Acute Otitis Media Clinical Trial
Official title:
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Verified date | June 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 15, 2017 |
Est. primary completion date | April 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Participants must be a pediatric emergency care clinicians providing care at an emergency department a participating children's hospital - Willing to agree to random assignment to either a smartphone otoscope device or a conventional otoscope device for the 6-month study period - Willing to log patient encounters that included the an otoscopic examination for non-traumatic indication for each shift - Willing to document and report episodes of care in which the assigned otoscopic device could not be used on a study-eligible otoscopic examination - Willing to complete an end of study assessment, if assigned to use the smartphone otoscope Exclusion Criteria: - Declines to give informed consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia |
United States | Children's Healthcare of Atlanta at Hughes Spalding | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Children's Healthcare of Atlanta, Georgia Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Antibiotic Prescriptions | The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician. | Month 6 | |
Secondary | Number of Diagnoses of Acute Otitis Media (AOM) | The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician. | Month 6 | |
Secondary | Number of Diagnoses of Otitis Externa | The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician. | Month 6 | |
Secondary | Clinician Acceptability of the Smartphone Otoscopic Device | Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing. | Month 6 |
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