November 7, 2011

Saving Lives and Money
By Carolyn Gutierrez
For The Record
Vol. 23 No. 20 P. 24

A quality improvement program that reduces potentially lethal bloodstream infections in ICUs also pays financial dividends.

In collaboration with Johns Hopkins researchers, ICUs in six Michigan hospitals dramatically reduced the number of central line-associated bloodstream infections (CLABSIs) by implementing a scientifically proven checklist protocol. In addition to improving care, the program also produced significant cost savings.

In a study released by the American Journal of Medical Quality, researchers led by Peter J. Pronovost, MD, PhD, a practicing anesthesiologist, critical care physician, and professor in the departments of anesthesiology and critical care medicine, surgery, and health and policy management at Johns Hopkins, showed that by following five basic safety measures, hospitals could not only curtail preventable harm to ICU patients but also save an average of $1.1 million per year.

“The Business Case for Quality: Economic Analysis of the Michigan Keystone Patient Safety Program in ICUs” was drawn from a statewide patient safety initiative launched in 2003 in which a total of 108 ICUs in more than 70 Michigan hospitals formed a collaborative with the Johns Hopkins Quality and Safety Research Group (QSRG).

“We designed the program, first at Johns Hopkins, and virtually eliminated CLABSIs,” Pronovost says. “We then put that program in the state of Michigan and virtually eliminated them there and then, remarkably, we showed that the results stayed low for over four years now. The mortality of all Medicare patients admitted to a Michigan ICU was reduced by about 10% more than the 11 surrounding hospitals.”

Recognizing the need for a business case that would illustrate an economic payoff for hospitals that undertake safety measures, the researchers chose six hospitals involved in the main Keystone project to use as a subsample for in-depth analysis. “We showed that the average hospital saved well over a $1 million from this, and we’ve now spread this program across the country, state by state. And across the U.S., these infection rates are down by 66%. It’s a remarkable success story that our team has achieved,” says Pronovost.

Bloodstream Infections
According to the Centers for Disease Control and Prevention (CDC), approximately 250,000 to 500,000 CLABSIs manifest in U.S. hospitals each year. “CLABSIs are an enormous public health problem. They kill almost as many people each year in the U.S. as breast cancer does,” Pronovost notes.

For decades, it seemed these infections were inevitable, a by-product of the hospital environment. Thin plastic tubes inserted into patients to administer fluids and medications and perform blood tests, central line catheters can easily become contaminated, resulting in potentially lethal infections. Other troubling healthcare-associated infections include surgical site infections, catheter-associated urinary tract infections, chest tube insertion infections, and ventilator-associated pneumonia.

Bloodstream infections are not only deadly; they are also costly. According to the business case study, a research review in 2007 showed that costs per CLABSI ranged from $2,820 to $13,000, with an average of $10,531 in 2005 dollars—the equivalent of about $12,208 in 2010 dollars. The medication necessary to bring patients out of their septic state is costly, as is the typical length of stay for ICU patients.

The study also notes that CLABSIs are responsible for an 18% increase in the probability of mortality and a 13-day average increase in length of stay. The annual financial burden related to CLABSIs and other healthcare-associated infections in the United States averages anywhere between $4.5 billion and $45 billion.

The Keystone ICU Safety Program
Backed by funding from the Agency for Healthcare Research and Quality, the Michigan Health and Hospital Association (MHA) reached out to Pronovost and his team at Johns Hopkins to collaborate on a program that would emphasize not only checklists but also a “culture of safety.”

Known as MHA Keystone: Intensive Care Unit, the program featured three key components. “The first,” says Pronovost, “was simplifying what to do to prevent these infections into a checklist. Medicine has a lot of guidelines, but they’re long, they’re often ambiguous, and they don’t prioritize what to do. And so we culled out from the CDC guidelines five simple things: Wash your hands; clean your skin with chlorhexidine; avoid placing catheters in the groin; cover yourself and the patient; and ask every day if you still need these catheters.”

Hand hygiene has long been the gold standard for preventing disease transmission. When addressing central line care, the CDC recommends that hand washing occur before and after palpation of the insertion site; before and after inserting, replacing, accessing, or dressing the catheter; when contamination is suspected or obvious; before and after any invasive procedure; between examining patients; before wearing and after removing gloves; and after using the bathroom. The agency recommends using chlorhexidine, a skin antiseptic shown to be more effective than other agents such as povidone-iodine.

Whenever possible, CDC guidelines and the Keystone checklist recommend using a subclavian site for catheter placement instead of jugular or femoral sites. It is believed that, in most cases, there is lesser chance of infection or complications using a subclavian approach.

The checklist recommends that clinicians maintain maximal barrier precautions, including the complete sterile covering of a patient from head to toe except for a small opening allowing access to the catheter. Clinicians should also use caps, gloves, masks, and gowns.

Reviewing the use of central lines in an ICU patient and asking on a daily basis whether they can be removed is a complex step in the checklist and difficult to standardize because individual needs vary between patients. But to reduce exposure to CLABSIs, a systematic approach to asking about catheter removal was added to a daily goals worksheet to help clinicians consolidate the day-to-day plans for each patient.

“The second leg of the stool,” says Pronovost, “is that we measured infection rates and fed them back to clinicians. Clinicians generally care deeply about their patients, but too often they don’t get data back on how well they’re doing.” Seeing CLABSI rates at a glance quickly engages clinicians and gives them the opportunity to troubleshoot and discuss intervention strategies. Dialogue with a hospital epidemiologist or infection control practitioner is also encouraged.

“And the third leg of the stool,” Pronovost adds, “was a program to change culture—to get doctors and nurses to work collaboratively for the benefit of the patient rather than acting as if they’re at odds with each other, which is too often the norm.”

The Johns Hopkins team found that many physicians believed their credibility would be challenged if they were corrected by nursing staff. The nurses believed their job was not to “police” physicians. By emphasizing teamwork and patient safety, Pronovost says the “program has turned out to be remarkably successful.”

He concedes that during the Michigan project’s initial stages, staff buy-in was difficult. “I’m an intensive care physician,” Pronovost says, “and some of the infectious disease clinicians weren’t so keen on having this ICU guy come in and talk above them—this is their turf. In the academic hospitals, they didn’t want a Hopkins team coming in, and the way we approached it was to say, ‘Hey, we’re here to work with you to help reduce infections. We’re not telling you what to do. You have the answers. But we are going to climb this hill.’ And I think that kind of collaborative community spirit was very well received. The program developed from within; it was created by this group. Hopkins kind of quarterbacked and facilitated it, but it was really their program.”

The Keystone project includes an array of professionals. In addition to ICU physicians and nurses, hospital teams include senior hospital administrators, ICU directors, ICU nurse managers, pharmacists, and department administrators who collaborate to collect data and share their knowledge with other hospital teams.

Pronovost says, “We did training—some training specifically on how to prevent infections, some about how to change culture, and a lot on what I call ‘the science of safety.’ And we did it by face-to-face meetings and biweekly webinars or conference calls where we would train them, or teams would present and we would coach them.”

Checklists and a Culture of Safety
The use of checklists in Pronovost’s safety programs has garnered much attention. The deceptively simple act of integrating hundreds of pages of medical recommendations into relatively short lists has been proven to save time, money, and lives.

Sam R. Watson, MSA, MT, senior vice president of patient safety and quality at the MHA and one of the authors of the business case study, says, “It’s really difficult for the bedside physician to take this huge document and distill it down on their own. They really need to have a centralized point in which that sort of information is provided. Once they have it in hand, it becomes a lot easier to implement.”

During all central line insertions, the safety program recommends that a bedside nurse be present to complete a checklist ensuring that protocol has been followed. Checklists effectively monitor whether clinicians adhere to evidence-based practices. The successful use of a checklist requires clinicians to cultivate interpersonal communication skills.

Patricia Posa, RN, BSN, MSA, a coauthor of the business case study and system performance improvement leader at Ann Arbor’s St Joseph Mercy Hospital, a participant in the economic analysis, says, “I believe that checklists are important, but it starts off with understanding why you’re doing them.”

A member of Keystone’s advisory board, Posa cites a 2005 study titled “Silence Kills” in which more than one-half of the 1,700 nurses, physicians, clinical care staff, and administrators surveyed said they had observed colleagues or coworkers break rules, make mistakes, demonstrate incompetence, and exhibit poor teamwork, among other troubling behaviors.

On top of those findings, 84% of the physicians surveyed witnessed colleagues take dangerous shortcuts in patient care. Despite full knowledge of the risks, less than 10% of survey participants spoke up or confronted their coworkers.

“By not speaking up, patients die,” says Posa. “Checklists have been proven to be vitally important, but they’re not the total package.”

Watson agrees, noting that “one of the key elements in these hospitals that have dramatically reduced intubated bloodstream infections and ventilator-associated pneumonia is the ability for others on the care team to speak up. If I’m the physician and I’m getting ready to insert a central line and I don’t wash my hands or I don’t fully drape the patient, the nurse who’s working with me can say ‘stop’ until I do these things.”

“Checklists are a key component to making these programs work,” says Pronovost, “but I don’t think that alone they would get us where we need to go. What is more important is the culture and the social norms—when the light switch goes on in the clinicians’ head that says, ‘Hey, these infections are my responsibility, and I’m able to make a difference in them,’ they’ll figure out the checklist. Checklists are important, but they’re not Harry Potter’s wand.”

In addition to checklists and training programs, Keystone hospitals implemented other tools to minimize compliance barriers.

“Besides the checklist,” says Posa, “we put things in place for bloodstream infection prevention, such as a line cart, because you want to make it easy for the staff to do the right thing.” Access to line carts containing insertion kits, sterile gowns, caps, masks, gloves, antiseptic, and documentation forms help clinicians sustain the most sterile environment possible when inserting central lines for patient care. Streamlining the search for supplies and equipment, line carts can be rolled into the patient’s room to save time and promote compliance.

“We took a very organized way of doing it,” says Posa. “That’s where Keystone was very beneficial, in that it wasn’t just putting in practice changes, it was stepping back and beginning to focus on the culture of safety, talking about everybody’s role and making sure things are safe for the patient and then engaging the executives as well as middle-level management and front-line staff all at the same time. It’s really about understanding and being able to let everyone know why we are doing this. We’re not just doing this to create more work, we’re doing this to save lives.”

According to the MHA’s Keystone Center, between 2004 and 2010, more than 1,830 lives were saved, more than 140,700 excess hospital days were avoided, and more than $300 million in healthcare dollars were saved.

Keystone of Savings
According to the business case study, before Keystone, there had been little financial incentive to put safety practices in place. Pronovost and his team recognized the need for a business case to analyze the cost-effectiveness of infection control. By deconstructing the results in six diverse hospitals, the researchers were able to present an economic analysis per infection and provide a cost benefit study from a hospital perspective.

According to the business case study, researchers found that “the cost of intervention is modest when compared with the healthcare costs associated with these infections … even using the conservative estimates of infection costs, The Keystone ICU Patient Safety Program clearly is financially beneficial to hospitals.”

An average of 29.9 CLABSI cases as well as 18 ventilator-associated pneumonia cases were prevented annually at each hospital participating in the project. An annual savings of approximately $36,500 per CLABSI and $10,000 per ventilator-associated pneumonia case was noted. The researchers showed that the return on investment was 10-fold and concluded that “the results of the study should further encourage hospitals to implement the Keystone ICU Patient Safety Program and other robust quality improvement programs.”

Michigan and Beyond
The success of Michigan’s Keystone program has lead to the implementation of the model on a national level as well as in other countries.

The National Implementation of the Comprehensive Unit-Based Safety Program to Reduce Central Line-Associated Bloodstream Infections in the ICU, otherwise known as the “On the CUSP, Stop BSI” project, has recruited more than 1,055 hospitals and 1,775 hospital teams. Its goal is to reduce CLABSI rates to less than one per 1,000 central lines in all participating U.S. hospitals.

“As of right now,” says Watson, “we’re entering our final cohort of replicating what we did in Michigan in the rest of the country, including the District of Columbia and Puerto Rico. There’s been dramatic appreciation for what can happen if you apply the evidence in a very rigorous manner and measure it.”

The Michigan Keystone program has become a microcosm of sorts for how medical communities can come together. Lessons learned in Michigan and the framework provided by the Johns Hopkins team can be applied to other efforts at quality improvement. In the case of Keystone, collaboration and communication saved lives.

“The way Michigan worked is that it’s what we call a clinical community,” says Pronovost. “That is, we pulled all of the hospitals together and realized that they have the wisdom about how to prevent these infections. It’s not going to be dictated from a regulator, it’s not going to be dictated from an insurer, or from their CEO, and they were both empowered and accountable for solving these problems. And when we think about why it was ultimately successful—fundamentally, it was a change in social norms. These infections stopped being perceived as inevitable and started being perceived as preventable. The clinicians believed that they were actually able to impact this. And I think if we could apply these lessons to other types of harm where we just accept them as the norm—we could have tremendous impact in healthcare quality.”

— Carolyn Gutierrez is a freelance writer based in New York City.