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NCT05608993 · ClinicalTrials.gov registry record · NA
RELAX: Reducing Length of Antibiotics for Children With Ear Infections
A NA study of Acute Otitis Media and Ear Infection, sponsored by Intermountain Health Care.
- Active
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT05608993 is a NA study of Acute Otitis Media and Ear Infection that is active but no longer recruiting, run by Intermountain Health Care. The registered enrollment target is 500 participants, above the 345-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (45% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05608993, a NA study of Acute Otitis Media and Ear Infection, is active but no longer recruiting, sponsored by Intermountain Health Care.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER High Intensity Intervention
- OTHER Low Intensity Intervention
Study Locations (1)
Colorado
- Denver Health and Hospital Authority - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2027-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608993
The ClinicalTrials.gov registry entry for NCT05608993 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 345-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (45% 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 2 interventions - of which High Intensity Intervention is the first listed.
NCT05608993 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05608993 about?
NCT05608993 is a clinical study titled "RELAX: Reducing Length of Antibiotics for Children With Ear Infections". 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 ...
What is the current status of trial NCT05608993?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2024-04-01. Estimated completion is 2027-10.
What conditions does trial NCT05608993 study?
This clinical trial studies the following conditions: Acute Otitis Media, Ear Infection, Pediatric Infectious Disease.
What interventions are being tested in trial NCT05608993?
The interventions under investigation include: High Intensity Intervention (OTHER), Low Intensity Intervention (OTHER).
Who is sponsoring clinical trial NCT05608993?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608993 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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