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

NCT02616458 | Completed

• 1 other identifier: 09-0270
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time from the initial index visit to the first otitis related visit.

  12 months

Other Outcomes (2)

• Influence of maternal ethnicity, education, marital status, and age on the effect of ear pain counseling

  12 months

• The site of each subsequent otitis related visit was documented (CHC, Emergency Department, Urgent care clinic, ENT clinic).

  12 months

Study Arms (2)

ear pain counseling

EXPERIMENTAL

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. The research assistant provided and reviewed proper dosing instructions for acetaminophen and ibuprofen, and provided a prescription for antipyrine/benzocaine analgesic ear drops to each family to use as pain relief if their child did develop ear pain in the subsequent 12 months.

Other: ear pain counseling

language power counseling

ACTIVE COMPARATOR

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.

Other: language power counseling

Interventions

ear pain counseling OTHER

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.

ear pain counseling

language power counseling OTHER

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.

language power counseling

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 12-15 months seen at the CHC for their preventive care visit were eligible for enrollment in the study.

You may not qualify if:

• Ventilating tubes
• Down syndrome
• Cardiac disease
• Immunodeficiency disorder
• Family's primary language was something other than English or Spanish

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Stephen Berman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 30, 2015
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)