Shared Decision Making in Parents of Children With Acute Otitis Media

Mayo Clinic101 enrolled

Overview

This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.

The Investigators long-term goal is to promote evidence-based, patient-centered evaluation in the acute care setting to more closely tailor antibiotic use to disease risk for Acute Otitis Media (AOM) in children. The Investigator will conduct a single-center cluster randomized control trial comparing the efficacy, safety and patient-centered outcomes of the shared decision-making decision aid 'Acute Otitis Media Choice' to usual care among children diagnosed with acute otitis media in the ED for whom antibiotics are being considered to engage parents in shared decision-making.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

101

Conditions

Acute Otitis Media

Interventions

Acute Otitis Media Choice Decision AidOTHER

Decision Aid

Usual CareOTHER

Usual Care

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion: 1. 6 months to 18 years in age 2. Acute Otitis Media diagnosed (AOM) at the time of visit, defined as: * Middle Ear Effusion- demonstrated by pneumatic otoscopy, air fluid level, or a bulging tympanic membrane PLUS * Evidence of Acute Inflammation- opaque, white, yellow, or erythematous tympanic membrane or purulent effusion PLUS * Symptoms of otalgia, fussiness or fever Exclusion: 1. Are currently on antibiotics 2. Have acute otitis media and another diagnoses that antibiotics are prescribed for 3. Have otitis-conjunctivitis syndrome 4. Have perforation of their tympanic membrane at time of diagnoses 5. Recurrent AOM defined as: 1. ≥3 or greater separate AOM episodes in the previous 6 months or 2. ≥4 or more greater AOM episodes in the previous 12 months with one in the last 6 months 6. Have a craniofacial abnormality 7. Have had previous ear tubes placed 8. Have an immunologic disorder 9. Are immunosuppression either by disease or medication 10. Are undergoing treatment for cancer :

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of parents completing the survey

Time frame: 15 months

Data from ClinicalTrials.gov

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