Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Otitis Media Choice Decision Aid | Other | For patients whose clinician is randomized to the decision aid arm:
|
|
| Usual Care | Other | the clinician will discuss management options with the parent in the clinician's usual fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Otitis Media Choice Decision Aid | Other | Decision Aid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of parents completing the survey | 15 months |
Not provided
Not provided
Inclusion:
6 months to 18 years in age
Acute Otitis Media diagnosed (AOM) at the time of visit, defined as:
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:
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jana L Anderson | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40753428 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual Care |
| Other |
Usual Care |
|