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EMR Defaults to Nudge Opioid Prescribing

2019年11月4日 更新者:University of California, San Francisco

Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments

The investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs).

研究概览

详细说明

In two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. These changes were made without announcement, and providers were not informed of the study itself.

研究类型

介入性

注册 (实际的)

104

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.

Exclusion Criteria:

  • none

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Null setting, forced entry

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at -blank-. This setting required the prescriber to enter a quantity in order to write a prescription.

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.

实验性的:5 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 5.

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.

实验性的:10 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 10.

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.

实验性的:15 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 15.

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.

有源比较器:Status quo default setting

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at the status quo value for each site (20 for site 1, 12 for site 2).

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Dispense quantity of prescribed opioids
大体时间:Through study completion, approximately 340 days
The dispense quantity of prescribed study drugs was collected from the electronic medical record at each site. The mean and median quantities per prescription according to each study arm were compared.
Through study completion, approximately 340 days

次要结果测量

结果测量
措施说明
大体时间
Proportion ≤12
大体时间:Through study completion, approximately 340 days
The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions at 12 or fewer tablets was compared across study arms.
Through study completion, approximately 340 days
Proportion at default setting
大体时间:Through study completion, approximately 340 days
The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions written for the given default setting was compared across treatment arms.
Through study completion, approximately 340 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Juan Carlos Montoy, MD, PhD、University of California, San Francisco

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年10月3日

初级完成 (实际的)

2017年9月3日

研究完成 (实际的)

2017年9月3日

研究注册日期

首次提交

2019年10月28日

首先提交符合 QC 标准的

2019年11月4日

首次发布 (实际的)

2019年11月7日

研究记录更新

最后更新发布 (实际的)

2019年11月7日

上次提交的符合 QC 标准的更新

2019年11月4日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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