Clinical Deterioration Early Warning System Score

NCT06499376 | Completed

• 1 other identifier: PI2019030
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

At present, there is no universal early warning system implemented in all Basque hospitals, but there are previous experiences, sometimes based on models generated in other health systems. In this project we intend to provide a robust model, based on the analysis of patient data from three Basque hospitals, i.e. generated in our population. A three-phase study has been designed:

1. 1.st phase: Derivation of the predictive model by means of a reprospective cohort study in which patients hospitalised at the Galdakao-Usansolo Hospital, Donostia University Hospital and Araba University Hospital will be recruited.
2. 2.nd phase: Creation of an alarm system based on the probability of risk of clinical deterioration and implementation of the system in the electronic medical record (EHR) of the HGU, in the form of an "Action Guide".
3. 3.rd phase: The model will be validated by comparing the percentages of clinical deterioration by means of a quasi-experimental intervention study, comparing the results of the HGU hospital where the system will be implemented, before and after the intervention and, on the other hand, with those of Hospital Universitario Donostia (HUD) and Hospital Universitario de Araba (HUA), where normal clinical practice will be followed, with an early warning system based on vital signs in HUD and clinical criteria in HUA.

Conditions

Clinical Deterioration

Keywords

Early warning system, clinical deterioration

Outcome Measures

Primary Outcomes (1)

• Clinical deterioration

  death in admission or length of stay more than 12 hours in intensive or intermediary care unit (ICU).

  at least 24 hours after admission

Study Arms (2)

PATIENTS ADMITTED IN THE HOSPITAL IN 2019

Inclusion criteria: patients over 18 years of age hospitalised on conventional hospital wards, in medical and surgical departments or awaiting a bed during their stay in the emergency department. Exclusion criteria: patients with poor vital prognosis and DNR orders.

PATIENTS ADMITTED IN THE HOSPITAL IN 2021

Inclusion criteria: patients over 18 years of age hospitalised on conventional hospital wards, in medical and surgical departments or awaiting a bed during their stay in the emergency department. Exclusion criteria: patients with poor vital prognosis and DNR orders.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical and surgical services of the Galdakao-Usansolo Hospital (HGU), Donostia University Hospital (HUD) and Alava University Hospital (HUA). The HGU alone deals with 28592 admissions per year, of which 1088 are admitted to the intensive care unit.

You may qualify if:

• patients over 18 years of age hospitalised on conventional hospital wards, in medical and surgical departments or awaiting a bed during their stay in the emergency department.

You may not qualify if:

• patients with a poor prognosis for life and a DNR order.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Biosistemak Institute for Health Systems Research: collaborator
• Biobizkaia: collaborator

Study Sites (1)

Hospital Galdakao Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

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

Study Officials

• Naia Mas, PhD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 12, 2024
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

ES (1)