Acute Otitis MediaNCT02918773
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
A study testing Smartphone otoscope and Conventional otoscope in people with Acute Otitis Media and Acute Otitis Externa, run by Emory University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media, Acute Otitis Externa
- What is being tested?
- Smartphone otoscope and Conventional otoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2016to 15 Apr 2017
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Declines to give informed consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, 30303
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
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.
Read the detailed description
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.
- Conditions
- Acute Otitis Media, Acute Otitis Externa
- Being tested
- Smartphone otoscope, Conventional otoscope
- Keywords
- Pediatrics, Emergency Medicine, Ear infection
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone otoscopeDevice
Also called CellScope-Oto
A smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period.
Conventional otoscopeDevice
A conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone otoscope | Experimental | Participating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period. Receives: Device: Smartphone otoscope |
| Conventional otoscope | Active comparator | Participating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period. Receives: Device: Conventional otoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Antibiotic Prescriptions
The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.
Measured: Month 6
Secondary outcomes (3)
Number of Diagnoses of Acute Otitis Media (AOM)
The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.
Measured: Month 6
Number of Diagnoses of Otitis Externa
The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.
Measured: Month 6
Clinician Acceptability of the Smartphone Otoscopic Device
Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start15 Oct 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
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 Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Emory 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology, Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Andi L. Shane, MD, Emory University
- Investigators
- Andrea Shane, MD, MPH, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918773
- Sponsor's protocol ID
- IRB00090777
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2016
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
- ClinicalTrials.gov ID
- NCT02918773
- Acronym / sponsor ID
- IRB00090777
- Conditions
- Acute Otitis Media, Acute Otitis Externa
- Keywords
- Pediatrics, Emergency Medicine, Ear infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology, Children's Healthcare of Atlanta
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone otoscope | Experimental | Device: Smartphone otoscopeParticipating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period. |
| Conventional otoscope | Active comparator | Device: Conventional otoscopeParticipating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Declines to give informed consent to participate in the study
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 |
|---|---|---|
| Smartphone otoscopeAlso: CellScope-OtoA smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period. | Device | Smartphone otoscope |
| Conventional otoscopeA conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period. | Device | Conventional otoscope |
Primary outcome
Number of Antibiotic Prescriptions
Time frame: Month 6
The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.
3 secondary outcomes
Number of Diagnoses of Acute Otitis Media (AOM)
Time frame: Month 6
Number of Diagnoses of Otitis Externa
Time frame: Month 6
Clinician Acceptability of the Smartphone Otoscopic Device
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Shane, MD, MPH, MSc principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone otoscope and Conventional otoscope in people with Acute Otitis Media and Acute Otitis Externa, run by Emory University at 2 sites 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 5 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 13 Jul 2018). 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?
Number of Antibiotic Prescriptions (time frame: Month 6). 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 13 Jul 2018.