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Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm.
For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology.
Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness.
Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy.
To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Digital Otoscopy | Experimental | Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope |
|
| No intervention: Control | No Intervention | No intervention - standard otoscopy to be used |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Digital Otoscope | Device | Use of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in proportion of visits with any respiratory diagnosis in which otitis media is diagnosed and treated with antibiotics (referred to as the otitis media treatment index - OMTI). | Difference-in-differences analysis of the change in OMTI from baseline to the intervention period comparing the intervention arm to the control arm using logistic regression with nested random effect at the practice level. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in overall antibiotic courses prescribed | Difference-in-differences analysis of the change in the overall number of antibiotic courses prescribed per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Vernacchio, MD, MSc | Boston Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Physicians' Organization at Children's | Wellesley | Massachusetts | 02481 | United States |
Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Four enrolled practices:
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| Change in overall prescribed antibiotic days |
Difference-in-differences analysis of the change in the overall number of prescribed antibiotic days per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level. |
| 6 months |
| Return acute respiratory tract illness visits | Comparison between intervention and control arm of the proportion of patients with an index visit with an acute respiratory tract illness diagnosis who return to the PCP for a visit with an acute respiratory tract illness diagnosis within 7 days of index | Within 7 days of index visit |