Acute Otitis MediaNCT02872558
Shared Decision Making in Parents of Children With Acute Otitis Media
A study testing Acute Otitis Media Choice Decision Aid in people with Acute Otitis Media, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Acute Otitis Media Choice Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2017to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- ≥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 :
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial
This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.
Read the 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.
- Conditions
- Acute Otitis Media
- Being tested
- Acute Otitis Media Choice Decision Aid, Usual Care
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Otitis Media Choice Decision AidOther
Decision Aid
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents completing the survey
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start26 Mar 2017
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana Anderson, Mayo Clinic
- Investigators
- Jana L Anderson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872558
- Sponsor's protocol ID
- 16-000627
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2016
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40753428
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial
- ClinicalTrials.gov ID
- NCT02872558
- Acronym / sponsor ID
- 16-000627
- Conditions
- Acute Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Otitis Media Choice Decision Aid | Other | Other: Acute Otitis Media Choice Decision AidFor 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. |
| Usual Care | Other | Other: Usual Carethe clinician will discuss management options with the parent in the clinician's usual fashion. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 6 months to 18 years in age
- Acute Otitis Media diagnosed (AOM) at the time of visit, defined as:
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Otitis Media Choice Decision AidDecision Aid | Other | Acute Otitis Media Choice Decision Aid |
| Usual CareUsual Care | Other | Usual Care |
Primary outcome
Number of parents completing the survey
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 40753428Anderson 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana L Anderson principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Otitis Media Choice Decision Aid in people with Acute Otitis Media, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parents completing the survey (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.