Community Pediatric Acceptability Study (CPAS)

Not Applicable

Completed

• Conditions: Otitis
• Interventions: Other: Conventional otoscope; Other: Smartphone otoscope

• Registration Number: NCT02610699
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

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Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional otoscope/Smartphone otoscope	Conventional otoscope	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).
Smartphone otoscope/Conventional otoscope	Smartphone otoscope	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).
Conventional otoscope/Smartphone otoscope	Smartphone otoscope	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).
Smartphone otoscope/Conventional otoscope	Conventional otoscope	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).

Primary Outcome Measures

Name	Time	Method
Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device	4 weeks following enrollment	The rate of antibiotic prescription will be assessed by a parent questionnaire. Parents will be asked if they felt comfortable watching and waiting before filling their child's antibiotic prescription. The number of prescriptions filled will be noted.

Secondary Outcome Measures

Name	Time	Method
Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device	4 weeks following enrollment	The rate of completion of the course of antibiotics will be assessed by a parent questionnaire. Parents will be asked if their child completed the course of prescribed antibiotics. The number of children who completed the entire course of antibiotics will be recorded.
Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device	4 weeks following enrollment	The acceptability of the management plan following examination with the smartphone otoscope as compared to conventional otoscope will be assessed by a parent questionnaire. A 'yes' response to questions relating to smartphone device images will indicate acceptability.
Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device	4 weeks following enrollment	The time of filling of the antibiotic prescription will be assessed by a parent questionnaire. Parents will be asked how long they waited before they filled their child's prescription and the response recorded.

Trial Locations

Locations (1)

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States