Ambient’s Sepsis Solution Helps Solve Common Sepsis Alert Errors

Introduction

In the United States hospital mortality for sepsis and septic shock are 14.9% & 34.2% respectively with over 250,000 deaths annually. Sepsis is the single most expensive condition treated in hospitals and accounts for over 13% of all hospital costs. Sepsis results in extended and extreme care for patients, including long stays in the ICU, where high levels of monitoring and attention are required. These requirements make sepsis a particularly expensive condition to treat, costing the US $24 billion annually. Sepsis accounts for over 20% of deaths worldwide, yet less than 50% of patients are correctly treated for sepsis, mostly due to clinicians missing the timeline for treatment. Learn more about Ambient Clinical Analytics’ sepsis solution and the benefits of having the correct sepsis solution in place.

What current sepsis solutions are available? How do they vary in sepsis detection?

Sepsis is a potentially life-threatening condition that occurs when the body's response to an infection causes injury to its own tissues and organs. Early detection and treatment of sepsis are crucial to improving patient outcomes and reducing the risk of death. There are several sepsis solutions available that can help healthcare providers identify and manage sepsis in a timely manner.

One type of sepsis solution is a clinical decision support tool, which is a software program that analyzes real-time patient data and provides alerts to healthcare providers when a patient may be at risk for sepsis. These tools often use indicative algorithms and predictive analytics to identify patterns in patient data that may indicate the presence of sepsis. Some of the better clinical decision support tools also provide guidance on the appropriate treatment for sepsis based on the patient's condition.

Another type of sepsis solution is a sepsis alert in an electronic health record (EHR), which uses data from a patient's electronic health record to identify and alert healthcare providers to the presence of sepsis. EHR-based systems may use a combination of clinical decision support tools and other algorithms to analyze patient data and provide alerts, but today they do not meet the FDA Class II requirements for a sepsis solution.

Both clinical decision support tools and EHR-based systems vary in their ability to accurately detect sepsis. Some sepsis solutions may have higher rates of false positives, which can lead to unnecessary testing and treatment, while others may have higher rates of false negatives, which can result in missed opportunities for early intervention. In addition, very few sepsis solutions or sepsis alerts meet the current FDA Class II requirements for detecting, monitoring, and driving sepsis treatment. It is important for healthcare providers to carefully evaluate the accuracy and reliability, as well as determine if the solution meets FDA Class II requirements for any sepsis solution they use.

Why do current sepsis alerts fail patients? Are there any commonalities?

There are several reasons why current sepsis alert systems may fail to accurately detect and alert healthcare providers to the presence of sepsis in patients. Some of these reasons include:

Algorithm limitations: Some sepsis alerts use a single algorithm for all patients to analyze patient data and identify patterns that may indicate sepsis. However, one algorithm will not accurately identify sepsis in all areas of the hospital. A sensitive screening algorithm may be needed to look at all patients coming into an Emergency Department, but that same algorithm may drive too many false positive detections in the ICU or Acute Care setting.

False positives and false negatives: Sepsis alerts may produce false positives, which are alerts that indicate a patient has sepsis when they do not, or false negatives, which are alerts that indicate a patient does not have sepsis when they do. Both false positives and false negatives can lead to inappropriate treatment or missed opportunities for early intervention. Utilizing the right detection algorithm for the appropriate area of the hospital optimizes the balance between sensitivity and specificity.

Lack of automation & user error: A sepsis solution may fail if they are not used correctly or if healthcare providers do not follow up on alerts in a timely manner. Many sepsis alert designs, fail to recognize the importance of tracking the progress and notification of the defined treatment bundle, leaving doctors and nurses unaware of additional protocols that are required for a specific septic patient.

One commonality among these failures is that current sepsis alerts focus on and may not be able to accurately identify what treatment elements are required for each patient leading to inappropriate treatment or missed opportunities for early intervention. The second and more egregious flaw in sepsis solutions is the lack of EHR workflow integration and clinical automation to drive appropriate care.

Why do current sepsis alerts cause alarm fatigue? What is the effect on the staff and patient outcomes?

Sepsis alerts are designed to alert healthcare providers to the presence of sepsis in patients so that appropriate treatment can be administered. Alternatively, an effective sepsis solution also monitors and facilitates the delivery of care by delivering a targeted sepsis alert. Unfortunately, untargeted alerts in EHRs do produce many general sepsis alerts. This leads to a phenomenon known as "alarm fatigue," where healthcare providers become desensitized to the alerts because they receive so many of them.

Alarm fatigue can have serious consequences for both staff and patient outcomes. When healthcare providers are constantly being bombarded with alerts that don’t provide value to them, they may lose trust in the sepsis solution and become less likely to take action when they receive a sepsis alert, even if it is an accurate indication of sepsis. This can lead to missed opportunities for early intervention and poor patient outcomes. In addition, the constant stream of alerts can be stressful and overwhelming for healthcare staff, which can negatively impact their well-being and job performance.

There are several ways in which current sepsis alert systems contribute to alarm fatigue, including:

High rates of false positives: As mentioned previously, sepsis alerts may produce false positives, which can lead to unnecessary testing and treatment. When healthcare providers receive too many false positives, they may become less likely to act when they receive an alert.

Lack of configurability: Many sepsis solutions are not configurable or customizable, which means that healthcare providers cannot adjust the sensitivity or threshold for sepsis alerts. Often, this can lead to an excessive number of alerts, particularly in settings where sepsis is less common.

Limited context: One of the biggest issues with EHR and many other sepsis alert systems is they do not provide enough context or information to help healthcare providers determine the appropriate course of action. So your sepsis alert detects sepsis, then what? Automation of what clinical therapies are needed following a sepsis alert is paramount. Most sepsis solutions do not have this functionality. Nurses and physicians feel a sense of responsibility to provide the best possible care to patients and may feel frustrated if they believe that the hospital is not properly equipped to manage sepsis cases. For doctors and nurses, poor performance on sepsis care can result in feelings of frustration, guilt, and burnout. They may feel that they have failed to provide the best possible care for their patients, which can have a negative impact on their job satisfaction and overall well-being. In some cases, poor performance on sepsis care may also lead to increased pressure and criticism from patients, families, and colleagues, further exacerbating the stress and burnout experienced by healthcare providers.

Overall, alarm fatigue has serious consequences for both the clinical staff's job satisfaction and patient outcomes. It is important for a sepsis solution to be designed in a way that minimizes unnecessary sepsis alerts and provides clear guidance on the appropriate course of action to take in response to a fired alert.

How can hospitals improve their sepsis alert performance? Does it require a complete overhaul of their systems, or can they make adjustments to be successful?

There are several ways in which hospitals can improve the performance of their sepsis solution to reduce the risk of alarm fatigue and improve patient outcomes. Some strategies for improving sepsis alert performance include:

Incorporating additional data sources: Hospitals can improve the accuracy of their sepsis alerts by incorporating a wide range of data sources, such as patient history, chief complaints, and lab results, in addition to vital signs. Additionally, leveraging these data resources and adjusting the tolerances to ensure the sepsis alert is trusted by clinicians is a major failure point in most hospitals.

Configuring alerts: Hospitals can configure their sepsis solutions to better fit the needs of their patients and clinical staff. For example, adjusting the tolerances for sensitivity and specificity to meet the needs of the location, or specific patient groups or conditions, as well as targeting specifically who needs to be notified for an event, leads to trusted sepsis alerts.

Providing context and guidance: Hospitals can improve the performance of their sepsis solution by providing clear guidance and context for healthcare providers on the appropriate course of action to take in response to an alert. To aid in the delivery of clinical therapies for sepsis, sepsis alerts can be configured to automate tasks. A good example of this is if a physician orders antibiotics but the medication has not been administered, then the sepsis solution should notify the nurse with a targeted notification that they should administer the antibiotic. Conversely, if the patient's condition changes and fluids are now required, a targeted notification should be sent to the responsible physician informing them that the patient now requires fluids, and they may want to consider ordering them. These types of targeted smart escalations drive compliance with the CMS Sep-1 Bundle and because they are specific don’t cause alarm fatigue.

Evaluating and refining algorithms: Hospitals can improve the accuracy of their sepsis solution by regularly evaluating and refining the algorithms used to analyze patient data and identify patterns that may indicate sepsis.

Overall, the majority of hospitals need to review and determine if they should replace their sepsis alerts with a configurable end-to-end sepsis solution to improve their performance. Making adjustments and improvements to existing systems, such as incorporating additional data sources and customizing alerts, can help to reduce the risk of alarm fatigue and improve patient outcomes but many times doesn’t solve the larger issue of meeting the bundle requirements. Most hospitals are fairly good at detecting sepsis and firing a sepsis alert. It's what they do after they understand that a patient is septic that is the larger problem today. Bundle compliance is a pervasive problem across healthcare.

How does Ambient detect sepsis and notify the staff of the threat requiring life-saving action?

Ambient’s Sepsis DART™ sepsis solution 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 of 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. That alone, not including improvements in outcomes and CMS compliance, often cost justifies any system costs.

The hidden benefits of Ambient in facilities; cost saving, clinical staff pressure, and provider efficiency

Sepsis DART™ is a real-time communication platform, integrated into your EHR’s workflow, that uses targeted smart notifications to reduce physician and nurse alert fatigue. With this level of integration with the EHR, the clinician's workflow is never disrupted. Sepsis DART™ has a proven Return on Investment that can save small to mid-sized hospitals up to $1M per year, save lives, and drive CMS sepsis bundle compliance into the 75%-85% rate in under 30 days, and continues to drive compliance even higher using Sepsis DART™ as the core to care quality improvement.

Ambient’s FDA-approved Class II SaMD sepsis solution provides configurable real-time sepsis alerts and reminders to clinicians, ensuring that patients receive prompt and effective treatment. This helps reduce the risk of missed or delayed diagnoses and care delivery, leading to improved outcomes for patients.

Ambient meets current FDA requirements, regulating sepsis solutions that indicate sepsis or suggest a sepsis treatment path, for Class II Medical Devices.

Sepsis is a life-threatening condition requiring prompt and effective treatment. With early detection and appropriate care, sepsis can be managed effectively, and patients can make a full recovery. However, if sepsis is not properly managed, patients are at sharply increased risk of morbidity and mortality.

On September 28, 2022, the FDA released Clinical Decision Support, Guidance for Industry, and Food and Drug Administration Staff. This guidance is long overdue, and with it comes the elimination of any protections for EHRs, or any other vendors, to pretend it’s OK to sell or deploy solutions for patient monitoring and care for life-threatening conditions like sepsis, that lack appropriate FDA-Clearance. To be clear, this has caused harm to patients for over a decade and will continue to do so until hospitals make serious efforts to follow the FDA Guidelines and police themselves.

A recent study from the University of Michigan suggests EHRs in the U.S. as a contributing cause of the U.S. having poor CMS Sep-1 sepsis bundle compliance. Current EHR sepsis alert detection models, won’t solve this issue since the approach is only focused on detection and not the follow-through for the treatment process. EHR solutions remain and will be for the foreseeable future, non-FDA-approved solutions. What is more, it’s not just EHRs, many other Clinical Decision Support and Population Health vendors are exacerbating the problem by selling ill-conceived non-FDA-approved sepsis alert solutions, that do not have appropriate clearances, into their customer base.

In order to ensure that patients receive the best possible care for sepsis, hospital systems should invest in FDA-approved software, like Ambient’s Sepsis DART™ for sepsis alert management. Ambient’s sepsis solution provides many benefits to hospital systems, including increased clinician efficiency, proven cost savings, and clinical efficacy.

Clinician Efficiency

One of the key benefits of an FDA-approved sepsis solution is increased clinician efficiency. Sepsis DART™ is designed to automate the detection and management of sepsis, streamlining the process, and reducing the need for manual data entry and analysis. With this sepsis solution, clinicians quickly and easily access the information they need to make informed treatment decisions through automated notifications of the care delivery requirements, improving their ability to manage sepsis effectively.

In addition, Sepsis DART™’s FDA-approved sepsis solution for sepsis alert management also provides real-time targeted alerts and smart notifications to clinicians, ensuring that patients receive prompt and effective treatment. This reduces the risk of missed or delayed diagnoses, and missed care, leading to improved outcomes for patients.

Proven Cost Savings

Another benefit of Ambient’s FDA-approved sepsis solution is the proven cost savings it provides. This software can help to reduce the cost of care for patients with sepsis by improving the efficiency of the sepsis management process. By automating the detection and management of sepsis, this sepsis solution reduces the length of stay, and the effort needed for manual data review and analysis, reducing the amount of time and resources required to manage sepsis effectively.

In addition, by improving the early detection and management of sepsis, the Sepsis DART™ FDA-approved sepsis solution reduces the risk of morbidity and mortality, ultimately reducing the cost of care for patients in the long term. By reducing the number of readmissions and prolonged hospital stays, Ambient’s sepsis solution software will help to reduce the overall cost of care for septic patients.

Clinical Efficacy

Ambient’s FDA-approved sepsis solution also provides several clinical benefits, improving the quality of care for patients with sepsis. This software is designed to automate the detection and management of sepsis, ensuring that patients receive prompt and effective treatment. With real-time smart sepsis alerts and smart reminders, quick and easy access to the information they need to make informed treatment decisions is delivered directly to the appropriate clinician, improving their ability to manage sepsis effectively and efficiently with higher job satisfaction. In addition, FDA-approved software for sepsis management also provides real-time data visualization and analytics, allowing clinicians to track patient progress and make data-driven treatment decisions. With Sepsis DART™’s at-a-glance data visualization, clinicians better understand the impact of their treatments on patients, leading to improved outcomes and a higher quality of care.

With Ambient’s Sepsis DART™ sepsis solution comes increased clinician efficiency, proven cost savings, and clinical efficacy. Ambient’s sepsis solution provides several benefits to hospital systems and improves the quality of care for patients with sepsis.

Conclusion

Hospital systems should invest in a sepsis solution like Ambient’s FDA-approved sepsis solution to ensure that patients receive the best possible care for this life-threatening condition. With increased clinician efficiency, proven cost savings, and clinical efficacy, Ambient’s sepsis solution will provide many benefits to hospital systems and improve the quality of care for patients with sepsis. Choosing the right sepsis solution can be the difference between life or death for many septic patients in your care.