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

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

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media
• Intervention / Treatment: Other: Usual Care; Other: Acute Otitis Media Choice Decision Aid

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 :

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Acute Otitis Media Choice Decision Aid; For patients whose clinician is randomized to the decision aid arm: The study coordinator will provide the decision aid for the parent/clinician dyad.; 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.; 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.; 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.; 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.	Other: Acute Otitis Media Choice Decision Aid; Decision Aid
Other: Usual Care; the clinician will discuss management options with the parent in the clinician's usual fashion.	Other: Usual Care; Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of parents completing the survey	15 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jana L Anderson, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2017
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: 16-000627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No