Shared Decision Making in Parents of Children With Acute Otitis Media

• ClinicalTrials.gov Identifier: NCT02872558
• Recruitment Status: Recruiting
• First Posted: August 19, 2016
• Last Update Posted: February 19, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Jana Anderson, Mayo Clinic

Tracking Information

• First Submitted Date: August 16, 2016
• First Posted Date: August 19, 2016
• Last Update Posted Date: February 19, 2019
• Actual Study Start Date: March 26, 2017
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 18, 2016): Number of parents completing the survey [ Time Frame: 15 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02872558 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Acute Otitis Media

Intervention

• Other: Acute Otitis Media Choice Decision Aid
  Decision Aid
• Other: Usual Care
  Usual Care

Study Arms

• 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.
  Intervention: Other: Acute Otitis Media Choice Decision Aid
• Usual Care
  the clinician will discuss management options with the parent in the clinician's usual fashion.
  Intervention: Other: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 18, 2016): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion:

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

Exclusion:

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 :

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02872558
• Other Study ID Numbers: 16-000627
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jana Anderson, Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jana L Anderson; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: February 2019