Shared Decision Making in Parents of Children With Acute Otitis Media

Mayo Clinic

Status: Completed

Conditions: Acute Otitis Media

Treatments: Other: Usual Care; Other: Acute Otitis Media Choice Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02872558

16-000627

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 :

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Acute Otitis Media Choice Decision Aid

Other group

Description:

For patients whose clinician is randomized to the decision aid arm: 1. The study coordinator will provide the decision aid for the parent/clinician dyad. 2. The study coordinator will provide a color-printed copy of the decision aid to the clinician prior to the clinician having the antibiotics discussion with the parents. 3. The study coordinator will offer to provide the treating clinician a concise refresher of the content included in the decision aid in the context of the trial. 4. The clinician will then, using the decision aid as a tool to facilitate discussion regarding the natural course of AOM, pain control, antibiotics exposure and deeper infections. 5. The clinician will then engage the parents in a shared decision regarding the use of immediate antibiotics versus a wait and watch prescription that is consistent with both the parent's values and preferences and the clinician's level of comfort.

Treatment:

Other: Acute Otitis Media Choice Decision Aid

Usual Care

Other group

Description:

the clinician will discuss management options with the parent in the clinician's usual fashion.

Treatment:

Other: Usual Care