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.
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.
Trials. 2021 Oct 11;22(1):695. doi: 10.1186/s13063-021-05562-5.
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.
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.
The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021.
ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.
评估使用电子脓毒症警报对住院病房患者进行脓毒症筛查与不使用警报对 90 天住院死亡率的影响。
SCREEN 试验设计为阶梯式楔形集群随机对照试验。医院病房（共 45 个病房，构成该设计中的集群）随机分为有主动警报和隐藏警报，每次 5 个病房，每个 5 个病房构成一个序列。该研究由 10 个为期 2 个月的阶段组成，分阶段引入干预措施。在第一个阶段，所有病房都有两个月的隐藏警报。之后，每隔 2 个月以新的序列实施干预措施（警报系统），直到所有序列都实施干预措施。干预措施包括在医院电子病历中实施基于快速序贯器官衰竭评估（qSOFA）的电子警报系统。警报系统会向床边护士、值班护士和初级医疗团队发送“可能的脓毒症警报”通知，并要求床边护士和医生在健康信息系统中确认。计算的样本量为 65250。主要终点是 90 天内的住院死亡率。
该试验于 2019 年 10 月 1 日开始，预计将在 2021 年 10 月底完成患者随访。
ClinicalTrials.gov NCT04078594。于 2019 年 9 月 6 日注册。
