NCT02616458

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

Completed NA Last updated 30 November 2015

What this trial tests

NA trial testing ear pain counseling in Otitis Media in 310 participants. Completed in 1 August 2015.

Timeline

1 November 2010

Primary endpoint
1 October 2011

1 August 2015

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	310
Start date	1 November 2010
Primary completion	1 October 2011
Estimated completion	1 August 2015
Sites	1 location across United States

Drugs / interventions tested

• ear pain counseling
• language power counseling

Conditions studied

• Otitis Media — all drugs for Otitis Media →

Sponsor

University of Colorado, Denver

Who can join

Adults 12 Months to 15 Months, any sex, with Otitis Media. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Otitis related visits by site of care
  Time frame: 12 months
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.