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

Yaseen M Arabi, Abdulmohsen Alsaawi, Mohammed Al Zahrani, Ali M Al Khathaami, Raed H AlHazme, Abdullah Al Mutrafy, Ali Al Qarni, Ahmed Al Shouabi, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K Al-Rabeah, Huda Al Ghamdi, Ebtisam Al Ghamdi, Mariam Alansari, Khadega A Abuelgasim, Abdulaleem Alatassi, John Alchin, Hasan M Al-Dorzi, Abdulaziz A Ghamdi, Fahad Al-Hameed, Ahmad Alharbi, Mohamed Hussein, Wasil Jastaniah, Mufareh Edah AlKatheri, Hassan AlMarhabi, Hani T Mustafa, Joan Jones, Saad Al-Qahtani, Shaher Qahtani, Ahmad S Qureshi, Salih Bin Salih, Nahar Alselaim, Nabiha Tashkandi, Ramesh Kumar Vishwakarma, Emad AlWafi, Ali H Alyami, Zeyad Alyousef, SCREEN Trial Group, Ahmed Al Arfaj, Mohamed S Al Moammary, Soud Rasheed, Turki Alwasaidi, Amal Matroud, Rasha Ebeid Al Anazi, Amar M Alhasani, Haifa Al Shammari, Majid M Alshamrani, Saleh Qasim, Saeed Obbed, Adnan A Munshi, Hadia Al Tabsh, Basem R Banat, Omar Abuskout, Anna Liza Marcelo, Mayadah M Alhabshi, Ibrahim J Jaber, Mohammad Shahin, Jamielah Yaakob, Hanan Al Somali, Clara Masala, Mohammed Al Qarni, Jamal Chalabi, Johanna E Greyvenstein, Abdul Rahman Jazieh, Noha Omaish, Azura Abdrahim, Mohammad Abdrabo, Abdullah Al Hamdan, Abdulaziz Al Qasem, Hattan Esilan, Yaseen M Arabi, Abdulmohsen Alsaawi, Mohammed Al Zahrani, Ali M Al Khathaami, Raed H AlHazme, Abdullah Al Mutrafy, Ali Al Qarni, Ahmed Al Shouabi, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K Al-Rabeah, Huda Al Ghamdi, Ebtisam Al Ghamdi, Mariam Alansari, Khadega A Abuelgasim, Abdulaleem Alatassi, John Alchin, Hasan M Al-Dorzi, Abdulaziz A Ghamdi, Fahad Al-Hameed, Ahmad Alharbi, Mohamed Hussein, Wasil Jastaniah, Mufareh Edah AlKatheri, Hassan AlMarhabi, Hani T Mustafa, Joan Jones, Saad Al-Qahtani, Shaher Qahtani, Ahmad S Qureshi, Salih Bin Salih, Nahar Alselaim, Nabiha Tashkandi, Ramesh Kumar Vishwakarma, Emad AlWafi, Ali H Alyami, Zeyad Alyousef, SCREEN Trial Group, Ahmed Al Arfaj, Mohamed S Al Moammary, Soud Rasheed, Turki Alwasaidi, Amal Matroud, Rasha Ebeid Al Anazi, Amar M Alhasani, Haifa Al Shammari, Majid M Alshamrani, Saleh Qasim, Saeed Obbed, Adnan A Munshi, Hadia Al Tabsh, Basem R Banat, Omar Abuskout, Anna Liza Marcelo, Mayadah M Alhabshi, Ibrahim J Jaber, Mohammad Shahin, Jamielah Yaakob, Hanan Al Somali, Clara Masala, Mohammed Al Qarni, Jamal Chalabi, Johanna E Greyvenstein, Abdul Rahman Jazieh, Noha Omaish, Azura Abdrahim, Mohammad Abdrabo, Abdullah Al Hamdan, Abdulaziz Al Qasem, Hattan Esilan

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.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

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

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