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Randomized Controlled Trial
. 2024 Feb 1;52(2):210-222.
doi: 10.1097/CCM.0000000000006057. Epub 2023 Dec 13.

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

Daniel E Leisman  1   2 , Hao Deng  2 , Andy H Lee  3   4 , Micah H Flynn  2 , Hayley Rutkey  2 , Martin S Copenhaver  2   5 , Elizabeth A Gay  1 , Sayon Dutta  3   4   6 , Dustin S McEvoy  6 , Lisette N Dunham  6 , Elizabeth A Mort  1 , David J Lucier  1 , Jonathan D Sonis  3   4 , Emily L Aaronson  3   4 , Kathryn A Hibbert  7   8 , Kyan C Safavi  2   5
Affiliations
Randomized Controlled Trial

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

Daniel E Leisman et al. Crit Care Med. .

Abstract

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.

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Conflict of interest statement

Drs. Leisman and Rutkey’s institution received funding from Harvard Medical Institution Incorporated. Dr. Gay’s institution received funding from the National Heart, Lung, and Blood Institute (1 R38 HL 150212-01); she received support for article research from the National Institutes of Health. Drs. Mort and Safavi’s institutions received funding from CRICO. Dr. Mort disclosed she teaches at Harvard Medical School; she received support for article research from CRICO. Dr. Sonis received funding for being an expert witness for emergency medicine-related medical malpractices cases. Drs. Aaronson and Hibbert received funding from CRICO. Dr. Aaronson received funding from Walmart Health and Wellness. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Comment in

References

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