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The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population

NCT02616458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2015-12-02

No results posted yet for this 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.

Conditions

  • Otitis Media

Interventions

OTHER

ear pain counseling

The Ear Pain counseling materials reviewed concepts such as how to recognize ear pain and safely provide pain relief, and how to recognize danger signs that require urgent medical attention. Families were also encouraged to schedule an appointment in the CHC for a possible ear infection rather than going to the emergency department or urgent care facility after hours.

OTHER

language power counseling

The Language Power materials explained the importance of frequent conversations between parents and children and of using encouraging rather than discouraging comments and the PRA reviewed age-appropriate activities in the Learning Games book, and the importance of daily reading using the provided children's book as an example.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Stephen Berman, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-10-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616458 on ClinicalTrials.gov