Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

NCT02918773 | Completed Results

• 1 other identifier: IRB00090777
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.

Conditions

Acute Otitis Media; Acute Otitis Externa

Keywords

Pediatrics; Emergency Medicine; Ear infection

Outcome Measures

Primary Outcomes (1)

• Number of Antibiotic Prescriptions

  The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.

  Month 6

Secondary Outcomes (3)

• Number of Diagnoses of Acute Otitis Media (AOM)

  Month 6

• Number of Diagnoses of Otitis Externa

  Month 6

• Clinician Acceptability of the Smartphone Otoscopic Device

  Month 6

Study Arms (2)

Smartphone otoscope

EXPERIMENTAL

Participating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period.

Device: Smartphone otoscope

Conventional otoscope

ACTIVE COMPARATOR

Participating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period.

Device: Conventional otoscope

Interventions

Smartphone otoscope DEVICE

A smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period.

Also known as: CellScope-Oto

Smartphone otoscope

Conventional otoscope DEVICE

A conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period.

Conventional otoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be a pediatric emergency care clinicians providing care at an emergency department a participating children's hospital
• Willing to agree to random assignment to either a smartphone otoscope device or a conventional otoscope device for the 6-month study period
• Willing to log patient encounters that included the an otoscopic examination for non-traumatic indication for each shift
• Willing to document and report episodes of care in which the assigned otoscopic device could not be used on a study-eligible otoscopic examination
• Willing to complete an end of study assessment, if assigned to use the smartphone otoscope

You may not qualify if:

• Declines to give informed consent to participate in the study

Sponsors & Collaborators

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

Study Sites (2)

Children's Healthcare of Atlanta at Hughes Spalding

Atlanta, Georgia, 30303, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Andi L Shane MD/MPH/MSc
• Organization: Emory University

ashane@emory.edu

404-727-9880

Study Officials

• Andrea Shane, MD, MPH, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: October 15, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2018-06

Locations

US (2)