PROJECT SUMMARY/ABSTRACT:
Acute otitis media (AOM) is the most commonly cited indication for antibiotics in children, accounting for 24%
of all pediatric antibiotic prescriptions and affecting 60% of children by 3 years of age. For most children = 2
years of age with AOM, 5-7 days, rather than 10 days, of antibiotics have been shown to be sufficient and
result in fewer adverse drug events with similar failure and recurrence rates. Thus, national guidelines
recommend short durations of antibiotics for non-severe AOM in this age group. Despite these
recommendations, >94% of children =2 years of age are prescribed longer than recommended antibiotic
durations and over 41% of antibiotic exposure days for AOM in this age group are likely unnecessary. In a
recent pilot study that compared a low-cost High-intensity intervention with clinician education, individualized
clinician audit and feedback with peer comparison and electronic health record (EHR) changes of prescription
fields to a Low-intensity intervention with only EHR changes prescribing of recommended short antibiotic
durations increased significantly (76% and 50%, absolute percentage). A definite study is needed to make
appropriate recommendations on which intervention to implement, while minimizing resource utilization. The
overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost
pragmatic interventions of different intensities to increase prescribing of recommended short antibiotic
durations for AOM for children 2 years of age and older. A multi-center cluster randomized controlled trial using
a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-intensity
intervention will include clinician education, individualized clinician audit and feedback with peer comparison,
and EHR changes of prescription fields, whereas the Low-intensity intervention will include clinician education
and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct
geographic regions in the United States will be randomized to one of the two interventions. The Practical
Robust Implementation and Sustainability Model will be used to guide implementation and the Reach
Effectiveness Adoption Implementation Maintenance framework will be used to evaluate outcomes. A mixed-
methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative
analyses, semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders at the
American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with
dissemination of findings and scaling of interventions.