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Completed

NCT Number: NCT06117618

Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the inpatient setting. The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the inpatient setting?

Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Hospitals

New York, 10032, United States

About this study

SEPTIC is a master protocol for two trials on distinct subpopulations: emergency department (ED) patients and inpatients. This protocol "ID: AAAU1002 - IP" describes the inpatient subpopulation study while "ID: AAAU1002 - ED" describes the ED subpopulation study.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving outcomes. International guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (EHR) as an interruptive 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. This study tests interruptive (pop-up) EHR alerts. Epic Systems, the company that produces the EHR, refers to these types of alerts as BestPractice Advisories (BPAs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • age > 18 years-old
  • meets SIRS criteria
  • physically located in an inpatient area of the hospital
  • not located in a hospital unit that takes care of pregnant and peri-partum patients
  • not SARS-COV-2 PCR positive in past 7 days
  • does not have an active order for "comfort measures only"

Patient Exclusion Criteria:

  • already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert)
  • already enrolled in the SEPTIC study (including as an emergency department patient or as an inpatient)

Treatment and study plan

Nurse SIRS alert

Other

An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.

Prescribing clinician SIRS alert

Other

An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.

Primary outcomes

  1. Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle

    Time frame: Up to 3 hours

    The primary outcome is whether a patient receives a modified SSC hour-1 bundle within three hours from the time of first SIRS alert. The modified SSC hour-1 bundle includes (1) lactate lab collected, (2) two blood cultures collected, (3) new intravenous antimicrobial administration (from the Centers for Disease Control and Prevention (CDC) Adult Sepsis Event (ASE) list). Patients will be tallied.

Secondary outcomes

  1. Time to modified SSC hour-1 bundle completion

    Time frame: 24 hours

    Time interval from first SIRS alert to a modified SSC hour-1 bundle completion, censored at 24 hours after the first alert time, in all patients and the subgroups of patients with CDC ASE, CDC Bacteraemia/Fungemia Shock Event (BSE), and Sepsis-3 sepsis definitions. This will be measured in minutes.

  2. Time to blood culture order

    Time frame: 24 hours

    Time from the first SIRS alert until two blood cultures ordered in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  3. Time to blood culture collection

    Time frame: 24 hours

    Time from the first SIRS alert until two blood cultures collected in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  4. Time to lactate order

    Time frame: 24 hours

    Time from the first SIRS alert until lactate lab ordered in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  5. Time to lactate collection

    Time frame: 24 hours

    Time from the first SIRS alert until lactate lab collected in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  6. Time to antibiotic order

    Time frame: 24 hours

    Time from the first SIRS alert until new antibiotic order in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  7. Time to antibiotic treatment

    Time frame: 24 hours

    Time from the first SIRS alert until new antibiotic administration in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.

  8. Sepsis incidence

    Time frame: Up to 90 days

    Sepsis incidence (CDC ASE, CDC BSE, Sepsis-3) across all alerting groups. Events will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  9. Percentage of patients transferred to ICU transfer

    Time frame: Up to 90 days

    Intensive care unit (ICU) transfers for patients not in the ICU at the time of first SIRS alert will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  10. Median number of days of hospitalization

    Time frame: Up to 90 days

    This is to determine the average length of stay in the hospital. Days will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  11. Percentage of patients discharged as deceased or discharged to hospice

    Time frame: Up to 90 days

    This is to measure the outcomes ended in death or hospice. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  12. Percentage of patients discharged home

    Time frame: Up to 90 days

    This is to measure the outcomes ended in returning to home. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  13. Percentage of patients discharged to rehab

    Time frame: Up to 90 days

    This is to measure the outcomes ended in rehab. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  14. Percentage of patients discharged to skilled nursing facility

    Time frame: Up to 90 days

    This is to measure the outcomes ended in skilled nursing facility. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  15. Percentage inpatient mortality at 90 days

    Time frame: Up to 90 days

    This is to measure inpatient mortality. Deaths will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  16. Number of positive blood cultures

    Time frame: Up to 90 days

    Positive blood cultures will be determined by blood tests. Positive cultures will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

  17. Adverse antibiotic events

    Time frame: Up to 90 days

    This is defined as new antibiotic allergy documented in 14 days after first SIRS alert or C. difficile infection or multi-drug resistant organism infection within 7-90 days of first SIRS alert. Events will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Inpatients

Acronym: SEPTIC-IP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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