A Study to Support Increased Information and Participation in the Decision Making Process for Parents of Children who have Acute Inflammation of the Middle Ear

Overview

About this study

The purpose of this study is to promote and evaluate the effectiveness of increasing the information provided to parents and involving them in the decision making process for the treatment of acute inflammation of the middle ear in their child, in the Emergency Department setting. Data will be collected to see if the information and decision aide will significantly decrease the rate of antibiotic use with no increase in adverse events.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Acute Otitis Media diagnosed at the time of visit, defined as
- Middle ear effusion demonstrated by pneumatic otoscopy, air fluid level, or a bulging tympanic membrane
- Evidence of Acute Inflammation opaque, white, yellow, or erythematous tympanic membrane or purulent effusion
- Symptoms of otalgia, fussiness or fever

Exclusion Criteria

Currently on antibiotics
Has acute otitis media and another diagnoses that antibiotics are prescribed for
Has otitis-conjunctivitis syndrome
Has perforation of the tympanic membrane at time of diagnoses
Recurrent acute otitis media defined as
- ≥ 3 or greater separate AOM episodes in the previous 6 months
- ≥ 4 or more greater AOM episodes in the previous 12 months with one in the last 6 months
Has a craniofacial abnormality
Has had previous ear tubes placed
Has an immunologic disorder
Has immunosuppression either by disease or medication
Is undergoing treatment for cancer

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jana Anderson, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jana Anderson, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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