What 2020 Has Taught Us About a Sepsis Alert and Solving Sepsis

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By Tim Kuebelbeck, Chief Customer Officer at Ambient Clinical Analytics & Kim McCloskey, Account Executive at Ambient Clinical Analytics

2020 has been a defining year in many ways for solving sepsis and for a sepsis alert. At Ambient Clinical Analytics, we learned many things this year and one of those is changing course and enhancing your current sepsis approach will help turn around your sepsis outcomes in 2021. During the course of the year, we have been reminded that there are three keys to solving sepsis: early detection, early intervention, and driving care and the delivery of the bundle components. In 2020 COVID has slowed our ability to meet with potential clients, but like many others, we have been able to overcome and adjust using remote conferencing technologies. The same can be said about solving sepsis. This pandemic has been devastating to our citizens, economy and incredibly challenging for our healthcare delivery system. This devastation is not limited to just providing care but has also stressed our physicians and nurses both emotionally and physically. Sepsis has not put itself on hold during the pandemic, and neither should you.



In fact, sepsis has been more prevalent during the pandemic. Which is why over the course of this year, we have asked many health care systems the following question: What is your biggest obstacle to solving sepsis in your health system? Some of the top responses heard, regardless of a systems size, number of hospital beds, and regardless of bundle compliance percentage was constant across all hospitals and health systems we interviewed. The following were three of the four biggest care delivery issues for sepsis.
    1. Fluid Delivery
 
    1. Follow on Profusion Assessment & Lactate Measurements
 
    1. Driving the entire treatment process (targeted therapy delivered within the 3 & 6-hour window)
  Notwithstanding the issues listed above, the most common theme we heard unfailingly across all sepsis subject matter experts we met with, was on the topic of the sepsis alert. Many still believe that the sepsis alert or sepsis algorithm is a silver bullet for solving sepsis. Clearly based on how the EHR vendor solutions have approached sepsis, they too believe a single algorithm is the answer. Unfortunately, this is not the case and is driving poor sepsis care in the U.S. while helping fuel a major sepsis crisis that hospitals and health systems aren’t eager to solve because of the large amounts of time, effort and money previously spent with EHR vendors in a failed attempt to fix sepsis. This flawed approach is leading to high mortality rates and poor outcomes. The common thinking is ‘if only our sepsis alert had more specificity and higher sensitivity.’ What they are really saying is they alarm with way too many false positives. False positives are a huge issue with a EHR provided sepsis alert or sepsis algorithm.

Think of it this way, you can’t use a sepsis alert algorithm developed for the ICU in the Emergency Department (ED). If you did, the sensitivity would be too low, and you would not cast a wide enough net, resulting is missing many sepsis cases in your ED. On the other hand, if you tried using a sepsis alert algorithm designed for the ED in the ICU, your specificity would be too low and resulting in a very high false positive rate, eventually ending in doctors and nurses not trusting the sepsis alert. Which is why it is vital to have the ability to use multiple sepsis alert algorithms in your sepsis strategy. So why would you trust your EHR vendor to solve sepsis with a single algorithm?

Case in point, the Massachusetts Sepsis Consortium released their findings on Advancing Sepsis Care in Emergency Medicine in 2019. In that report, healthcare systems listed their challenges providing high quality sepsis care. 29.5 percent of respondents reported that the facility EHR system was a barrier to successful implementation of standardized screening and treatment protocols for a variety of reasons, including:
    1. The EHR is outdated
 
    1. The EHR cannot be customized without significant investment of resources
 
    1. The hospital does not have the staff/expertise to create a useful electronic tool
 
  1. The ED and inpatient units have different EHR systems that are not interoperable¹
However, sepsis detection is only a tiny sliver of the entire sepsis detection solution. CMS data have shown that since implementation, organizations that follow all the steps have significantly lower mortality rates for patients diagnosed with severe sepsis and septic shock². Your sepsis solution must be able to handle a different sepsis alert and sepsis algorithms for different locations. Just as important, within a single hospital location, your sepsis alert solution must be able to handle different sepsis algorithms in different units.

There are multitudes of claims by companies to the efficacy of their sepsis alert or sepsis algorithm in terms of sensitivity and specificity, but few have scientific, clinical, peer reviewed, and published studies to back it up. Ambient has several peer reviewed published studies with Mayo Clinic that scientifically prove the efficacy of our sepsis alert solutions. We have an end-to-end solution that is much more than just a sepsis patient tracker board, called Sepsis DART™. Sepsis DART™ was developed with Mayo Clinic, and it also includes an indicative sepsis alert that is customizable by each health system, and even customizable down to the unit level. Because different units have different algorithm requirements, we typically run a multitude of algorithms in each site we install at. We can start with the St. John’s algorithm, but we also have other out of the box algorithms we have developed with other healthcare systems that we can utilize as starting points for you. Without the ability to run multiple algorithms, you will find yourself spending money, time, and effort on a sepsis alert solution without improving your sepsis bundle compliance or sepsis outcomes, leaving you in the same situation you were in the previous year.

Above we have spent a lot of time talking about the first key component, which is early detection with a sepsis alert, but it is also important to understand that you must drive early intervention which is the second key component to solving sepsis. With each hour that you don’t act, mortality for sepsis increases 7.6 percent. While deploying Sepsis DART™ in hospital systems across the U.S. this year, we saw three effective response models, depending on the quality systems, management processes, and investment levels at the hospital.
    1. Upon sepsis alert remind all responsible team members
 
    1. Upon sepsis alert remind all responsible team members PLUS sepsis response teams
 
  1. Clinical control tower or clinical command center model


Any of these three models by themselves or combined, coupled with the right technical automation solution (like Sepsis DART™) will yield substantial patient care improvements and cost reductions. The model that will work for an individual health system will depend on the system design and workflow of each hospital, and there are many differences, especially in the quality of the staffing, information electronically available, and the investment made in centralized functions like sepsis response and central incidence management.

This brings us to the third component which is delivering care and the sepsis bundle elements within the appropriate time windows. Beyond driving early intervention as described above it is critical that your sepsis solution has sepsis patient tracker board functionality that provides automatic sepsis surveillance and at-a-glance awareness of patient status, enabling bedside and remote monitoring of large numbers of patients simultaneously. We also learned that sepsis solutions must also employ smart alerts that directly notify the right care givers of a potential sepsis development in a patient and using smart escalation continue to notify care givers until someone on the team takes the appropriate action. Unlike EHR’s, Sepsis DART™ does all of this and most importantly, graphically tracks the delivery of the sepsis care bundle (as appropriate for that patient) while providing smart notification and reminders where elements of the bundle may be in jeopardy of not being delivered correctly or in a timely fashion.

This brings us to the newest innovation and maybe one of the most important for solving sepsis in every facility across the United States. Sepsis solution vendors need to provide Sepsis as a Service or Tele-Sepsis. With many hospital and health system organizations unable to fund the investment to create a centralized Clinical Control Tower environment or the inability to staff sepsis monitoring teams 24/7, it is important to pick a sepsis solution (like Sepsis DART™) that allows for Sepsis as a Service or Tele-Sepsis. Companies like Ambient can provide outsourced sepsis monitoring through their Clinical Control Tower technology.

It is evident that despite improvements in modern statistical techniques and machine learning approaches, sepsis alert performance has not improved much in the past decade. The biggest question is: What is the best path to solve sepsis moving forward? Over the years and especially in 2020, we have learned that in recognizing and treating sepsis there are three elements critical to sepsis surveillance, improved clinical outcomes, and reduced mortality for effected patients. To summarize:
    1. Early detection. Ideally this should be automated with sepsis surveillance happening in the background so the potential development of sepsis can be brought to the attention of a provider or nurse while they are providing care to their patients. Subtle changes may be taking place in the patient’s condition, and often the care team can become very focused on the current problem(s) they are dealing with and might miss the onset of sepsis.
 
    1. Early intervention. Detecting sepsis in a patient is great but does absolutely no good unless a provider steps in, reviews the patient’s case, and declares that the patient does indeed have sepsis, and then begin to institute treatment.
 
  1. Timely delivery of all required care elements. The treatment bundle for sepsis is well defined, and if delivered comprehensively and within the defined time windows, provides remarkable improvements in not only the survivability of sepsis, but also in reductions of total care and length of hospitalization for patients who acquire sepsis. They (bundles) induced more consistent and timely application of evidence-based care and reduced practice variability³.
Sepsis DART™ is an FDA Class II approved solution that was clinically vetted with Mayo Clinic. One of the reasons we are the only FDA Class II cleared end-to-end sepsis solution on the market today, is the FDA requires that vendors have the capability to customize algorithms, which we do, and it allows us to tune algorithms to fit any health system.

For more information on how you can solve sepsis in your organization with Ambient Clinical Analytics please contact tim.kuebelbeck@ambientclinical.com.

About Ambient Clinical Analytics - As an industry leader, Ambient is supporting leading healthcare systems and has done so since its founding in 2013. Our solutions are designed by clinicians to be easy-to-use by every caregiver in your organization and are configured to be up and running rapidly. We are trusted by a community of high-performing healthcare providers across the United States. Our solutions are powerful real-time point-of-care and remote healthcare platforms designed to deliver life-saving solutions using data visualization, communication, and analytics based clinical decision support.

Ambient’s AWARE™ and Sepsis DART™ solutions are exceptionally secure, high-performance, FDA Class II approved and CE Marking certified Software as a Medical Device (SaMD) platforms. Ambient’s Sepsis DART™ product has been accepted into the Patient Safety Movement’s Actionable Patient Safety Solutions (APSS) #9 for Sepsis. Ambient has achieved ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry. The ISO 13485 standard sets out the requirements for a quality management system specific to the medical device industry. Ambient is also deploying the AWARE™ family of solutions, to help manage COVID-19. Ambient’s Virtual ICU platforms are ideal for dealing with current and possible future outbreaks. For more information, visit https://ambientclinical.com.
  1. Massachusetts Sepsis Consortium, Advancing Sepsis Care in Emergency Medicine, April 2019
  2. HHS.gov, Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden, HHS.gov , February 14, 2020
  3. Jozwiak M, Monnet X, Teboul JL., Implementing sepsis bundles, NCBI, September, 2016