Antimicrobial Stewardship, Otitis Media
Conditions
Keywords
Otoscopy
Brief summary
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.
Interventions
DEVICEDevice: Digital Otoscope
Use of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Four enrolled practices: * Two will receive the intervention (digital otoscopy) * Two will not receive an intervention (control)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. PPOC practices with 4-9 patient exam rooms, willing to commit to using digital otoscopy for 6 months. 2. Not currently using digital otoscopy. 3. Not involved in the network's previous digital otoscopy study
Exclusion criteria
* Currently using any digital otoscope
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in overall antibiotic courses prescribed | 6 months | 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. |
| Change in overall prescribed antibiotic days | 6 months | 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. |
| Return acute respiratory tract illness visits | Within 7 days of index visit | 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 |
Countries
United States
Contacts
STUDY_DIRECTORLouis Vernacchio, MD, MSc
Boston Children's Hospital
Outcome results
None listed