Clinical Trial: The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
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 Summary:
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 t
Sponsor: University of Colorado, Denver
Current Primary Outcome: Number of Otitis related visits by site of care [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time from the initial index visit to the first otitis related visit. [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: University of Colorado, Denver
Dates:
Date Received: November 11, 2015
Date Started: November 2010
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015
