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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality
• Intervention / Treatment: Behavioral: Risk Stratification; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years and older
• Hospitalized on study unit

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - 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.	Behavioral: Risk Stratification; Every night, subjects will be risk stratified into low-risk or medium- to high-risk using a physiologic risk score, eCART. Subjects who meet the low-risk criteria will not be woken up for routine nighttime vitals (typically at midnight and at 4 am). However, subjects will continue to be woken up for laboratory draws, procedures, or treatments as per usual. Subjects who are medium- to high-risk will continue to be woken up at night for routine nighttime vitals. Alarms for all subjects, including low-risk subjects, will continue to alert nurses in real-time. If the primary nurse of a low-risk subject is alerted of an alarm, the nurse will have to go into the subject's room to turn off the alarm and therefore check on the patient.
Active Comparator: Control - Usual Care; Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk.	Behavioral: Usual Care; The subject will continue to receive routine vital sign measurements and charting, standard for the ward or according to the physician orders, including routine spot-check vital signs, regardless of risk level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Pittsburgh Sleep Quality Index	5 days
Sleep Quality	Karolinska Sleep Log	5 days
Sleep Quality	Potential Hospital Sleep Disruptions and Noises Questionnaire	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Rate	ICU transfer or cardiac arrest	within 24 hours of risk stratification

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: EarlySense Ltd.
• Investigators: Principal Investigator: Dana P Edelson, MD, MS, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB13-0885

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No