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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sleep Quality

Intervention / Treatment
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* Behavioral: Risk Stratification
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Risk Stratification<br>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<br>* 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.<br>|
| Active Comparator: Control - Usual Care<br>Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk. | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Rate | ICU transfer or cardiac arrest | within 24 hours of risk stratification |