Paramedic-Initiated CMS Sepsis Core Measure Bundle Prior to Hospital Arrival: A Stepwise Approach.
Authors: Walchok JG, Pirrallo RG, Furmanek D, Lutz M, Shope C, Giles B, Gue G, Dix A.
Published in: Prehosp Emerg Care, 2017 May–Jun; 21(3): 291–300.
This month’s article is dedicated to EMS innovation. There are a ton of topics we could have covered that fall into the innovation category, but one has been discussed more and more in our field: prehospital sepsis care. Not only has EMS research indicated that we see a lot of sepsis patients prehospitally, but this appears to be an area of prehospital patient care in which we can truly make a positive, empirically verified impact on patient morbidity and mortality.
One thing to keep in mind with sepsis care is that it can require medications that historically have not been given in the prehospital environment. It can also require new patient assessment skills, blood draws, cultures, etc. Many in our field don’t routinely perform these interventions. So it may be reasonable to ask whether EMS can successfully assess and manage sepsis patients. Fortunately, Jason Walchok—currently the stroke, STEMI and sepsis coordinator for the South Carolina Bureau of EMS—and coauthors recently published a manuscript titled "Paramedic-Initiated CMS Sepsis Core Measure Bundle Prior to Hospital Arrival: A Stepwise Approach." The study objective was to determine whether paramedics can reliably initiate the CMS sepsis core measure bundle in the prehospital environment.
The study was performed in a single EMS agency that examined all adult 9-1-1 patients who triggered a sepsis alert in their system. The study period spanned from November 2014 to February 2016. This system used a prehospital sepsis assessment tool based on the 2012 Surviving Sepsis guidelines. This tool evaluated four systemic inflammatory response syndrome (SIRS) criteria. These included a heart rate greater than 90 bpm, respiratory rate greater than 20 or mechanical ventilation, and a body temperature of greater than 38 degrees Celsius or less than 36 degrees Celsius. If the patient had at least two of these signs as well as a known or suspected source of infection, the paramedic was required to initiate a sepsis alert.
Prior to beginning the study, every paramedic in the EMS agency received 12 hours of sepsis education and skills training. Training included didactic, simulation and skills stations. To complete it, paramedics were required to obtain 90% on a written exam and verify critical blood culture collection competency using a high-fidelity simulation manikin. All 120 paramedics successfully completed this training.
This study required a significant amount of preliminary work. Not only did this EMS agency have to petition the state EMS office to add antibiotics to the state medication formulary, they also had to develop a prehospital sepsis care protocol in conjunction with a local established EMS sepsis committee. This protocol dictated that after calling the sepsis alert into the receiving facility, the paramedic would gain IV access, obtain blood cultures as well as a venous blood sample for lactate analysis, begin fluid resuscitation at 3mg/kg, and screen for penicillin allergy.
As discussed above, a substantial amount of red tape needed to be cut through for this study. The addition of antibiotics to the state formulary was not approved until a few months into the study. Once they were approved, paramedics initiated antibiotics in the field following a screen for allergies. Each assessment and intervention was implemented using a stepwise approach in which each area of the CMS bundle was incorporated into the prehospital setting and evaluated for success prior to the implementation of the next step.
The study outcomes of interest included the evaluation of agreement of the paramedics’ sepsis identification and the ICD-9/ICD-10 discharge diagnosis codes for sepsis, severe sepsis and septic shock. The authors also evaluated blood culture contamination and received feedback from the receiving hospitals’ sepsis coordinator regarding adverse effects.
With the background, red tape and study methods having been discussed, we are ready to dive into the results. During the study period over 57,000 EMS patients were seen and a total of 1,185 sepsis alerts were triggered. There was almost an equal distribution of males and females (50.3% male) and the average patient age for those who triggered a sepsis alert was 70 years.
As is common with most research, there was some missing data. There were 31 patients who did not have a complete ICD-9/ICD-10 discharge diagnosis. However, for those who did have complete data, the results are encouraging. In total, 73.5% of the sepsis alert patients had a diagnosis code consistent with sepsis. Almost 83% of the patients who had a sepsis diagnosis code had blood successfully collected for lactate analysis. Among all the 1,185 sepsis alert patients, 946 had a blood culture collected and over 95% of these were not contaminated during collection. There were also 571 patients who received prehospital antibiotics following authorization to add antibiotics to the formulary. In 94.1% of sepsis alert patients, the emergency department continued sepsis care. Finally, there were no adverse effects, such as fluid overload or allergic reaction, reported by the receiving facilities’ sepsis coordinator.
This was a very well-conducted study that provides some evidence that paramedics can successfully assess and manage a sepsis patient in the prehospital environment. All studies have limitations, and this one is no different. Limitations include performing a study in a single EMS system, missing data, and limitations in the statistical analyses made possible by the data collection method. The authors were also not able to evaluate patient outcomes.
For regular readers of this column: First, thanks for reading! However, you may notice that this is the first study we've reviewed that did not include any p-values. This was a descriptive study and no statistical tests were performed. Though this was not a statistically rigorous paper, it significantly added to the literature on prehospital sepsis care.
Some questions were not answered in this manuscript. As discussed, a lot of preparatory work was needed to add medications to the state formulary, develop a prehospital sepsis protocol, and train 120 paramedics. However, the authors described this study as a retrospective case series. In other words, they completed all preliminary work but then looked back at the data and analyzed them after these data were collected.
This could have just been an oversight in which the EMS agency in conjunction with their local hospitals were so motivated to begin caring for sepsis patients that they forgot to develop a prospective data collection plan. Yet the authors stated that they evaluated each step of the CMS sepsis core measure bundle prior to implementing the next step. Clearly, there was some thought put into a prospective analysis. It just does not appear to have been enough to support the analyses required to meet the stated study objective. This is unfortunate because a more sophisticated data collection plan that included patient outcome data could have really helped us understand the true impact of implementing the CMS bundle.
One of the most encouraging things about this manuscript is that the first author is a paramedic. It is encouraging to see our field making important contributions to research. So for all those reading this who might be intimidated by the thought of getting involved in research, Mr. Walchok has shown that you don’t have to be an epidemiologist or even a physician to make a substantial contribution. Great work can be performed without sophisticated statistical tests and reporting p-values. I hope to see more EMS research led by EMTs and paramedics.
Look for PCRF research podcasts based on the topics featured in this column at www.pcrfpodcast.org.
Antonio R. Fernandez, PhD, NRP, FAHA, is research director at the EMS Performance Improvement Center and an assistant professor in the Department of Emergency Medicine at the University of North Carolina–Chapel Hill. He has been a nationally certified paramedic since 2005 and completed the EMS Research Fellowship at the National Registry of Emergency Medical Technicians.