Back to resultsShared Decision Making in Parents of Children With Acute Otitis Media
Primary Purpose
Acute Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Otitis Media Choice Decision Aid
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media
Eligibility Criteria
Inclusion:
- 6 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
Exclusion:
- 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 :
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Acute Otitis Media Choice Decision Aid
Usual Care
Arm Description
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.
the clinician will discuss management options with the parent in the clinician's usual fashion.
Outcomes
Primary Outcome Measures
Number of parents completing the survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02872558
Brief Title
Shared Decision Making in Parents of Children With Acute Otitis Media
Official Title
Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute Otitis Media Choice Decision Aid
Arm Type
Other
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
the clinician will discuss management options with the parent in the clinician's usual fashion.
Intervention Type
Other
Intervention Name(s)
Acute Otitis Media Choice Decision Aid
Intervention Description
Decision Aid
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Number of parents completing the survey
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
6 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
Exclusion:
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 :
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana L Anderson
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Shared Decision Making in Parents of Children With Acute Otitis Media
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