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临床试验/NCT04219553
NCT04219553已完成不适用

Moving Antimicrobial Stewardship Into Community Pharmacy: A Pre-post Study of Acute Otitis Media Management

University of Toronto4 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2017年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
188
试验地点
4
主要终点
Change in guideline congruence

研究概览

简要总结

Acute otitis media (AOM) is the most common indication for antibiotics for Canadian paediatric patients. As the gatekeepers of safe and effective prescription pharmacotherapy, community pharmacists are well positioned to influence and optimize antibiotic use. The purpose of this project is to develop, implement, and evaluate an antimicrobial stewardship program in the community pharmacy setting that aims to optimize antibiotic use for AOM. This nonrandomized pre-post study includes children aged 6 months to 12 years presenting with an antibiotic prescription for AOM at two community pharmacies in Toronto, Ontario. Participants are excluded if they exhibit signs/symptoms of mastoiditis, have an additional indication for systemic antibiotics, or parents/guardians cannot consent in English. The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist. Prescriptions are reviewed and adapted by the pharmacist to optimize congruence with 2016 Canadian Paediatric Society AOM guidelines. The primary outcome is the percentage change in guideline congruence attributable to pharmacist intervention. This study will provide insight into the opportunities and barriers of developing large-scale antimicrobial stewardship programs for community pharmacies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Prescribed systemic oral antibiotic therapy
  • Antibiotics are indicated for the treatment of acute otitis media (AOM) as reported verbally or in writing by parent/guardian or prescriber

排除标准

  • signs/symptoms of mastoiditis
  • a diagnosis in addition to AOM for which systemic antibiotics are indicated
  • parents/guardians cannot consent to the study in English

结局指标

主要结局

Change in guideline congruence

时间窗: Pre-post study intervention (comparison of two 4-6 month periods)

% change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention

次要结局

  • Choice of antibiotic(Pre-post study intervention (comparison of two 4-6 month periods))
  • Antibiotic dosing(Pre-post study intervention (comparison of two 4-6 month periods))
  • Antibiotic duration(Pre-post study intervention (comparison of two 4-6 month periods))
  • Acceptance of pharmacist recommendations(Post-intervention study arm (6 month period after start of intervention))
  • Balancing measure: resolution of AOM(7-14 days after antibiotics were dispensed)

研究者

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

Katherine Koroluk

Principal Investigator

University of Toronto

研究点 (4)

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