An interventional study of Smartphone otoscope and Conventional otoscope in Acute Otitis Media and Acute Otitis Externa, sponsored by Emory University. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 22 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period.
Device: Smartphone otoscope
Participating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period.
Device: Conventional otoscope
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.
Also known as: CellScope-Oto
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.
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.
Time frame: Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Twenty-two volunteer clinicians were randomly assigned to use either a smartphone otoscope device or a conventional otoscope for a six-month period from October 15, 2016 to April 15, 2017. This study was conducted at two children's hospital emergency departments in Atlanta, Georgia.
| Milestone | Conventional Otoscope Encounters | Smartphone Otoscope Encounters |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 11 |
| Not completed | 0 | 0 |
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.
| Emergency department encounters | Conventional Otoscope Encounters | Smartphone Otoscope Encounters |
|---|---|---|
| Antibiotic prescribed | 140 | 115 |
| Antibiotic not prescribed | 6 | 7 |
| Unknown | 0 | 1 |
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.
| Emergency department encounters | Conventional Otoscope Encounters | Smartphone Otoscope Encounters |
|---|---|---|
| AOM Diagnosed | 146 | 123 |
| AOM Not Diagnosed | 630 | 491 |
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.
| Emergency department encounters | Conventional Otoscope Encounters | Smartphone Otoscope Encounters |
|---|---|---|
| Otitis Externa Diagnosed | 0 | 0 |
| Otitis Externa Not Diagnosed | 776 | 614 |
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.
| Participants | Clinicians Assigned to the Smartphone Otoscope Group |
|---|---|
| Preferred smartphone over conventional otoscope | 8 |
| Smartphone increased ability to diagnose AOM | 3 |
| Smartphone did not impact antibiotic prescribing | 6 |
Collected over Adverse events were collected during the 6-month intervention period of October 15, 2016 to April 15, 2017.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Otoscope Encounters | 0/776 (0%) | 0/776 (0%) | 0/776 (0%) |
| Smartphone Otoscope Encounters | 0/614 (0%) | 0/614 (0%) | 0/614 (0%) |
The attributes of the children seen in the pediatric emergency department who were examined by clinicians participating in the study are presented in the baseline analysis. Only minimal information was collected from the medical records regarding the baseline characteristics of these children..
| Age, Continuous(age in months of encounter subjects) | Conventional Otoscope Encounters | Smartphone Otoscope Encounters | Total |
|---|---|---|---|
| Mean | 43.5 ± 38.8 | 49.0 ± 42.0 | 45.90 ± 40.34 |
| Sex/Gender, Customized(Emergency department encounters) | Conventional Otoscope Encounters | Smartphone Otoscope Encounters | Total |
|---|---|---|---|
| Not collected | 776 | 614 | 1390 |
| Race and Ethnicity Not Collected(Participants) | Conventional Otoscope Encounters | Smartphone Otoscope Encounters | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Emergency department encounters) | Conventional Otoscope Encounters | Smartphone Otoscope Encounters | Total |
|---|---|---|---|
| United States | 776 | 614 | 1390 |
| Reason for clinic visit(Emergency department encounters) | Conventional Otoscope Encounters | Smartphone Otoscope Encounters | Total |
|---|---|---|---|
| Fever | 522 | 424 | 946 |
| Ear pain | 106 | 96 | 202 |
| Congestion/runny nose | 270 | 182 | 452 |
| Cough | 365 | 274 | 639 |
| Other | 338 | 317 | 655 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.