Sepsis Alert and Diagnostic System: Integrating Clinical Systems to Enhance Study Coordinator Efficiency

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Screening patients for clinical studies is time-consuming for researchers. Inefficiencies from human-based eligibility screening cause delay in scientific breakthroughs and are costly. We sought to determine the reliability of an automated computer-based real-time eligibility screening tool. A time-motion diary study was conducted in two university-based intensive care units using a cohort-controlled design. Time saved by automated eligibility screening and the positive and negative predictive values of the integrated eligibility screening system were compared with the gold standard of manual chart review. Sepsis Alert and Diagnostic System sensitivity and specificity were 82% and 95%, respectively. Positive and negative predictive values were 87.5% and 93%, respectively. During evaluation, Sepsis Alert and Diagnostic System saved a minimum of 137 minutes for the study coordinator. Sepsis Alert and Diagnostic System serves as a reliable tool for real-time eligibility screening in an intensive care unit setting. Time efficiencies through use of Sepsis Alert and Diagnostic System may translate into cost savings for funding agencies. The concept and methodology deployed in this study are applicable to any facility with electronic medical record capacity, as long as the data within that system are granular enough to support the specific query.

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