pharmacokinetics which renders their effectiveness and safety largely unpredictable. One strategy to ensure achievement of therapeutic concentrations is drug level testing ("therapeutic drug monitoring"; TDM). While studies have suggested promise with beta-lactam TDM, it is not yet widely available or implemented. This protocol presents a mixed-methods study designed to examine healthcare practitioners' perspectives on the use and implementation of beta-lactam TDM in the critically ill. METHODS: An explanatory sequential mixed-methods design will be used [QUANT → qual]. First, quantitative data will be collected through a web-based questionnaire directed at clinicians at three academic medical centers at different phases of beta-lactam TDM implementation (not yet implemented, partially implemented, fully implemented). The sampling frame will include providers from a variety of disciplines that interact with drug level testing and interpretation in the critical care environment including pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers. Second, approximately 30 individuals will be purposively sampled from survey respondents to conduct in-depth qualitative interviews to explain and expand upon the results from the quantitative strand. Normalization Process Theory and the Consolidated Framework for Implementation Science will be used to guide data analysis. DISCUSSION: These data will be used to answer two specific questions: "What are ICU practitioners' perspectives on implementing beta-lactam TDM?" and "What factors contribute to the success of beta-lactam TDM program implementation?" Results of this study will be used to design future implementation strategies for beta-lactam TDM programs in the critically ill. TRIAL REGISTRATION: NCT04755777 .
BACKGROUND: Beta-lactams (i.e., penicillins, cephalosporins, carbapenems, monobactams) are the most widely used class of antibiotics in critically ill patients. There is substantial interpatient variability in beta-lactam pharmacokinetics which renders their effectiveness and safety largely unpredictable. One strategy to ensure achievement of therapeutic concentrations is drug level testing ("therapeutic drug monitoring"; TDM). While studies have suggested promise with beta-lactam TDM, it is not yet widely available or implemented. This protocol presents a mixed-methods study designed to examine healthcare practitioners' perspectives on the use and implementation of beta-lactam TDM in the critically ill. METHODS: An explanatory sequential mixed-methods design will be used [QUANT → qual]. First, quantitative data will be collected through a web-based questionnaire directed at clinicians at three academic medical centers at different phases of beta-lactam TDM implementation (not yet implemented, partially implemented, fully implemented). The sampling frame will include providers from a variety of disciplines that interact with drug level testing and interpretation in the critical care environment including pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers. Second, approximately 30 individuals will be purposively sampled from survey respondents to conduct in-depth qualitative interviews to explain and expand upon the results from the quantitative strand. Normalization Process Theory and the Consolidated Framework for Implementation Science will be used to guide data analysis. DISCUSSION: These data will be used to answer two specific questions: "What are ICU practitioners' perspectives on implementing beta-lactam TDM?" and "What factors contribute to the success of beta-lactam TDM program implementation?" Results of this study will be used to design future implementation strategies for beta-lactam TDM programs in the critically ill. TRIAL REGISTRATION: NCT04755777 .
Entities:
Keywords:
Beta-lactams; Implementation; Intensive care unit; Mixed-methods; Pharmacokinetics/pharmacodynamics; Study protocol; Therapeutic drug monitoring
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