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De-escalating Vital Sign Checks

2019年12月2日 更新者:University of California, San Francisco

Using Predictive Analytics to Reduce Vital Sign Checks in Stable Hospitalized Patients

The overall goals for this study are: 1) to develop a predictive model to identify patients who are stable enough to forego vital sign checks overnight, 2) incorporate this predictive model into the hospital electronic health record so physicians can view its output and use it to guide their decision-making around ordering reduced vital sign checks for select patients.

研究概览

详细说明

Patients in the hospital often report poor sleep. A lack of sleep not only affects a patient's recovery from illness and their overall feeling of wellness, but it is a leading factor in the development of delirium in the hospital. One method for improving sleep in the hospital is to reduce the number of patient care related interruptions that a patient experiences. Vital sign checks at night are one example. In hospitalized patients who are clinically stable, vital sign checks that interrupt sleep are often unnecessary. However, identifying which patients can forego these checks is not a simple task. Currently, the hospital's quality improvement team asks physicians to think about this issue every day and order reduced, or "sleep promotion", vital sign checks on patients they believe could safely tolerate it. The investigators goal is to use a predictive analytics tool to reduce the cognitive burden of this task for busy physicians.

The investigators plan to develop a logistic regression model, trained on data from the electronic health record (EHR), to predict, for a given patient on a given night, whether they could safely tolerate the reduction of overnight vital sign checks. The model will use variables, such as the patient's age, the number of days they have been in the hospital, the vital signs from that day, the lab values from that day, and other clinical variables to make its prediction. The outcome is a binary variable, whether the patient will or will not have abnormal vital signs that night. The training data is retrospective therefore it contains the nighttime vitals that were observed, which the investigators will code as a binary variable and use as the outcome variable for the model to train against.

The investigators will incorporate this algorithm into an EHR alert so physicians can observe its output during their work, and use this information, complemented by their own clinical judgment, to decide about ordering reduced vital sign checks for a given patient.

The investigators will study the effect of this EHR alert on several outcomes: in-hospital delirium (measured by nurse assessment), sleep opportunity (a measurement, based on observational EHR data, of patient care related sleep interruptions), and patient satisfaction (measured by nationally-administered post-hospitalization HCAHPS surveys). Balancing measures, to ensure that reduced vital sign checks do not cause patient harm, will be rapid response calls and code blue calls.

Physician teams will be randomized to either see the EHR alert (intervention arm) or not see the EHR alert.

研究类型

介入性

注册 (实际的)

1436

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94143
        • UCSF

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:

  • All physician teams that operate under the UCSF Division of Hospital Medicine

Exclusion Criteria:

  • N/A

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 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:EHR Alert
Physician teams will observe the EHR alert as they perform their clinical duties in the EHR.
A pop-up window in the EHR will notify a physician that their patient has been judged by a predictive algorithm to be safe for reduced overnight vital sign checks.
安慰剂比较:No Alert
Physician teams will perform their clinical duties in the EHR as usual, with no visible alert.
No change to EHR function; no alert visible to providers

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
delirium
大体时间:average will be measured at study completion (6 months from study start date - Sep 11, 2019)
Nursing Delirium Screening Scale (Nu-DESC score) - assessed by the nurse, can range from zero to ten, a score > 2 has good accuracy for delirium
average will be measured at study completion (6 months from study start date - Sep 11, 2019)

次要结果测量

结果测量
措施说明
大体时间
sleep opportunity
大体时间:average will be calculated at study completion (6 months from study start date - Sep 11, 2019)
a *novel* measurement based on observational EHR data - for every night in the hospital, the investigators can extract from the EHR all event timestamps that could have interrupted the patient's sleep (measured between 11 pm and 6 am). These are blood pressure recordings, fingerstick glucose checks, blood draws for labs, and not-as-needed medication administrations. The maximum time period between such events is considered the patient's sleep opportunity for that night (measured in hours). A higher sleep-opportunity on a given night is better. The investigators can calculate an average sleep-opportunity for a hospital encounter and then an average sleep-opportunity for all encounters in a clinical trial arm.
average will be calculated at study completion (6 months from study start date - Sep 11, 2019)
patient satisfaction
大体时间:average score will be measured at study completion (6 months from study start date - Sep 11, 2019)
results from Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys administered to patients after discharge from the hospital (scale is a categorical response: never, sometimes, usually, or always)
average score will be measured at study completion (6 months from study start date - Sep 11, 2019)

其他结果措施

结果测量
措施说明
大体时间
number of code blue events
大体时间:average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
when a patient has a code blue (respiratory or cardiac arrest) called on them in the hospital, the resuscitation team that responds then writes a note documenting the event; the investigators can count these notes as a proxy for counting code blue events themselves (lower number is better)
average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
number of rapid response calls
大体时间:average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
when a patient has a rapid response (significant change in vital signs or alertness) called on them in the hospital, the team that responds writes a note documenting the event and the investigators can count these notes as a proxy for counting rapid response events themselves (lower number is better)
average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)

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

  • 研究主任:Mark Pletcher, MD、Director of the UCSF Informatics and Research Innovation Program

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)

2019年3月11日

初级完成 (实际的)

2019年11月4日

研究完成 (实际的)

2019年11月4日

研究注册日期

首次提交

2018年3月9日

首先提交符合 QC 标准的

2019年8月2日

首次发布 (实际的)

2019年8月6日

研究记录更新

最后更新发布 (实际的)

2019年12月4日

上次提交的符合 QC 标准的更新

2019年12月2日

最后验证

2019年12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)?

IPD 计划说明

Participants are physician teams. The investigators may submit their alert-response data to an online resource.

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

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