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
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000627
NCT ID: NCT02872558
Sponsor Protocol Number: 16-000627
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 |
|
More information
Publications
Publications are currently not available