Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04296448 |
| Other study ID # |
IRB00187508 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
March 1, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to
capture HIPAA compliant images and video recordings of the external and middle ear structure.
This technology allows multiple providers, at different levels of training, the ability to
simultaneously exam a child's external and middle ear structures. The investigators
hypothesize this device will result in improved concordance in trainee/supervisor exam
findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions,
and fewer repeat exams by multiple providers. Thus, this study has the potential to improve
physician training and examination confidence, decrease the unnecessary use of antibiotics,
and improve the patient/caregiver experience in healthcare interactions.
Description:
Abstract
Concerns about middle and external ear infections and discomfort are frequent chief
complaints that bring children to pediatric providers. On top of this, there are numerous
non-ear complaints (e.g. head trauma) that warrant a complete evaluation of the middle and
external ear structures. At present, the middle and external ear is examined with standard
direct otoscopy, commonly using a handheld otoscope. Otoscopy is defined as the visualization
of the external and middle ear structures, including the tympanic membrane, ossicles, middle
ear fluid, ear canal, etc. The skill of otoscopy is taught early in the medical trainees'
career, most often in the first or second year of medical school. This skill is further honed
during the pediatric medical student clerkship and pediatric residency, however there is not
an efficient and patient-centered mechanism for direct visualization and teaching of
trainees. Because of this, it is nearly impossible for trainees to receive feedback on
trainees' visualization and interpretation skills. Based on the investigators' experience,
trainee exams are often not repeated by clinical supervisors as the trainees progress in
training. When supervisors do repeat ear exams (i.e., trainee is uncertain of findings), it
is challenging to determine if the trainee fully appreciates exam findings. Ear exam findings
directly inform the clinical decision-making (e.g., prescribing antibiotics for acute otitis
media (AOM)) and uncertainty often results in unnecessary prescribing.
Objectives
Aim 1: To establish whether a smartphone otoscope improves diagnostic accuracy of tympanic
membrane (TM) pathology for trainees, compared to supervisor.
Aim 2: To determine whether smartphone otoscope improves diagnostic confidence of trainees,
thereby reducing frequency of antibiotic prescriptions for AOM.
Aim 3: To determine whether there is a change in repeat exam rates by supervisors, comparing
with/without Cellscope.
Aim 4: To determine whether trainees convert to traditional otoscope use during the weeks
that Cellscope is available.
