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OpenTrials
Completed

NCT Number: NCT02872558

Shared Decision Making in Parents of Children With Acute Otitis Media

This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

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:
  • ≥3 or greater separate AOM episodes in the previous 6 months or
  • ≥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 :

Treatment and study plan

Acute Otitis Media Choice Decision Aid

Other

Decision Aid

Usual Care

Other

Usual Care

Primary outcomes

  1. Number of parents completing the survey

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Shared Decision Making in Parents of Children With Acute Otitis Media: The Acute Otitis Media Choice Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2016
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.