Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring
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|ClinicalTrials.gov Identifier: NCT03010774|
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Quality||Behavioral: Risk Stratification Behavioral: Usual Care||Not Applicable|
The purpose of this study is:
- To determine the correlation between subjective and objective sleep quality measures.
- To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group.
- 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 (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|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|
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.
- 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
- Adverse Event Rate [ Time Frame: within 24 hours of risk stratification ]ICU transfer or cardiac arrest
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
|Contact: Nicole M Twu, MSemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Nicole Twu, MS firstname.lastname@example.org|
|Principal Investigator:||Dana P Edelson, MD, MS||University of Chicago|