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Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
sepsis e-alert
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sepsis focused on measuring sepsis, ward patients, Screening, qSOFA

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Ward level inclusion and exclusion criteria

Inclusion Criteria:

1. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia

Exclusion Criteria:

  1. Cardiology, transplant, pediatric, obstetric wards
  2. Intensive Care Units and Emergency Department
  3. Operating rooms
  4. Outpatients
  5. Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.

Patient level inclusion and exclusion criteria

Inclusion Criteria:

  1. Aged 14 years or older
  2. Checked in as inpatient status to one of the study ward

Exclusion Criteria:

1. No commitment for full life support on the time of arrival to the study ward

Sites / Locations

  • Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental wards

Contol wards

Arm Description

Active sepsis e-alert

Masked sepsis e-alert. The wards will have masked sepsis e-alert.

Outcomes

Primary Outcome Measures

All-cause hospital mortality by day 90
Percentage of all-cause hospital mortality

Secondary Outcome Measures

Hospital length of stay
Censored at 90 days
Transfer to ICU
ICU admission within 90 days
ICU-free days
In the first 90 days
Critical care response team activation
Critical care response team activation within 90 days
Cardiac arrest
Cardiac arrest within 90 days
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy
Within 90 days
Antibiotic-free days
Antibiotic-free days within 90 days
The acquisition of MDROs
The percentage of patients with MDROs within 90 days
Clostridium difficile infection
The percentage of patients with clostridium difficile infection within 90 days

Full Information

First Posted
January 17, 2019
Last Updated
March 12, 2023
Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz Medical City, Jeddah, Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah, King Abdulaziz Hospital, Al Ahsa, Imam Abdulrahman Al Faisal Hospital - Dammam
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1. Study Identification

Unique Protocol Identification Number
NCT04078594
Brief Title
Electronic Early Notification of Sepsis in Hospitalized Ward Patients
Acronym
SCREEN
Official Title
Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz Medical City, Jeddah, Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah, King Abdulaziz Hospital, Al Ahsa, Imam Abdulrahman Al Faisal Hospital - Dammam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Screening for sepsis has been recommended by the Surviving Sepsis Campaign Clinical Practice Guidelines to facilitate early identification and early management of sepsis. However, the optimal tool remains unknown.The objective of this trial is to examine the effect of an electronic sepsis alert tool on reducing hospital mortailty in patients admitted to medical-surgical-oncology wards.
Detailed Description
The study aims to examine the effect of screening for sepsis using an electronic sepsis alert versus no alert in hospitalized patients admitted to wards using an active sepsis alert system compared with wards with no active (masked) sepsis alert system on hospital mortality by day 90. The wards will be randomized in a stepped-wedge cluster fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, ward patients, Screening, qSOFA

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-wedge Cluster Randomized Controlled Trial
Masking
None (Open Label)
Masking Description
The electronic alert will be masked on the control wards.
Allocation
Randomized
Enrollment
65250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental wards
Arm Type
Experimental
Arm Description
Active sepsis e-alert
Arm Title
Contol wards
Arm Type
No Intervention
Arm Description
Masked sepsis e-alert. The wards will have masked sepsis e-alert.
Intervention Type
Other
Intervention Name(s)
sepsis e-alert
Intervention Description
At 2-each month interval, the e-alert will be activated in five new randomly selected wards, until all wards eventually will have active alert
Primary Outcome Measure Information:
Title
All-cause hospital mortality by day 90
Description
Percentage of all-cause hospital mortality
Time Frame
90 Day
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
Censored at 90 days
Time Frame
90 Day
Title
Transfer to ICU
Description
ICU admission within 90 days
Time Frame
90 Day
Title
ICU-free days
Description
In the first 90 days
Time Frame
90 Day
Title
Critical care response team activation
Description
Critical care response team activation within 90 days
Time Frame
90 Day
Title
Cardiac arrest
Description
Cardiac arrest within 90 days
Time Frame
90 Day
Title
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy
Description
Within 90 days
Time Frame
90 Day
Title
Antibiotic-free days
Description
Antibiotic-free days within 90 days
Time Frame
90 Day
Title
The acquisition of MDROs
Description
The percentage of patients with MDROs within 90 days
Time Frame
90 Day
Title
Clostridium difficile infection
Description
The percentage of patients with clostridium difficile infection within 90 days
Time Frame
90 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ward level inclusion and exclusion criteria Inclusion Criteria: 1. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia Exclusion Criteria: Cardiology, transplant, pediatric, obstetric wards Intensive Care Units and Emergency Department Operating rooms Outpatients Day care wards, endoscopy, outpatient procedure areas, hemodialysis units. Patient level inclusion and exclusion criteria Inclusion Criteria: Aged 14 years or older Checked in as inpatient status to one of the study ward Exclusion Criteria: 1. No commitment for full life support on the time of arrival to the study ward
Facility Information:
Facility Name
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34809672
Citation
Arabi YM, Vishwakarma RK, Al-Dorzi HM, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E; SCREEN Trial Group. Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN). Trials. 2021 Nov 22;22(1):828. doi: 10.1186/s13063-021-05788-3.
Results Reference
derived
PubMed Identifier
34635151
Citation
Arabi YM, Alsaawi A, Al Zahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Al Shouabi A, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E, Alansari M, Abuelgasim KA, Alatassi A, Alchin J, Al-Dorzi HM, Ghamdi AA, Al-Hameed F, Alharbi A, Hussein M, Jastaniah W, AlKatheri ME, AlMarhabi H, Mustafa HT, Jones J, Al-Qahtani S, Qahtani S, Qureshi AS, Salih SB, Alselaim N, Tashkandi N, Vishwakarma RK, AlWafi E, Alyami AH, Alyousef Z; SCREEN Trial Group. Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Oct 11;22(1):695. doi: 10.1186/s13063-021-05562-5.
Results Reference
derived

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Electronic Early Notification of Sepsis in Hospitalized Ward Patients

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