CEWS: CSAPG Early Warning Score

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04905095
• Collaborator: (none)
• Enrollment: 2,760
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 230.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication	Diagnostic Test: EWS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2760 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: CSAPG Early Warning Score
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EWS Early Warning Score will be implemented in the computer system of the nursing station	Diagnostic Test: EWS; Early Warning Score will be implemented in the computer system of the nursing station. 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.
No Intervention: Control Nursing supervision will be carried out in the usual way.

Outcome Measures

Primary Outcome Measures

1. Hospital stay [1 year]

   Average days of hospital admission

Secondary Outcome Measures

1. Mortality [1 year]

   Percentage of patients deceased during hospital admission

2. Complications [1 year]

   Percentage of patients who develop health complications during hospital admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consorci Sanitari de l'Alt Penedès i Garraf	Vilafranca Del Penedès	Barcelona	Spain

Sponsors and Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consorci Sanitari de l'Alt Penedès i Garraf
• ClinicalTrials.gov Identifier: NCT04905095
• Other Study ID Numbers: CSAPG-11
• First Posted: May 27, 2021
• Last Update Posted: Sep 14, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Consorci Sanitari de l'Alt Penedès i Garraf: Hospital Stay; Mortality; Complication

Study Results

No Results Posted as of Sep 14, 2021