Otitis Media Clinical Trial
Official title:
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 (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.
Status | Completed |
Enrollment | 310 |
Est. completion date | August 2015 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Months to 15 Months |
Eligibility |
Inclusion Criteria: - Children aged 12-15 months seen at the CHC for their preventive care visit were eligible for enrollment in the study. Exclusion Criteria: - Ventilating tubes - Down syndrome - Cardiac disease - Immunodeficiency disorder - Family's primary language was something other than English or Spanish |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Influence of maternal ethnicity, education, marital status, and age on the effect of ear pain counseling | 12 months | No | |
Other | The site of each subsequent otitis related visit was documented (CHC, Emergency Department, Urgent care clinic, ENT clinic). | 12 months | No | |
Primary | Number of Otitis related visits by site of care | 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. | 12 months | No |
Secondary | Time from the initial index visit to the first otitis related visit. | 12 months | No |
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