Stephen Claypool, M.D., is Vice President of Clinical Development & Informatics, Clinical Solutions, with Wolters Kluwer Health and Medical Director of its Innovation Lab. He can be reached at steve.claypool@wolterskluwer.com.
Three-week-old Jose Carlos Romero-Herrera was rushed to the ER, lethargic and unresponsive with a fever of 102.3. His mother watched helplessly as doctors, nurses, respiratory therapists and assorted other clinicians frantically worked to determine what was wrong with an infant who just 24 hours earlier had been healthy and happy.
Hours later, Jose was transferred to the PICU where his heart rate remained extremely high and his blood pressure dangerously low. He was intubated and on a ventilator. Seizures started. Blood, platelets, plasma, IVs, and multiple antibiotics were given. Still, Jose hovered near death.
CT scans, hourly blood draws and EEGs brought no answers. Despite all the data and knowledge available to the clinical team fighting for Jose’s life, it was two days before the word “sepsis” was uttered. By then, his tiny body was in septic shock. It had swelled to four times the normal size. The baby was switched from a ventilator to an oscillator. He received approximately 16 different IV antibiotics, along with platelets, blood, plasma, seizure medications and diuretics.
“My husband and I were overwhelmed at the equipment in the room for such a tiny little person. We were still in shock about how we’d just sat there and enjoyed him a few hours ago and now were being told that we may not be bringing him back home with us,” writes Jose’s mother, Edna, who shared the story of her baby’s 30-day ordeal as part of the Sepsis Alliance’s “Faces of Sepsis” series.
Jose ultimately survived. Many do not. Three-year-old Ivy Hayes went into septic shock and died after being sent home from the ER with antibiotics for a UTI. Larry Przybylski’s mother died just days after complaining of a “chill” that she suspected was nothing more than a 24-hour bug.
Sepsis is the body’s overwhelming, often-fatal immune response to infection. Worldwide, there are an estimated 8 million deaths from sepsis, including 750,000 in the U.S. At $20 billion annually, sepsis is the single most expensive condition treated in U.S. hospitals.
Hampering Efforts to Fight Sepsis
Two overarching issues hamper efforts to drive down sepsis mortality and severity rates.
First, awareness among the general population is surprisingly low. A recent study conducted by The Harris Poll on behalf of Sepsis Alliance found that just 44% of Americans had ever even heard of sepsis.
Second, the initial presentation of sepsis can be subtle and its common signs and symptoms are shared by multiple other illnesses. Therefore, along with clinical acumen, early detection requires the ability to integrate and track multiple data points from multiple sources—something many hospitals cannot deliver due to disparate systems and siloed data.
While the Sepsis Alliance focuses on awareness through campaigns including Faces of Sepsis and Sepsis Awareness Month, hospitals and health IT firms are focused on reducing rates by arming clinicians with the tools necessary to rapidly diagnose and treat sepsis at its earliest stages.
A primary clinical challenge is that sepsis escalates rapidly, leading to organ failure and septic shock, resulting in death in nearly 30 percent of patients. Every hour without treatment significantly raises the risk of death, yet early screening is problematic. Though much of the data needed to diagnose sepsis already reside within EHRs, most systems don’t have the necessary clinical decision support content or informatics functionality.
There are also workflow issues. Inadequate cross-shift communication, challenges in diagnosing sepsis in lower-acuity areas, limited financial resources and a lack of sepsis protocols and sepsis-specific quality metrics all contribute to this intractable issue.
Multiple Attack Points
Recognizing the need to attack sepsis from multiple angles, our company is testing a promising breakthrough in the form of POC Advisor™. The program is a holistic approach that integrates advanced technology with clinical change management to prevent the cascade of adverse events that occur when sepsis treatment is delayed.
This comprehensive platform is currently being piloted at Huntsville Hospital in Alabama and John Muir Medical Center in California. It works by leveraging EHR data and automated surveillance, clinical content and a rules engine driven by proprietary algorithms to begin the sepsis evaluation process. Mobile technology alerts clinical staff to evaluate potentially septic patients and determine a course of treatment based on their best clinical judgment.
For a truly comprehensive solution, it is necessary to evaluate specific needs at each hospital. That information is used to expand sepsis protocols and add rules, often hundreds of them, to improve sensitivity and specificity and reduce alert fatigue by assessing sepsis in complex clinical settings. These additional rules take into account comorbid medical conditions and medications that can cause lab abnormalities that may mimic sepsis. This helps to ensure alerts truly represent sepsis.
The quality of these alerts is crucial to clinical adoption. They must be both highly specific and highly sensitive in order to minimize alert fatigue. In the case of this specific system, a 95% specificity and sensitivity rating has been achieved by constructing hundreds of variations of sepsis rules. For example, completely different rules are run for patients with liver disease versus those with end-stage renal disease. Doing so ensures clinicians only get alerts that are helpful.
Alerts are also coupled with the best evidence-based recommendations so the clinical staff can decide which treatment path is most appropriate for a specific patient.
The Human Element
To address the human elements impacting sepsis rates, the system in place includes clinical change management to develop best practices, including provider education and screening tools and protocols for early sepsis detection. Enhanced data analytics further manage protocol compliance, public reporting requirements and real-time data reporting, which supports system-wide best practices and performance improvement.
At John Muir, the staff implemented POC Advisor within two medical/surgical units for patients with chronic kidney disease and for oncology patient populations. Four MEDITECH interfaces sent data to the platform, including lab results, pharmacy orders, Admit Discharge Transfer (ADT) and vitals/nursing documentation. A clinical database was created from these feeds, and rules were applied to create the appropriate alerts.
Nurses received alerts on a VoIP phone and then logged into the solution to review the specifics and determine whether they agree with the alerts based on their clinical training. The system prompted the nursing staff to respond to each one, either through acknowledgement or override. If acknowledged, suggested guidance regarding the appropriate next steps was provided, such as alerting the physician or ordering diagnostic lactate tests, based on the facility’s specific protocols. If alerts were overridden, a reason had to be entered, all of which were logged, monitored and reported. If action was not taken, repeat alerts were fired, typically within 10 minutes. If repeat alerts were not acted upon, they were escalated to supervising personnel.
Over the course of the pilot, the entire John Muir organization benefited from significant improvements on several fronts:
- Nurses were able to see how data entered into the EHR was used to generate alerts
- Data could be tracked to identify clinical process problems
- Access to clinical data empowered the quality review team
- Nurses reported being more comfortable communicating quickly with physicians based on guidance from the system and from John Muir’s standing policies
Finally, physicians reported higher confidence in the validity of information relayed to them by the nursing staff because they knew it was being communicated based on agreed upon protocols.
Within three months, John Muir experienced significant improvements related to key sepsis compliance rate metrics. These included an 80% compliance with patient screening protocols, 90% lactate tests ordered for patients who met screening criteria and 75% initiation of early, goal-directed therapy for patients with severe sepsis.
Early data from Huntsville Hospital is equally promising, including a 37% decline in mortality on patient floors where POC Advisor was implemented. Thirty-day readmissions have declined by 22% on screening floors, and data suggest documentation improvements resulting from the program may positively impact reimbursement levels.
This kind of immediate outcome is generating excitement at the pilot hospitals. Though greater data analysis is still necessary, early indications are that a multi-faceted approach to sepsis holds great promise for reducing deaths and severity.
When I first started learning about EHR, the idea of using an EHR to help providers determine what is going on with a patient and what should be done was a primary objective – but with no one knowing how long it would be before this could happen. Clearly, codifying ‘rules’ was and is a huge challenge, but once it is clear that good can result, more should jump on that band wagon. This sounds like a good start!