Implementation of a qSOFA Score in the Emergency Department (qSOFA2)

Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Procedure: emergency vital room; Procedure: box

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• body temperature below 36 °C or above 38 °C
• require hospitalization

Exclusion Criteria:

• hospital transfer,
• patients with pre hospital care
• language barrier,
• refusal to participate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with qSOFA ≥ 2; adult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room	Procedure: emergency vital room; At the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room
Other: patients with qSOFA <2; adult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box	Procedure: box; patient with score < 2 will be supported in box

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate	compare mortality rate with orientation in emergency	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
support time to medical contact	compare support time with orientation of patients according to the orientation of the patient in the emergency department	1 day
support time to initiation of antibiotics	compare support time with initiation antibiotics of patients according to the orientation of the patient in the emergency department	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; screening; qSOFA; Emergency care unit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: P/2019/452

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No