<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03010774</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-0885</org_study_id>
    <nct_id>NCT03010774</nct_id>
  </id_info>
  <brief_title>Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring</brief_title>
  <official_title>Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EarlySense Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, all patients in the hospital are woken up throughout the night to check for vital&#xD;
      signs, no matter how sick they are. The investigators are doing this study to determine&#xD;
      whether skipping routine vital sign checks at night improves participant sleep quality and&#xD;
      satisfaction without increasing the risk of adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is:&#xD;
&#xD;
        1. To determine the correlation between subjective and objective sleep quality measures.&#xD;
&#xD;
        2. To compare the objective and subjective measures of sleep quality and satisfaction&#xD;
           between the intervention group and the control group.&#xD;
&#xD;
        3. To compare the adverse event rates in the intervention group and the control group,&#xD;
           defined as ICU transfer or cardiac arrest occurring within 24 hours of risk&#xD;
           stratification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>5 days</time_frame>
    <description>Pittsburgh Sleep Quality Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>5 days</time_frame>
    <description>Karolinska Sleep Log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>5 days</time_frame>
    <description>Potential Hospital Sleep Disruptions and Noises Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Event Rate</measure>
    <time_frame>within 24 hours of risk stratification</time_frame>
    <description>ICU transfer or cardiac arrest</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Sleep Quality</condition>
  <arm_group>
    <arm_group_label>Intervention - Risk Stratification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Risk Stratification</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention - Risk Stratification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>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.</description>
    <arm_group_label>Control - Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Hospitalized on study unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide consent&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Order for physical wound checks&#xD;
&#xD;
          -  Order for cardiac telemetry monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana P Edelson, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03010774
org study id: IRB13-0885
nct id: NCT03010774
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Sleep Quality
time frame: 5 days
description: Pittsburgh Sleep Quality Index
measure: Sleep Quality
time frame: 5 days
description: Karolinska Sleep Log
measure: Sleep Quality
time frame: 5 days
description: Potential Hospital Sleep Disruptions and Noises Questionnaire
measure: Adverse Event Rate
time frame: within 24 hours of risk stratification
description: ICU transfer or cardiac arrest
arm group label: Intervention - Risk Stratification
arm group type: Experimental
description: 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.
arm group label: Control - Usual Care
arm group type: Active Comparator
description: Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk.
intervention type: Behavioral
intervention name: Risk Stratification
description: 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.
arm group label: Intervention - Risk Stratification
intervention type: Behavioral
intervention name: Usual Care
description: 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.
arm group label: Control - Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dana P Edelson, MD, MS
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor