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

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ear pain counseling
language power counseling
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Otitis Media

Eligibility Criteria

12 Months - 15 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Childrens Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ear pain counseling

language power counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2015
Last Updated
November 30, 2015
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02616458
Brief Title
The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
Official Title
The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The research assistant provided a structured 10 minute education session using 10 PowerPoint slides specific to the subject's assigned group. This was done in the exam room during the child's clinic visit using a portable laptop computer to display the slides, and a copy of the slides was provided to each family at the end of the session. 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. All participating families completed a demographics survey that included information on race/ethnicity, insurance status, language(s) spoken in the home, and family composition In addition, participants completed the StimQ, the Parent Evaluation of Developmental Status (PEDS), and the he MacArthur-Bates Communicative Development Inventory. At the child's 24 month preventive care visit, or approximately 12 months after the initial encounter, a research assistant blinded to the participant's study arm assignment met with each family and asked them to once again complete each of the above listed surveys and questionnaires. Those participants who did not present to the CHC for a clinic visit between 24 and 27 months of age, most commonly because they had switched providers or were delayed in scheduling the child's 24 month visit, were contacted by phone and asked to complete the surveys and questionnaires via US mail. If no follow up data had been collected by the time the child reached 30 months of age, that subject was considered lost to follow up. 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. The site of each subsequent otitis related visit was documented (CHC, Emergency Department, Urgent care clinic, Ear, Nose and Throat (ENT) clinic) as well as antibiotic that was prescribed. The EMR review documented the number of otitis related visits for each child in total and by site of care as well as the time from the initial index visit to the first otitis related visit with and without an associated antibiotic prescription. Appropriate statistical tests analyzed differences between study groups and baseline demographic characteristics. Interactions between the study group and dichotomous demographic variables were tested in negative-binomial regression models. When socio-demographic data was missing the enrollee was not included in that sub-analysis. Final stratified regression models represent the relationship between ear pain visits, the study group, and the dichotomous demographic characteristic. Each stratified model was analyzed to represent the appropriate intervention vs. control comparison for each level of the demographic factor [e.g., Post High School education (intervention vs. control) and ≤ High School education (intervention vs. control)].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ear pain counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
language power counseling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ear pain counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
language power counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Otitis related visits by site of care
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time from the initial index visit to the first otitis related visit.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Influence of maternal ethnicity, education, marital status, and age on the effect of ear pain counseling
Time Frame
12 months
Title
The site of each subsequent otitis related visit was documented (CHC, Emergency Department, Urgent care clinic, ENT clinic).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Berman, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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

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