Study Comparing Two Methods to Reduce Unnecessary Antibiotic Use for Children with Ear Infections

What this Trial Is About

Researchers are evaluating two approaches to reduce unnecessary antibiotic prescribing for children with ear infections, also known as acute otitis media AOM. This common condition affects millions of children yearly and often leads to overuse of antibiotics despite guidelines recommending watchful waiting. The study compares a standard Health System Level Intervention with a Hybrid Intervention that adds a Shared Decision-Making component to involve parents more in their childs care. The goal is to increase parent satisfaction and align treatment with national guidelines while reducing antibiotic use and adverse effects. The study involves 33 clinics across the United States, where clinics are randomly assigned to one of two groups. The Health System Level Intervention includes changes to electronic health records EHR to support guideline-based prescribing, audit and feedback reports for clinicians, and virtual education sessions offering continuing medical education credits. The Hybrid Intervention includes all these elements plus use of a validated Shared Decision-Making aid and additional clinician education on how to use it effectively during visits. Participants include children aged 6 months to 17 years diagnosed with AOM, their parents or legal guardians, clinicians, and administrators. Data collection includes surveys, focus groups, interviews, and observation of shared decision-making use. Outcomes measured include parent satisfaction and antibiotic use at 10 days post-visit, as well as quality of life, symptom duration, adverse drug events, and treatment failure. The study also assesses implementation challenges and preferences to support future wider use of these interventions.

Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections