A team of clinicians and quality leaders from the Institute for Healthcare Improvement (IHI) is helping to drive forward the work of a remarkable international partnership, the Surviving Sepsis Campaign, dedicated to reducing the global toll of a deadly syndrome that kills more people in a year in North America than breast cancer, lung cancer, and colon cancer combined. Worldwide, 1,400 people die each day from sepsis.
Sepsis can come in several forms. The most common manifestation, sometimes referred to as ‘uncomplicated’ sepsis, may affect more than a million people each year. It develops when bacteria from a contaminated wound, a dental abscess, or a urinary tract infection, for example, gain access to the bloodstream. While patients with this form of sepsis may become quite ill and require hospitalization, they are more likely to respond to treatment than patients at the next level.
Severe sepsis is a much more serious condition. It can occur in otherwise healthy people when a bacterial infection invades the body and pollutes the bloodstream with toxic products. But it often develops in hospitalized patients who have catheters and intravenous lines tunneled beneath the skin, people with compromised immune systems, burn victims, or anyone with open wounds. Individuals with severe sepsis — an estimated 750,000 individuals a year in North America alone — must be aggressively treated. When severe sepsis is undiagnosed, or treatment is delayed or perhaps inadequate, a patient may progress to septic shock — a medical emergency leading to potentially fatal complications.
Even with the best resources available, the mortality rates associated with sepsis are extremely high: 30 to 50 percent for severe sepsis and 50 to 60 percent for septic shock. Contributing to the prevalence of sepsis, with its steep mortality rates, are more aggressive medical treatments and invasive procedures.
According to Mitchell M. Levy, MD, a Professor of Medicine at Brown University Medical School, and Director of the Medical Intensive Care Unit at Rhode Island Hospital, “Data suggest that the incidence of severe sepsis, given the graying of North America, is going to double over the next 25 or 30 years — with enormous implications for resource allocation and utilization.”
Advances in Science Compel Action
Several years ago, Dr. Levy and colleagues affiliated with the US-based Society of Critical Care Medicine
(SCCM), realized that such dismal outcomes were no longer beyond their control. Based on compelling, widely published data, they felt there was a strong case for making systemic changes in the care of patients with sepsis. While for years physicians had limited treatment options, explains Dr. Levy, “Today we have interventions targeting specific stages of sepsis, and some very good data reflecting a survival benefit with these interventions.”
Levy’s colleague, Sean R. Townsend, MD, cites an example. Dr. Townsend is a Fellow in Pulmonary and Critical Care at the Massachusetts General Hospital, and an IHI faculty member. He says a landmark study reported in the New England Journal of Medicine in 2001, demonstrated a 16 percent reduction in mortality from sepsis with a new protocol known as “early goal-directed therapy.” *
The approach, explains Dr. Townsend, is based on early identification. Once severe sepsis is diagnosed, the strategy demands the early use of antibiotics and measurement of circulatory and metabolic function, to guide the delivery of intravenous fluids and other essential medications.
Unprecedented International Collaboration
“We felt that there were enough advances in the literature,” explains Dr. Levy, “to allow us to greatly improve the standard of care offered to patients with sepsis and significantly improve mortality rates.” The unprecedented collaboration and consensus on the data, he believes, reflect growing awareness that “the era of individual practice variations really needs to come to an end.”
The first step the Campaign leaders took was to synthesize best practice data from the literature into a single document, a unified set of recommended procedures. In March 2003, they published the resulting guidelines in two key critical care journals. “This was a huge step,” says Dr. Levy, but of limited impact because the new protocol was fairly long and complex. As he puts it, “It’s not enough to write guidelines, you have to make them usable at the bedside.”
Operationalizing New Guidelines at the Bedside
To do that, the Campaign leaders partnered with IHI. Kelly McCutcheon Adams, who directs IHI’s Breakthrough Series Collaborative in ICU care, says, “The international coalition turned to IHI for its expertise in accelerating change, helping providers on the front lines translate new science into results.”
A team from IHI led by Terry P. Clemmer, MD, a critical care director at LDS Hospital in Salt Lake City, UT, employed a proven strategy known as “bundling.” Dr. Clemmer’s team condensed the new practice guidelines into small, simple units (bundles), comprised of multiple changes that, when implemented together, result in better outcomes than when performed individually.
Several critical care teams have tested early versions of the sepsis bundle
, and the design team is incorporating their changes in the final formatting of the bundle. The international societies and several hospital groups are offering input as well toward the final version.
To further support clinicians implementing new procedures, the IHI team and Campaign leaders created a new section on the IHI website dedicated to sepsis treatment. The site is meant to be a hands-on resource, says Dr. Levy, “designed in a ‘how to’ format.” It offers clinicians simple instructions and support in implementing the change steps.
The site includes the process and outcome measures associated with the bundle, and a data tracking and reporting tool called an Improvement Tracker
. For organizations new to quality improvement science, it introduces the Model for Improvement
, the methodology at the heart of IHI’s quality philosophy. There are also links to supporting materials and resources on the web, as well as a community forum in which clinicians can share their experiences while making the changes.
The leaders of the Surviving Sepsis Campaign acknowledge the challenges ahead and say closing the gap between current practice and best practice in sepsis care will require overcoming significant obstacles. The new practice guidelines are difficult to implement, admits Dr. Townsend of Massachusetts General Hospital. “Early goal-directed therapy requires attention of physicians to a lot of details, and staff resources to measure and monitor patients.”
Further, says Dr. Townsend, the process demands cooperation among typically isolated clinical teams: emergency department (EDs) and intensive care units (ICUs). Patients with severe sepsis often arrive in the ED and get transferred to the ICU for treatment. To succeed, the new guidelines require a seamless flow of interventions throughout the hospital stay — continuity of care across departments, with physicians at every level on the same page.
The Key Ingredient: Will to Change
There are very real challenges ahead that are logistical, practical, and cultural. But, Dr. Levy notes, this is nothing new: “All of us, researchers and clinicians alike, have struggled to incorporate research into bedside practice. It takes time and it isn’t easy, but the rewards drive us forward.” He feels that his team has laid the foundation for a “movement” to improve survival rates for sepsis, by publishing the guidelines, developing the bundles and creating the new website.
With these efforts, Levy says, the partnering societies are doing everything they can to “make it easier for physicians to adopt the new research — to make the right thing to do the easy thing.” Dr. Levy and his colleagues are getting the word out internationally, with presentations and website demonstrations. It has been interactive and engaging process. “We want people to go to the website, look at the measures, download the tools, and tell us what you think,” says Dr. Levy. “This can only work if clinicians implement these tools in their institutions, begin to measure their results, and report back to us. Give us your feedback and we will respond.”
Complementary programs to educate and support clinicians in the field are already underway. Beginning November 2, 2004, IHI is holding a Calls to Action conference call series on Innovations for Treating Sepsis. The calls will be hosted by the physicians behind the Surviving Sepsis Campaign and the developers of these new tools. IHI is also finalizing related programs in sepsis treatment for coming months.
Dr. Townsend, who himself has one foot in a hectic critical care unit of a large urban teaching hospital, takes a ‘big picture’ view of the situation. “From my perspective, these tools exist now, with the real potential to save thousands of lives. Short of curing infectious diseases, these are things physicians can do now to make a real difference.” He adds, “The only thing stopping us is lack of will to get it done.”