Community Pediatric Acceptability Study (CPAS)

NCT02610699 | Completed

• 1 other identifier: IRB00074526
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis

Outcome Measures

Primary Outcomes (1)

• Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device

  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.

  4 weeks following enrollment

Secondary Outcomes (3)

• 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

• Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device

  4 weeks following enrollment

• Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device

  4 weeks following enrollment

Study Arms (2)

Smartphone otoscope/Conventional otoscope

ACTIVE COMPARATOR

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).

Other: Conventional otoscope; Other: Smartphone otoscope

Conventional otoscope/Smartphone otoscope

ACTIVE COMPARATOR

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).

Other: Conventional otoscope; Other: Smartphone otoscope

Interventions

Conventional otoscope OTHER

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.

Conventional otoscope/Smartphone otoscope; Smartphone otoscope/Conventional otoscope

Smartphone otoscope OTHER

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.

Also known as: CellScope-Oto

Conventional otoscope/Smartphone otoscope; Smartphone otoscope/Conventional otoscope

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to to complete study telephone questionnaires

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Andrea Shane, MD, MPH, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (1)