Electronic Early Notification of Sepsis in Hospitalized Ward Patients

Conditions

Sepsis

Keywords

sepsis, ward patients, Screening, qSOFA

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.

Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S, SCREEN Trial Group and the Saudi Critical Care Trials Group.

2025-03-0110 citations

10.1001/jama.2024.25982

Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN).

Arabi YM, Vishwakarma RK, Al-Dorzi HM, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E, SCREEN Trial Group.

2021-11-222 citations

10.1186/s13063-021-05788-3

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

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.

2021-10-118 citations

10.1186/s13063-021-05562-5

Interventions

OTHERsepsis 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Masking description

The electronic alert will be masked on the control wards.

Intervention model description

Stepped-wedge Cluster Randomized Controlled Trial

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

Saudi Arabia

Outcome results

None listed