OTO-MATIC: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 14
- 主要终点
- Change the clinician rate of antibiotic prescriptions
研究概览
简要总结
A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.
详细描述
Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting.
For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months.
Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them.
A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the Prospective Subjects
- •Inclusion Criteria:
- •Pediatric subjects between 6 months and 17 years of age
- •Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM)
- •Pediatric subjects where otoscopy would traditionally be indicated
- •Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent
排除标准
- •The parent or guardian who attends visits does not speak the same language as their physician
- •Pediatric subjects enrolled in another clinical trial
- •Pediatric subjects with:
- •Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial
- •Anatomical conditions that would affect their ability to undergo an otoscopy.
- •For the Retrospective Case Match Controls
- •Inclusion Criteria:
- •Pediatric subjects between 6 months and 17 years of age (< 18 years old).
- •Index visit took place 11 - 25 months prior to the Treatment match's Baseline Visit.
- •Index visit was for an ear-related chief complaint.
- •An otoscopic exam was completed at index visit.
- •Subjects have a follow up visits (telehealth included) in the time period between the index visit and firstTreatment subject's enrollment date.
结局指标
主要结局
Change the clinician rate of antibiotic prescriptions
时间窗: Baseline to 12 month Follow Up
Antibiotic stewardship
Change the number of antibiotic rounds per patient
时间窗: Baseline to 12 month Follow Up
Antibiotic stewardship
Change costs associated with management of pediatric patients presenting with ear-related pain
时间窗: Baseline to 21 month Follow Up
Change in overall costs
次要结局
- Change in unnecessary antibiotic prescriptions(Baseline to 12 month Follow Up)
- Change in prescription adherence(Baseline to 12 month Follow Up)
- Change medical resource utilization(Baseline to 30 days Follow Up)
- Impact clinician confidence(Baseline to 12 month Follow Up)
- Improve patient outcomes(Baseline to 12 month Follow Up)
- Change in Health-related Quality of Life (HQoL)(Baseline to 12 month Follow Up)
- Change in antibiotic prescription rate when fluid not present(Baseline to 12 month Follow Up)
- Impact caregiver satisfaction(Baseline to 12 month Follow Up)
- Change unnecessary medical intervention(Baseline to 12 month Follow Up)