Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/15/2018 |
| Start Date: | October 15, 2016 |
| End Date: | April 15, 2017 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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