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

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The University of Chicago

Status

Completed

Conditions

Sleep Quality

Treatments

Behavioral: Risk Stratification
Behavioral: Usual Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03010774
IRB13-0885

Details and patient eligibility

About

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.

Full 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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

166 participants in 2 patient groups

Intervention - Risk Stratification
Experimental group
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.
Treatment:
Behavioral: Risk Stratification
Control - Usual Care
Active Comparator group
Description:
Study participants will be woken at night for routine nighttime spot-check vital signs regardless of patient disease severity or risk.
Treatment:
Behavioral: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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