Ear InfectionNCT04296448
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
A study testing Cellscope in people with Ear Infection and Pediatric Disease, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ear Infection, Pediatric Disease, Acute Otitis Media
- What is being tested?
- Cellscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All trainees and supervisors
- All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21212
About this study
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.
Read the 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.
- Conditions
- Ear Infection, Pediatric Disease, Acute Otitis Media
- Being tested
- Cellscope
- Keywords
- cellscope, mobile device, pediatric trainees, acute otitis media, ear infection
- Medical subject headings
- Otitis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellscopeDevice
Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cellscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Number of Patients Who Receive Antibiotics
Number of patients who receive antibiotics between traditional otoscope and cellscope.
Measured: 6 months
Number of Participants Who Receive a Repeat Examination
Number of participants who receive a repeat examination between traditional otoscope and cellscope.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Sep 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ear InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Therese Canares, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296448
- Sponsor's protocol ID
- IRB00187508
- Status last verified
- Aug 2021
- First submitted
- 3 Mar 2020
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cellphone Based Otoscopy in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04296448
- Acronym / sponsor ID
- IRB00187508
- Conditions
- Ear Infection, Pediatric Disease, Acute Otitis Media
- Keywords
- cellscope, mobile device, pediatric trainees, acute otitis media, ear infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomization, pediatric trainees are exposed in 2-week blocks: 1 week with Cellscope available, 1 week with the traditional otoscope
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: CellscopePediatric 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All trainees and supervisors
- All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellscopeCellphone otoscope (Cellscope) to evaluate pediatric patient ears. | Device | Cellscope |
Primary outcome
Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic
Time frame: 6 months
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.
3 secondary outcomes
Interrater Reliability as Assessed by a Kappa Statistic
Time frame: 6 months
Number of Patients Who Receive Antibiotics
Time frame: 6 months
Number of Participants Who Receive a Repeat Examination
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Canares, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellscope in people with Ear Infection and Pediatric Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.