LabAlert:通过电子干预改善实验室监测来提高用药安全
LabAlert:通过电子干预提高用药安全性以提高用药安全性
研究概览
详细说明
临床医生为预防或治疗疾病而开出的许多药物可能会导致无法预料和意外的毒性作用。 许多国家临床指南建议进行基线和定期实验室监测以避免不良药物事件。 我们的处方安全项目 (SIP) 发现了药物安全方面的许多重大差距。 Lab Alert 将评估电子工具,以提高 Kaiser Permanente 在实验室监测方面的表现,以避免药物不良事件。 我们将招募正在服用高危药物且未接受实验室监测的患者。 这项为期 2 年的研究的主要结果是在干预后 1 周和 3 周接受基于指南的实验室监测的患者比例。
15 个初级保健诊所将被随机分配到:(1)常规护理(UC)(2)电子信息提醒(EMR)(3)自动语音信息(AVM)(4)药房外展团队(Pharmacy)。 提醒将通知患者由于药物使用而需要进行指南指定的实验室测试。 使用电子数据,将识别并筛选出 600 名患者(每个干预组 200 名),并将 PCP 分配到干预诊所并接受研究指定药物治疗的患者。 患者将根据分配给他们通常诊所的情况分配到治疗组。 在干预和观察期之后,并使用用于识别干预组患者的相同时间范围和纳入和排除标准,我们将回顾性地确定常规护理诊所中的 200 名患者队列。 因此,大约 800 名患者将被纳入研究。 基线、随访和结果数据将从电子记录中获取。
研究定义的药物将由研究团队和质量委员会最终确定。 这些药物是根据以前的工作确定的,并以合理的频率开处方,通常在实验室监测方面存在差距,具有显着的毒性风险,并且由于先前和潜在的不良事件而引起参与的 HMO 的兴趣。 我们预计将重点放在新处方的基线监测上。 新开始将被定义为具有索引处方但在前 6 个月内没有其他分配该药物的患者。
Lab Alert 将评估针对初级保健提供者 (PCP) 的患者特定电子病历 (EMR) 篮内提醒(EMR 提醒)、给患者的自动录制语音消息 (AVM)、药房团队外展 (与常规护理 (UC) 相比,药房)增加接受所有基于指南的实验室监测的患者比例。 如果任何干预措施优于 UC,Lab Alert 将评估和比较其有效性和成本。 该研究还将评估 PCP 和患者的干预体验,以便在未来改进干预措施。
研究类型
注册
阶段
- 不适用
联系人和位置
学习地点
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Oregon
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Portland、Oregon、美国、97227
- Kaiser Permanente Center for Health Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 分配 12 种药物或药物类别中的一种,其中建议进行基线安全实验室监测,并且实验室在药物分配前 6 个月或药物分配后 5 天未完成。
- 18岁或以上
- 12 个月的 HMO 会员资格
- 药物福利覆盖范围
- 有电话号码
排除标准:
- 建议的基线实验室监测完成
- 接受护理和/或居住在临终关怀、疗养院、HMO 以外的护理
- 参加其他护理管理计划
- 非英语人士需要翻译服务
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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在干预后一周和二十五天内完成建议的实验室监测的患者人数。
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该研究将评估完成推荐实验室的时间。
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该研究还将评估 PCP 和患者对干预措施的体验,以便在未来改进干预措施。
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合作者和调查者
调查人员
- 首席研究员:Adrianne C. Feldstein, MD, MS、Northwest Permanente
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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