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临床试验/NCT00727610
NCT00727610已完成不适用

Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department

University of British Columbia2 个研究点 分布在 1 个国家目标入组 1,588 人开始时间: 2008年5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
1,588
试验地点
2

研究概览

简要总结

Adverse Drug Related Events (ADREs) are a leading cause of Emergency Department (ED) visits in Canada. However emergency physicians recognize only half of all ADREs in patients presenting to the ED, missing opportunities to intervene. The objective of this study is to develop a screening strategy that identifies patients with ADREs. Our hypothesis is that the development of a user-friendly, reliable screening strategy for ADREs in patients presenting to the ED is feasible. We believe that this will lead to improved patient care.

详细描述

Background Between 9250 and 23,750 Canadians die each year because of preventable adverse events related to medical care. ADREs account for 50% of all preventable adverse events and cause up to 12% of ED visits. Unfortunately, emergency physicians recognize only half of all ADREs, missing crucial opportunities to intervene.

Objective The objective of this study is to derive a clinical decision rule that accurately stratifies patients presenting to the ED into risk categories for drug-related morbidity. This instrument will allow early identification of clinically significant ADREs allowing rational referral for medication optimization, treatment of ADREs and prevention of future events.

Hypothesis The development of a rapid, user-friendly reliable clinical decision rule for ADREs in patients presenting to the ED is feasible.

Methodology This prospective observational study will evaluate predictor variables (from the history, physical examination and laboratory tests) for ADREs in a representative sample of ED patients using standardized assessments by emergency nurses and physicians. Inter-rater agreement of predictor variables will be measured, and clinical pharmacists, blinded to the nursing and physician assessments, will use a standardized, validated algorithm to identify ADREs. Recursive partitioning and/or logistic regression analysis will be used to determine the optimal combination of predictor variables to detect the presence of an ADRE. We will report diagnostic test characteristics of the derived clinical decision rule. Validation of the clinical decision rule is planned in a future study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over the age of 19 years
  • Reported having used at least one prescription or over-the-counter medication in the 2 weeks prior to presentation
  • Speak English and/or translator available at the time of presentation.

排除标准

  • Patients previously enrolled
  • Patients transferred directly to an admitting service.
  • Patients who leave prior to being seen or against medical advice.
  • Patients returning to the ED for a scheduled revisit.

研究者

申办方类型
Other

研究点 (2)

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