Shared Decision Making in Parents of Children With Acute Otitis Media



Status:Recruiting
Conditions:Other Indications, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 18
Updated:2/21/2019
Start Date:March 26, 2017
End Date:December 2019

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Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial

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.

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 :
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-255-5056
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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