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NCT02616458 · ClinicalTrials.gov registry record · NA
The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
A NA study of Otitis Media, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 310
- Enrollment target
- 1
- Study location
NCT02616458: Completed NA study of Otitis Media, sponsored by University of Colorado, Denver.
NCT02616458 is a NA study of Otitis Media that has completed, run by University of Colorado, Denver. The registered enrollment target is 310 participants, below the 4,321-participant average among 14 other Otitis Media trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02616458, a NA study of Otitis Media, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 310 participants
- Enrollment target
- 1
- Study location
Study Summary
Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a program of anticipatory guidance counseling for ear pain at the 12-15 month routine preventive care visit in a predominantly low income population can reduce medical visits to clinic, emergency department (ED), and urgent care (UC). Design: Single blind randomized control trial of an ear pain counseling program. Setting: The Child Health Clinic (CHC), a primary care clinic at Children's Hospital Colorado, which serves a predominantly low income population with diverse cultural and ethnic backgrounds. Participants: 310 mothers were enrolled at their child's 12-15 month well child visit. Intervention: Structured 10-minute education intervention, given by a research assistant, used a slide presentation that reviewed ear pain Main Outcome and Measures: Number of ED, UC, and clinic visits for otitis media for the 12 month period after entry into the study and whether the visit included a prescription for antibiotics.
Primary Outcome
The electronic medical record (EMR) for each child (EPIC) was reviewed for a diagnosis of otitis media using all otitis related diagnostic codes for 12 months following their initial index visit.
Conditions Studied
Interventions
- OTHER ear pain counseling
- OTHER language power counseling
Study Locations (1)
Colorado
- Childrens Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT02616458 record still lists
NCT02616458 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 4,321-participant average among 14 other Otitis Media trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Otitis Media appearing as the primary indexed condition, and to 2 interventions - of which ear pain counseling is the first listed.
NCT02616458 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02616458 about?
NCT02616458 is a clinical study titled "The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population". Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a program of anticipatory guidance counseling for ear pain at the 12-15 month routine preventive care visit in a predominantly low income population can reduce medical visits to clinic, emergency department (E...
What is the current status of trial NCT02616458?
This trial is currently completed. It is a NA study. The enrollment target is 310 participants. The study started on 2010-11. Estimated completion is 2015-08.
What conditions does trial NCT02616458 study?
This clinical trial studies the following conditions: Otitis Media.
What interventions are being tested in trial NCT02616458?
The interventions under investigation include: ear pain counseling (OTHER), language power counseling (OTHER).
Who is sponsoring clinical trial NCT02616458?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02616458 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02616458's enrollment target sits among peer trials
310 4th of 14 higher than 11 of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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