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. 2021 Oct 11;22(1):695.
doi: 10.1186/s13063-021-05562-5.

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

Yaseen M Arabi  1 , Abdulmohsen Alsaawi  2 , Mohammed Al Zahrani  3 , Ali M Al Khathaami  4 , Raed H AlHazme  5   6 , Abdullah Al Mutrafy  7 , Ali Al Qarni  8   9   10 , Ahmed Al Shouabi  11 , Eman Al Qasim  12 , Sheryl Ann Abdukahil  13 , Fawaz K Al-Rabeah  5 , Huda Al Ghamdi  5 , Ebtisam Al Ghamdi  5 , Mariam Alansari  14 , Khadega A Abuelgasim  15 , Abdulaleem Alatassi  4 , John Alchin  16 , Hasan M Al-Dorzi  13 , Abdulaziz A Ghamdi  17 , Fahad Al-Hameed  18 , Ahmad Alharbi  19 , Mohamed Hussein  20 , Wasil Jastaniah  21 , Mufareh Edah AlKatheri  4 , Hassan AlMarhabi  22 , Hani T Mustafa  8 , Joan Jones  16 , Saad Al-Qahtani  13 , Shaher Qahtani  23 , Ahmad S Qureshi  24 , Salih Bin Salih  25 , Nahar Alselaim  26 , Nabiha Tashkandi  16   27 , Ramesh Kumar Vishwakarma  20 , Emad AlWafi  28 , Ali H Alyami  29 , Zeyad Alyousef  26 ; SCREEN Trial Group
Collaborators, Affiliations

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

Yaseen M Arabi et al. Trials. .

Abstract

Background: To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality.

Methods: The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of "possible sepsis alert" to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days.

Discussion: The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021.

Trial registration: ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

Keywords: Alert; Electronic medical records; Mortality; Screening; Sepsis; qSOFA.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SCREEN trial design as a stepped-wedge cluster randomized trial
Fig. 2
Fig. 2
SPIRIT figure for the SCREEN trial
Fig. 3
Fig. 3
Workflow of the electronic alert
See this image and copyright information in PMC

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