Abstract
BackgroundDespite a strong evidence base and clinical guidelines specifically recommending against prolonged post-procedural antimicrobial use, studies indicate that the practice is common following cardiac device procedures. Formative evaluations conducted by the study team suggest that inappropriate antimicrobial use may be driven by information silos that drive provider belief that antimicrobials are not harmful, in part due to lack of complete feedback about all types of clinical outcomes. De-implementation is recognized as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excess antimicrobial use following cardiac device procedures; however, investigations into strategies that lead to successful de-implementation are limited. The overarching hypothesis to be tested in this trial is that a bundle of implementation strategies that includes audit and feedback about direct patient harms caused by inappropriate prescribing can lead to successful de-implementation of guideline-discordant care.MethodsWe propose a hybrid type III effectiveness-implementation stepped-wedge intervention trial at three high-volume, high-complexity VA medical centers. The main study intervention (an informatics-based, real-time audit-and-feedback tool) was developed based on learning/unlearning theory and formative evaluations and guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) Framework. Elements of the bundled and multifaceted implementation strategy to promote appropriate prescribing will include audit-and-feedback reports that include information about antibiotic harms, stakeholder engagement, patient and provider education, identification of local champions, and blended facilitation. The primary study outcome is adoption of evidence-based practice (de-implementation of inappropriate antimicrobial use). Clinical outcomes (cardiac device infections, acute kidney injuries and Clostridioides difficile infections) are secondary. Qualitative interviews will assess relevant implementation outcomes (acceptability, adoption, fidelity, feasibility).DiscussionDe-implementation theory suggests that factors that may have a particularly strong influence on de-implementation include strength of the underlying evidence, the complexity of the intervention, and patient and provider anxiety and fear about changing an established practice. This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements in provision of guideline-concordant antimicrobial use. Findings will improve understanding about factors that impact successful or unsuccessful de-implementation of harmful or wasteful healthcare practices.Trial registrationClinicalTrials.govNCT05020418
Highlights
In the USA, more than 300,000 cardiovascular implantable electronic devices (CIEDs), such as pacemakers and defibrillators, are placed annually [1, 2]
Discontinuation within 24 h after skin closure is recommended because prolonged antimicrobials cause harm, including acute kidney injuries (AKI) and Clostridioides difficile infections, but do not reduce infections [3, 5, 6, 7]
Formative evaluations with electrophysiologists who perform these procedures concluded that these clinicians are highly motivated to prevent infections but that they overestimate benefits of prolonged antimicrobial use and underestimate harms, in part due to lack of feedback about the adverse consequences that result from prolonged antimicrobial prophylaxis [9]
Summary
In the USA, more than 300,000 cardiovascular implantable electronic devices (CIEDs), such as pacemakers and defibrillators, are placed annually [1, 2]. Guidelines about timing and duration of antimicrobial prophylaxis are often not adhered to, and excessive antimicrobials are prescribed after more than 50% of CIED procedures, leading to patient harms [8]. Formative evaluations with electrophysiologists who perform these procedures concluded that these clinicians are highly motivated to prevent infections but that they overestimate benefits of prolonged antimicrobial use and underestimate harms, in part due to lack of feedback about the adverse consequences that result from prolonged antimicrobial prophylaxis [9]. De-implementation is recognized as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excess antimicrobial use following cardiac device procedures; investigations into strategies that lead to successful de-implementation are limited. The overarching hypothesis to be tested in this trial is that a bundle of implementation strategies that includes audit and feedback about direct patient harms caused by inappropriate prescribing can lead to successful de-implementation of guideline-discordant care
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
