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Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
NCT06034080 · View on ClinicalTrials.gov ↗
Study Summary
This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a "gold standard" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for child ear infection care. The "gold standard" approach is a Health System Level Intervention. On its own, it involves clinician education, tools in electronic medical records, and audit and feedback reports for clinician prescribing habits. The hybrid intervention includes the elements of the health systems level intervention in addition to a Shared Decision-Making component, which allows for both an increase in the role parents play in their child's care, as well as clinician education for how to use this method. The goals of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear infections, align medical care with the current national guidelines, and evaluate differences in the two intervention groups. Both groups will be evaluated for implementation outcomes to improve dissemination and scalability for future use of these models in antibiotic prescribing for children with ear infections. This study will recruit a diverse group of patients and clinicians to complete surveys, parents to participate in focus groups, and clinicians and administrators to be interviewed in order to meet study aims and receive sufficient feedback on the interventions performed. There are two hypotheses for this research: 1. The Hybrid Intervention will have higher parent satisfaction and reduced antibiotic use compared to the Health-System Level Intervention and 2. The Hybrid Intervention will be more challenging to implement than the Health-System Level Intervention, but will be preferred by parents, clinicians, and administrators.
Conditions Studied
Interventions
- OTHER Changes to the electronic health record (EHR)
- OTHER Individualized audit and feedback reporting for clinicians
- OTHER Clinician education sessions
- OTHER Use of a shared decision-making (SDM) aide
- OTHER Shared decision-making (SDM) education
Study Locations (3)
Colorado
- Denver Health and Hospital Authority — Denver
Illinois
- AllianceChicago — Chicago
Utah
- Intermountain Health — Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,566 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2029-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06034080
The ClinicalTrials.gov registry entry for NCT06034080 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,566 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 58 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Acute Otitis Media appearing as the primary indexed condition, and to 5 interventions — of which Changes to the electronic health record (EHR) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06034080 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Illinois, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06034080 about?
NCT06034080 is a clinical study titled "Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections". This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a "gold standard" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for chil...
What is the current status of trial NCT06034080?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,566 participants. The study started on 2025-02-03. Estimated completion is 2029-06.
What conditions does trial NCT06034080 study?
This clinical trial studies the following conditions: Acute Otitis Media, Ear Infection, Pediatric Infectious Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06034080?
The interventions under investigation include: Changes to the electronic health record (EHR) (OTHER), Individualized audit and feedback reporting for clinicians (OTHER), Clinician education sessions (OTHER), Use of a shared decision-making (SDM) aide (OTHER), Shared decision-making (SDM) education (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06034080?
This trial is sponsored by Intermountain Health Care, which has 58 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06034080 being conducted?
This trial has 3 study locations across Colorado, Illinois, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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