Background: Ear infections are the most common reason antibiotics are prescribed to children and affect 60 percent of children by three years of age. Though most ear infections will resolve without an antibiotic, more than 95 percent of children are prescribed an antibiotic. Unnecessary antibiotic use harms children by reducing their quality of life, increasing antibiotic resistance which makes future infections harder to treat, causing side effects and increasing risk for Clostridioides difficile diarrhea and chronic diseases such as inflammatory bowel disease later in life. For every 100 children with an ear infection treated with an antibiotic it is estimated that five will benefit while over 26 will experience harm. Therefore, the American Academy of Pediatrics recommends that most children with ear infections be managed with watchful waiting and use an antibiotic only if they worsen or do not improve. In clinical trials watchful waiting reduced antibiotic use by over 60 percent. Children managed with watchful waiting had similar outcomes as those who received an antibiotic right away and parents were equally satisfied with watchful waiting and giving an antibiotic. Despite these findings, fewer than 5 percent of children with ear infections are managed with watchful waiting and parents are often not provided with enough information to make informed decisions about how their child’s ear infection is managed. Two types of interventions have been shown to reduce unnecessary antibiotic use for ear infections. However, it is not clear which intervention works best or which one aligns best with child and parent values and preferences. The goal of this study is to determine the best strategy to increase parent satisfaction and reduce unnecessary antibiotics taken for ear infections. The project team also aims to determine the best way to implement and scale the interventions in the future.

Comparators: The study will compare two evidence-based interventions to improve care for ear infections including 1) a “gold-standard” health-system-level intervention based on the Centers for Disease Control and Prevention Core Elements of Stewardship and 2) a hybrid intervention that includes the health-system-level Intervention and Shared Decision-Making. The health-system-level intervention includes education for clinicians, changes to the electronic medical record and feedback to clinicians on how their prescribing compares to other clinicians in their practice. The study team previously showed that this type of intervention increased use of watchful waiting by 27 percent. The hybrid intervention includes the health-system-level intervention and a previously created shared decision-making aid. Shared decision making has been shown to increase parent satisfaction by 17percent and increase use of watchful waiting by 20 percent. Additionally, over 70percent of parents preferred shared decision making over traditional paternalistic care for acute otitis media.

Methods: In total, 29 clinics serving over 5,000 children with ear infection each year will be randomized to one of the interventions. The study will take place in urgent care centers and pediatric and family medicine clinics that are part of Alliance Chicago in the Midwest, Denver Health and Hospital Authority in Colorado and Intermountain Healthcare in the West. To understand how to best implement the interventions the study team will conduct interviews with clinicians and administrators and focus groups with parents. To determine the effectiveness of each intervention the study team will evaluate parent satisfaction and if antibiotics were taken by the child. The study team will also evaluate child quality of life; shared decision making; pain severity and duration; treatment failure; side effects from antibiotics and days of missed work, daycare and school. To understand how to best scale and implement the interventions in the future the study team will look at electronic medical record data, survey clinicians and administrators, conduct focus groups of parents, assess if clinics implemented all parts of the interventions and evaluate if the results are likely to be sustained. The study team will collect data from parents, clinicians, clinics and health systems. A stakeholder advisory council that includes parents, clinicians, and clinic administrators will help guide the study. National stakeholders at the American Academy of Pediatrics, Centers for Disease Control and Prevention and the PEW Charitable Trusts will provide input and guidance and help share the results.