Shared Decision Making in Parents of Children With Acute Otitis Media

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02872558
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.6
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Otitis Media	Other: Acute Otitis Media Choice Decision Aid; Other: Usual Care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial
• Actual Study Start Date: Mar 26, 2017
• Actual Primary Completion Date: Jun 15, 2019
• Actual Study Completion Date: Jun 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of parents completing the survey [15 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

6. ≥3 or greater separate AOM episodes in the previous 6 months or

7. ≥4 or more greater AOM episodes in the previous 12 months with one in the last 6 months

8. Have a craniofacial abnormality

9. Have had previous ear tubes placed

10. Have an immunologic disorder

11. Are immunosuppression either by disease or medication

12. Are undergoing treatment for cancer :

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Jana L Anderson, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Jana Anderson, M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02872558
• Other Study ID Numbers: 16-000627
• First Posted: Aug 19, 2016
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Otitis; Otitis Media

Study Results

No Results Posted as of Jan 4, 2022