Shared Decision Making in Parents of Children With Acute Otitis Media
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|ClinicalTrials.gov Identifier: NCT02872558|
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Other: Acute Otitis Media Choice Decision Aid Other: Usual Care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
Acute Otitis Media Choice Decision Aid
For patients whose clinician is randomized to the decision aid arm:
Other: Acute Otitis Media Choice Decision Aid
the clinician will discuss management options with the parent in the clinician's usual fashion.
Other: Usual Care
- Number of parents completing the survey [ Time Frame: 15 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT02872558
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Jana Anderson, MD 507-255-5056 firstname.lastname@example.org|
|Contact: Derek VanMeter 5072555056 email@example.com|
|Principal Investigator:||Jana L Anderson||Mayo Clinic|