De-escalating Vital Sign Checks

Not Applicable

Completed

• Conditions: Delirium; Sleep Disturbance
• Interventions: Other: No EHR alert; Behavioral: Nighttime Vital Sign EHR Alert

• Registration Number: NCT04046458
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-03-09
• Study Start: 2019-03-11
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1436

Inclusion Criteria

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

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Alert	No EHR alert	Physician teams will perform their clinical duties in the EHR as usual, with no visible alert.
EHR Alert	Nighttime Vital Sign EHR Alert	Physician teams will observe the EHR alert as they perform their clinical duties in the EHR.

Primary Outcome Measures

Name	Time	Method
delirium	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

Secondary Outcome Measures

Name	Time	Method
sleep opportunity	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.
patient satisfaction	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)

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States