Stephen C. Hines
Abstract
National improvement campaigns to reduce healthcare-associated infections (HAI) are demonstrating promising results but still need to become more efficient and effective. The Agency for Healthcare Research and Quality (AHRQ) has funded the Health Research & Educational Trust (HRET) to lead multiple national improvement efforts, including the On the CUSP: STOP BSI campaign that led to a 41 percent relative reduction in central line-associated infections (CLABSI) in participating units. These projects suggest four insights for how to successfully plan and execute large HAI and quality improvement initiatives. First, leaders must recognize not all changes constitute improvements and must carefully assess and foster only the activities causally linked to the targeted outcomes. Second, leaders must recognize that some changes can spread rapidly without a national campaign and must adapt to an external environment that can shift quickly. Third, factors that affect how quickly changes will spread can be identified and leveraged to plan more successful campaigns. Factors that affect which initiatives and parts of the improvement campaign will be rapidly adopted and spread include: environmental factors, ease of implementation, effort required to assess impact, the number of individuals or systems that must participate in the change, and organizational capacity, culture, and competing priorities. These three insights lead to a fourth: leaders of large scale improvement efforts must define their role as managing the effort rather than speeding change implementation. This perspective acknowledges their need to both encourage changes that contribute to reducing patient harms and also to recognize and discourage unproductive or counterproductive changes that may accompany their improvement efforts. These insights are illustrated by examples drawn from the range of AHRQ-funded national improvement campaigns that HRET has led.
Introduction
National health care quality improvement (QI) campaigns are attracting considerable attention from policymakers, payers, and the leaders of health care organizations. Recent efforts—such as the Institute for Healthcare Improvement's (IHI's) 100,000 Lives Campaign and the more focused On the CUSP: Stop BSI (bloodstream infections) initiative funded by the Agency for Healthcare Research and Quality (AHRQ)—presented evidence that a large scale impact is achievable.1,2 More recent initiatives by AHRQ, the Hospital Engagement Network (HEN) funded by the Center for Medicare & Medicaid Innovation (CMMI) within the Centers for Medicare & Medicaid Services (CMS), and IHI's expanded Five Million Lives campaign reflect the belief that large scale improvement efforts are a viable method for substantially improving the quality of American health care.
Along with growing investments in large scale improvement campaigns, there is also substantial discussion about how to overcome the slow pace of spread for many innovations that improve safety and quality. Berwick has noted that improvements in health have proceeded quite slowly, including straightforward steps to prevent scurvy that took almost 250 years for full implementation.3 Barth pointed to similar long delays in the widespread implementation of safety devices in cars, estimating it takes about three decades for new safety improvements to become standard on most vehicles.4 The recognition that the spread of improvements is difficult has been accompanied by research, articles, and even whole conferences devoted to examining how we can speed up the spread of health care improvements.
The Health Research and Educational Trust (HRET) possesses a unique perspective on the opportunities and challenges associated with helping national initiatives to reduce the spread of healthcare-associated infections (HAI) succeed. Under contracts with AHRQ, HRET partnered with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality and the Michigan Health & Hospital Association Keystone Center for Patient Safety & Quality to lead the national On the CUSP: Stop BSI initiative that expanded a successful pilot project in Michigan into a successful national project that achieved a relative reduction of 41 percent in rates of central line-associated bloodstream infection (CLABSI).5 HRET leveraged the infrastructure developed through that project to subsequently lead the ongoing AHRQ-funded On the CUSP: Stop CAUTI (catheter-associated urinary tract infection) initiative. In partnership with the University of Michigan and the Michigan Health & Hospital Association Keystone Center for Patient Safety & Quality, that project has reported modest reductions in CAUTI rates, particularly outside the intensive care unit (ICU) setting.6 Concurrent with these efforts, HRET has partnered with the Kidney Epidemiology and Cost Center at the University of Michigan and Renal Network 11 to develop and conduct a limited pilot test of a change package to reduce vascular access infections in end-stage renal dialysis facilities. Further, in partnership with the Harvard University School of Public Health, HRET is serving as prime contractor on the AHRQ-funded initiative to reduce harms in the ambulatory surgery setting.a
These projects, coupled with insights HRET has gained while leading a large HEN for CMS and our ongoing efforts to promote QI in hospitals through the American Hospital Association (AHA)-funded Hospitals in Pursuit of Excellence (HPOE) initiative, have reinforced our belief that national improvement projects have considerable potential to create a safer health care system that delivers higher quality care. But, our experiences have also provided periodic painful reminders that achieving this potential is difficult, sometimes slow, and never possible without constantly adapting our efforts in response to a continuously changing health care landscape.
Efforts to ensure that future initiatives to reduce health care associated infections (HAI) will achieve their intended goals are clearly warranted. However, there is some risk that focusing on methods to speed the pace of implementation may produce unintended and undesirable consequences. We believe these risks can be reduced by reframing goals for spreading HAI reduction strategies and other QI initiatives. An effective strategy should foster the improved management of spread, which includes both increasing the speed with which true improvements are broadly implemented and decreasing or stopping the spread of changes that are not beneficial. This paper draws on our experiences in implementing large-scale HAI QI initiatives to provide four observations designed to support this reframing.
a. For more information, go to http://www.ahrq.gov/research/findings/factsheets/translating/action12/index.html for the award announcement and http://ascsafetyprogram.org/about-the-program/national-program-team for the program Web site.
Some Changes May Not Lead to Improvement
Health care expends substantial resources on a broad range of change efforts, and most within health care acknowledge that many of these change efforts fail to achieve their intended goals. Although HRET has observed significant improvements in CLABSI rates on one of our projects, other initiatives are producing mixed results. A full taxonomy of types of failures is beyond the scope of this paper, but common failure types include:
- Changes that yield nominal improvements for anyone.
- Changes that produce benefits for some organizations, patients, or units but prove not beneficial for most others.
- Duplicative changes that have no additive benefits.
- Improvements in some outcomes with accompanying harms in others.
Changes that yield nominal improvements for anyone. Many changes are implemented between the bedside and back office functionalities that appear to offer benefits that are never achieved. In some cases, this is because the change fixes something that turns out not to be the true cause of the underlying problem; in other cases, it may be that the solution proved impossible to actually implement or because the change simply did not yield the expected benefit. Frequently, initially promising data may be the result of random variation or other factors that do not persist over time, but efforts to spread sometimes begin before the limitations in the initial results are understood.
HRET began its CLABSI project with a compelling implementation model tested with proven results across the state of Michigan. But because that intervention had multiple components, including clinical fixes and cultural changes, it was impossible to determine whether all of these components were necessary to produce improvement. This prompted ongoing reflection by HRET, our project partners, and AHRQ leadership to attempt to determine whether some of the activities we were promoting were unnecessary dimensions that were correlated with improvement but not causing it. This constant search for the most parsimonious methods to reduce HAI rates is essential to make future QI efforts as efficient and effective as possible.
Changes that produce benefits for some organizations, patients, or units but prove not beneficial for most others. In some cases, changes benefit a specific organization because that organization has a unique problem. In other cases, a solution that is viable in one hospital or unit cannot be replicated elsewhere because the success factors are distinctive and unavailable in most other situations. For example, in several of our projects, engaging with hospitalists proved extremely valuable to achieving HAI rate reductions. However, both our CLABSI and CAUTI projects also included many small and some critical access hospitals that did not employ any hospitalists. These hospitals also improved rates on targeted HAIs, but they did so by making changes quite different from those used in some larger hospitals.
Duplicative changes that have no added benefits. In some cases, multiple changes can produce comparable improvements for a targeted problem. But when some of the changes are already in place, adding others may yield no additional improvement. For example, evidence is good that using a defined QI method such as Lean or Six Sigma can help hospitals improve their quality. But once one method is in place, the additional value of other methods is frequently minimal. Unpublished data we have examined across several of our large improvement initiatives suggest there is little to distinguish among results achieved by hospitals employing different improvement methods. On the other hand, when hospitals lack any defined method to guide their improvement efforts, they tend to struggle.
Improvements in some outcomes with accompanying harms in others. New drugs and medical technologies provide many examples of this, ranging from thalidomide to silicone breast implants. Although short-term benefits were clearly observable, these were ultimately outweighed by longer term harms.7,8 In other cases, benefits may prove to be nominal, while financial costs to the health care system are dramatic. Whether the added costs associated with some new drugs and technologies are justified by nominally better results compared to appreciably cheaper treatment options continues to be an ongoing discussion among policymakers. HRET and its partners are addressing this issue in our CAUTI reduction initiatives. Efforts to reduce CAUTI can lead providers to screen for it more extensively. But if these screenings identify asymptomatic bacteriuria that are then treated with antibiotics, antimicrobial resistance, adverse drug events, and increased costs may result. To avoid these risks, HRET and its partners have emphasized avoiding unnecessary catheter insertions and have stressed the importance of removing a catheter as soon as it is no longer needed.
While it may seem obvious that not all changes constitute improvements, each of our improvement projects has required us to carefully assess which changes offer true benefit. The most effective HAI reduction efforts will be those that balance the potential benefits of spreading improvements against the risks associated with using scarce spread resources to promote changes that prove unbeneficial or potentially counterproductive.
Some Changes Spread Rapidly Without National Improvement Campaigns
Many improvements in health care do require substantial time and effort to be broadly disseminated. However, a fixation on issues where spread was difficult and slow can result in inattention to cases where spread was very rapid. Vaccines for polio and small pox spread rapidly in response to widespread public concern about the consequences of contracting these conditions.1,9 The prescribing of drugs such as Prozac and Thalidomide expanded dramatically in very short periods of time.10,11 And the use of some medical technologies such as computed tomography (CT) scanners and robotic surgery systems has spread very rapidly in short periods of time.12,13 In some cases these expansions were enormously beneficial; in others, clinical improvements have been nominal, but the cost impact has been significant.14,15 In still other cases, the expansions caused great harm to patients they were intended to help.16
If all innovations in health care were improvements that spread slowly, then those leading QI initiatives could focus on increasing the speed of improvements throughout the health care system. But sometimes, genuine improvements occur surprisingly quickly. Recently reported dramatic reductions in rates of early elective deliveries (EEDs) required that ongoing efforts to reduce these rates shift rapidly from assuming that most hospitals had significant improvement opportunities to focusing on a much smaller set of hospitals whose rates remained high. Despite occasional successes, such as reductions in EED rates, many potential changes may not yield benefits to patients. And since some of these changes spread rapidly, effective QI must take into account how to speed some spread efforts and slow or even prevent the spread of other efforts.
On several of our HAI reduction projects, HRET has had to address efforts to endorse and spread very detailed and very long checklists that attempt to comprehensively catalog all that must be done (and not done) in order to prevent avoidable infections. There clearly is an important role for organizations that provide comprehensive summaries of all known infection risks and strategies for their avoidance. HRET works closely with the Centers for Disease Control and Prevention (CDC) and many medical societies that produce invaluable summaries of such risks. Nevertheless, on several projects, participants have converted these summaries into extensive operational checklists consisting of dozens of items that staff are then expected to routinely use in the clinical setting. While these checklists are intuitively appealing (if a short checklist can reduce infections to some degree, then a long checklist will reduce them even more), HRET has benefited from thought leaders such as Atul Gawande17 and Peter Pronovost18 who have both argued for the necessity to keep checklists short enough to remember and focused on the factors most likely to have the biggest impact. Success has required recognizing that some changes can spread quickly. Fostering and encouraging rapid changes that are productive, while simultaneously intervening to prevent undesirable changes from spreading, have been important to the success of our projects.
Factors that Impede or Promote the Speed of Spread
In a separate paper under review elsewhere, we have identified factors affecting the speed of spread that fall into four general categories:
- Environmental factors.
- Nature of the innovation.
- Individuals required to embrace the change.
- Organizational factors.
Environmental factors. When people or organizations benefit financially from a change—either through generating revenue, reducing costs, or minimizing legal costs—spread is faster. When regulations mandate a change, adoption is quicker, as it is when there is public awareness of the change's value or there is a champion publicly advocating for the change. But when the environment includes other changes competing for the same resources or any of these other factors are missing, change will be slower or simply not happen. On our CLABSI reduction project, it was appreciably easier to make a financial case to hospitals for why CLABSI prevention is essential. Because the financial burden of treating CAUTI is lower than that of CLABSI, motivating hospitals to reduce CAUTI rates has proven more difficult and may be one reason among many why national CAUTI rates are not declining substantially.
Nature of the innovation. Changes with a strong evidence base that are affirmed by key opinion leaders such as professional societies will spread more rapidly. Moreover, changes that are easier to understand and to successfully implement, as well as changes that produce visible results, will spread more rapidly. Gawande recently contrasted the rapid spread in the use of anesthesia with the slow spread of methods to prevent sepsis, arguing that these differences were attributable to the visible impacts of anesthesia and the invisible impacts of infections leading to sepsis.19 The rapid reduction in EED rates provides another such example. Evidence of EED harms was compelling, EED reduction was championed by the Federal Government and opinion leader organizations, and the innovation was straightforward—avoid inducing labor. Efforts to reduce CLABSI also benefited from having a short list of relatively simple changes for which there was good evidence that linked the changes to CLABSI reduction. In contrast, efforts to reduce harms in ambulatory surgery are complicated by very low published rates for harms. When baseline rates are low, it is difficult for participants to see improvements, even when those improvements are taking place.
Individuals required to embrace the change. When a change can be made by an individual, rapid adoption is more common. Drugs and medical technologies may spread quickly because there often are strong financial incentives for their use, and decisions about whether to use them often can be made by single individuals. When changes require coordinated efforts from physicians, nurses, other clinicians, and organizational leadership, spread tends to be far slower and more challenging.20 Efforts to prevent CAUTI illustrate this challenge. Some patients have a catheter on admission to the hospital; others have one placed in the emergency department. Some of these catheter insertions are medically necessary; others may be driven by convenience or in response to the expressed concerns of the patient or family. A patient may be given a catheter in a general hospital unit to which he or she is admitted or be placed on one in an ICU. Because catheters may be placed by so many staff in so many locations within the hospital and for so many reasons, it has proven much more challenging to help hospitals coordinate a reduction in their rates of unnecessary catheter use.
Organizational factors. When organizations have competing priorities for limited resources, conflicting internal priorities, and a culture that is averse to change, spread will be very slow and difficult. Conversely, when organizations have fewer decisionmakers, aligned internal and external priorities, and a culture with a history of successful innovation, change will be far more rapid.21,22 HRET has worked with some hospitals on two or more improvement projects, including AHRQ-led efforts to reduce CLABSI and CAUTI and our CMS-funded HEN initiative. Although the analyses we are doing are preliminary, they appear to show that smaller hospitals can make changes more rapidly than larger, more complex organizations. Moreover, hospitals that have been successful (or unsuccessful) on one of our national projects tend to show similar results on others. While not conclusive, these preliminary results do suggest the importance of organizational factors in determining how quickly improvement efforts will spread.
There are no empirical data that quantify the comparative impact of each of these spread factors, but we believe it is very possible for those leading large-scale improvement efforts to make reasonably accurate judgments concerning which potential changes will spread quickly, slowly, or not at all. In general, changes that can be made by individuals or small groups within organizations that are supportive of change, changes that will produce visible improvements to outcomes, and changes that will help make money will almost invariably spread rapidly and with little need for assistance. Conversely, changes linked to multiple factors that impede spread will be difficult or impossible for most providers to successfully implement. This dynamic suggests the value of providing participants with a range of improvement options they can prioritize based on what they perceive will be the most beneficial and easiest to implement within their organizations. Peter Pronovost emphasized the value of providing options and allowing participants to set improvement priorities on the CLABSI project.23 We regard this as one of many strategic insights that contributed to the success of that project.
Focus on the Management of Spread
Federal organizations, including AHRQ, CMS and CDC, are all investing substantial resources in supporting national spread campaigns to reduce HAIs and improve health care quality and the efficiency of the health care system. While spreading improvements is a laudable goal, we believe that better results may be achieved if these organizations and the individuals they select to lead these initiatives view their efforts as "managing" rather than "promoting" the spread of innovations. Based on our experiences in leading national HAI reduction efforts, we believe this perspective is optimal because it recognizes that:
- Efforts to promote change entail risks and costs that must be clearly understood, managed, and monitored. If not all changes are improvements and not all changes will be successful, then QI leadership must begin by carefully assessing the evidence for what benefits a potential improvement effort will yield and whether the improvement effort will be viable.
- There are limits to what is achievable and one must operate within these limits. In cases where a change offers substantial benefits but is unlikely to spread because of one or more of the factors noted above, good improvement strategy should focus on changing the underlying factors before investing in improvement campaigns. Changes to financial incentives, regulations, and investments in research that will strengthen the evidence base supporting the innovation may yield much greater benefit than an investment in a premature campaign that is unlikely to overcome strong disincentives to change that are present in the existing system.
- With limited resources, change efforts that have limited benefits will absorb resources that are needed for change efforts that have greater positive impact. Effective leadership of national improvement campaigns should seek to reduce resources being allocated to improvement activities or innovations with marginal benefits because this creates resources that can be reallocated more productively. Investments in medical technologies, data systems, or improvement methodologies that may not benefit patients directly limit investments in other areas where patient benefits may be more pronounced. As a result, effective QI leadership should de-incentivize unproductive change efforts while incentivizing those with the greatest potential value.
If QI leaders frame their goal as "managing" the spread of innovations within health care, they will focus on three issues that currently receive insufficient attention.
Determine Priorities for Spread and Spread Avoidance
Activities designed to promote the spread of improvements frequently are not coordinated with comparable efforts to develop or adjust policies designed to curtail the spread of innovations that are unhelpful or counterproductive. Holistic discussions of both spread and spread avoidance are needed because reducing resources allocated on unhelpful change is critical to the success of efforts to promote positive changes. Across all of our projects, we have found that success requires helping providers stop doing things that are unnecessary while coordinating and aligning things they are currently doing inefficiently. That assistance creates capacity that can be reallocated to doing new things that directly contribute to HAI reduction.
Adjusting Policies and Regulations that Enhance or Impede Spread
While some efforts are being made to align national improvement campaigns with other policy and regulatory initiatives related to those campaigns, strengthening these efforts will yield better results. For example, if outcomes targeted by a campaign are publicly reported, results of the campaign will be more visible, and the data collection burden will be reduced. Once CMS began requiring hospitals to report CLABSI (and now CAUTI) data into the National Healthcare Safety Network (NHSN), HRET was able to reduce the resources we had been expending to promote data collection. Moreover, once hospital leaders knew public reporting of CLABSI and CAUTI would be coming, leadership engagement became easier as well. Beyond data collection and public reporting, if financial incentives to participate in an improvement effort exist, or if disincentives have been removed, the campaign is more likely to succeed. For example, financial incentives to meet meaningful use requirements are driving hospitals to invest heavily in their health information technology (IT) systems, while the creation of protections for hospitals to discuss and learn from medical errors under the rubric of the patient safety organizationsb has increased willingness among hospital leaders to talk about issues that would not have been discussed before due to medical liability concerns.
b.For more information on patient safety organizations, go to www.pso.ahrq.gov.
Investing in the Most Viable HAI Reduction Campaigns
Prudent leadership must recognize that some improvements are likely to occur without extensive resources from the government or private philanthropies and should avoid investing scarce resources unnecessarily. Conversely, effective leaders also will recognize that some spread efforts may be extraordinarily difficult and expensive, and so they will channel resources to HAI reduction campaigns that are likely to be more successful at an affordable cost.
Conclusion
Because the number of changes that may benefit the health care system is vast, strategies that focus scarce resources on the promotion of changes with the largest positive impact are essential. We believe that HAI reduction efforts will improve if leaders view their efforts as "managing" the spread of change in health care rather than "promoting" it. Focusing on the management of change calls greater attention to the critical issue of which changes will lead to substantial improvements. It also acknowledges the fact that some changes occur rapidly and independently and encourages an assessment of the factors that will influence how quickly and easily a targeted change is likely to spread. This assessment can lead to strategies that integrate and align a range of change drivers that will help maximize investments in national spread campaigns.
Acknowledgments
This manuscript was developed using insights drawn from four contracts HRET has held with the Agency for Healthcare Research and Quality (AHRQ): On the CUSP: STOP BSI (HHSA290200600022I, task order 7), On the CUSP: STOP CAUTI (HHSA290200600022I, task order 8), National Opportunity to Improve Care in ESRD (HHSA290201000025I, task order 4) and Development and Demonstration of a Surgical Unit-based Safety Program in Ambulatory Surgery (SUSP-AS) to Reduce Surgical Site Infections (SSI) and Other Surgical Complications (HHSA290201000025I, task order 5). The findings and conclusions in this document are those of the author, who is responsible for its content, and do not represent the view of AHRQ. No statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Resources.
The author benefited greatly from the support of James Battles and Kendall Hall, the two AHRQ project officers. I also acknowledge valuable insights from Maulik Joshi, Barb Edson, and other colleagues within HRET; our partners from the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality; Sam Watson and others from the Michigan Health & Hospital Association Keystone Center for Patient Safety & Quality; and HRET's other close collaborators from the University of Michigan and the Harvard School of Public Health. Their perspectives along with those of our many valued partners from professional societies and State hospital associations and from project participants have taught us much about effective quality improvement.
Author Affiliation
Stephen C. Hines, Ph.D., is Chief Research Officer at the Health Research and Educational Trust.
Address correspondence to: Stephen Hines, Chief Research Officer, Health Research and Educational Trust, Suite 400, 155 N. Wacker Drive, Chicago IL 60606; Email SHINES3@AHA.org.
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