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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010774
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
EarlySense Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Quality Behavioral: Risk Stratification Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

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.




Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: 5 days ]
    Pittsburgh Sleep Quality Index

  2. Sleep Quality [ Time Frame: 5 days ]
    Karolinska Sleep Log

  3. Sleep Quality [ Time Frame: 5 days ]
    Potential Hospital Sleep Disruptions and Noises Questionnaire


Secondary Outcome Measures :
  1. Adverse Event Rate [ Time Frame: within 24 hours of risk stratification ]
    ICU transfer or cardiac arrest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010774


Contacts
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Contact: Nicole M Twu, MS 773-834-4489 ntwu@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Nicole Twu, MS       ntwu@bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
EarlySense Ltd.
Investigators
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Principal Investigator: Dana P Edelson, MD, MS University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03010774    
Other Study ID Numbers: IRB13-0885
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No