Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2024-07-22

Brief Summary

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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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Detailed Description

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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).

Conditions

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Sepsis Electronic Health Records Clinical Decision Support Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

If a patient is randomized to a group without an alert, the alert will instead be a hidden "silent" alert that does not display. However, a timestamp of when the alert was triggered is still recorded even though the alert did not display. This timestamp is used for the primary and secondary outcomes.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Care providers will be unblinded in that nurses and clinicians will be aware if they receive an alert for the patient.

Study Groups

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No alert

Participants will receive no physician alert or registered nurse (RN) alert.

Group Type NO_INTERVENTION

No interventions assigned to this group

Nurse alert

Participants will receive RN alert.

Group Type EXPERIMENTAL

Nurse SIRS alert

Intervention Type OTHER

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

Prescribing clinician alert

Participants will receive physician alert.

Group Type EXPERIMENTAL

Prescribing clinician SIRS alert

Intervention Type OTHER

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

Nurse alert and prescribing clinician alert

Participants will receive physician alert and RN alert.

Group Type EXPERIMENTAL

Nurse SIRS alert

Intervention Type OTHER

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

Prescribing clinician SIRS alert

Intervention Type OTHER

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

Interventions

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Nurse SIRS alert

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

Intervention Type OTHER

Prescribing clinician SIRS alert

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

Intervention Type OTHER

Eligibility Criteria

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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"

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No