By Kelly M. Pyrek
The use of a medical or surgical checklist is now a familiar activity for many healthcare professionals, but experts are asking if they are impacting patient outcomes and contributing to patient safety in a meaningful way. And now, the data from a new study are indicating that a Johns Hopkins-led safety checklist program that virtually eliminated bloodstream infections in intensive care units throughout Michigan appears to have also reduced deaths by 10 percent. Although previous research pointed to a major reduction in central-line related bloodstream infections at hospitals using the checklist, the new study is the first to show its use directly lowered mortality.
“There are a lot of skeptics,” acknowledges patient safety expert Peter J. Pronovost, MD, PhD, a professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. “Perhaps rightfully so in order to keep the science honest. People are asking if things like checklists really work and we’re really delighted to say that the answer is yes. And we’re making progress on so many more fronts than ever before.”
Pronovost says that it was previously known that applying safety-science principles to the delivery of healthcare dramatically reduces infections in ICUs, but now, there is proof that lives are also being saved. Pronovost, lead author of the aforementioned study published in the British Medical Journal, adds, “Thousands of people are believed to have survived because of this effort to reduce bloodstream infections.”
Pronovost is known for coupling a cockpit-style, infection prevention-related checklist he developed with a work environment that encourages nurses to speak up if safety rules aren’t followed. This strategy reduced central-line bloodstream infections in the ICU to nearly zero at the Johns Hopkins Hospital in Baltimore and at hospitals throughout the states of Michigan and Rhode Island. Experts say an estimated 80,000 patients a year with central lines get infected, some 31,000 die, and the cost of treating them may be as high as $3 billion nationally.
In the BMJ study, Pronovost and his team (Allison Lipitz-Snyderman, PhD; Donald Steinwachs, PhD; Dale M. Needham, MD, PhD; Elizabeth Colantuoni, PhD; and Laura L. Morlock, PhD) used Medicare claims data to study hospital mortality of patients admitted to ICUs in Michigan before, during and after what is known as the Keystone ICU Project, which features the checklist. They compared the Michigan information to similar data from 11 surrounding states. While data from both Michigan and the other states showed a reduction in hospital deaths of elderly patients admitted to ICUs over the five-year period from October 2001 to December 2006, the patients in Michigan were significantly more likely to survive a hospital stay during and after the Keystone project.
These findings cannot definitively attribute the mortality reduction to the Keystone project, Pronovost says, but no other known large-scale initiatives were uniquely introduced across Michigan during the study period. “This is perhaps the only large-scale study to suggest a significant reduction in mortality from a quality-improvement initiative,” he says.
researchers in Rhode Island reported in a study published in the December issue of the journal Quality and Safety in Health Care, that the rate of central-line associated bloodstream infections (CLABSIs) fell by 74 percent across Rhode Island’s 23 ICUs over two and a half years. Researchers estimate the interventions prevented 42 CLABSIs, saved 10 lives, reduced ICU stays by 608 days and saved $2 million. Late last year, researchers demonstrated that the results achieved in Pronovost’s Keystone ICU Project in Michigan weren’t a fluke. Using the Johns Hopkins checklist and other patient-safety tools,
“This study verifies that the Michigan results can be replicated across another entire state,” says Pronovost, who is also director of the Johns Hopkins Quality and Safety Research Group and the study’s leader. “We saw an even greater reduction in bloodstream infections in Rhode Island, providing strong evidence that these patient safety initiatives can be successful across the nation.”
In the Rhode Island project, conducted between January 2006 and June 2008, the average rate of ICU bloodstream infections decreased from 3.73 infections per catheter day to .97 infections per catheter day. More than half of the ICUs reported zero catheter-related infections. Pronovost says he expects CLABSI rates to continue to stay low in Rhode Island, just as they have in the more than 100 ICUs in Michigan. A separate study recently published by Pronovost and his team found that Michigan had been able to sustain its results for three years after first adopting these standardized procedures. The Pronovost team worked with the Rhode Island ICU Collaborative, a statewide quality improvement initiative. The research was funded by Blue Cross & Blue Shield of Rhode Island and United Health Care of New England.
Before heading to Michigan and Rhode Island, Pronovost tested the checklist and other interventions at The Johns Hopkins Hospital in Baltimore, where catheter-related infections have now been virtually eliminated. “Nearly all of these infections are preventable,” Pronovost says. “Unlike breast cancer, we have a cure. Yet some hospital infection rates are 10 times what they should be.”
That “cure” that Pronovost speaks of is a focus on infection prevention within a healthcare institution’s culture of responsibility and making institutions and clinicians accountable for patient outcomes. The challenge is, Pronovost says, the healthcare industry doesn’t yet have measurable, achievable and routine ways to prevent patient harm — and that, in many cases, there are too many barriers in the way to attain them.
In a commentary published in the July 14, 2010 issue of the Journal of the American Medical Association, Pronovost argues that one of the most important first steps is to eliminate the arrogance — of physicians who are overconfident about the quality of care they provide or always believe things will go right and aren’t prepared when they don’t -- and of hospital officials who fail to aggressively address problems such as hospital-acquired infections.
"It’s unconscionable that so many people are dying because of these arrogance barriers," says Pronovost. "You can’t have arrogance in a model for accountability."
Annually, roughly 100,000 people die from healthcare-associated infections, another 44,000 to 98,000 die of other preventable mistakes and tens of thousands more die from diagnostic errors or failure to receive recommended therapies, he writes. Arrogance, he says, is responsible for too many of them. Despite ongoing efforts to improve patient safety, there is limited evidence of improved patient outcomes, he says. The same scientific rigor applied to other areas of medicine needs to be applied to the study of patient safety.
"To be accountable for patient harms, healthcare needs valid and transparent measures, knowledge of how often harms are preventable, and interventions and incentives to improve performance," Pronovost writes. But he also acknowledges that the science of patient safety is immature and underfunded. "Few patient harms can be accurately measured, or the extent of preventability even known," he writes.
One major success story, he notes, is central line-associated bloodstream infections, which are common and costly and kill 31,000 patients a year in the United States. These, however, have been proven to be accurately measured and largely preventable. Pronovost’s checklist concept has shown that these infections can be brought to nearly zero. Once thought of as an inevitable risk associated with a hospital stay, Pronovost’s work has shown that they can be largely avoided.
But it was not just the checklist that led to the dramatic improvements in patient safety in these ICUs, he says. Equally important was the changing of the prevailing medical cultures of each institution. In this new culture, nurses are allowed — even encouraged — to question doctors who may have skipped a step or otherwise violated safety protocols. Feedback is given constantly on infection rates so everyone knows the extent of the problem. Patient safety is put ahead of individual egos.
It is an example of how hospitals and physicians can indeed be held accountable for patient safety. Many hospitals won’t report their infection rates publicly. Without knowing how big the problem is, Pronovost argues, how can it be suitably addressed?
The work to reduce these bloodstream infections is spreading to other states and there is a federal mandate to reduce them by 75 percent over three years — the "first quantifiable patient safety goal in the U.S.," he writes.
"Some hospitals have reduced infections, most have not," Pronovost writes. "Some hospitals claim they use the checklist, despite having high or unknown infection rates. Some hospitals are content to meet the national average, despite evidence that these rates may be reduced by half. Some hospital administrators say their patients are too sick; these infections are inevitable. Yet, intensive care units in several large academic hospitals have nearly eliminated CLASBIs, or central-line associated bloodstream infections. Some hospitals blame competing priorities for their inattention to these infections. If these lethal, expensive, measurable, and largely preventable infections are not a priority, what is?"
Working together — holding hospital leaders accountable for infection rates, getting financial incentives from insurers for reducing infections and, when needed, imposing regulatory sanctions — Pronovost says, "we can remedy this pandemic and move on to other types of preventable harm."
Pronovost says the feedback from this JAMA article “has been mostly positive” and adds that, “Physicians say to me, ‘You’re right, and I’d love to get involved but I don’t have any support for it.’ A couple of administrators said to me, ‘W ell, we gave physicians money and resources but they never did anything with it.’ My sense is that’s a management issue for these healthcare institutions. I see much of the medical field as being polarized. Doctors, nurses, administrators and regulators act as if we are battling each other. I truly believe people are in healthcare because they want to do the right thing and we all want the same goals, we just have many different ways of getting there. It’s critical to help the field realize that we’re all well intentioned, that we all want the same thing, and that we are all on the same team to help protect patients. I think we’ll get there with time and practice, and hopefully end the battles.”
Despite a few bumps in the road to culture change, PPronovost’s method is now paying off for the most lethal and common healthcare-associated infection -- ventilator-associated pneumonia (VAP). In a new study published in Infection Control and Hospital Epidemiology (ICHE), researchers demonstrated that the number of VAP cases was reduced by more than 70 percent in Michigan hospitals when clinicians used the Johns Hopkins checklist. According to some estimates, these kinds of pneumonias kill as many as 36,000 Americans annually.
Their findings emphasize how a relatively simple series of steps, coupled with an education program and a culture that promotes patient safety, can save tens of thousands of lives and millions of dollars in healthcare costs.
“Far too many patients continue to suffer preventable harm from these respirator-linked pneumonias,” says study author Sean M. Berenholtz, MD, MHS, an associate professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. “Healthcare organizations need to be held accountable for ensuring that patients get safe and effective treatments to prevent these infections. Broad use of this intervention could prevent the vast majority of those 36,000 deaths.”
Severely ill or injured intensive-care patients who can’t breathe on their own need ventilators, but they’re at serious risk for infections such as ventilator-associated pneumonia (VAP), which afflicts an estimated 250,000 patients each year. The risk of VAP increases about 1 percent to 3 percent for every day on a ventilator, Berenholtz says.
For the ICHE study, caregivers in 127 ICUs at 82 hospitals in Michigan were instructed to use a group of evidence-based therapies for the prevention of VAP and other ventilator-related complications. The therapies, known as the ventilator bundle, became a checklist for caregivers to follow for patients on breathing machines.
The five therapies include elevating the head of the bed more than 30 degrees to keep bacteria from migrating into the lungs; giving antacids or proton pump inhibitors to prevent stomach ulcers; giving anticoagulants to prevent blood clots; lessening sedation to allow patients to follow commands; and daily assessment of readiness to remove the breathing tube. While only the first intervention specifically addresses bacteria that can cause pneumonia, all are designed to shorten the length of time on the ventilator — a key to reducing risk of infection, the researchers say.
“If we evaluate patients every day with objective tests to see how well they are breathing on their own, patients will come off ventilators sooner,” Berenholtz says. “And the less time they spend on the ventilator, the lower their risk of developing an infection.”