Effect of Automated Real-Time Feedback on Early-Sepsis Care: A Pragmatic Clinical Trial.

OBJECTIVES: To determine if a real-time monitoring system with automated clinician alerts improves 3-hour sepsis bundle adherence. DESIGN: Prospective, pragmatic clinical trial. Allocation alternated every 7 days. SETTING: Quaternary hospital from December 1, 2020 to November 30, 2021. PATIENTS: Adult emergency department or inpatients meeting objective sepsis criteria triggered an electronic medical record (EMR)-embedded best practice advisory. Enrollment occurred when clinicians acknowledged the advisory indicating they felt sepsis was likely. INTERVENTION: Real-time automated EMR monitoring identified suspected sepsis patients with incomplete bundle measures within 1-hour of completion deadlines and generated reminder pages. Clinicians responsible for intervention group patients received reminder pages; no pages were sent for controls. The primary analysis cohort was the subset of enrolled patients at risk of bundle nonadherent care that had reminder pages generated. MEASUREMENTS AND MAIN RESULTS: The primary outcome was orders for all 3-hour bundle elements within guideline time limits. Secondary outcomes included guideline-adherent delivery of all 3-hour bundle elements, 28-day mortality, antibiotic discontinuation within 48-hours, and pathogen recovery from any culture within 7 days of time-zero. Among 3,269 enrolled patients, 1,377 had reminder pages generated and were included in the primary analysis. There were 670 (48.7%) at-risk patients randomized to paging alerts and 707 (51.3%) to control. Bundle-adherent orders were placed for 198 intervention patients (29.6%) versus 149 (21.1%) controls (difference: 8.5%; 95% CI, 3.9-13.1%; p = 0.0003). Bundle-adherent care was delivered for 152 (22.7%) intervention versus 121 (17.1%) control patients (difference: 5.6%; 95% CI, 1.4-9.8%; p = 0.0095). Mortality was similar between groups (8.4% vs 8.3%), as were early antibiotic discontinuation (35.1% vs 33.4%) and pan-culture negativity (69.0% vs 68.2%). CONCLUSIONS: Real-time monitoring and paging alerts significantly increased orders for and delivery of guideline-adherent care for suspected sepsis patients at risk of 3-hour bundle nonadherence. The trial was underpowered to determine whether adherence affected mortality. Despite enrolling patients with clinically suspected sepsis, early antibiotic discontinuation and pan-culture negativity were common, highlighting challenges in identifying appropriate patients for sepsis bundle application.

Design and Implementation of a Real-time Monitoring Platform for Optimal Sepsis Care in an Emergency Department: Observational Cohort Study.

BACKGROUND: Sepsis is the leading cause of death in US hospitals. Compliance with bundled care, specifically serial lactates, blood cultures, and antibiotics, improves outcomes but is often delayed or missed altogether in a busy practice environment. OBJECTIVE: This study aims to design, implement, and validate a novel monitoring and alerting platform that provides real-time feedback to frontline emergency department (ED) providers regarding adherence to bundled care. METHODS: This single-center, prospective, observational study was conducted in three phases: the design and technical development phase to build an initial version of the platform; the pilot phase to test and refine the platform in the clinical setting; and the postpilot rollout phase to fully implement the study intervention. RESULTS: During the design and technical development, study team members and stakeholders identified the criteria for patient inclusion, selected bundle measures from the Center for Medicare and Medicaid Sepsis Core Measure for alerting, and defined alert thresholds, message content, delivery mechanisms, and recipients. Additional refinements were made based on 70 provider survey results during the pilot phase, including removing alerts for vasopressor initiation and modifying text in the pages to facilitate patient identification. During the 48 days of the postpilot rollout phase, 15,770 ED encounters were tracked and 711 patient encounters were included in the active monitoring cohort. In total, 634 pages were sent at a rate of 0.98 per attending physician shift. Overall, 38.3% (272/711) patients had at least one page. The missing bundle elements that triggered alerts included: antibiotics 41.6% (136/327), repeat lactate 32.4% (106/327), blood cultures 20.8% (68/327), and initial lactate 5.2% (17/327). Of the missing Sepsis Core Measures elements for which a page was sent, 38.2% (125/327) were successfully completed on time. CONCLUSIONS: A real-time sepsis care monitoring and alerting platform was created for the ED environment. The high proportion of patients with at least one alert suggested the significant potential for such a platform to improve care, whereas the overall number of alerts per clinician suggested a low risk of alarm fatigue. The study intervention warrants a more rigorous evaluation to ensure that the added alerts lead to better outcomes for patients with sepsis.