NCT02872558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 26, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

August 16, 2016

Last Update Submit

January 3, 2022

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

  • Number of parents completing the survey

    15 months

Study Arms (2)

Acute Otitis Media Choice Decision Aid

OTHER

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.

Other: Acute Otitis Media Choice Decision Aid

Usual Care

OTHER

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

Other: Usual Care

Interventions

Acute Otitis Media Choice Decision AidOTHER

Decision Aid

Acute Otitis Media Choice Decision Aid
Usual CareOTHER

Usual Care

Usual Care

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • months to 18 years in age
  • 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

You may not qualify if:

  • Are currently on antibiotics
  • Have acute otitis media and another diagnoses that antibiotics are prescribed for
  • Have otitis-conjunctivitis syndrome
  • Have perforation of their tympanic membrane at time of diagnoses
  • Recurrent AOM defined as:
  • ≥3 or greater separate AOM episodes in the previous 6 months or
  • ≥4 or more greater AOM episodes in the previous 12 months with one in the last 6 months
  • Have a craniofacial abnormality
  • Have had previous ear tubes placed
  • Have an immunologic disorder
  • Are immunosuppression either by disease or medication
  • Are undergoing treatment for cancer :

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Anderson JL, Oliveira J E Silva L, Hess EP, Vanmeter DE, Mullan A, Brito JP, Hargraves IG, Bellolio F. Shared decision-making for pediatric acute otitis media in the United States: a randomized emergency department trial. BMC Emerg Med. 2025 Aug 2;25(1):146. doi: 10.1186/s12873-025-01305-w.

    PMID: 40753428DERIVED

Related Links

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jana L Anderson

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

March 26, 2017

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)