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Shared Decision Making in Parents of Children With Acute Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02872558
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : February 19, 2019
Information provided by (Responsible Party):
Jana Anderson, 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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Other: Acute Otitis Media Choice Decision Aid Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 : March 26, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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.
Other: Acute Otitis Media Choice Decision Aid
Decision Aid

Usual Care
the clinician will discuss management options with the parent in the clinician's usual fashion.
Other: Usual Care
Usual Care

Primary Outcome Measures :
  1. Number of parents completing the survey [ Time Frame: 15 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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


  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 :

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02872558

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jana Anderson, MD    507-255-5056   
Contact: Derek VanMeter    5072555056   
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Jana L Anderson Mayo Clinic

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Responsible Party: Jana Anderson, M.D., Mayo Clinic Identifier: NCT02872558     History of Changes
Other Study ID Numbers: 16-000627
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases