An interventional study of High Intensity Intervention and Low Intensity Intervention in Acute Otitis Media, Pediatric Infectious Disease and Ear Infection, sponsored by Intermountain Health Care, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Intermountain Health Care, Inc. · Not applicable, Interventional, and Health services research
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.
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 500 is above the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Intermountain Health Care, Inc. is the lead sponsor of 120 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Secondary use data of encounters for children with AOM
B. Clinician and administrator interviews
C. Parent focus groups
D. Clinician and administrator surveys
Exclusion Criteria:
A. Secondary use data of encounters for children with AOM
1. Complicated infection (determined a priori)
B. Clinician and administrator interviews 1. Medical trainee
C. Parent focus groups
D. Clinician and administrator surveys
1. Medical trainee
Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.
Other: High Intensity Intervention
Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.
Other: Low Intensity Intervention
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.
The Low Intensity intervention will include clinician education and EHR changes only.
Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.
Determine the effectiveness of a High and Low intensity intervention to increase prescribing of recommended antibiotic durations (short, 5 days) for AOM in children ≥ 2 years of age.
Time frame: 5 years
Mean days of antibiotics prescribed
Mean number of days of antibiotics prescribed for children ≥ 2 years of age with AOM
Time frame: 5 years
Adverse drug event
Number of adverse drug events among children ≥ 2 years of age prescribed antibiotics for AOM
Time frame: 5 years
Treatment failure
Treatment failure defined as a new antibiotic associated with an AOM encounter within 3-14 days of the initial encounter.
Time frame: 5 years
Recurrence
Recurrence defined as a new antibiotic associated with an AOM encounter within 15-30 days of initial encounter.
Time frame: 5 years
Plan to share: No — IPD will not be shared with other researchers.
Started Apr 2024 (actual). Primary completion is estimated for Apr 2027, 36 months after the start.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 36 months is close to that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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