Shared Decision Making in Parents of Children With Acute Otitis Media

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872558
• Other study ID #: 16-000627
• Status: Completed
• Phase: N/A
• Start date: March 26, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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 :

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Other:
• Acute Otitis Media Choice Decision Aid
Decision Aid
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of parents completing the survey		15 months

External Links

•   Mayo Clinic Clinical Trials