In 2015, Centers for Medicare & Medicaid (CMS) published their sepsis core measure (SEP-1). This represented a nationally mandated sepsis management strategy presented in the form of a 3 and 6-hour bundle. Since its publication, the Surviving Sepsis Campaign (SSC) released their own 1-hour bundle (1), adding even more urgency to an already frenetic effort to initiate treatment in patients presenting to the Emergency Department with sepsis and septic shock.
We have described the dangers of time-based treatment metrics such as the SSC’s 1-hour bundle in the past (2, 3, 4, 5). A recent publication in the Annals of Emergency Medicine addressed the difficulties encountered when striving to meet both SEP-1 and the SSC’s performance metrics (6).
Filbin et al conducted a retrospective look at a single institution’s efforts to deploy a sepsis screening protocol and its effects on timeliness of antibiotic administration. The authors identified all patients diagnosed with severe sepsis or septic shock, enrolling patients one year prior and one year following the initiation of the sepsis screening protocol. They defined severe sepsis or septic shock as, either confirmed source of infection or high suspicion for infection documented in the admission note; and development of persistent hypotension (systolic blood pressure <90 mm Hg on at least 2 measurements), or elevated lactate level greater than or equal to 4.0 mmol/L, or use of vasopressor medication in the ED.
Following the initiation of their sepsis screening protocol, patients were identified at triage as potentially having sepsis using the Shock Precautions on Triage (SPoT) rule. Patients screened positive if they had mild vital sign abnormalities (pulse rate >systolic blood pressure or systolic blood pressure <100 mm Hg), and clinical concern for infection. In addition, case-specific performance feedback was emailed to treating clinicians informing them of their time-based performance metrics. Using a standardized data entry form, two trained chart reviewers, blinded to outcome data, independently reviewed clinical notes and extracted the necessary data. Any disagreements were resolved by majority vote during a review session that included a third reviewer.
From April 2014 to March 2016, the authors enrolled a total of 654 patients, 297 in the pre-intervention period and 357 following the initiation of their sepsis screening protocol. Patients appeared fairly similar among the two groups. The authors noted a statistically significant decrease in the number of patients experiencing delayed antibiotic administration in the post-screening protocol period. When using the SEP-1 3-hour bundle as the time-based performance metric, 30% of patients experienced a delay to antibiotic administration in the pre-implementation period, with only 21% of cases in the post implementation period (–9% ARR [95% confidence interval {CI} –16% to –2%]). If the SSC 1-hour bundle was used 85% vs 71% (–14% ARR [95% CI –20% to –8%]), experienced delays to antibiotic administration.
This screening protocol certainly improved the processes of care, reducing the amount of patients experiencing delays to antibiotic administration. How exactly do these improvements in time based metrics affect clinical outcomes? What effect do these screening protocols have on the remainder of the Emergency Department? The authors employed the SPoT sepsis rule in their screening protocol, which identified only 58% of the patients included in the final post-implementation cohort. The quick SOFA (qSOFA) score, also measured by the authors, identified only 26%. The authors did not report how many patients were falsely identified as positive by the SPoT score, thus unnecessarily exposed to the harms of early aggressive broad-spectrum antibiotics. One can imagine it is a large group. Despite their efforts, 71% of the patients still experienced delays to antibiotic administration if the SSC’s 1-hour bundle was used as the time-based metric. How broad must a screening protocol have to be to enable the majority of patients to receive antibiotics within an hour of presentation to triage?
Even if one could develop a protocol which ensured all patients received appropriate antibiotics within 1 hour, what effects would these efforts have on patient centered outcomes? In this cohort those effects were minimal. The authors noted, despite decreased delays to antibiotic administration, the implementation of their sepsis screening protocol did not change the number of patients admitted to the ICU, intubated in the ED, or in-hospital mortality.
This article has its limitations, but it certainly illustrates the folly of striving to achieve time-based metrics that have very little evidence supporting their implementation. Despite their best efforts, the vast majority of patients did not receive antibiotics within 1-hour of presentation. To achieve such an unrealistic goal, one would have to administer broad-spectrum antibiotics to everyone as they present to the ED to be triaged. Of course, this is an absurd proposition. But such absurdities become protocols when senseless time-based metrics are presented as the standard of care. An alternative would be to employ a screening tool that identifies the small subset of patients presenting with sepsis who truly have a time-sensitive illness at triage, and endeavor to treat them in a timely fashion.
Sources Cited:
- Levy MM, Evans LE, Rhodes A. The Surviving Sepsis campaign bundle: 2018 update. Intensive Care Med. 2018;44:925-928.
- Spiegel R, Farkas JD, Rola P, et al. The 2018 Surviving Sepsis Campaign's Treatment Bundle: When Guidelines Outpace the Evidence Supporting Their Use. Ann Emerg Med. 2019;73(4):356-358.
- Marik PE, Farkas JD, Spiegel R, Weingart S. Rebuttal From Drs Marik, Farkas, Spiegel et al. Chest 2019; 155(1):17-18.
- Marik PE, Farkas JD, Spiegel R, Weingart S. POINT: Should the Surviving Sepsis Campaign Guidelines Be Retired? Yes. Chest 2019; 155(1):12-14.
- Petition to retire the surviving sepsis campaign guidelines
- Filbin MR, Thorsen JE, Zachary TM, et al. Antibiotic Delays and Feasibility of a 1-Hour-From-Triage Antibiotic Requirement: Analysis of an Emergency Department Sepsis Quality Improvement Database. Ann Emerg Med. 2019
- EM Nerd-The Case of the Partial Cohort - May 24, 2020
- EM Nerd: The Case of the Sour Remedy Continues - January 20, 2020
- EM Nerd-The Case of the Adjacent Contradictions - December 23, 2019
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