Is a Failing Grade Good Enough for Quality & Safety Outcomes, Performance Improvement, Cost Containment, & Sustainability?

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By Tim Kuebelbeck, Chief Customer Officer at Ambient Clinical Analytics

The Problem

Obviously, the answer to the title of this white-paper blog is no. So much information has been written over the last year on sepsis but none of it linked poor health system performance to patient outcomes and financial performance. Sepsis is a deadly global killer and worldwide takes over 20% of all people who die on any given day. But it doesn’t have to be that devastating if hospitals and health systems would provide the appropriate care to patients. At least half of all U.S. hospitals are sitting well below 50% for sepsis CMS bundle compliance and the better ones are achieving 60% - 80% typically with inconsistent fluctuations. Achieving only 80% on CMS sepsis bundle compliance is indefensible and treating 50%, or less, of your septic patients appropriately is untenable. Obviously in academic terms a 50% is an F and 60% is a D. As a parent, I wouldn’t accept D’s and F’s from my kids and we certainly shouldn’t accept failing grades from our care providers either. Yet many hospitals and health systems appear to be very comfortable with D’s and F’s and even more disturbing, the high performers are OK with C’s and B’s when it comes to sepsis treatment. Would failing grades be acceptable when it comes to cancer care or surgery? How about birth centers or Covid-19 care? Obviously not. So why do health systems continue to accept failing grades for sepsis treatment when it is a problem that can be solved? While a solution is readily available, the reasons hospitals choose to be in this predicament are complex.

Motivate & empower clinicians and IT to enhance quality and safety, improve both outcomes and the human experience, and drive performance excellence... Easy, right? Using a system wide approach to measurement and achievement of quality objectives is no simple task, unless you have the appropriate clinical decision support software, which very few have. Hospital environments demands high reliability and sustainability across all aspects of care and there should be no discrimination to which clinical problems they choose to put effort into. Yet we see many healthcare organizations that tell us they are at 60% CMS bundle compliance for sepsis, and that’s good enough. Which is the equivalent of telling your patients only 6 out 10 of you are going to get the appropriate care if you come to our facility with sepsis. Analogously, your child telling you a D is good enough in school would be less than tolerable. The results of this mentality are devastating to the 4 in 10 or 5 in 10 patients, depending on which health system you choose, and many are much worse. Keep in mind the 4 in 10 or 5 in 10 odds are typically the good performers. For healthcare, those are self-imposed and cruel odds to give your patients for appropriate treatment for something that is completely controllable. For any missed bundle element, mortality goes up an average of 8.5%, and even higher if you miss more than one element in the bundle or delay care. The incidence of septic shock, severe septic shock, long term organ damage, amputations, and 30 day readmits goes up along with mortality when you miss multiples of either elements or timelines. Most hospitals and health systems find this to be acceptable with 40-50% of their patients. This mindset should change.

The second issue is the lack of impact EHR vendors are having on solving sepsis. Trying to fix sepsis using your EHR has been and continues to cost patients their lives, limbs, organ damage, and permanent long-term health issues. As a health system executive, if that doesn’t make you squirm and take immediate action, you’re in the wrong business. The EHR positioning itself, and senior executives in health systems allowing it, to be the only workflow that physicians will accept despite its failings clinically, is gross negligence towards patients and a massive contributor to the financial crisis our health systems face in today’s pandemic economic environment. Much of the hesitancy to truly address sepsis is because acute healthcare systems have typically tried to solve the issue inside of their EHR, already spent big money on consulting services with their EHR vendor and have been led to believe by the vendor that this is something they can solve. Only to find out that with their approach and technology, the vendor really can’t help, and you end up holding a bag of mixed results at best, and even then, those result aren’t sustainable long term.

The third complexity is EHR related too. I’m going to be very clear...the standard EHR is not the answer. It’s been tried over and over in healthcare systems across the U.S. (and the globe) and to date no EHR vendor has a sustainable solution, and they will not solve it in the future either. Decision support systems that require FDA Class II clearance to drive detection and treatment aren’t the EHR vendors priority, and never will be. Then why do EHR vendors offer an embedded sepsis algorithm? They want to keep the physician’s workflow entirely inside the EHR. It’s how they keep healthcare clients under control, and it is costing people their lives. Choosing to make it extremely difficult to integrate to their EHR’s workflow is common and often causes healthcare systems to take the easy and incorrect path of least resistance. As a healthcare system you may move the quality needle after you install an algorithm provided by your vendor, but a singular algorithm alone does not solve the problem. Those gains are always temporary. Sure, your algorithm can alert a provider to a potential sepsis case but then what? Are the false positives too high and the physicians and nurses ignoring it? Dropping an order for a sepsis bundle using the best practice alerts in your EHR kicks off the process, but what mechanisms are in place for follow up to make sure they are completed? How does the EHR communicate that bundle elements are in jeopardy? Clearly, an electronic or paper checklist doesn’t fix the issue. If you choose the appropriate Clinical Decision Support system you ensure they workflow stays in the EHR and more importantly, that the CMS sepsis bundle is followed and completed in a timely fashion. Taking the easy path is rarely the correct path and doing the right thing clinically is often hard.

As a healthcare executive, after reading the paragraphs above you should have many and large concerns on how your health system is handling septic patients and rightly so. It’s a weak link in your care process that is costing lives, and it is that way because of self-selection. Solving sepsis is a complex process, but rest assured it is much easier than you think if you enlist professional subject matter experts and FDA Class II cleared solutions in toolbox. And the EHR is not the answer.

And if you think you don’t have a sepsis crisis in your facility, or someone is telling you that the problem is solved, think again, because someone’s not giving you the entire picture. So, what’s the answer to this unsolved sepsis crisis in the U.S. and how do we fix it? It requires us to break down the issue into three parts. In this white paper blog, we are addressing sepsis but, you should understand you can apply this same process to any clinical challenges health systems face such as MI, Stroke, CHF, CAUTI, CLABSI, VTE, DVT, etc... The list is long. The argument for having a true Clinical Decision Support (CDS) platform to address these issues is stronger than ever.

Addressing Sepsis

At Ambient Clinical Analytics, over the years, we have learned and been reminded that there are three keys to solving sepsis permanently. If you attack those keys correctly, you can and will solve sepsis.
  1. Early detection
  2. Early intervention
  3. Care delivery automation
Many have taken a stab at fixing the first key but have done so in a marginal fashion. Almost none or at best, very few have solved the second or third keys. Until health systems can figure out how to drive early intervention and timely care, they will be stuck risking lives and underperforming in the 40-50% CMS sepsis bundle compliance range. Providing a communication technology that allows for remote patient monitoring of an end-to-end sepsis surveillance solution, communications platform, and if needed, tele-sepsis services, is critical. A focus on automating best practices using innovative technology to identify sepsis, treat sepsis and ensure that protocols don’t slip through the cracks is critically important. Without it, you will continue to fail your patients by leaving them at risk.

Sepsis Detection (Sepsis Alert)

There are multitudes of claims 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. Ambient has several peer reviewed published studies with Mayo Clinic that scientifically prove the efficacy of our sepsis detection 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 configurable by each health system, and even configurable down to the unit level. Because different units have different sepsis detection requirements, we typically run a multitude of algorithms in each site we install at. We can start with the Mayo Clinic sepsis detection algorithm, but we also have other out of the box sepsis alert algorithms we have developed with other healthcare systems that we can utilize as starting points for you. If you want to truly solve sepsis, you must have a solution that allows you to run multiple sepsis algorithms.

Early Intervention

It is also important to understand that with sepsis surveillance you must drive early intervention which is the second key component to solving sepsis. With each hour you fail to intervene, mortality for sepsis increases a minimum of 7.6%. 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

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
  2. Upon sepsis alert remind all responsible team members PLUS sepsis response teams
  3. Clinical control tower or clinical command center model
  Any of these three models by themselves or combined, coupled with the right automated sepsis surveillance solution (like Sepsis DART™) will yield substantial patient outcome 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.

Care Delivery Automation - Delivering Timely Care and Quality Beyond the Bundle Elements

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 detection 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 alert solutions must also employ smart notifications that directly notify the right care givers at the right time of a potential sepsis development in a patient and using smart escalation, continue to notify care givers via a smart sepsis alert until someone on the team takes the appropriate action. Unlike EHR’s, Sepsis DART™ does all of this automatically and most importantly, graphically tracks the delivery of the sepsis care bundle (as appropriate for that patient) while providing both smart sepsis alert notification and reminders where elements of the bundle may be in jeopardy of not being delivered correctly or in a timely fashion.

Summary

Mastering the three sepsis care key components and solving sepsis in your health system requires using a modern electronic FDA cleared CDS solution outside of your existing EHR. In some ways EHR’s do the job, but ultimately they fail to deliver end to end care causing risk for your patients. Your sepsis solution must be an end-to-end specialized communication platform designed to manage sepsis that also allows for smart notifications to be received by doctors and nurses even if they are not in the EHR, or any other clinical system, and it must deliver those same smart notifications and escalations when the timely delivery of the correct care elements is in jeopardy.

Continuing to accept failing grades on any delivery of care process continues to cause poor performance both clinically and financially, especially around sepsis care. The greater take away from the discussion above is we should no longer accept failing grades on sepsis treatment, or any other clinical therapy delivery, from either providers or IT departments simply because people want to keep workflows contained in an EHR system and that system is not designed to deliver the quality controls contained in FDA approved clinical decision support solutions. It is negligent and devastating to patients and families, not to mention it unintentionally abandons and discriminates against large portions of your patient population. For further information on how you can solve this issue in your health system please contact Ambient Clinical Analytics today and find out how you can fix your failing grade on sepsis today.

Sepsis DART™
Ambient Clinical Analytics has developed an FDA Class II cleared clinical decision support tool called Sepsis DART which assists hospitals with sepsis diagnosis, early intervention, 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. It moves with the patient through different hospital services and environments, integrates with any EMR system, and is configurable for various institutional purposes. Sepsis DART™ is an FDA Class II approved 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 configure algorithms, which we do, allowing us to tune algorithms to fit any health system down to the unit level.

The Sepsis DART™ alert system 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. We have a library of configurable unit-based algorithms that we bring to the mix and will work to configure any previous algorithm efforts you have created within your health system. Because Sepsis DART keeps all the 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. The reduction in CMS reporting efforts, savings from reduced costs, improvements in outcomes and CMS compliance will always cost justify and bring returns on investment in significantly less than 12 months.



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 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.

Citations
  1. Kumar 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.