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NCT06034080 · ClinicalTrials.gov registry record · NA
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
A NA study of Acute Otitis Media and Ear Infection, sponsored by Intermountain Health Care.
- Recruiting
- Registry status
- NA
- Development phase
- 1,566
- Enrollment target
- 3
- Study locations
NCT06034080 is a NA study of Acute Otitis Media and Ear Infection that is actively recruiting participants, run by Intermountain Health Care. The registered enrollment target is 1,566 participants, above the 212-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (639% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT06034080, a NA study of Acute Otitis Media and Ear Infection, is actively recruiting participants, sponsored by Intermountain Health Care.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,566 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,566 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 212-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (639% higher). The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
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.
NCT06034080 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Illinois, Utah.
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.
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).
Who is sponsoring clinical trial NCT06034080?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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