Single-blind Randomized Trial of a Commercially Sold Electronic Health Record Based Severe Sepsis Early Warning Best Practice Alert.

Sepsis is the leading cause of mortality at Stanford Hospital and ranks only 54th out of 119 hospitals according to UHC data with approximately 60 episodes of documented sepsis per quarter. Based on some preliminary data, there is concern that sepsis is both being recognized late and not treated in a timely enough fashion. In fact, there are evidence and expert guidelines that suggestion-delaying antibiotics in a patient with septic shock can increase mortality by 6.7% per hour (1C recommendation in severe sepsis by the Surviving Sepsis Campaign authors). As part of a hospital wide initiative to improve our treatment of sepsis and ultimately reduce sepsis-related mortality, an EHR-based clinical decision support (aka BPA) will be implemented. This BPA will be an algorithm that will alert practitioners and trigger clinical workflow after criteria are met. Criteria include lab values, vital signs and nursing flow sheet descriptions of perfusion (Table 1). The algorithm will alert when, in a 24 hour period, three criteria from the manifestation group, one criteria from the suspected infection group and one criteria from the organ dysfunction group. Note that one variable (eg creatinine > 2) can fulfill criteria in more than one group. Figure 1 contains details of proposed EHR workflow. After criteria are met, whomever is next in the chart with RN or MD user-type, will receive an interruptive alert via the EHR; simultaneously a page will automatically be sent by the EHR to a crisis nurse who will assess the patient and notify the primary MD and RN.

Electronic early warning systems and predictive analytic tools lack rigorous evaluation and standardization. There are literature demonstrating unintended consequences and even harms from the implementation of electronic health records and clinical decision support tools. As such, this is a situation of clinical equipoise in which it is unclear whether this quality improvement initiative will benefit patient care or not. To evaluate this question, the severe sepsis BPA will be initiated in a randomized fashion with each patient randomly assigned to either potentially generate this alert as described above or to generate this alert silently such that only quality improvement staff will be aware that criteria have been met via the EHR.

This is a randomized, single-blind prospective quality improvement study. Patients will be randomized by encounter to have the BPA visible or invisible during hospital admission. If visible, the alert will display to the primary nurse and physician and send a page to a crisis nurse when BPA criteria are met. If invisible, the alert will be triggered but will be invisible to the care team (only visible to quality improvement staff via the EHR)

• Inclusion criteria

o Admitted to Stanford Hospital (inpatient or observation status) to any medical or surgical service for at least 24 hours during the period of the study

• Exclusion criteria