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

NCT03010774 | Completed DMC

• 1 other identifier: IRB13-0885
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse Event Rate

  within 24 hours of risk stratification

Study Arms (2)

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.

Behavioral: Risk Stratification

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.

Behavioral: Usual Care

Interventions

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.

Intervention - Risk Stratification

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.

Control - Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Hospitalized on study unit

You may not qualify if:

• Inability to provide consent
• Non-English speaking
• Order for physical wound checks
• Order for cardiac telemetry monitoring

Sponsors & Collaborators

• University of Chicago: lead
• EarlySense Ltd.: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dana P Edelson, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 5, 2017
• Study Start: February 14, 2017
• Primary Completion: November 10, 2018
• Study Completion: December 31, 2018
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

US (1)