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临床试验/NCT04568668
NCT04568668Unknown不适用

Implementing and Evaluating ActionADE to Transform Medication Safety Among Patients With Adverse Drug Reactions

University of British Columbia0 个研究点目标入组 3,600 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,600
主要终点
Culprit or same-class medication re-dispensing during follow-up

研究概览

简要总结

Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. The investigators designed ActionADE to enable rapid documentation of adverse drug events, and communication of standardized information across health sectors by integrating ActionADE with legacy systems.

The investigators will leverage ActionADE's implementation to conduct a randomized trial on patients diagnosed with adverse drug reactions in the main trial. This study will take place in Vancouver, British Columbia, Canada.

详细描述

Medication use is rising due to an aging population and expanding treatment indications for chronic diseases. Simultaneously, adverse drug events-harmful and unintended events related to medication use or misuse-have increased. In Canada, adverse events to outpatient medications cause over two million emergency department visits and 700,000 hospital admissions, costing over $1 billion in healthcare expenditures annually. Optimizing the benefits of medications while limiting their potential for harm is a public health priority across patient populations, health settings and medical disciplines.

Patients with adverse drug events often seek care in hospitals due to the unexpected and serious nature of these events. After assessment and treatment, patients are discharged back into the care of a community-based provider who often cannot access the hospital's medical record, may not receive a legible or detailed discharge summary, and is at risk of either re-starting the culprit medication for chronic disease management in the case of an adverse drug reaction. The investigators developed ActionADE to address this type of information discontinuity. ActionADE was integrated to a province-wide network that links all pharmacies in British Columbia to a central data system, allowing users to see their patient's medication dispensing history.

The investigators will conduct a triple-blind randomized controlled trial to evaluate the effectiveness of ActionADE on preventing subsequent adverse drug reactions. The trial will take place in two urban tertiary care (Vancouver General and Saint Paul's Hospitals) and one urban community hospital (Lions Gate Hospital) within the Greater Vancouver area, in British Columbia, Canada. Other hospitals may be added to accelerate recruitment into the trial if approved by the British Columbia Ministry of Health.

The primary objective of the main trial is to evaluate the effect of providing information continuity about adverse drug reactions using ActionADE on culprit drug re-dispensations over 12 months compared to standard care. Secondary objectives are to evaluate the effect on outpatient and emergency department visits, admissions, hospital-days and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Study participants, outcomes assessors, and study investigators will be blinded to treatment allocation. Community pharmacists cannot be blinded to the intervention, as we are studying the change in pharmacists' dispensing behavior due to the provision of new adverse drug event information. The information will only appear for patients in the experimental arm.

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 19 years of age or older presenting to the participating emergency departments with an adverse drug reaction to a prescribed outpatient medication that was reported in ActionADE.

排除标准

  • Patients whose adverse drug event is categorized as life threatening will be excluded.
  • Patients without a Provincial Health Number will be excluded as this will prevent linkage with PharmaNet and other administrative data for outcomes ascertainment.
  • Patients diagnosed with adverse drug events to culprit medications not on the provincial formulary will be excluded as we will not be able to ascertain re-dispensations outcomes for these medications using PharmaNet data.

结局指标

主要结局

Culprit or same-class medication re-dispensing during follow-up

时间窗: 12 months

The summary measure will be the proportion of patients with a culprit medication re-dispensation within 12 months. The effect measure will be the between-group difference in the proportion with a 12 month re-dispensation.

次要结局

  • Hospital stay(12 months)
  • Hospital visits(12 months)
  • Mortality(12 months)

研究者

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

Corinne Hohl

Associate Professor

University of British Columbia

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