CSAPG Early Warning Score

NCT04905095 | Completed

• 1 other identifier: CSAPG-11
• Study Type: interventional
• Target: 15,998
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undefined

Keywords

Hospital Stay; Mortality; Clinical Deterioration

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  Average days of hospital admission

  from baseline to hospital discharge, as much 3 months

Secondary Outcomes (2)

• Mortality

  from baseline to hospital discharge, as much 3 months

• Complications

  from baseline to hospital discharge, as much 3 months

Study Arms (2)

EWS

EXPERIMENTAL

Early Warning Score will be implemented in the computer system of the nursing station

Other: EWS

Control

ACTIVE COMPARATOR

Nursing supervision will be carried out in the usual way.

Other: usual clinical care

Interventions

EWS OTHER

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.

EWS

usual clinical care OTHER

Nurses perform their clinical monitoring activities as usual. EWS will not be implemented in their nursing station

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari de l'Alt Penedès i Garraf

Vilafranca del Penedès, Barcelona, Spain

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Ramos, Nurse

  CSAPG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• 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.

Locations

ES (1)