{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA",
        "Center for Patient Safety Science, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA",
        "Department of Biomedical Informatics, Columbia University, New York, New York, USA",
        "NewYork-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Benjamin L Ranard"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA"
      ],
      "name": "Min Qian"
    },
    {
      "affiliations": [
        "Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA",
        "NewYork-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Matthew J Cummings"
    },
    {
      "affiliations": [
        "Northwell, New Hyde Park, New York, USA"
      ],
      "name": "David Y Zhang"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA"
      ],
      "name": "Shing M Lee"
    },
    {
      "affiliations": [
        "Division of Pulmonary, Critical Care and Sleep Medicine, New York University Grossman School of Medicine, New York, New York, USA"
      ],
      "name": "Jeremy R Beitler"
    },
    {
      "affiliations": [
        "Center for Patient Safety Science, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA"
      ],
      "name": "Jo R Applebaum"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Division of Pulmonary and Critical Care Medicine, Department of Medicine, Weill Cornell Medical College, New York, New York, USA"
      ],
      "name": "Edward J Schenck"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA"
      ],
      "name": "Hassan Mohamed"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA"
      ],
      "name": "Richard Trepp"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Emergency Medicine, Weill Cornell Medical College, New York, New York, USA"
      ],
      "name": "Hanson Hsu"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Emergency Medicine, Weill Cornell Medical College, New York, New York, USA"
      ],
      "name": "Jean Scofi"
    },
    {
      "affiliations": [
        "Division of Hospital Medicine, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York, USA"
      ],
      "name": "William N Southern"
    },
    {
      "affiliations": [
        "Department of Biomedical Informatics, Columbia University, New York, New York, USA",
        "Columbia University School of Nursing, New York, New York, USA"
      ],
      "name": "Sarah C Rossetti"
    },
    {
      "affiliations": [
        "Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA",
        "NewYork-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Natalie H Yip"
    },
    {
      "affiliations": [
        "Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Daniel Brodie"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, NewYork-Presbyterian Queens, Flushing, New York, USA"
      ],
      "name": "Manish Sharma"
    },
    {
      "affiliations": [
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA"
      ],
      "name": "Baruch S Fertel"
    },
    {
      "affiliations": [
        "Center for Patient Safety Science, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA",
        "Department of Biomedical Informatics, Columbia University, New York, New York, USA",
        "NewYork-Presbyterian Hospital, New York, New York, USA",
        "Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA"
      ],
      "name": "Jason S Adelman"
    }
  ],
  "title": "Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol",
  "uid": "21b8f5ee-ec6b-5396-adea-1a2fc848510e"
}