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临床试验/NCT01734642
NCT01734642Unknown不适用

A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital

Universita di Verona4 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
8,000
试验地点
4
主要终点
Number of participants with adverse drug reactions due to medication errors occurring during hospitalization

研究概览

简要总结

A medication error is a failure in the treatment process that leads to, or has the potential to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in hospital. They can occur in different phases of the therapeutic process (prescribing, distribution, administration and monitoring) and have significant impact on morbidity and mortality. Prescribing faults and prescription errors are major problem among medication errors .Prescription errors account for 70 % of medication errors that could potentially result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises from a medication error it is potentially preventable. The medication errors project was devised to analyze and limit through educational audit and other tools, as much as possible, damages due to the therapeutic process. The project will include 5 phases. Preliminary phase: organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II :educational audits directed to health professionals will be organized. Tools to reduce the medication errors will be proposed. Phase III: the same procedure of the first phase. Final phase (IV): analysis of data with publication of a scientific article.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients hospitalized in the involved units who gave their informed consent. Patients hospitalized during the week-end will be enrolled on the next monday.

排除标准

  • all patients with evident mental and physical problems and all patients who did not give their informed consent.

结局指标

主要结局

Number of participants with adverse drug reactions due to medication errors occurring during hospitalization

时间窗: within the first 3 months

次要结局

  • Number of participants with preventable ADRs due to medication errors(3 months)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

GIAMPAOLO VELO

Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy

Universita di Verona

研究点 (4)

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