“Saving one’s life or one’s child’s life should not be luck of the draw.”
These were the words that stuck with me most when I interviewed Ciaran Staunton last week, the father of Rory Staunton, a 12-year-old boy who tragically died from sepsis in 2012.
The story of Rory Staunton is a powerful one, an emotional undertaking for anyone to write or read. It can probably be best told here, in a story last month in People Magazine, but I will do my best to sum up the important details for the context of this piece.
In March 2012, during a normal school day in Jackson Heights, N.Y., Rory got a cut on his arm in gym class while diving for a ball. According to the People report, a gym teacher—not a nurse—put two Band-Aids on the cut without stopping to clean the wound first. The next day, Rory visited his pediatrician’s office, as he began to vomit with a 104-degree fever while complaining of pain in his leg. Then came a trip to the ER at NYU Langone Medical Center, where doctors treated him for dehydration and an upset stomach. But Rory’s fever would not subside; the next day he was brought back the ER, this time to the ICU. His parents were told that night that Rory was fighting for his life. According to the story in People, “Rory’s body was in septic shock brought on by an avalanche of responses his immune system was bringing to bacteria that had gotten into his blood through the cut in his arm.” Two days later, Rory would lose the battle, dying in the ICU.
In America, sepsis kills more people than AIDS, breast cancer, and stroke—combined. Worldwide, someone dies from sepsis every four seconds, according to an educational video embedded inside the People story. Now, according to the Centers for Disease Control and Prevention (CDC), sepsis is a medical emergency. Every year there are at least 1.7 million cases of sepsis and 270,000 deaths, the CDC says. What’s more, up to half of hospital deaths are due to sepsis, according to research published in the Journal of the American Medical Association.
Sepsis starts with any kind of infection or any time germs enter the bloodstream; in Rory’s case, the cut from gym class. The human body tries to fight the infection, but fails. The organs shut down, one by one. But what’s unique about sepsis, compared to cancer, for instance, is that there is a known cure—usually antibiotics and fluids are suffice. Therein lies the challenge in the medical community, though, since the issue here is about detection rather than treatment.
While speaking with Ciaran Staunton last week, I also spoke with Sean Benson, vice president and general manager of specialized surveillance at Wolters Kluwer, a global information services company with one of its specialties being healthcare. Benson is the creator of a sepsis surveillance tool created a few years ago that has proven to reduce sepsis mortality by more than 50 percent as well as reduce the 30-day readmission rate from 19 percent to 13 percent. What’s more, the system had observed sensitivity of 95 percent and specificity of 82 percent for detecting sepsis compared to gold-standard physician chart review, according to the research.
Explaining further, Benson says that the single biggest challenge seen over the years with sepsis, a challenge that was taken on by his team when it started to build out the product, is that alert fatigue is a huge problem with clinical systems. “If we can’t build a system that has very limited alert fatigues, one that is highly accurate and identifies patients very early in the condition, then there won’t be any value,” says Benson. “We have studied what the EHRs [electronic health records] and other systems have done, and they have very low ‘specificity,’ which basically ties to the accuracy of the alert. So they can perhaps be good in catching and identifying the patients at some point in the process, but there is a lot of over-alerting and false positive alerts.”
Indeed, a KLAS report from earlier this year which interviewed providers who are employing sepsis solutions noted that because most EMR vendors lack easily deployed sepsis solutions, some providers are looking to other sources, with infection control and surveillance vendors such as Wolters Kluwer and VigiLanz perceived as most focused. “(Wolters Kluwer’s) POC Advisor pulls data out of our EHR to an engine with all of these rules and then shoots alerts to mobile devices,” the research report quoted one CMIO.
It should be noted that the KLAS report also stated that the adoption of Cerner’s and Epic’s sepsis technology is higher than all other sepsis solutions combined, with customers of both reporting improved outcomes, including mortality reductions. The report quoted an IT director as saying, “We have been using (the Cerner sepsis) product for seven months with excellent results.”
Explaining how the POC Advisor tool works, Benson says that the system surveils patients in real time anywhere in the hospital—the floor, the ED, or the ICU, for example—and pulls data out of all of the clinical systems that are relevant, such as the EHR, lab system, and pharmacy system. It pulls that information into the cloud and runs the data across hundreds of clinical rules that the content team has built internally. The tool can also pull unstructured data, such as physician progress notes.
Benson’s team then analyzes that data in real time. “When a patient who has an issue is identified as potentially showing early signs of sepsis or another urgent condition, we send a very patient-specific evidence-based, targeted, actionable alert back down to point of care to the right person—the nurse, physician, rapid response team, or pharmacist—giving them a rationale for why they are receiving the alert and very specific advice on what to do next,” Benson explains.
There is also a follow-up approach to make sure that those clinicians are following the protocols, says Benson. For instance, if a nurse agrees to order a test to measure lactate levels to see if a patient might have sepsis, the team starts to monitor what the nurse has agreed to do, and if the nurse doesn’t order the test or the test results are not seen, an alert is sent to the nurse to make sure it’s being ordered. “There is a need to follow through on every single alert,” notes Benson.
The results from this tool, which is currently up-and-running in a handful of hospitals, speak for themselves. Particularly touting that the system had observed sensitivity of 95 percent and specificity of 82 percent for detecting sepsis, Benson says these results are “unprecedented in literature,” adding that “no other system has come close to this.”
A Father Continues His Fight
Meanwhile, for Ciaran Staunton, the days are spent fighting for more states to improve their sepsis protocols. "Rory's Regulations” have been created, with the goal to require hospitals to quickly perform a checklist of safety measures when people show up at hospitals with sepsis. A recent New England Journal of Medicine report found the faster hospitals completed the checklist of care and administered antibiotics, the lower the risk of death in hospitals from sepsis. With each additional hour it took, the risk of death increased by 4 percent. Nonetheless, according to Staunton, only New Jersey, New York, Pennsylvania and Illinois have enacted Rory’s Regulations thus far.
Staunton points to the fact that since these regulations were enacted in New York four years ago, at least 5,000 lives in the state were saved from what would have been sepsis-related deaths. But over that same time period, more than 1 million Americans have died in other states. “If this was Ebola or something else, would [enacting these regulations] be happening at this snail’s pace?” asks Staunton, noting that not so long ago, the CDC had nothing on its website related to sepsis. “Finally, after four years of heavy lobbying, sepsis has been declared a medical emergency,” Staunton says.
After speaking with Staunton, I was inspired to contact the CDC to get its thoughts on this problem. In a statement, a spokesperson said, “CDC looks forward to learning from the approaches that states are taking to improve sepsis recognition and care. Sepsis is a medical emergency that every American needs to be aware of….CDC recently launched Get Ahead of Sepsis, an educational initiative which calls on healthcare professionals to educate patients, prevent infections, suspect and identify sepsis early, and start sepsis treatment quickly. Detecting sepsis early and starting immediate treatment is often the difference between life and death.”
I also reached out to the Centers for Medicare & Medicaid Services (CMS) for a statement. The agency said it has a national sepsis measure that assesses how well hospitals follow evidence-based protocol care. In the statement, a CMS spokesperson noted that the sepsis measure is contributing to hospital sepsis care improvement nationally, with over 99 percent of hospitals across the country successfully reporting the measure. Since the introduction of the measure in October 2015, CMS data shows that hospitals give antibiotics within three hours and check appropriate lab tests more consistently. The data analysis also shows that there is statistically significant reduction in the association between a case passing the measure (using protocol) and reduced mortality.
In our call, Staunton had a skeptical tone on what government health agencies have done so far to help with sepsis early detection. But can you really blame him? He said he would love to see the government paying as much attention to sepsis as it did in recent years to Ebola and Zika. It’s hard to argue with him when you consider that the 2014 Ebola outbreak led to one death in the U.S., while the Zika virus epidemic in 2015 to 2016 also resulted in one total death.
This hasn’t stopped Staunton from doing his part, going state-to-state meeting with health administrators. “By the time I talk to you next year, between a quarter and a half-a-million people will have died from sepsis, people who would still be alive if they lived in New York. Why is it OK to die from sepsis but not from other [conditions]?” he asks.
Obviously it’s not OK, and more needs to be done to reduce these tragic death toll figures. In New York, Northwell Health physician Martin Doerfler, M.D., last year received the Sepsis Alliance’s Sepsis Heroes Award for his work in raising awareness of the deadly condition and leading clinical efforts that have saved thousands of lives. And thankfully, due to tools like the POC Advisor, health IT can play a large role as well. KLAS researchers concluded from the aforementioned report that “Sepsis detection and treatment is taking a big step forward as providers increasingly utilize surveillance and monitoring technology.”
Let’s hope that this momentum continues and that more states enact mandated protocols, because as Ciaran Staunton says, “Saving one’s life or one’s child’s life should not be luck of the draw.”