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

Autor: Arabi YM; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia. yaseenarabi@yahoo.com., Alsaawi A; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al Zahrani M; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., Al Khathaami AM; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., AlHazme RH; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.; College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, Florida, USA., Al Mutrafy A; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdullah Specialized Children's Hospital, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al Qarni A; Department of Medicine, King Abdulaziz Hospital, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia.; King Abdullah International Medical Research Center, Al Ahsa, Saudi Arabia.; King Saud bin Abdulaziz University for Health Sciences, Al Ahsa, Saudi Arabia., Al Shouabi A; Imam Abdulrahman Al Faisal Hospital, Ministry of National Guard Health Affairs, Dammam, Saudi Arabia., Al Qasim E; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Abdukahil SA; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al-Rabeah FK; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al Ghamdi H; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al Ghamdi E; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Alansari M; Department of Internal Medicine, Imam Abdulrahman Al Faisal Hospital, Ministry of National Guard Health Affairs, Dammam, Saudi Arabia., Abuelgasim KA; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Oncology Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Alatassi A; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Alchin J; King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Nursing Services Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al-Dorzi HM; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Ghamdi AA; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Quality and Patient Safety Department, King Abdulaziz Hospital Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia., Al-Hameed F; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., Alharbi A; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Hussein M; King Saud Bin Abdulaziz University for Health Sciences, Bioinformatics and Bioinformatics Department, King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Jastaniah W; 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, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., AlKatheri ME; 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, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., AlMarhabi H; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Quality and Patient Safety Department, Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., Mustafa HT; Department of Medicine, King Abdulaziz Hospital, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia., Jones J; King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Nursing Services Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Al-Qahtani S; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Qahtani S; King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Quality and Patient Safety Department, Imam Abdulrahman Al Faisal Hospital, Ministry of National Guard Health Affairs, Dammam, Saudi Arabia., Qureshi AS; 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, Ministry of National Guard Health Affairs, Madinah, Saudi Arabia., Salih SB; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Alselaim N; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Surgery, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., Tashkandi N; King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Nursing Services Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.; Saudi Nursing Professional Council, Saudi Commission for Health Specialties, Riyadh, Saudi Arabia., Vishwakarma RK; King Saud Bin Abdulaziz University for Health Sciences, Bioinformatics and Bioinformatics Department, King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia., AlWafi E; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., Alyami AH; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Surgery, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia., Alyousef Z; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Department of Surgery, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Oct 11; Vol. 22 (1), pp. 695. Date of Electronic Publication: 2021 Oct 11.
DOI: 10.1186/s13063-021-05562-5
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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