The introduction of a controversial new core measure for sepsis bundles is refocusing attention on one of health care’s most vexing conditions.
The Centers for Medicare & Medicaid Services has wanted to launch a core measure for sepsis care for years, but emergency department physicians and others have opposed it, saying some elements of the core measure bundle are not evidence-based.
Nonetheless, use of the sepsis bundle has reduced the death toll from the condition, and CMS is trying to standardize care for the huge population of patients who acquire it. Every year, 750,000 Americans are diagnosed with the condition and 220,000 of them die, according to the Joint Commission.
In 2014, 11 percent of patients discharged from an acute care hospital had a sepsis diagnosis — and 48 percent of patients who died in a hospital suffered from sepsis. Nationally, the mortality rate for sepsis is between 25 and 50 percent, but health systems that have made it a priority have demonstrated that it can be much lower.
North Shore-Long Island Jewish Health System in New York is one of them. The 15-hospital system received a 2014 John M. Eisenberg Patient Safety and Quality Award from the Joint Commission and the National Quality Forum for reducing sepsis mortalities by 50 percent since 2009.
Traditionally, says Martin Doerfler, M.D., senior vice president of clinical strategy and development, sepsis was considered the purview of the intensive care department and the goal was to keep patients with septic shock from dying.
When CEO Michael Dowling highlighted sepsis mortality as an organizational priority, about a dozen clinical leaders — emergency physicians, critical care physicians, nurse leaders and quality officers — convened to figure out what to do. “That group came to the conclusion that if we were really going to make a difference, the best way was to move upstream,” Doerf- ler says. “Instead of focusing on the specific subgroup that was dying, we should try to minimize the number of individuals who went downstream and, therefore, were at risk of dying.”
The multidisciplinary group, which started its work in 2010, identified the need to develop triage criteria to screen ED patients for sepsis and re-engineer processes to speed:
- Administering early antibiotics to septic patients.
- Returning serum lactate test results to physicians so they know whether a patient has severe sepsis.
- Starting fluids appropriately.
“Doing that with a variety of folks with different viewpoints in the room and having a consensus on where to start were critical to the success we’ve since demonstrated and hope to continue,” Doerfler says.
Today, all New York hospitals are subject to regulations, enacted in 2013, that require protocols for the early diagnosis and treatment of sepsis. The New York Department of Health estimates that the regulations will save at least 5,000 lives each year.
Rory’s Regulations, as they are called, became law after 12-year-old Rory Staunton died of sepsis that went unrecognized by his pediatrician and ED clinicians. Doerfler serves on the medical advisory board of the Rory Staunton Foundation, which advocated for the law and seeks to raise awareness and improve the diagnosis and treatment of it.
At North Shore-LIJ, two departments — quality and improvement science — collaborated with a systemwide task force to develop new care algorithms. Those include antibiotics that will be administered within 180 minutes of sepsis diagnosis and within 60 minutes of severe sepsis diagnosis. The group also determined the metrics used to track compliance and monitor progress. Each hospital has its own sepsis task force, and the processes used to carry out the work are determined at the department level within each facility. “We allow each different environment to figure out how they will best accomplish it, because they have unique challenges and unique resources, as well as sometimes different patient populations that they will encounter,” Doerfler says.
North Shore-LIJ partnered with the Institute for Healthcare Improvement to address sepsis and used IHI’s methodology to support process re-engineering. The work also was supported by quarterly off-site learning sessions at which front-line teams received education about the science of sepsis care and improvement science.
To keep sepsis care as a priority, Doerfler’s department hosts a biweekly all-sepsis collaborative conference call for staff throughout the system to discuss their progress and challenges.
The 50 percent drop in sepsis mortalities has come without an expensive infrastructure, he says. A nurse manager in the improvement science department dedicates 40 percent of her time to support the sepsis project, and an industrial engineer spends 20 percent of her time helping local hospital teams to identify and remove barriers to compliance with the system’s sepsis care protocols. “For everybody else, this is embedded into their day jobs because it’s how we want to care for patients,” Doerfler says. “This is something that is scalable and can be picked up in other organizations, because we did not create a big addition to the budget to do this work.”
Data — the best medicine
Intermountain Healthcare also deployed protocols for the aggressive detection and treatment of sepsis to reduce its sepsis mortality rate by more than 50 percent. Over a six-year period beginning in 2004, Intermountain cut the rate from 20.2 percent — already one of the best in the nation — to less than 9 percent.
Success was tied directly to an intensive implementation at 15 Intermountain hospitals that have both an ED and an ICU, achieving 80 percent compliance with a bundle of 11 clinical elements — four specific to the ED, four for the ICU and three that could be applied in either setting — during the first 24 hours of treatment. In 2011, the bundle was reduced to seven elements; two were eliminated based on new medical evidence and two were removed for reporting purposes, but not for practice.
Intermountain’s sepsis protocols are saving more than 100 lives each year, and there is still room for progress, says Todd Allen, M.D., who chairs the ED development team in Intermountain’s Intensive Medicine Clinical Program.
For one thing, Intermountain is trying to identify patients with sepsis earlier and more consistently by working with urgent care centers and non-intensive care inpatient units to improve screening, detection and early treatment. “The second effort is to continue to refine our data systems and our reporting so that they become more accurate and more real-time, assuring that we have good data upon which we can make good administrative and clinical decisions,” Allen says.
Indeed, the use of data is an important part of Intermountain’s success in curtailing deaths from sepsis. For starters, Intermountain leaders use a scoreboard to monitor each facility’s compliance with the entire bundle and each individual element in the bundle. They also track three main outcome measures: mortality, inpatient length of stay and cost.
The data support continuous improvement in two ways. “I can look at the dashboard and say, ‘Hey McKay-Dee Hospital, you’re doing great on the element of antibiotics in three hours — how are you doing this?’ What can we share?’” he says.
Additionally, the performance variation among hospitals can be analyzed to determine what elements of the bundle are most significant to good outcomes or where root-cause analysis may be needed. Beyond that, data about all sepsis patients — lab and X-ray results, length of stay, intervention results, comorbidities and more — have been systematically collected for the past 11 years into a sepsis “datamart.” “We can do our own research, using formal or informal research methods, to discover new information about questions that we come up with,” Allen says.
That rich data set also allows Intermountain to embed its electronic health record system with decision support “alerts” that notify the care team when a patient’s condition is beginning to match those of previous patients who have suffered sepsis.
Bringing everybody on board
Wake Forest Baptist Health put sepsis on the front burner when analysis of benchmarking data showed that its sepsis mortality index was significantly higher than those of its comparative institutions.
Its sepsis initiative worked. Within two years, the average amount of time to start antibiotics for a septic patient on an inpatient floor fell from 396 minutes to 53 minutes, and total compliance with a four-element bundle of care for sepsis patients went from 13 to 71 percent. The result: the sepsis mortality index dropped below that at benchmark health systems, and has remained there for nearly three years.
The keys, says Ryan LeFebvre, performance improvement adviser, were executive support and multidisciplinary collaboration. “When it’s something that the folks at the top really believe in, and they’re willing to put themselves out there as advocates, it’s going to happen,” he says.
An hour-long educational session, featuring patient stories and a review of protocols, was mandatory for everyone from physicians to receptionists.
For the first six months, Cathy Messick-Jones, M.D., the physician champion for sepsis care at that time, tracked the response to every Code Sepsis incident. If any element of the bundle was not completed in the appropriate time, she called or emailed to find out why.
“Dr. Jones would actually reach out to physicians individually and say, ‘What happened here? Why weren’t we compliant?’” LeFebvre says. “Having that level of executive support was huge. It made people feel like this was an important thing to do.
Sepsis is an injury to the body resulting from the immune system’s attempt to eradicate an infection. “Think of it as collateral damage in a military sense, where you’re trying to get the enemy but, in the meantime, you are destroying whatever else is in town because it just happens to be in the same area,” says Martin Doerfler, M.D., senior vice president of clinical strategy and development at North Shore-LIJ Health System.S in New York.
Sepsis is a tricky topic because there are three stages of the condition, diagnosis can be difficult and definitions may be changing. At the moment:
- Sepsis is defined as infection plus the presence of at least two systemic inflammatory response syndrome criteria, such as rapid heart rate, high or low body temperature, low blood pressure, unexplained altered mental state and others.
- Severe sepsis means there is organ dysfunction caused by sepsis.
- Septic shock is severe sepsis plus low blood pressure or high serum lactate not reversed with fluid resuscitation.
The definition of basic sepsis is under attack by some specialists who think it is too broad, prompting patients to be treated unnecessarily, and by others who think the definition misses some patients who should be treated immediately. A debate about the definition is playing out in medical literature.
Despite that, everyone agrees that early diagnosis and treatment are essential to prevent a patient’s condition from deteriorating to the more advanced stages, where death is common. More than 220,000 people in the United States die from sepsis each year, and it is the most expensive disease to treat in the hospital, costing about $24 billion annually, according to the Agency for Healthcare Research and Quality.
Despite its burden on patients and the health care system, sepsis has not received as much attention as some other treatable conditions. That is because it is more challenging in a few ways.
Surgical-site infections, for example, can be targeted by interventions along the well-defined path from preoperative evaluation through rehabilitation that every surgery patient travels. By contrast, sepsis can attack anyone, but is most common in patients who are very young or very old, have a compromised immune system, have wounds or injuries, have serious comorbidities or have invasive devices. That means that just about every acute inpatient throughout a hospital is at risk.
It’s fairly obvious who should be part of the clinical team responsible for tackling surgical-site infections because of the patients they serve. The team to address sepsis, on the other hand, needs to include ED and critical care physicians, hospitalists, nurses and others who might not immediately come to mind. “One of the most important lessons that I learned leading this effort was that I had to have a phlebotomist on all of my teams if I really wanted to maximize our ability to make a difference,” Allen says.
Another challenge: Because there is little awareness of sepsis among the public, patients and family members rarely recognize symptoms that might point to that diagnosis in a more timely fashion.
And, while treatment guidelines do exist, the knowledge base about sepsis includes major gaps. For example, there is no consensus definition for septic shock in different care settings, and there is uncertainty about optimal treatment.— Lola Butcher
Q&A: Andrea Kabcenell, IHI
When the Institute for Healthcare Improvement began working on critical care two decades ago, sepsis management was not on its hit list. But as the sepsis toll became clear, IHI spent several years focused on reducing sepsis mortality. “We are very excited to see that this topic has taken hold and it has become a widespread concern and another opportunity to reduce unnecessary deaths,” says Andrea Kabcenell, R.N., an IHI vice president.
Why is the new sepsis bundle core measure, which is debuting this year, controversial?
Kabcenell: A lot of people who haven’t had experience with the sepsis resuscitation bundle fear it is not safe science yet and it’s out of reach. So, having a core measure about it feels like a push too soon.
Creating a core measure is a strong way to [get hospitals to focus on sepsis mortality], but it’s an effective way to do it. When something becomes a core measure, it gets attention. But there may be unexpected consequences along the way as people struggle to get up to speed.
Sepsis management used to be considered an intensive care unit problem, but now there is a wide range of approaches to improving sepsis care. What do you advise?
Kabcenell: The quickest way to reduce sepsis mortality is to start in the emergency department and focus on early diagnosis and adherence to the sepsis bundle as an all-or-none bundle, not just one or two elements of it. That’s been productive for almost everyone because if you can catch people with sepsis early in their ED stay and before they are sent to a unit, they have a good start. The discipline to get that diagnosis right and, under those circumstances, have the confidence to get the communication right and load up on fluids when needed serves well when you move to other parts of the hospital.
There are reasons people want to start in the ICU — there’s a team there and it’s easier to control the work, and often emergency departments are so beleaguered that people don’t want to start there with a new initiative. But ultimately, if they want to reduce mortality in the organization, the biggest bang for the buck is in the ED.
Hospitals typically have sepsis mortality rates between 20 and 50 percent. What should leaders set as the target?
Kabcenell: They should not start with the idea, ‘Oh, well, we’re already at 20 percent, so we don’t have to worry.’ That’s not the right attitude. The right attitude is that, unless you have an unusually low mortality rate — like 10 percent or lower — you can make big gains wherever you are. In fact, you’ll probably cut the rate in half over a couple of years.
Start by looking at compliance rates to make sure the individual elements of the sepsis resuscitation bundle are improving and compliance is approaching 100 percent. Then look for high compliance with the entire bundle. Then you’ll start to see the sepsis mortality move.
What makes sepsis management so challenging?
Kabcenell: Getting sepsis mortality down in most hospitals requires a lot of cross-boundary communication. When a patient who has sepsis leaves the ED and goes to the unit, coordination is really tough, and the ability to take care of those patients across boundaries challenges everyone.” — Lola Butcher
Evan Benjamin, M.D., senior vice president for quality and population health and chief quality officer for Baystate Health in Springfield, Mass., serves on the board of trustees of Mercy Health, which operates more than 200 health care organizations in Ohio and Kentucky. Shortly after the Mercy Health board started receiving mortality reports, it became clear that sepsis deserved a hard stare.
His recommendations for trustees:
- Insist on best-practice care protocols that have been vetted by a national organization. The Surviving Sepsis Campaign care bundles — four steps to be taken within three hours of diagnosis and three additional steps to be taken within six hours, depending on patient need — is one example.
- Ask for sepsis care compliance to be reported as an all-or-none score at the per patient level. Management must track compliance with individual elements of the sepsis bundle for performance improvement efforts, but board members need the bottom line. “In other words, what percent of patients are really getting perfect care?” Benjamin asks.
- Evaluate the system’s performance using a risk-adjusted mortality rate, rather than the simple mortality rate. The risk-adjusted rate compares the actual number of inpatient deaths during a specific period with the predicted number of deaths based on patients’ levels of illness. A mortality ratio of less than 1 is good; higher than 1 is bad. Compare the risk-adjusted sepsis mortality rate with that of other health systems to assess your own performance.
- Monitor mortality and compliance data for each hospital in the system, as well as the system as a whole.