Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward. (COCOMO)

Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.

In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.

The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.

Study Overview

• Status: Completed
• Conditions: Clinical Deterioration
• Intervention / Treatment: Other: Continuous Monitoring

• Study Type: Observational
• Enrollment (Actual): 3896

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult general ward patients of the GE-surgery and Internal Medicine wards of a Dutch tertiary academic hospital.

Description

Inclusion Criteria:

• Admission on Inclusion ward.

Exclusion Criteria:

• Opt out of file study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General Ward Inpatients 2017-2018; ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2017-august 31st 2018.
General Ward Inpatients 2018-2019; ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2018-august 31st 2019.	Other: Continuous Monitoring; Wireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unexpected Intensive Care Unit Admissions	Unexpected Intensive Care Unit Admissions	During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Rapid Response Team Activations	Rapid Response Team Activations	During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Length of stay on the ward, ICU and Hospital stay as whole	During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Early Warning Scores; Continuous Vital Sign Monitoring; Escalation of Care; ICU-Transfer; Deterioration prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: 2018-4330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No