Shared Decision Making in Parents of Children With Acute Otitis Media

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02872558

Enrollment

101

Registered

2016-08-19

Start date

2017-03-26

Completion date

2019-06-15

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media

Brief summary

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

Detailed description

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.

Interventions

OTHERAcute Otitis Media Choice Decision Aid

Decision Aid

OTHERUsual Care

Usual Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

Healthy volunteers

Inclusion criteria

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 :

Design outcomes

Primary

Measure	Time frame
Number of parents completing the survey	15 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026