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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 10, 2018

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sleep Quality
    • Time Frame: 5 days
    • Pittsburgh Sleep Quality Index
  • Sleep Quality
    • Time Frame: 5 days
    • Karolinska Sleep Log
  • Sleep Quality
    • Time Frame: 5 days
    • Potential Hospital Sleep Disruptions and Noises Questionnaire

Secondary Measures

  • Adverse Event Rate
    • Time Frame: within 24 hours of risk stratification
    • ICU transfer or cardiac arrest

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Collaborator
    • EarlySense Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dana P Edelson, MD, MS, Principal Investigator, University of Chicago

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