Shared Decision Making in Parents of Children With Acute Otitis Media

Not Applicable

Completed

• Conditions: Acute Otitis Media
• Interventions: Other: Usual Care; Other: Acute Otitis Media Choice Decision Aid

• Registration Number: NCT02872558
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Study Start: 2017-03-26
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	the clinician will discuss management options with the parent in the clinician's usual fashion.
Acute Otitis Media Choice Decision Aid	Acute Otitis Media Choice Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
Number of parents completing the survey	15 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States