Otitis Clinical Trial
Official title:
CellScope Oto - Community Pediatric Acceptability Study (CPAS)
Ear infections, or otitis media, are a leading cause of health expenditures and
antimicrobial prescriptions in children. Diagnosis of otitis media requires the ability to
view the tympanic membrane. An instrument called an otoscope with a light source and a
magnifying lens with a plastic tip that conforms to the ear canal is currently the standard
of care for examining the tympanic membrane. Interpretation of otoscopic examinations is
operator-dependent and cannot be seen by anyone other than the person holding the otoscope.
A pocket size attachment that uses the technology and light source of a smartphone to
capture images of the ear canal and tympanic membrane facilitates image documentation of the
otic examination. In previous studies with the device, the investigators have shown that
image quality of photographs of the tympanic membrane taken with the smartphone otoscope are
equivalent to those taken with a camera-fitted conventional otoscope.
In this study, the Community Provider Assessment Study (CPAS), the investigators will
perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use
a smartphone otoscope as the standard of care device for all ear examinations and 3-4
pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months.
The parents of children examined during the study period with both devices will be invited
to participate in 3 telephone surveys assessing parental satisfaction with the device and
antimicrobial use by their child for the otic complaint. The results of this study have the
potential to improve diagnosis and management of otitis media, thus improving patient care,
reducing costs, and decreasing the opportunity for the development of antimicrobial
resistance.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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