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 sepsis a priority have demonstrated that it can be much lower.
Diagnosing and treating early
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.
That success stems from a total overhaul in the way North Shore-LIJ approaches sepsis diagnosis and treatment. 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.
A Primer On Sepsis: 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.
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,” Doerfler 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 emergency department 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.
Framing the Issue
• A new core measure for sepsis care was launched for fiscal 2016.
• Nearly half of patients who die in the hospital have sepsis.
• The mortality rate for patients with severe sepsis ranges from 25 to 50 percent in most U.S. hospitals.
• While sepsis cannot be eradicated, health systems that make an effort are able to drastically reduce sepsis mortality.
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 New York law and seeks to raise awareness of sepsis and improve the diagnosis and treatment of sepsis broadly.
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. “Allowing the front-line team to understand ‘This is the goal, but we can decide how we’re going to get there and own that’ has been a piece of our success.”
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 during which staff throughout the system discuss their progress and challenges.
The 50 percent reduction 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, starting in the ED, 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, where it remains.
Success was tied directly to an intensive implementation at 15 Intermountain hospitals that have both an ED and an intensive care unit, 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 emergency department 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 sepsis 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.
Those data points support continuous improvement efforts 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?'” Allen says. 'What can we share? How can we make those learning opportunities transparent across the system?'”
Additionally, the performance variation among Intermountain 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 to identify barriers to good performance.
Beyond that, data about all Intermountain’s sepsis patients — laboratory and X-ray results, length of stay, intervention results, comorbidities and more — have been systematically collected for the past 11 years. The sepsis “datamart” includes information about thousands of patients, and it grows with every new sepsis diagnosis.
“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.
“If we are successful in identifying patients who are on a path to sepsis, and we intervene appropriately and in a timely fashion, we make them — as we use the term here — ineligible for developing septic shock,” Allen says. “The key is to use this robust database of thousands of patients to have a maximally sensitive, maximally specific alerting system that prevents patients from populating that database in the future.”