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Trial record 7 of 434 for:    OTITIS

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
Sponsor:
Information provided by (Responsible Party):
Jana Anderson, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE March 26, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Number of parents completing the survey [ Time Frame: 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02872558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shared Decision Making in Parents of Children With Acute Otitis Media
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Otitis Media
Intervention  ICMJE
  • Other: Acute Otitis Media Choice Decision Aid
    Decision Aid
  • Other: Usual Care
    Usual Care
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02872558
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Jana Anderson, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jana L Anderson Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP