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

Details

Title
Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial
Author
Arabi, Yaseen M. 1   VIAFID ORCID Logo  ; Alsaawi, Abdulmohsen 2 ; Al Zahrani, Mohammed 3 ; Al Khathaami, Ali M. 4 ; AlHazme, Raed H. 5 ; Al Mutrafy, Abdullah 6 ; Al Qarni, Ali 7 ; Al Shouabi, Ahmed 8 ; Al Qasim, Eman 9 ; Abdukahil, Sheryl Ann 1 ; Al-Rabeah, Fawaz K. 10 ; Al Ghamdi, Huda 10 ; Al Ghamdi, Ebtisam 10 ; Alansari, Mariam 11 ; Abuelgasim, Khadega A. 12 ; Alatassi, Abdulaleem 4 ; Alchin, John 13 ; Al-Dorzi, Hasan M. 1 ; Ghamdi, Abdulaziz A. 14 ; Al-Hameed, Fahad 15 ; Alharbi, Ahmad 16 ; Hussein, Mohamed 17 ; Jastaniah, Wasil 18 ; AlKatheri, Mufareh Edah 4 ; AlMarhabi, Hassan 19 ; Mustafa, Hani T. 20 ; Jones, Joan 13 ; Al-Qahtani, Saad 1 ; Qahtani, Shaher 21 ; Qureshi, Ahmad S. 22 ; Salih, Salih Bin 23 ; Alselaim, Nahar 24 ; Tashkandi, Nabiha 25 ; Vishwakarma, Ramesh Kumar 17 ; AlWafi, Emad 26 ; Alyami, Ali H. 27 ; Alyousef, Zeyad 24 ; Al Arfaj, Ahmed; Al Moammary, Mohamed S.; Rasheed, Soud; Alwasaidi, Turki; Matroud, Amal; Al Anazi, Rasha Ebeid; Alhasani, Amar M.; Al Shammari, Haifa; Alshamrani, Majid M.; Qasim, Saleh; Obbed, Saeed; Munshi, Adnan A.; Al Tabsh, Hadia; Banat, Basem R.; Abuskout, Omar; Marcelo, Anna Liza; Alhabshi, Mayadah M.; Jaber, Ibrahim J.; Shahin, Mohammad; Yaakob, Jamielah; Al Somali, Hanan; Masala, Clara; Al Qarni, Mohammed; Chalabi, Jamal; Greyvenstein, Johanna E.; Jazieh, Abdul Rahman; Omaish, Noha; Abdrahim, Azura; Abdrabo, Mohammad; Al Hamdan, Abdullah; Al Qasem, Abdulaziz; Esilan, Hattan

1  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
2  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
3  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
4  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Quality and Patient Safety Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
5  Ministry of National Guard Health Affairs, College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Information Technology Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419); Nova Southeastern University, College of Osteopathic Medicine, Florida, USA (GRID:grid.261241.2) (ISNI:0000 0001 2168 8324) 
6  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
7  Ministry of National Guard Health Affairs, Department of Medicine, King Abdulaziz Hospital, Al Ahsa, Saudi Arabia (GRID:grid.415252.5); King Abdullah International Medical Research Center, Al Ahsa, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891); King Saud bin Abdulaziz University for Health Sciences, Al Ahsa, Saudi Arabia (GRID:grid.412149.b) (ISNI:0000 0004 0608 0662) 
8  Ministry of National Guard Health Affairs, Imam Abdulrahman Al Faisal Hospital, Dammam, Saudi Arabia (GRID:grid.490184.0) (ISNI:0000 0004 0608 2457) 
9  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Research Office, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
10  Ministry of National Guard Health Affairs, College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Information Technology Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
11  Ministry of National Guard Health Affairs, Department of Internal Medicine, Imam Abdulrahman Al Faisal Hospital, Dammam, Saudi Arabia (GRID:grid.490184.0) (ISNI:0000 0004 0608 2457) 
12  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Oncology Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
13  Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Nursing Services Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
14  King Abdulaziz Hospital Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Quality and Patient Safety Department, Al Ahsa, Saudi Arabia (GRID:grid.416641.0) 
15  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
16  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Division of Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
17  Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences, Bioinformatics and Bioinformatics Department, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
18  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Princess Noorah Oncology Center, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
19  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Quality and Patient Safety Department, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.415254.3) (ISNI:0000 0004 1790 7311) 
20  Ministry of National Guard Health Affairs, Department of Medicine, King Abdulaziz Hospital, Al Ahsa, Saudi Arabia (GRID:grid.415252.5) 
21  Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Quality and Patient Safety Department, Imam Abdulrahman Al Faisal Hospital, Dammam, Saudi Arabia (GRID:grid.412149.b) (ISNI:0000 0004 0608 0662) 
22  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, Prince Mohammed bin Abdulaziz Hospital, Madinah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
23  King Abdullah International Medical Research Center, Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia (GRID:grid.415254.3) (ISNI:0000 0004 1790 7311) 
24  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Surgery, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419) 
25  Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Nursing Services Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia (GRID:grid.416641.0) (ISNI:0000 0004 0607 2419); Saudi Commission for Health Specialties, Saudi Nursing Professional Council, Riyadh, Saudi Arabia (GRID:grid.467047.6) (ISNI:0000 0004 0419 5626) 
26  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
27  Ministry of National Guard Health Affairs, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Surgery, King Abdulaziz Medical City, Jeddah, Saudi Arabia (GRID:grid.452607.2) (ISNI:0000 0004 0580 0891) 
Pages
695
Publication year
2021
Publication date
Dec 2021
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-021-05562-5
ProQuest document ID
2730339860
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.