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临床试验/NCT02610699
NCT02610699已完成不适用

CellScope Oto - Community Pediatric Acceptability Study (CPAS)

Emory University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device

研究概览

简要总结

Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial prescriptions in children. Diagnosis of otitis media requires the ability to view the tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens with a plastic tip that conforms to the ear canal is currently the standard of care for examining the tympanic membrane. Interpretation of otoscopic examinations is operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A pocket size attachment that uses the technology and light source of a smartphone to capture images of the ear canal and tympanic membrane facilitates image documentation of the otic examination. In previous studies with the device, the investigators have shown that image quality of photographs of the tympanic membrane taken with the smartphone otoscope are equivalent to those taken with a camera-fitted conventional otoscope.

In this study, the Community Provider Assessment Study (CPAS), the investigators will perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a smartphone otoscope as the standard of care device for all ear examinations and 3-4 pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months. The parents of children examined during the study period with both devices will be invited to participate in 3 telephone surveys assessing parental satisfaction with the device and antimicrobial use by their child for the otic complaint. The results of this study have the potential to improve diagnosis and management of otitis media, thus improving patient care, reducing costs, and decreasing the opportunity for the development of antimicrobial resistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of an otic complaint
  • Willing to undergo otoscopy

排除标准

  • Unwilling or unable to to complete study telephone questionnaires
  • Do not meet inclusion criteria

结局指标

主要结局

Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device

时间窗: 4 weeks following enrollment

The rate of antibiotic prescription will be assessed by a parent questionnaire. Parents will be asked if they felt comfortable watching and waiting before filling their child's antibiotic prescription. The number of prescriptions filled will be noted.

次要结局

  • Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)
  • Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)
  • Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andi L. Shane, MD

Associate Professor of Pediatrics

Emory University

研究点 (2)

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