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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04905095
Other study ID # CSAPG-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact Alejandro Rodríguez-Molinero, Dr
Phone 34-938960025
Email arodriguez@csapg.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2760
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients admitted during study period to the participant hospital units. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Consorci Sanitari de l'Alt Penedès i Garraf Vilafranca Del Penedès Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital stay Average days of hospital admission from baseline to hospital discharge, as much 3 months
Secondary Mortality Percentage of patients deceased during hospital admission from baseline to hospital discharge, as much 3 months
Secondary Complications Percentage of patients who develop health complications during hospital admission from baseline to hospital discharge, as much 3 months
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