The Importance of Sepsis Detection & a Sepsis Alert for Improved Sepsis Outcomes

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By Tim Kuebelbeck, Chief Customer Officer, Ambient Clinical Analytics

Executive Brief

Sepsis Detection and the sepsis alert are monumentally important when it comes to sepsis outcomes. If sepsis is left untreated or not treated in a timely fashion, sepsis is a runaway train for a patient’s immune system. In an untreated environment, sepsis rapidly develops into a life-threatening medical event. It is essential to ensure proper clinical therapies, commonly known as sepsis bundle elements, are delivered in the appropriate timeframe. Minutes can be the difference between tissue damage, amputation, long term organ damage, and death. Septic patients who are treated in a timely fashion are much more likely to return to a normal life.

A digital health solution with a sepsis detection algorithm and a trusted sepsis alert are extraordinarily critical for patient outcomes. The World Health Organization states that sepsis is a condition affecting over 30 million people globally annually and is responsible for roughly 6 million deaths. The Centers for Disease Control and Prevention report that 1.5 million Americans contract the disease every year and approximately a third of these patients die.

Hospitals have access to the correct data to treat sepsis, unfortunately many do not have the appropriate digital heath solutions to leverage that data. Early and accurate sepsis detection along with trusted sepsis alerts, ensure treatment is delivered in the first critical 6 hours after diagnosis. If treated early and appropriately during the CMS established timelines, for the most part, these become preventable deaths. Unfortunately, the disease is also notoriously difficult to diagnose. Chronic under-diagnosing, delayed treatment, missed delivery of bundle elements, and subsequent deaths are the motivation behind worldwide campaigns to improve sepsis recovery strategies. Sepsis often results in extended and extreme care, including long ICU stays, where patients need a high level of monitoring and attention. These requirements make it a particularly expensive condition to treat, costing the US $24 billion annually.

Six Critical Components

Patients pay the price for poor sepsis compliance and excellent sepsis compliance starts with digital health systems that indicate an accurate sepsis detection and a trusted sepsis alert. Over the years, we have learned many valuable lessons when it comes to solving sepsis. During that time, we have documented that there are six (6) critical components that drive excellent sepsis care using digital health platforms, and they are all directly entwined with sepsis detection, sepsis alerts, and effectively solving sepsis:

  1. End to End Solution. It’s not just about the algorithm. It’s about a digital health solution that is accretive to the EHR, detects, tracks, and ensures complete delivery of the appropriate sepsis bundle elements.

  2. Early sepsis detection. Multiple and configurable algorithms are a must so that the detection approach matches local needs and supports deploying different algorithms in different units.

  3. Early sepsis intervention. Digital health solutions that directly fire a trusted sepsis alert for a patient requires a provider to step in, review the case, & declare that the patient does indeed have sepsis.

  4. Timely delivery of all required sepsis care elements. When the complete care bundle is delivered within defined timeline windows, remarkable improvements in the survivability of sepsis, and in reductions of total care, and length of stay are achieved. Delivering a sepsis alert for bundle elements that are in jeopardy is just as important as firing a sepsis alert for the original sepsis detection.

  5. Automated Communication & Workflow Integration. Communication functionality that is automated provides automatic sepsis alerts & at-a-glance awareness of patient status, enabling bedside and remote patient monitoring of large numbers of patients simultaneously. Digital Health platforms that deliver a sepsis alert through automated communication have far superior outcomes than any EHR or singular sepsis algorithm solutions. If a Digital Health platform is lacking automated communication, the result is an inability to notify physicians and nurses of clinical issues and elements of care that may be in jeopardy. Deficiencies around automated communication will undeniably cause you to struggle in achieving your specified clinical goals around sepsis. Workflow integration into the EHR is also requisite for digital health sepsis solutions. Keeping the physicians and nurses inside their natural workflows drives efficiency, utilization, and trust in the solution. Providing the native UX & UI in parallel to the workflow integration within the EHR is elemental. Native UI allows for at scale monitoring of septic or potentially septic patients across multiple hospitals.

  6. Certification & Validation. It has been proven repeatedly that you can’t fix sepsis in your EHR. Effective sepsis solutions have both the appropriate FDA certifications and peer reviewed and published validation. Certifications such as FDA, CE Mark, & ISO demonstrates a vendor has met a rigorous standard of excellence which is extremely important to health systems and enhance their competitive advantage. Validation establishes that the digital health platform is working as expected. Without the peer reviewed published validation data (required to achieve FDA clearance), you will never really know how well a medical device or digital health platform is performing.



Using Sepsis Detection & Sepsis Alert for Early and Continued Intervention

There is a wealth of assertions by companies to the efficacy of their sepsis detection in terms of sensitivity and specificity, but few have scientific, clinical, peer reviewed, and published studies to back it up. Some of those that do have that type of validation also market it in liberal ways, so make sure you read the studies. Having peer reviewed published studies with respected health systems that scientifically prove the efficacy of a sepsis detection and sepsis alert solution is paramount when it comes to addressing this national healthcare failure. End-to-end solutions need to be much more than just a sepsis patient tracker board. These solutions must also include an indicative sepsis alert that is configurable by each health system, and even configurable down to the unit level. Because different units have different sepsis detection requirements, we have confirmed that organizations that run multiple sepsis detection algorithms, in a digital health solution, tend to have physicians and nurses that trust their sepsis alerts and consequently are much more effective at delivering the appropriate and lifesaving CMS sepsis bundle elements. Without the ability to run multiple sepsis detection algorithms, you will find yourself spending money, time, and effort on a sepsis alert solution without improving your CMS sepsis bundle compliance or sepsis outcomes, leaving you in the same situation you were in prior to your latest sepsis improvement initiative.

Above we have spent a lot of time talking about early sepsis detection and the sepsis alert, but it is also important to understand that with sepsis surveillance you must drive early and continued intervention. Many organizations we work with tell us they have a great sepsis detection algorithm, but they also have poor ‘Hospital Compare’ compliance scores. Stated another way, it’s great that hospitals have a good detection algorithm and an alert, but then what do they do after the initial detection and alert to manage sepsis? How do you ensure that the appropriate care is given to the patient over the course of the three (3) and six (6) hour bundle windows? With each hour that you don’t act, mortality for sepsis increases 7.6 percent to 10.5%. In fact, each hour of delay in antimicrobial administration over the ensuing 6 hours was associated with an average decrease in survival of 7.6%. Administration of an antimicrobial effective for isolated or suspected pathogens within the first hour of documented hypotension was associated with a survival rate of 79.9%.1

We have tested several approaches to sepsis alert and sepsis detection management. We have established that there are three effective response models using digital health platforms. Which approach works best for any health system is dependent on the quality systems, management processes, and investment levels at the hospital. The following are the three proven approaches:

  1. Upon sepsis alert remind all responsible team members
  2. Upon sepsis alert remind all responsible team members PLUS response teams
  3. Leveraging Clinical Control Tower™ or Clinical Mesh Network™ model


Any of these three models by themselves or combined, coupled with the right digital health solution that provides automated sepsis surveillance, yields substantial patient outcome improvements and cost reductions. The model that will work for an individual health system depends on the system design and workflow of each hospital. 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 teams.

Delivering Care and Quality Beyond the Bundle Elements

This brings us to delivering care and the sepsis bundle elements within the appropriate time windows. Beyond driving early intervention as described above, it is critical that your digital health and sepsis detection solution has sepsis patient tracker board functionality that provides automatic sepsis surveillance and at-a-glance awareness of patient status. At-a-glance situational awareness enables bedside and remote monitoring of large numbers of patients simultaneously. We also substantiated that digital health sepsis alert solutions must also employ two types of sepsis alerts. First, a Smart Notification™ that sends a sepsis alert to directly notify the right care givers, at the right time, of a potential sepsis development in a patient. Second, using a Smart Escalation™, continue to notify care givers via a smart sepsis alert until someone on the team takes the appropriate action. Unlike EHR’s, any true digital health platform will do this, and graphically track the delivery of the sepsis care bundle while providing a sepsis alert for both Smart Notifications™ and Smart Escalations™ for when elements of the bundle may be in jeopardy of delivery in a timely fashion.

Even the most vigilant humans get tired, make mistakes, and miss subtle patterns.2 Selecting and implementing a digital health sepsis detection and sepsis alert system in your hospital is crucial to early detection and in ensuring mistakes and missed cues are minimized. Specificity and sensitivity are a central part of an effective sepsis alert. If a sepsis alert has low specificity, which causes a high false alert ratio, then physicians and nurses may start to ignore and lose trust in the sepsis alert over time. Conversely if the sensitivity is too low, the sepsis alert may not cast a wide enough net to catch most of your sepsis cases. A warning to anyone researching a vendor that provides a sepsis alert solution, there are multitudes of claims by companies to the efficacy of their sepsis alert algorithm in terms of sensitivity and specificity, but few have scientific, clinical, peer reviewed, and published studies to back it up. Make sure vendors that you are evaluating have several peer reviewed published articles with major teaching university health systems that scientifically proves the efficacy of their sepsis alert solutions. Another cautionary note, a sepsis alert, although very important, is only a portion of the entire sepsis solution. Solving sepsis is not just an algorithm race.

Carrying pocket sepsis bundle cards, egg timers and other manual labor-intensive approaches is never the answer, and neither is a non-FDA cleared EHR sepsis alert solution. Health systems continue to deploy non-FDA cleared algorithmic EHR electronic sepsis alert solutions masked as consumer devices, and this has proven to be ineffective. Deployment of FDA cleared digital health sepsis alert solutions that are clinically vetted, facilitates accurate and early sepsis detection and more importantly, drives delivery of the sepsis bundle within the appropriate time windows.

You wouldn’t allow a non-FDA cleared medical device to be used in your hospital on your patients, so why would you allow non-FDA cleared digital health solution for sepsis to be used on your patients? Again, many vendors mask medical devices as a consumer device to avoid having to spend the time and money on obtaining the proper FDA approvals and this continues to bring harm to patients and is a major contributor to our national sepsis crisis.

Summary

Delivering appropriate care requires a multidisciplinary approach utilizing a digital health communication platform. 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 shock.3 Digital health clinical decision support solutions specifically designed for sepsis with the appropriate approvals and certification drive compliance and reduce mortality.

The current health system model of deploying a non-FDA cleared EHR sepsis alert solution drives a U.S. national average of 49% bundle compliance for sepsis.4 Which is why health systems lose enormous amounts of money on treating sepsis patients. Nationally, less than 1 in 2 septic patients receive the appropriate treatment. Which highlights a massive failure by hospitals and health systems in using EHR’s and other non-FDA approved sepsis alert solutions.

Would you allow for only 50% of your births or surgeries to be delivered or completed appropriately? If not, then why allow 50% of your sepsis cases to be treated appropriately. The current hospital strategy for septic patients is broken and needs to be re-evaluated. In the U.S. there are plenty of digital health solutions that can drive your bundle compliance well into the 90th percentile. Today, we are failing in over half of the septic population when it comes to sepsis treatment, we must do better, and it all starts with digital health, an effective sepsis detection and sepsis alert system.

Sepsis DART™

Ambient Clinical Analytics has developed an FDA Class II cleared digital health clinical decision support tool called Sepsis DART which assists hospitals with sepsis diagnosis, timely delivery and management of treatment, and reporting.

Sepsis DART™ (Detection And Response Tool) is designed to analyze patient data and identify potential sepsis conditions early, offering medical staff the right information for detection, and using smart sepsis alerts, support tracking of the treatment process. DART works under the covers and keeps physicians and nurses inside of the EHR workflow. DART moves with the patient through different hospital services and environments, integrates with any EMR system, and is configurable for various institutional purposes. DART™ is malleable to other conditions such as AKI, SSI, Stroke, etc... that requires early detection and adherence to a specific clinical process.

Sepsis DART™ is an FDA Class II certified solution that was clinically vetted with Mayo Clinic that has a strong return on investment. One of the reasons Ambient is the only FDA approved 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. Ambient has also achieved CE Mark approval and ISO 13485:2016 certified.

The Sepsis DART™ alert system is a communication platform that monitors and communicates regarding all aspects of sepsis treatment bundles to the right practitioners at the right time, maintaining information on septic patients even between care locations and shifting staff. This reduces errors and omissions, as the entire care team understands on a real-time basis what treatment elements have and have not been delivered, and how much time is left to successfully complete treatment. Published research from Mayo Clinic shows that AWARE Sepsis DART provides a high level of sensitivity and specificity as well as improved compliance with sepsis treatment delivery guidelines. Because Sepsis DART keeps all pertinent data for each case in a single repository, all centrally available and correlated to the “time zero” of the sepsis event, the effort required to abstract and report on sepsis cases is substantially reduced and that alone, not including improvements in outcomes and CMS compliance, often cost justifies any system costs.

For more detailed 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 FDA Class II Certification, CE Mark Approval, & ISO 13485:2016 certification. ISO 13485 is 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 Digital Health, Tele-Health, and Virtual ICU platforms are ideal for dealing with today’s remote patient monitoring needs for acute care. For more information, visit https://ambientclinical.com.

Citations:

1Kumar A, et al Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. PMID: 16625125.

2Strickland, Eliza, Hospitals Roll Out AI Systems to Keep Patients From Dying of Sepsis, IEEE Spectrum, October 19, 2018

3HHS.gov, Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden, HHS.gov, February 14, 2020

4Castellucci, M., Just 49% of hospitals follow CMS’ sepsis treatment protocols, Modern Healthcare, July 27, 2018