Evaluation of Cellphone Based Otoscopy in Pediatric Patients

NCT04296448 | Completed Results DMC

• 1 other identifier: IRB00187508
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Infection; Pediatric Disease; Acute Otitis Media

Keywords

cellscope; mobile device; pediatric trainees; acute otitis media; ear infection

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Interrater Reliability as Assessed by a Kappa Statistic

  6 months

• Number of Patients Who Receive Antibiotics

  6 months

• Number of Participants Who Receive a Repeat Examination

  6 months

Study Arms (2)

Traditional Otoscope

NO INTERVENTION

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.

Cellscope

EXPERIMENTAL

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.

Device: Cellscope

Interventions

Cellscope DEVICE

Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.

Cellscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21212, United States

Location

MeSH Terms

Conditions

Otitis; Otitis Media

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Therese Canares
• Organization: Johns Hopkins University Department o Peidaitrics Division of Pediatric Emergency Medicne

therese.canares@jhmi.edu

(410) 955-6146‬

Study Officials

• Therese Canares, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization, pediatric trainees are exposed in 2-week blocks: 1 week with Cellscope available, 1 week with the traditional otoscope

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: September 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 26, 2021
• Results First Posted: September 3, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)