RELAX: Reducing Length of Antibiotics for Children With Ear Infections

The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost interventions of different intensities to increase prescribing of recommended short antibiotic durations for acute otitis media (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 electronic health record (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 (PRISM) will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) 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.

NCT Number	NCT05608993
Lead Sponsor	Intermountain Health Care, Inc. Collaborators: Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University Medical Center, Washington University School of Medicine
Conditions	Acute Otitis Media, Pediatric Infectious Disease, Ear Infection
Enrollment	500 participants
Start Date	2024-04-01
Primary Completion	2027-04 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2025-08-17