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De-escalating Vital Sign Checks

Primary Purpose

Delirium, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nighttime Vital Sign EHR Alert
No EHR alert
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EHR Alert

No Alert

Arm Description

Physician teams will observe the EHR alert as they perform their clinical duties in the EHR.

Physician teams will perform their clinical duties in the EHR as usual, with no visible alert.

Outcomes

Primary Outcome Measures

delirium
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

sleep opportunity
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
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)

Full Information

First Posted
March 9, 2018
Last Updated
December 2, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04046458
Brief Title
De-escalating Vital Sign Checks
Official Title
Using Predictive Analytics to Reduce Vital Sign Checks in Stable Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Sleep Disturbance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators' intervention, which is a notification to the physician that is seen in the EHR, is randomized at the patient level. The patients randomized to the control group do not have a notification shown to their physician while the intervention patients do.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EHR Alert
Arm Type
Experimental
Arm Description
Physician teams will observe the EHR alert as they perform their clinical duties in the EHR.
Arm Title
No Alert
Arm Type
Placebo Comparator
Arm Description
Physician teams will perform their clinical duties in the EHR as usual, with no visible alert.
Intervention Type
Behavioral
Intervention Name(s)
Nighttime Vital Sign EHR Alert
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No EHR alert
Intervention Description
No change to EHR function; no alert visible to providers
Primary Outcome Measure Information:
Title
delirium
Description
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
Time Frame
average will be measured at study completion (6 months from study start date - Sep 11, 2019)
Secondary Outcome Measure Information:
Title
sleep opportunity
Description
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.
Time Frame
average will be calculated at study completion (6 months from study start date - Sep 11, 2019)
Title
patient satisfaction
Description
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)
Time Frame
average score will be measured at study completion (6 months from study start date - Sep 11, 2019)
Other Pre-specified Outcome Measures:
Title
number of code blue events
Description
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)
Time Frame
average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
Title
number of rapid response calls
Description
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)
Time Frame
average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All physician teams that operate under the UCSF Division of Hospital Medicine Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Pletcher, MD
Organizational Affiliation
Director of the UCSF Informatics and Research Innovation Program
Official's Role
Study Director
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants are physician teams. The investigators may submit their alert-response data to an online resource.
Citations:
PubMed Identifier
34962506
Citation
Najafi N, Robinson A, Pletcher MJ, Patel S. Effectiveness of an Analytics-Based Intervention for Reducing Sleep Interruption in Hospitalized Patients: A Randomized Clinical Trial. JAMA Intern Med. 2022 Feb 1;182(2):172-177. doi: 10.1001/jamainternmed.2021.7387.
Results Reference
derived

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De-escalating Vital Sign Checks

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