Promoting de-implementation of inappropriate antimicrobial use in cardiac device procedures by expanding audit and feedback: protocol for hybrid III type effectiveness/implementation quasi-experimental study

Abstract

Background: Despite 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.

Methods: We 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).

Discussion: De-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 registration: ClinicalTrials.gov NCT05020418.

Keywords: Antimicrobial stewardship; De-implementation; Hybrid type III implementation/effectiveness; Informatics; Learning/unlearning; Stepped wedge; i-PAHRIS.

Conflict of interest statement

WBE was the site PI of a COVID-19 therapeutics trial funded by Gilead Sciences (funds to institution). WBE is a paid expert witness for DLA Piper, LLC, Medtronic, and CRICO. All other authors report no competing interest.

The views expressed are those of the authors and do not necessarily represent those of the US Federal Government or the Department of Veterans Affairs.

© 2022. The Author(s).

Figures

Fig. 1

Conceptual model of information feedback loops, how they reinforce delivery of guideline-discordant care, and how they influence clinical decision-making