The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2010 |
| End Date: | August 2015 |
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.
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.
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)].
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)].
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
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