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 were really delighted to say that the answer is yes. And were 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 arent 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 Islands 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 Pronovosts Keystone ICU Project in Michigan werent 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 studys 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 institutions culture of responsibility and making institutions and clinicians accountable for patient outcomes. The challenge is, Pronovost says, the healthcare industry doesnt 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 arent prepared when they dont -- and of hospital officials who fail to aggressively address problems such as hospital-acquired infections.
"Its unconscionable that so many people are dying because of these arrogance barriers," says Pronovost. "You cant 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. Pronovosts 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, Pronovosts 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 wont 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, Youre right, and Id love to get involved but I dont 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 thats 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. Its critical to help the field realize that were 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 well get there with time and practice, and hopefully end the battles.
Despite a few bumps in the road to culture change, PPronovosts 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 cant breathe on their own need ventilators, but theyre 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.
Checklists, the Hopkins patient safety team cautioned, do not tell the whole story. As part of the VAP reduction program, staff members also were trained to use teamwork and better communication to ensure that the bundle was being properly administered and that the focus was on getting patients off respirators as early as possible. A program was put in place to allow caregivers to learn from their mistakes. Another strategy in developing a culture of safety involved educating patients families about the therapies and encouraging them to ask questions to ensure that their loved ones were getting the appropriate care, a measure that can help keep caregivers on their toes, Berenholtz says.
The study encompassed data from 112 ICUs at 72 Michigan hospitals from October 2003 through September 2005 and then for up to 30 months after the checklist-implementation period. At the beginning of the study, the percentage of ventilator days on which patients received all five therapies was 32 percent. At 16-to-18 months post-implementation, the proportion rose to 75 percent and it was 84 percent at 28-to-30 months post-implementation.
Those figures coincide with what Berenholtz calls a dramatic and unprecedented reduction in ventilator-associated pneumonia in Michigan, with rates falling up to 71 percent and more than half of ICUs reporting no infections within months after the checklist-implementation period. Those reductions were sustained for up to two and a half years. Berenholtzs VAP research was conducted as part of the Keystone ICU Project.
We had quite good success with bloodstream infections but we really didnt know for sure whether these results would be applicable to other types of preventable harm, and what this study really shows is that yes, checklists and culture change could be applied quite broadly to other healthcare-associated infections and make some significant improvements, says Pronovost, the VAP studys senior author. We hope that we can replicate these results nationally, reducing ventilator-associated pneumonia just as we have reduced bloodstream infections.
The study was funded by the Agency for Healthcare Research & Quality and conducted in partnership with the Michigan Health and Hospital Association. Other Johns Hopkins researchers involved in the study include Julius C. Pham, MD, PhD; David A. Thompson, DScN, RN; Dale M. Needham, MD, PhD; Lisa H. Lubomski, PhD; Sara E. Cosgrove, MD; Elizabeth Colantuoni, PhD; and Christine A. Goeschel, ScD, RN, MPA, MPS.
patient safety movement, Pronovost says. As you know, were now more than 10 years out from when the Institute of Medicine report, To Err is Human was published and the field, quite frankly, was getting a little depressed. With more and more papers coming out on how the rates of medical errors and other adverse events havent improved, clinicians were becoming disappointed. I think our work has restored hope, and perhaps provided a more realistic assessment that theres no quick fix involved, however. This kind of work is hard and it requires commitment, but the results worth it. Were saving many more lives, and that is quite encouraging. These recent studies depicting the success of the checklists and culture of safety are reinvigorating the
Pronovost acknowledges that clinicians must guard against allowing checklists to become rote, with the intentions behind the checklists becoming lost amidst the hustle and bustle of patient-care delivery.
That tension is something we all struggle with, Pronovost says. In the Lancet paper A Reality Check for Checklists, one of the things we cautioned about is ensuring that tools like checklists are deeply ingrained in a healthcare institutions culture of change. Its about getting doctors, nurses and infection preventionists to work together, and without that culture change I think it does risk just becoming about checking the box and not really doing the specific interventions. I would be leery of engaging in these kinds of efforts without also paying attention to the culture component of the interventions.
In that Lancet paper of 2009, Pronovost and Christine Goeschel of Johns Hopkins University, writing with
social scientists Charles Bosk of the University of Pennsylvania and Mary Dixon-Woods of the University of Leicester in the UK, called for a greater understanding of how medical checklists can be used to improve patient safety. They say that widespread deployment of medical checklists without an appreciation of how or why they work is a potential threat to patient safety and to high-quality care.
According to the authors, the real threat to safety arises when a hospital thinks it has solved a problem by handing the workers a checklist and telling them to use it. The reality is that getting the checklist is just the beginning. The key, say the authors, is getting people motivated to cooperate.
The big challenge is how to get staff to use checklists consistently, says Bosk, a professor of sociology in the School of Arts and Sciences at the University of Pennsylvania and senior fellow in Penns Center for Bioethics. Theyre not a magic pill. A checklist isnt something a hospital can swallow and expect care to get better, safer or cheaper.
The mistake most commonly made when introducing checklists is to assume that a checklist can solve a cultural problem. It is a mistake, the authors contend, to think that you can get workers to use checklists just by insisting on it. A widely cited study that thrust medical checklists into favor involved using a five-step checklist to minimize the risk of patients getting catheter-related bloodstream infections. When the program was implemented in 103 ICUs in Michigan for 18 months, infection rates dropped by 66 percent, resulting in estimated savings of $200 million and as many as 2,000 lives. The authors say that the popular study shows the need to create incentives for people to cooperate. This includes using audit and feedback to create reputational and social incentives and having advocates within the organization who act as champions.
The science of checklist implementation is in its infancy and needs much more attention, says Dixon-Woods, professor of medical sociology at the University of Leicester.
In the article, Bosk points out that simply having checklists in a hospital does not stop errors from occurring. He recounts the example of a 17-year-old girl who died in 2003 when she was given an organ transplant with a mismatched blood type. That error happened even though there were checklists for checking blood type, he says.
The Lancet paper also indicated that checklists work well for some types of problems in healthcare but not others. For example, aviation checklists help pilots complete take-off and landing safely. Its less well known that checklists are also used for baggage handling, too, and there they dont work so well.
Checklists can be a really good way of making healthcare safer, says Pronovost. Theres no doubt about that. They work by improving recall, prompting people to do all the necessary steps, and by making clear the minimum expectations. But they have to be used wisely.
The checklists are one of many tools clinicians are using these days to achieve a shift from treatment to prevention of infections and other kinds of healthcare harm. One of the more recent initiatives that is supporting the Johns Hopkins research is the On The CUSP: Stop BSI campaign, established as a response to direct feedback from teams who were seeking innovative ways to improve physician participation. This two-year hospital-based safety project is designed to implement CUSP and CLABSI interventions nationwide. The key project goals for this AHRQ-funded national project are to reduce the mean CLABSI rate across the nation to less than 1 per 1,000 catheter days over two years; to improve safety culture; and to partner with the CDC to support the measurement and timely feedback of CLABSI and other healthcare-associated infection data, and for state hospital associations to partner with state-based organizations to address the elimination of HAIs.
The results of these kinds of initiatives are really impressive, Pronovost says. A large number of states have replicated what we have done in Michigan, and its really breath-taking. The states are excited, and they believe they are doing great work. I have visited all of these states, working with frontline doctors, nurses and infection preventionists and their hearts are in it completely. Theres no doubt that the checklists and tools are important clinical teams are super smart and theyll figure that out but its helping them believe in themselves that they can save patients lives.
The Keystone ICU Project and Central Line Infection Prevention
The Keystone ICU Project, developed at Johns Hopkins, includes a checklist for doctors and nurses to follow when placing a central-line catheter, highlighting five cautionary and basic steps, including handwashing to avoiding placement in the groin area where infection rates are higher. Along with the checklist, the program promotes a culture of safety that comprises safety science education, training in ways to identify potential safety problems, development of evidence-based solutions, and measurement of improvements. The program also empowers all caregivers, no matter how senior or junior, to question each other and stop procedures if safety is compromised. In 2009, U.S. Health and Human Services Secretary Kathleen Sebelius called for a 50 percent reduction in catheter-related infections nationwide by 2012. To that end, in partnership with a branch of the American Hospital Association and the Michigan Hospital Association, the Johns Hopkins model is being rolled out state-by-state across the country. Forty states have launched the program, and preliminary data from some of the early adopters is very encouraging, Pronovost says. The original Keystone project was funded by HHSs Agency for Healthcare Research and Quality. The study that first outlined the success of the Keystone ICU Project was published in the New England Journal of Medicine in 2006. In it, Peter J. Pronovost, MD, PhD, and colleagues Dale Needham, MD, PhD, Sean Berenholtz, MD, David Sinopoli, MPH, MBA, Haitao Chu, MD, PhD, Sara Cosgrove, MD, Bryan Sexton, PhD. Robert Hyzy, MD, Robert Welsh, MD, Gary Roth, MD, Joseph Bander, MD, John Kepros, MD, and Christine Goeschel, RN, MPA, conducted a collaborative cohort study predominantly in ICUs in Michigan. An evidence-based intervention was used to reduce the incidence of catheter-related bloodstream infections. Multilevel Poisson regression modeling was used to compare infection rates before, during, and up to 18 months after implementation of the study intervention. Rates of infection per 1,000 catheter-days were measured at three-month intervals, according to the guidelines of the National Nosocomial Infections Surveillance System. The study intervention targeted clinicians' use of five evidence-based procedures recommended by the Centers for Diseae Control and Prevention (CDC) and identified as having the greatest effect on the rate of catheter-related bloodstream infection and the lowest barriers to implementation. The recommended procedures are handwashing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine gluconate, avoiding the femoral site if possible, and removing unnecessary catheters. According to the researchers, "Clinicians were educated about practices to control infection and harm resulting from catheter-related bloodstream infections, a central-line cart with necessary supplies was created, a checklist was used to ensure adherence to infection-control practices, providers were stopped (in nonemergency situations) if these practices were not being followed, the removal of catheters was discussed at daily rounds, and the teams received feedback regarding the number and rates of catheter-related bloodstream infection at monthly and quarterly meetings, respectively." What is important to note is that in addition to the aforementioned interventions, the ICUs implemented the use of a daily goals sheet to improve clinician-to-clinician communication within the ICU, an intervention to reduce the incidence of ventilator-associated pneumonia, and a comprehensive unit-based safety program to improve the safety culture. Also, before implementing any of the components of the study intervention, the ICUs were asked to designate at least one physician and one nurse as team leaders. These individuals were instructed in the science of safety and in the interventions and then disseminated this information among their colleagues. The teams received supporting information on the efficacy of each component of the interventions, suggestions for implementing them, and instruction in methods of data collection. Team leaders were partnered with their local hospital-based infection preventionist to assist in the implementation of the intervention and to obtain data on catheter-related bloodstream infections at the hospital. A total of 108 ICUs agreed to participate in the study, and 103 reported data. The analysis included 1981 ICU-months of data and 375,757 catheter-days. The median rate of catheter-related bloodstream infection per 1000 catheter-days decreased from 2.7 infections at baseline to zero at three months after implementation of the study intervention (P0.002), and the mean rate per 1000 catheter-days decreased from 7.7 at baseline to 1.4 at 16 to 18 months of follow-up (P<0.002). The regression model showed a significant decrease in infection rates from baseline, with incidence-rate ratios continuously decreasing from 0.62 (95% confidence interval [CI], 0.47 to 0.81) at zero to three months after implementation of the intervention to 0.34 (95% CI, 0.23 to 0.50) at 16 to 18 months. The researchers concluded that an evidence-based intervention resulted in a large and sustained reduction (up to 66 percent) in rates of catheter-related bloodstream infection that was maintained throughout the 18-month study period. Reference: Pronovost PJ, et al. An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU. N Engl J Med. 355:2725-2732. 2006.