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临床试验/NCT04000542
NCT04000542已完成不适用

Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making for Patients Receiving QT Prolonging Medications

Northeast Iowa Medical Education Foundation2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Frequency of medication order changes due to QTc interval prolongation

研究概览

简要总结

Torsade de pointes (TdP) is a cardiac arrhythmia associated with QT interval prolongation which may lead to cardiac arrest. Prescription medications which cause QT interval prolongation are commonly used in daily practice. To lessen risk of TdP, pharmacists work to minimize combinations of QT interval prolonging drugs. If community pharmacists had real-time information about a patient's QT interval duration, this would have the direct ability to inform their decision making about which patients may be at highest risk of TdP and who may need heightened avoidance of QT prolonging drugs. This project will provide 3 community pharmacies with mobile ECG devices to easily determine QT intervals among patients who have a prescription profile alert for QT interval prolongation. Study outcomes will include: frequency of QT interval prolongation, changes in drug therapy related to QT interval determination, and patient and pharmacist satisfaction with having pharmacist assessment of QT interval.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • Male or female at least 18 years of age.
  • Subject is receiving a prescription medication for which there is a "QT/QTc interval prolongation" alert observed on the dispensing pharmacy prescription software.
  • English speaking

排除标准

  • Patients with implantable pacemakers or automatic implantable cardioverter defibrillators
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Patient has known atrial or ventricular arrhythmia

结局指标

主要结局

Frequency of medication order changes due to QTc interval prolongation

时间窗: through study completion (anticipated to last 8 months)

Physician/provider will be contacted if elevated QTc interval is present (\>470 ms for males, \>480 ms for females). Frequency of medication changes due to QTc interval prolongation will be assessed.

次要结局

未报告次要终点

研究者

发起方
Northeast Iowa Medical Education Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jim Hoehns

Research Director

Northeast Iowa Medical Education Foundation

研究点 (2)

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