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

Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: sepsis e-alert

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.

• Study Type: Interventional
• Enrollment (Actual): 65250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental wards; Active sepsis e-alert	Other: sepsis e-alert; 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
No Intervention: Contol wards; Masked sepsis e-alert. The wards will have masked sepsis e-alert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause hospital mortality by day 90	Percentage of all-cause hospital mortality	90 Day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: King Abdulaziz Medical City, Jeddah; King Abdulaziz Hospital, Al Ahsa; Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah; Imam Abdulrahman Al Faisal Hospital - Dammam

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Screening; sepsis; qSOFA; ward patients
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: RC18/112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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