Reducing length of antibiotics for children with ear infections: protocol for a cluster-randomized trial in the USA

Aim: Preventing unnecessarily long durations of antibiotic therapy is a key opportunity to reduce antibiotic overuse in children 2 years of age and older with acute otitis media (AOM). Pragmatic interventions to reduce durations of therapy that can be effectively scaled and sustained are urgently needed. This study aims to fill this gap by evaluating the effectiveness and implementation outcomes of two low-cost interventions of differing intensities to increase guideline-concordant antibiotic durations in children with AOM. Methods: The higher intensity intervention will consist of clinician education regarding guideline-recommended short durations of antibiotic therapy; electronic health record (EHR) prescription field changes to promote prescribing of recommended short durations; and individualized clinician audit and feedback on adherence to recommended short durations of therapy in comparison to peers, while the lower intensity intervention will consist only of clinician education and EHR changes. We will explore the differences in implementation effectiveness by patient population served, clinician type, clinical setting and organization as well as intervention type. The fidelity, feasibility, acceptability and perceived appropriateness of the interventions among different clinician types, patient populations, clinical settings and intervention type will be compared. We will also conduct formative qualitative interviews with clinicians and administrators and focus groups with parents of patients to further inform the interventions and study. The formative evaluation will take place over 1.5 years, the interventions will be implemented over 2 years and evaluation of the interventions will take place over 1.5 years. Discussion: The results of this study will provide a framework for other healthcare systems to address the widespread problem of excessive durations of therapy for AOM and inform national antibiotic stewardship policy development. Clinical Trial Registration: NCT05608993 (ClinicalTrials.gov) Plain language summary What is this article about? Ear infections are the most common reason children are prescribed antibiotics. National guidelines recommend 5–7 days of antibiotics for most children over 2 years of age, but over 90% of children are prescribed durations over 5–7 days, resulting in unnecessary exposure to antibiotics. This article details the protocol for a study that evaluates two interventions that aim to reduce antibiotic overuse in children 2 years of age and older with ear infections. This study takes place in 35 clinics at Vanderbilt University Medical Center in Nashville, TN, USA and Washington University Medical Center in MO, USA. How will the results of this study be used? The results of this study will provide a framework for other healthcare systems to address the widespread problem of longer than necessary durations of antibiotic treatment and help inform the development of policies to guide how clinicians prescribe antibiotics for childhood ear infections. Tweetable abstract: This study evaluates interventions to reduce antibiotic overuse in children with ear infections. It will provide a framework to address the problem of excessive durations of therapy and inform stewardship policy.