The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

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)].
    

Intervention name(s): ear pain counseling; language power counseling
Intervention type(s): Other; Other
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention