Community Pediatric Acceptability Study (CPAS)

Emory University

Status: Completed

Conditions: Otitis

Treatments: Other: Smartphone otoscope; Other: Conventional otoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02610699

IRB00074526

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of an otic complaint
• Willing to undergo otoscopy

Exclusion criteria

• Unwilling or unable to to complete study telephone questionnaires
• Do not meet inclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Smartphone otoscope/Conventional otoscope

Active Comparator group

Description:

Participating clinicians will use a smartphone otoscope for one month followed by a conventional otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).

Treatment:

Other: Conventional otoscope

Other: Smartphone otoscope

Conventional otoscope/Smartphone otoscope

Active Comparator group

Description:

Participating clinicians will use a conventional otoscope for one month followed by a smartphone otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).

Treatment:

Other: Conventional otoscope

Other: Smartphone otoscope