Site Randomized Clinical Trial of the Effect of Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PPOC practices with 4-9 patient exam rooms, willing to commit to using digital otoscopy for 6 months.
- •Not currently using digital otoscopy.
- •Not involved in the network's previous digital otoscopy study
排除标准
- •Currently using any digital otoscope
研究组 & 干预措施
No intervention: Control
No intervention - standard otoscopy to be used
Experimental: Digital Otoscopy
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
干预措施: Device: Digital Otoscope (Device)
结局指标
主要结局
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).
时间窗: 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.
次要结局
- Change in overall antibiotic courses prescribed(6 months)
- Change in overall prescribed antibiotic days(6 months)
- Return acute respiratory tract illness visits(Within 7 days of index visit)
研究者
Jon Hatoun
Director of Data Analytics
Boston Children's Hospital