Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis

Study Overview
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Brief Summary
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Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. International guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. Following guideline bundles is associated with a decrease in mortality. Key to timely intervention is timely diagnosis. Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis. The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.

Detailed Description
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A means to identify patients before they become ill may improve the effectiveness of established therapies.Epic's electronic medical record (Epic systems, Verona, WI) contains a surveillance tool that uses predictive analytics to identify patients at risk of becoming septic four hours after the alert becomes active. This affords the opportunity to intervene sooner, but it remains unclear what the best course of action should be in a population at risk of sepsis, only some of which may go on to develop the illness. We propose an automatic intervention, consisting of enhanced monitoring, that is tied to the alert. No therapeutics will be mandated. Instead, additional monitoring information will lead to faster diagnosis and therapy, and improved clinical outcomes.

Official Title
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Sepsis Pre-Alert Monitoring Intervention: A Phase I Randomized, Single Blind Study to Investigate Targeted Enhanced Monitoring for Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Other: Vital Signs at 2 Hours
* Other: Confusion Assessment method for the ICU (CAM-ICU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any inpatient at NYU Langone Health System Exclusion Criteria: not an inpatient at NYU Langone Health System

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vital Signs at 2 Hours + CAM-ICU<br>enhanced vital sign and delirium monitoring in patients for who the per-sepsis algorithm reaches alert threshold. | Other: Vital Signs at 2 Hours<br>* Patients vital signs assessed at 2 hours of arrival at ICU<br>Other: Confusion Assessment method for the ICU (CAM-ICU)<br>* patient must have altered mental status/fluctuating course and inattention, and either disorganized thinking or altered level of consciousness to be CAM positive; these features are determined by observing the patient during bedside cognitive testing.<br>|
| No Intervention: No Intervention<br>No intervention. Patient treated per standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of in-hospital mortalities |  | 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital Admission