Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring

Not Applicable

Completed

• Conditions: Sleep Quality
• Interventions: Behavioral: Usual Care; Behavioral: Risk Stratification

• Registration Number: NCT03010774
• Lead Sponsor: University of Chicago

Brief Summary

Currently, all patients in the hospital are woken up throughout the night to check for vital signs, no matter how sick they are. The investigators are doing this study to determine whether skipping routine vital sign checks at night improves participant sleep quality and satisfaction without increasing the risk of adverse events.

Detailed Description

The purpose of this study is:

1. To determine the correlation between subjective and objective sleep quality measures.

2. To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group.

3. To compare the adverse event rates in the intervention group and the control group, defined as ICU transfer or cardiac arrest occurring within 24 hours of risk stratification.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Start: 2017-02-14
• Primary Completion: 2018-11-10
• Study Completion: 2018-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Age 18 years and older
• Hospitalized on study unit

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Exclusion Criteria

• Inability to provide consent
• Non-English speaking
• Order for physical wound checks
• Order for cardiac telemetry monitoring

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Usual Care	Usual Care	Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk.
Intervention - Risk Stratification	Risk Stratification	Study participants will be risk stratified according to the eCART scoring algorithm each night. If they are stratified as low risk, they will not receive routine nighttime spot-check vital signs unless indicated by a change in patient status or monitor alarm.

Primary Outcome Measures

Name	Time	Method
Sleep Quality	5 days	Potential Hospital Sleep Disruptions and Noises Questionnaire

Secondary Outcome Measures

Name	Time	Method
Adverse Event Rate	within 24 hours of risk stratification	ICU transfer or cardiac arrest

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States