Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

Acute Otitis Media Clinical Trial

Official title:

Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918773
• Other study ID #: IRB00090777
• Status: Completed
• Phase: N/A
• Start date: October 15, 2016
• Est. completion date: April 15, 2017

Study information

• Verified date: June 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A smartphone otoscope (CellScope-Oto) is a pocket size attachment that employs the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. Previous studies with this device demonstrated that images taken with both the smartphone otoscope and a camera-fitted conventional analogue otoscope were equivalent with respect to image quality and that the smartphone otoscope was acceptable as an educational and diagnostic tool to health professional students. A pilot study with a similar design to this study conducted in two offices of an ambulatory pediatric clinic demonstrated a trend toward decreased antimicrobial prescription filling among families whose children were examined with the smartphone otoscope compared to those who were examined with a conventional otoscope. To further assess this trend, this study proposes an evaluation of the impact of device use on antimicrobial prescribing for children with an otic complaint in a pediatric emergency department (PED) setting. This study will enroll 20 clinicians for the 6-month study period; 10 who will be randomly assigned to use a smartphone otoscope for the 6-month study period and 10 who will be assigned to use a conventional otoscope for all otoscopic exams. Data will be abstracted via retrospective review of the electronic medical record of encounters in with an otoscopic exam was performed as part of the diagnostic evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Declines to give informed consent to participate in the study

Related Conditions & MeSH terms

• Acute Otitis Externa
• Acute Otitis Media
• Emergencies
• Otitis
• Otitis Externa
• Otitis Media

Intervention

Device:
• Smartphone otoscope
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.
• Conventional otoscope
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	Children's Healthcare of Atlanta at Hughes Spalding	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta, Georgia Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Diagnoses of Acute Otitis Media (AOM)	The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.	Month 6
Secondary	Number of Diagnoses of Otitis Externa	The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.	Month 6
Secondary	Clinician Acceptability of the Smartphone Otoscopic Device	Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.	Month 6