Skip to main content
AgileMD logo

eCARTv5 Clinical Deterioration Suite

by AgileMD

Contact Information

hello@agilemd.com

Release Stage

Production

Release Date

2024-07-01

Version

v5

Regulatory Approval

FDA 510(k) clearance (K233253)

Global Availability

US

Summary

eCART is a software product that provides automated risk stratification and early warning for impending patient deterioration, signified as the composite outcome of death or ICU transfer. It is intended to be used on hospitalized ward patients 18 years of age or older by trained medical professionals. As a clinical decision support device, eCART’s risk score and trend analysis is intended to aid clinical teams in identifying which patients are most likely to clinically deteriorate. eCART provides additional information and does not replace the standard of care or clinical judgment. eCART scoring is initiated by the documentation of any vital sign on an adult ward patient. The device calculates risk only from validated EHR data, such as vitals that have been confirmed by a registered nurse (RN); unvalidated data streaming from monitors/devices will not be used until confirmed by a healthcare professional. The product predictions are for reference only and no therapeutic decisions should be made based solely on the eCART scores. See FDA 510(k) summary.

eCART has repeatedly been found to have the highest performance metrics when compared to other early warning scores. In the initial multicenter validation study, involving nearly two million patient encounters, eCART had an AUROC of 0.834 (95% CI, 0.834–0.835) for predicting clinical deterioration within 24 hours, significantly outperforming MEWS and NEWS. In a second multicenter study eCART outperformed not only MEWS and NEWS but also the Rothman Index and Epic’s Deterioration Index, with and AUROC of 0.895 (95% CI, 0.891-0.900).

Further, eCART is the only early warning system that includes not only a predictive analytic, but fully integrated EHR clinical workflows in the form of customizable pathways.

Uses and Directions

Intended Use

eCART is intended to inform and augment clinical management by identifying hospitalized adult ward patients who may be at increased risk of clinical deterioration. The solution operates with full human oversight and does not automate clinical decisions or actions. Risk scores are displayed within the EHR and incorporated into institution-defined workflows for evaluation, escalation, and monitoring. The tool has been validated across all age, sex and race and specifically in sepsis, heart failure, and COPD, as well as in perioperative and post-partum patient populations.

Primary Users

Registered nurses, physicians, advanced practice providers, and other trained healthcare professionals involved in adult inpatient care

How to Use

eCART scoring is initiated following documentation of validated vital signs in the EHR. The system updates risk scores as new validated data become available. Clinicians review the risk score, trend, and contextual information and determine appropriate next steps using independent clinical judgment and local protocols.

Target Population

Hospitalized adult ward patients (18 years of age and older)

Cautioned Out-of-Scope Settings

Cautioned Out-of-Scope Settings

eCART has not been cleared for use in pediatric populations or in ICU or ambulatory settings.

EHR Compatibility

Compatible EHRs:

  • Epic
  • Cerner / Oracle Health