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临床试验/NCT02703389
NCT02703389已完成3 期

Video, Ear Infections & Antibiotic Stewardship: Knowledge Translation Upon Emergency Department Discharge

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
136
试验地点
2
主要终点
Proportion of participants who fill antimicrobial prescription early

研究概览

简要总结

The amount and speed of emergency department (ED) discharge instructions often make it difficult for patients/caregivers to know the final diagnosis and to remember instructions. We hypothesize that a video on ear infections and antibiotics' role in their management will facilitate caregiver understanding and will increase the likelihood of caregivers properly following discharge instructions.

To verify this hypothesis, a large multi-centre clinical trial is needed. Prior to this, it is only ethical to conduct a smaller 'pilot' trial. Previously healthy children (6 months-5 years) diagnosed with mild ear infections at the McMaster Children's Hospital ED will be eligible to participate. If the child and caregiver decide to participate, before discharge, the caregiver will either: 1)watch the aforementioned video, 2)be given a pamphlet with the same information, or 3)standard of care (no additional information). Participants will fill a knowledge survey before discharge. The research assistant will contact all participants by phone to determine if the caregiver followed the discharge instructions.

详细描述

As most acute otitis media cases self-resolve, observation as initial management for mild acute otitis media (AOM) is recommended by Canadian and American authorities. However, North American children receive more antibiotics for AOM than for any other reason, making AOM-related prescribing a key focus for antimicrobial stewardship interventions. Low uptake of the ED suggested management strategies may be caused by caregiver under-appreciation of antibiotic-associated harms or from problems understanding the discharge plan, of which both could be remedied by a novel video-based knowledge translation platform.

The aim of this pilot study is to determine the feasibility of a follow-up large trial. The main clinical research question is: for caregivers of previously healthy children aged 6-59 months who are diagnosed by the ED physician with acute otitis media and judged to be eligible for a watchful waiting approach, will the use of an innovative informative video lead to lower rates of unnecessary antibiotic use as compared to a pamphlet or no intervention (reference standard)?

This will be a single-centre, randomized, controlled, pilot trial. Caregivers of previously well children aged 6-59 months presenting to the McMaster Children's Hospital (MCH) ED with non-severe AOM eligible for a watchful waiting approach will be enrolled and randomized to a video intervention, a pamphlet intervention, or standard care (no intervention). The primary outcome is the proportion of caregivers who fill a prescription for antimicrobials <48 hours after recruitment, as caregivers are generally advised to wait 48-72 hours prior to administering antibiotics to healthy children with mild AOM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • caregivers of children aged 6-59 months diagnosed with non severe acute otitis media at the McMaster Children's Hospital ED

排除标准

  • caregivers of children with severe symptoms (severe otalgia, fever > 39 C, impending perforation of tympanic membrane)
  • caregivers who cannot readily access medical care
  • caregivers who may not be able to recognize signs of worsening illness
  • caregivers of children with immunodeficiency, malignancy, chronic cardiac or pulmonary disorders, anatomical abnormalities of head/neck, trisomy 21, or previous complicated otitis media

结局指标

主要结局

Proportion of participants who fill antimicrobial prescription early

时间窗: <48 hours after recruitment

The number of participants in each arm who fill and start administering a prescription for antimicrobials less than 48 hours after recruitment will be recorded.

次要结局

  • Caregiver retention of stewardship knowledge(3 months after recruitment)
  • Proportion of participants who fill antimicrobial prescription inappropriately early(<48 hours after recruitment)
  • Caregiver satisfaction with management plan (treatment arm)(2-5 days after recruitment)

研究者

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

Jeffrey Pernica

Head, Division of Pediatric Infectious Disease

Hamilton Health Sciences Corporation

研究点 (2)

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