Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02610699
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2015-11-18
Brief Title:
Community Pediatric Acceptability Study CPAS
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
CellScope Oto - Community Pediatric Acceptability Study CPAS
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPAS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None