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NCT05608993
RELAX: Reducing Length of Antibiotics for Children With Ear Infections
Conditions: Acute Otitis Media, Pediatric Infectious Disease, Ear Infection
Sex: All
Ages: 2 Years – 17 Years
Phase: NA
Enrollment: 500
Sponsor: Denver Health and Hospital Authority
Summary
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.
Eligibility Criteria
Inclusion Criteria:A. Secondary use data of encounters for children with AOMAged 2-17-years-old (inclusive)Diagnosis of AOM by ICD10 codeAOM is uncomplicatedPrescribed an oral antibioticB. Clinician and administrator interviewsLicensed clinician (physician or advanced practice clinician) that cares for children with AOMPractices in an intervention study siteIs not a medical trainee (student, resident, fellow, etc.)Aged >=18 years-no maximumC. Parent focus groupsParent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University18 years of age or older and able/willing to consentD. Clinician and administrator surveysLicensed clinician (physician or advanced practice clinician) that cares for children with AOMPractices in an intervention study siteIs not a medical trainee (student, resident, fellow, etc.)Aged >=18 years-no maximumExclusion Criteria:A. Secondary use data of encounters for children with AOM1. Complicated infection (determined a priori)B. Clinician and administrator interviews 1. Medical traineeC. Parent focus groupsNot parent or legal guardianDoes not speak English or Spanish (focus groups can only be conducted in these languages).D. Clinician and administrator surveys1. Medical trainee
Source: ClinicalTrials.gov (NCT05608993). StuddyBuddy aggregates publicly available trial information.