Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol
Daniel Brodie,
Manish Sharma,
Matthew J Cummings,
Hassan Mohamed,
William N Southern,
Edward J Schenck,
Benjamin L Ranard,
David Y Zhang,
Jeremy R Beitler,
Min Qian,
Jo R Applebaum,
Jason S Adelman,
Shing M Lee,
Richard Trepp,
Hanson Hsu,
Jean Scofi,
Sarah C Rossetti,
Natalie H Yip,
Baruch S Fertel
Affiliations
Daniel Brodie
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
Manish Sharma
Department of Emergency Medicine, NewYork-Presbyterian Queens, Flushing, New York, USA
Matthew J Cummings
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA
Hassan Mohamed
NewYork-Presbyterian Hospital, New York, New York, USA
William N Southern
Division of Hospital Medicine, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York, USA
Edward J Schenck
NewYork-Presbyterian Hospital, New York, New York, USA
Benjamin L Ranard
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA
David Y Zhang
Northwell, New Hyde Park, New York, USA
Jeremy R Beitler
Division of Pulmonary, Critical Care and Sleep Medicine, New York University Grossman School of Medicine, New York, New York, USA
Min Qian
Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA
Jo R Applebaum
Center for Patient Safety Science, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA
Jason S Adelman
Department of Biomedical Informatics, Columbia University, New York, New York, USA
Shing M Lee
Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA
Richard Trepp
NewYork-Presbyterian Hospital, New York, New York, USA
Hanson Hsu
Department of Emergency Medicine, Weill Cornell Medical College, New York, New York, USA
Jean Scofi
NewYork-Presbyterian Hospital, New York, New York, USA
Sarah C Rossetti
Department of Biomedical Informatics, Columbia University, New York, New York, USA
Natalie H Yip
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA
Baruch S Fertel
NewYork-Presbyterian Hospital, New York, New York, USA
Introduction Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.Methods and analysis The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.Ethics and dissemination Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.Trial registration number ClinicalTrials.gov: NCT06117605 and NCT06117618.
