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| Name | Class |
|---|---|
| EarlySense Ltd. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Risk Stratification | Experimental | 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. |
|
| Control - Usual Care | Active Comparator | Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Stratification | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Rate | ICU transfer or cardiac arrest | within 24 hours of risk stratification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana P Edelson, MD, MS | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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|
| Usual Care | Behavioral | 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. |
|
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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