Sepsis Care Enters New Era

They are principles key to transforming health care: teamwork and adherence to standards. In a demonstration of exactly these qualities, a worldwide movement, the Surviving Sepsis Campaign (SSC), in partnership with the Institute for Healthcare Improvement (IHI), is breaking new ground in a battle against an elusive foe.
 
Sepsis occurs when bacteria invade the body and enter the bloodstream. It has several forms, representing a continuum of evolving symptoms.  Sepsis can arise from infections as common as a urinary tract infection, a skin infection, appendicitis, or a dental abscess. Severe sepsis develops when vital organs such as the heart, lungs or kidneys start to malfunction. If treatment at this stage is delayed or inadequate, patients with severe sepsis can lapse into a septic shock, a dire condition in which blood pressure plummets, the cardiovascular system begins to fail, and cells throughout the body are progressively starved of oxygen. 
 
Mortality rates for severe sepsis are 30 to 50 percent; for septic shock, as high as 50 percent. In the US alone there are approximately 750,000 new cases of sepsis each year, with some 225,000 ultimately fatal. Worldwide, 13 million people become septic each year and four million die. And the incidence of sepsis is increasing and will continue to do so as the population ages. 
 
The Surviving Sepsis Campaign is challenging these dismal numbers. The initiative, sponsored by the Society of Critical Care Medicine (SCCM) and partner organizations in Europe, has brought together communities of physicians across medical specialties, professional societies and continents who all treat patients with sepsis, yet rarely in unison. The combined coalition has pledged to redefine sepsis care by embracing standards: a set of evidence-based guidelines for the care of critically ill patients with sepsis. A core team has defined and packaged the guidelines for front-line implementation; a clear, easy-to-use web-based suite of information and tools that hospital systems and networks worldwide are just now adopting.
 
Parallel efforts underway based on the methodology and approach advocated by the SSC have brought exciting results. In recent projects where they have been applied, patients with severe sepsis are staying alive, increasingly spared the most harmful consequences of the disease. The campaign is gaining support and momentum at a pace that brings the ambitious target, to reduce sepsis mortality by 25 percent in five years — some 80,000 lives each year in the US and one million globally — within reach. The initiative is also timely. According to Sean Townsend, MD, IHI faculty member and Fellow in Pulmonary and Critical Care Medicine at Massachusetts General Hospital (MGH) in Boston: “I see the SSC as the sister campaign to IHI’s 100,000 Lives Campaign.  We’re at least the ‘80,000 Lives Campaign’ — and we’re only one disease.”
 
The Challenge
We are all at potential risk of sepsis, but certain populations much more so: people with a weakened immune system because of underlying disease or certain treatments they are receiving including chemotherapy. Burn victims and trauma patients, those wounded in car accidents or violence, for example, are also at greater risk. Hospitalized patients are especially prone to develop sepsis because of exposure to resistant bacteria in the hospital, sub-optimal use of antibiotics, and the nature of certain treatments; intravenous tubes, wound drainage and catheters all present avenues for germs to enter the body and spread.
 
Despite its prevalence and serious consequences, awareness of sepsis remains low.  According to Townsend: “Sepsis is frequently under-diagnosed at an early stage when it is still potentially reversible. Many patients don’t receive aggressive therapy early enough in their course.”  
 
Several years ago, a team of physicians led by Mitchell M. Levy, MD, Professor of Medicine at Brown Medical School and Medical Director of the Medical Intensive Care Unit at Rhode Island Hospital, resolved to take action. They assessed the factors behind the unacceptably high sepsis mortality rates in light of new research findings.  Levy and his colleagues associated with the Society of Critical Care Medicine saw an opportunity. They realized there was much they could do to improve the odds for their patients with sepsis.
 
The first step was to formally mobilize. They introduced the Surviving Sepsis Campaign at a series of international critical care medicine conferences in 2004, setting in motion an unprecedented process of global collaboration among three leading professional organizations in the field of sepsis: Levy’s SCCM, the European Society of Intensive Care Medicine, and the International Sepsis Forum. A consensus committee representing nearly a dozen international organizations involved in sepsis care then began crafting standards. They pulled together the best of the newest science into a set of evidence-based guidelines for the management of severe sepsis and septic shock. To help translate these guidelines into widespread practice, the SSC leaders turned to IHI. 
 
Packaging Guidelines for the Front Lines
A team of IHI faculty with clinical backgrounds in critical care and emergency medicine, including MGH’s Townsend, Phillip Dellinger, MD, of Cooper University Hospital, Roger Resar, MD, from the Mayo Health System, and Terry Clemmer, MD, of LDS Hospital and the University of Utah School of Medicine, distilled the practice guidelines into a manageable format for hands-on practice. They followed a proven strategy of packaging the central elements into a sepsis ‘bundle.’ A bundle, which is a concept developed by IHI, is a group of interventions that, when implemented together, result in better outcomes then when implemented individually.  
 
There are two Severe Sepsis Bundles, available with clear instructions for use on the web. The two bundles address the management of patients at different stages of sepsis. Each bundle is a short list of interventions to be started immediately and completed within a fixed number of hours. The steps are technical and specific; they call for obtaining blood cultures and measures of circulatory and metabolic function, aggressive administration of antibiotics and delivery of intravenous fluids, and so on. 
 
The power of the bundles, explains Sean Townsend, comes from both the body of science behind them and method of execution: with absolute consistency. “Recent trials demonstrate a mortality benefit with new interventions, but they are not being applied uniformly or quickly enough to the patients who need them.” This shortcoming, he says, has made treatment for severely septic patients unreliable, at times idiosyncratic. 
 
Addressing this gap, the Severe Sepsis Bundles require that every single step be completed for every severely septic patient. At the same time, explains Townsend, the developers built in a level of flexibility: “The bundles are not ready-made clinical protocols for individual hospitals,” he says, but “should be used as templates to develop customized clinical pathways to fit the needs and care patterns of each institution.” 
 
Terry Clemmer, also a contributor to the bundle design, says: “Our philosophy is, don’t try to micromanage. We wanted to make the bundles more general.  So we say ‘give antibiotics,’ but we leave it up to the physicians in a hospital which one they use.” 
 
The joint SSC/IHI website package also includes 11 quality indicators to gauge whether the changes clinicians are making are actually leading to improvement.  Hospital teams create their protocol from these tools, and are guided by the website in collecting data for measurement, assessment and aggregate analysis.
 
Parallel Developments
In parallel with the introduction of the SSC’s Severe Sepsis Bundles, several other US groups have reported notable results from complementary sepsis improvement campaigns. One of these is out of Loma Linda University in California, where Dr. H. Bryant Nguyen developed a protocol for improving sepsis care for patients treated in the emergency department (ED). Nguyen’s initiative, named the 6-hour Strategies to Timely Obviate the Progression of Sepsis, or STOP Sepsis bundle, is built on the SSC guidelines, adapted for Loma Linda’s emergency department environment.
 
The basis of the STOP Sepsis bundle is a methodology pioneered by Dr. Emanuel P. Rivers known as early goal-directed therapy (EGDT). EGDT dictates rapid identification of sepsis in the earliest phases, followed by immediate initiation of specific interventions. Nguyen’s group at Loma Linda achieved a 22 percent drop in sepsis mortality in the ED using the STOP Sepsis Bundle, from 34.2 percent to 12.5 percent.
 
Another major three-year initiative targeting sepsis mortality was launched in 2003 by VHA Health Foundation, in which Johns Hopkins University, VHA Inc., and the Joint Commission on the Accreditation of Healthcare Organizations joined together to develop national measures of quality for sepsis care. This effort focused on sepsis care in the intensive care unit (ICU), the other main setting in which patients with sepsis are treated. Twelve hospitals have been testing a set of sepsis metrics, an approach that mirrors that of SSC: adopting a set of evidence-based interventions to redesign the process of care, then measure the results, evaluate outcomes and refine changes.
 
Combining the Best of the Best from Complementary Efforts
According to Sean Townsend, both the STOP Sepsis and VHA initiatives support the SSC strategy and potential for success. “They’ve shown us that the goals are achievable. We’re building on the findings from both projects, coming up with a combined set of indicators for the field. Our combined approach should enjoy greater success than the more limited focus of the other initiatives.” 
 
In particular, the SSC measure set is geared to both emergency department and critical care settings because, as IHI’s Terry Clemmer explains: “ED physicians see sepsis patients coming in from outside the hospital, but the ICU also sees another group: patients who develop sepsis in the hospital from an infection after surgery, for instance. We know we have to work together, we have to cross domains.”  The SSC package also integrates the early goal-directed therapy approach of the STOP Sepsis bundle with other clinical features in the VHA’s bundle.  
 
In related activities, the US hospital accreditation body, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), is defining core measures for sepsis care based on these advances. The SSC is now working with JCAHO in an ongoing collaboration that reflects JCAHO’s broader commitment to uniform, industry-wide standards.
 
The SSC’s Mitchell Levy describes a growing implementation framework, worldwide hospital systems and networks signing on to the project by the day. He says Surviving Sepsis Campaign networks are forming in the UK, Ireland, Portugal, Spain and France, and through statewide hospital associations in the US.  The networks are engaged and enthusiastic. “In three to four months,” says Levy, “we should have 30 to 50 hospitals collecting data on the sepsis bundles.” Given such progress, says Levy: “Our expectation that this would become a global effort at improving sepsis care and reducing mortality rates is in fact becoming a reality.” 
 
New Model of Care
Townsend is equally optimistic about reaching the implementation phase of the Surviving Sepsis Campaign: “The resources are there, the measures have matured and are ready to deploy. The website will help physicians basically implement their own improvement campaigns. You can’t ask for more than that in trying to promote change.” 
 
Townsend also sees the SSC as a potential model for improved health care delivery more broadly. “By finding better ways of working together and new methods of reducing variability and increasing the reliability of our care, we’ll create new practice styles that can be applied to other areas of medicine.” 
 
Carol Haraden, PhD, IHI’s Vice President overseeing patient safety and critical care initiatives, is the first to acknowledge the significant hurdles faced by lead team in the project. She says refining the components of the toolset has demanded many changes and continued patience, dedication and negotiation to ensure a truly unified approach.  But the rewards, she reminds us, are priceless: “Unrecognized and untreated sepsis kills thousands of people of all ages every year. This work has taken us one step closer to saving a lot of those lives.”
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