NCT02610699

Community Pediatric Acceptability Study (CPAS)

CellScope Oto - Community Pediatric Acceptability Study (CPAS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Otitis

Interventions

Type	Name	Description
OTHER	Conventional otoscope	The conventional analogue otoscope will be used to provide a two-dimensional view of the ear canal. Clinicians will use this for one month periods for a total of 3 months.
OTHER	Smartphone otoscope	The smartphone otoscope is a pocket size smartphone attachment that uses technology and light source of a smartphone to capture reproducible images of the middle ear and tympanic membrane. Images and videos can be transmitted via real-time communication software from the device to another smartphone. Clinicians will use this for one month periods for a total of 3 months.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-11-20
• Last updated: 2016-01-26

Locations

1 site across 1 country: United States