CSAPG Early Warning Score (CEWS)

February 10, 2025 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

The Early Warning Score (EWS) has been shown in previous studies to be correlated with mortality and mean hospital stay, but it is unknown whether the implementation of the scale improves mortality and mean hospital stay.

This trial aims to study whether the implantation of the EWS in a regional hospital reduces the mean hospital stay (primary objective), mortality and complications (secondary objectives).

For this, an open clinical trial will be carried out in which the hospitalization floors of the hospital will be administratively divided into two sections (two study branches); the EWS scale will be implemented in the computer equipment of one of the sections of each floor, acting the another section as a control branch.

All the patients admitted to the participating hospital floors during one year will be included in the study. The mean stay, mortality and complications will be compared between study branches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15998

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Vilafranca Del Penedès, Barcelona, Spain
        • Consorci Sanitari de l'Alt Penedès i Garraf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted during study period to the participant hospital units.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EWS
Early Warning Score will be implemented in the computer system of the nursing station
Other: EWS
Early Warning Score will be implemented in the computer system of the nursing station which belong to this intervention group. When the nurses enter the vital signs of the patients into the system, the EWS will be automatically calculated and an alarm will be displayed if an intervention is necessary, which is protocolized.
Active Comparator: Control
Nursing supervision will be carried out in the usual way.
Other: usual clinical care
Nurses perform their clinical monitoring activities as usual. EWS will not be implemented in their nursing station

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: from baseline to hospital discharge, as much 3 months
Average days of hospital admission
from baseline to hospital discharge, as much 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: from baseline to hospital discharge, as much 3 months
Percentage of patients deceased during hospital admission
from baseline to hospital discharge, as much 3 months
Complications
Time Frame: from baseline to hospital discharge, as much 3 months
Percentage of patients who develop health complications during hospital admission
from baseline to hospital discharge, as much 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Investigators

  • Principal Investigator: Cristina Ramos, Nurse, CSAPG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSAPG-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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