Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

Study Overview
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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.

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).

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

Conditions
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Sepsis, Electronic Health Records, Clinical Decision Support Systems

Intervention / Treatment
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* Other: Nurse SIRS alert
* Other: Prescribing clinician SIRS alert


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No alert<br>Participants will receive no physician alert or registered nurse (RN) alert. | |
| Experimental: Nurse alert<br>Participants will receive RN alert. | Other: Nurse SIRS alert<br>* An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.<br>|
| Experimental: Prescribing clinician alert<br>Participants will receive physician alert. | Other: Prescribing clinician SIRS alert<br>* An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.<br>|
| Experimental: Nurse alert and prescribing clinician alert<br>Participants will receive physician alert and RN alert. | Other: Nurse SIRS alert<br>* An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.<br>Other: Prescribing clinician SIRS alert<br>* An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle | 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. | Up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to modified SSC hour-1 bundle completion | 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. | 24 hours | 
| Time to blood culture order | 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. | 24 hours | 
| Time to blood culture collection | 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. | 24 hours | 
| Time to lactate order | 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. | 24 hours | 
| Time to lactate collection | 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. | 24 hours | 
| Time to antibiotic order | 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. | 24 hours | 
| Time to antibiotic treatment | 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. | 24 hours | 
| Sepsis incidence | 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. | Up to 90 days | 
| Percentage of patients transferred to ICU transfer | 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. | Up to 90 days | 
| Median number of days of hospitalization | 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. | Up to 90 days | 
| Percentage of patients discharged as deceased or discharged to hospice | 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. | Up to 90 days | 
| Percentage of patients discharged home | 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. | Up to 90 days | 
| Percentage of patients discharged to rehab | 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. | Up to 90 days | 
| Percentage of patients discharged to skilled nursing facility | 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. | Up to 90 days | 
| Percentage inpatient mortality at 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. | Up to 90 days | 
| Number of positive blood cultures | 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. | Up to 90 days | 
| Adverse antibiotic events | 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. | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, alerts, clinical decision support systems, informatics, health information technology