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Evaluation of Cellphone Based Otoscopy in Pediatric Patients

Primary Purpose

Ear Infection, Pediatric Disease, Acute Otitis Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cellscope
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ear Infection focused on measuring cellscope, mobile device, pediatric trainees, acute otitis media, ear infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All trainees and supervisors
  • All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team

Exclusion Criteria:

  • None

Sites / Locations

  • Johns Hopkins Children's Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional Otoscope

Cellscope

Arm Description

Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.

Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.

Outcomes

Primary Outcome Measures

Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic
Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.

Secondary Outcome Measures

Interrater Reliability as Assessed by a Kappa Statistic
Kappa statistic (Fleiss' Kappa) of trainee and supervisor utilizing the OMgrade scale. The kappa statistic ranges from 0-1. The closer the number is to 1 the higher the agreement.
Number of Patients Who Receive Antibiotics
Number of patients who receive antibiotics between traditional otoscope and cellscope.
Number of Participants Who Receive a Repeat Examination
Number of participants who receive a repeat examination between traditional otoscope and cellscope.

Full Information

First Posted
March 3, 2020
Last Updated
August 24, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04296448
Brief Title
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
Official Title
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Infection, Pediatric Disease, Acute Otitis Media
Keywords
cellscope, mobile device, pediatric trainees, acute otitis media, ear infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Block randomization, pediatric trainees are exposed in 2-week blocks: 1 week with Cellscope available, 1 week with the traditional otoscope
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Otoscope
Arm Type
No Intervention
Arm Description
Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
Arm Title
Cellscope
Arm Type
Experimental
Arm Description
Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.
Intervention Type
Device
Intervention Name(s)
Cellscope
Intervention Description
Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Primary Outcome Measure Information:
Title
Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic
Description
Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Interrater Reliability as Assessed by a Kappa Statistic
Description
Kappa statistic (Fleiss' Kappa) of trainee and supervisor utilizing the OMgrade scale. The kappa statistic ranges from 0-1. The closer the number is to 1 the higher the agreement.
Time Frame
6 months
Title
Number of Patients Who Receive Antibiotics
Description
Number of patients who receive antibiotics between traditional otoscope and cellscope.
Time Frame
6 months
Title
Number of Participants Who Receive a Repeat Examination
Description
Number of participants who receive a repeat examination between traditional otoscope and cellscope.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All trainees and supervisors All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therese Canares, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Cellphone Based Otoscopy in Pediatric Patients

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