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Randomized Controlled Trial
. 2025 Mar 4;333(9):763-773.
doi: 10.1001/jama.2024.25982.

Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial

Yaseen M Arabi  1   2   3 Abdulmohsen Alsaawi  2   3   4 Mohammed Alzahrani  5   6   7 Ali M Al Khathaami  2   3   8 Raed H AlHazme  2   9   10 Abdullah Al Mutrafy  2   3   4 Ali Al Qarni  11   12   13 Ramesh Kumar Vishwakarma  14   15 Rasha Al Anazi  2   16 Eman Al Qasim  1   2   3 Sheryl Ann Abdukahil  1   2   3 Fawaz K Al-Rabeah  2   9   10 Huda Al Ghamdi  2   9   10 Abdulaleem Alatassi  2   3   8 Hasan M Al-Dorzi  1   2   3 Fahad Al-Hameed  6   7   17 Razan Babakr  18 Abdulaziz A Alghamdi  12   13   19 Salih Bin Salih  2   3   20 Ahmad Alharbi  2   3   21 Mufareh Edah AlKatheri  2   3   8 Hani Mustafa  12   13   22 Saad Al-Qahtani  1   2   3 Shaher Al Qahtani  23 Nahar Alselaim  2   3   24 Nabiha Tashkandi  2   16 Ali H Alyami  6   7 Zeyad Alyousef  2   3   24 Omar AlDibasi  14 Abdul Hadi Al-Qahtani  2   3   8 Abdulaziz Aldawood  1   2   3 Angela Caswell  2   16 Nouf Al Ayadhi  2   9   10 Hadeel Al Rehaili  2   9   10 Ahmed Al Arfaj  11   12   13 Hatami Al Mubarak  25 Turki Alwasaidi  26 Saleh Zahrani  27 Yousef Alalawi  28 Abdulrahman Alhadab  2   3   4   29 Tariq Nasser  6   7   30 Tagwa Omer  6   31   32 Sameera M Al Johani  2   3   33 Abdulaziz Alajlan  2   3   33 Musharaf Sadat  1   2   3 Mohammed Alzunitan  2   3   34 Saad Al Mohrij  2   3   35 SCREEN Trial Group and the Saudi Critical Care Trials Group
Collaborators, Affiliations
Randomized Controlled Trial

Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial

Yaseen M Arabi et al. JAMA. .

Abstract

Importance: Sepsis screening is recommended among hospitalized patients but is supported by limited evidence of effectiveness.

Objective: To evaluate the effect of electronic sepsis screening, compared with no screening, on mortality among hospitalized ward patients.

Design, setting, and participants: In a stepped-wedge, cluster randomized trial at 5 hospitals in Saudi Arabia, 45 wards (clusters) were randomized into 9 sequences, 5 wards each, to have sepsis screening implemented at 2-month periods. The study was conducted between October 1, 2019, and July 31, 2021, with follow-up through October 29, 2021.

Intervention: An electronic alert, based on the quick Sequential Organ Failure Assessment score, was implemented in the electronic medical record in a silent mode that was activated to a revealed mode for sepsis screening.

Main outcomes and measures: The primary outcome was 90-day in-hospital mortality. There were 11 secondary outcomes, including code blue activation, vasopressor therapy, incident kidney replacement therapy, multidrug-resistant organisms, and Clostridioides difficile.

Results: Among 60 055 patients, 29 442 were in the screening group and 30 613 in the no screening group. They had a median age of 59 years (IQR, 39-68), and 30 596 were male (51.0%). Alerts occurred in 4299 of 29 442 patients (14.6%) in the screening group and 5394 of 30 613 (17.6%) in the no screening group. Within 12 hours of the alert, patients in the screening group were more likely to have serum lactate tested (adjusted relative risk [aRR], 1.30; 95% CI, 1.16-1.45) and intravenous fluid ordered (aRR, 2.17; 95% CI, 1.92-2.46) compared with those in the no screening group. In the primary outcome analysis, electronic screening resulted in lower 90-day in-hospital mortality (aRR, 0.85; 95% CI, 0.77-0.93; P < .001). Screening reduced vasopressor therapy and multidrug-resistant organisms but increased code blue activation, incident kidney replacement therapy, and C difficile.

Conclusions and relevance: Among hospitalized ward patients, electronic sepsis screening compared with no screening resulted in significantly lower in-hospital 90-day mortality.

Trial registration: ClinicalTrials.gov Identifier: NCT04078594.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Arabi reported a patent for US 20180150606 pending (King Abdulaziz Medical City). Dr AlKatheri reported nonfinancial support from the Ministry of National Guard–Health Affairs for serving as deputy executive director of quality and patient safety. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Ward and Participant Flow in the SCREEN Trial
Numbers in boxes for each period and sequence represent the total number of patients and mean (SD) per ward. SCREEN indicates Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients. aTwo wards, 1 in each of sequences 3 and 9, were excluded after randomization, because they were backup nonoperational wards at the beginning of the study then were converted to intensive care units (ICUs) with the COVID-19 pandemic. bData were excluded from 1 ward in sequence 5 in periods 5 to 10 and from 1 ward in sequence 7 in periods 6 to 10 because they were converted to ICUs. In addition, 1 ward in sequence 3 was converted to an ICU between June 1, 2020, and August 31, 2020; therefore, it contributed data partially in periods 4 and 5. cDuring the first wave of COVID-19 cases, total admissions to most wards declined substantially; therefore, 2 consecutive periods (starting June 2020) were extended from 2 to 3 months each to account for the decline in cluster size.
Figure 2.
Figure 2.. Results of Prespecified Subgroup Analyses of the Primary Outcome (90-Day In-Hospital Mortality)
The effect of screening compared with no screening was tested using a generalized linear mixed model accounting for periods and nested clustering within wards as random effects and hospitals and COVID-19 status as fixed effects, and the results were reported as relative risk with 95% confidence intervals. The size of each square is proportional to the subgroup sample size. Two-sided P values for interaction are reported. aThe false discovery rate accounts for multiplicity by calculating the expected proportion of tests with false-positives at a specified rank of a set of tests. bPatients with documented infection source included those with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification codes for respiratory infection, urinary tract infection, skin, soft tissue infection or cardiovascular infection, intra-abdominal infection, or other infections. cFor the subgroup based on COVID-19 status, the same model was used with the exception of not including COVID-19 status as a fixed effect.

Comment in

  • Do Sepsis Alerts Help?
    Angus DC. Angus DC. JAMA. 2025 Mar 4;333(9):759-760. doi: 10.1001/jama.2024.25818. JAMA. 2025. PMID: 39658870 No abstract available.

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