Making the Health Care System Safer
Second Annual Patient Safety Research Conference: Conference Summary (continued 2)
Challenges in Translating and Implementing Research Into Practice
The fourth panel evaluated the challenges in translating and implementing research into practice, as well as strategies for overcoming these challenges. Christine G. Williams, M.Ed., Director of the Office of Communications and Knowledge Transfer at AHRQ, who served as facilitator for the session, noted that research must not only be incorporated into medical practice, but also translated into Federal, State, and local policies, since these policies can function as important intermediaries between research findings and practice change.
Challenging Facing Health Systems and Hospitals
Paul Conlon, Pharm.D., J.D., vice president of clinical quality and patient safety at Trinity Health, offered the health system and hospital perspective on the challenges.
Dr. Conlon highlighted several critical challenges facing hospitals and health systems as they attempt to translate research into practice.
- Physicians are not employees, and may be reluctant to dedicate scarce, revenue-producing time to patient safety efforts.
- Operating costs continue to increase.
- Little capital is available.
- Hospitals were developed and still function as independent organizations.
- Hospitals face multiple external patient safety "standards."
- Hospitals tend to have hierarchical organizational structures.
- Hospitals and physicians remain fearful of legal liability issues.
Overcoming These Challenges
Dr. Conlon believes that the key to overcoming these challenges is to treat physicians as partners. The best way to establish this partnership is to make sure that any patient safety program or other initiative truly adds value to physician practices. Value enhancement can come in a variety of forms, including higher quality of care, more efficient care systems (especially in the hospitals in which physicians work), and a respectful work environment for both physicians and nurses. Hospitals should also seek physician input into the design of care. In short, the hospital goal should be to become the partner of choice for physicians.
Health care systems can play many other roles in promoting the use of research findings:
- Education, through the sharing of transparent performance data with the community, hospital governance, the medical staff, and employees.
- Facilitation of improvements, including more efficient operations, clinician-friendly information systems, and the reporting of errors and near misses.
- Motivation of key stakeholders, by exploiting and rewarding practitioners' competitive nature to be the best, and by emphasizing that patient safety is the right thing to do, that everyone is responsible for improving safety, and that providing excellent patient care is why clinicians entered the profession in the first place.
A Foundation's Experience in Working to Incorporate Research into Practice
Karen Wolk Feinstein, Ph.D., president of the Jewish Healthcare Foundation, offered the perspective of both a family member of a victim of an error and the head of a major foundation with funds to invest in patient safety.
Foundation-supported Study Not Enough to Encourage Change
A number of years ago Dr. Feinstein's active 93-year old father-in-law entered a well-known, highly respected hospital for a procedure, only to leave the facility disoriented and unable to manage his life. A rapid downward spiral after the hospitalization ultimately led to his death. This experience convinced her to fund a foundation-led study to investigate comorbidities that arise in elderly patients from hospital stays. The study uncovered a number of low-cost techniques for improving the situation. The hospital that cared for her father-in-law agreed to make these changes, and Dr. Feinstein felt very good about the study.
But when Dr. Feinstein's mother entered the same hospital none of these procedures had been put in place. What was most irritating to Dr. Feinstein was that her elderly mother was constantly woken at 3 a.m. to have her vital signs (e.g., blood pressure) checked, despite the fact that one of the study's recommendations was not to wake elderly patients who are sleeping unless absolutely necessary. Evidently, the nurses and other caregivers on this unit were too busy to figure out how to implement this change. In addition, no one at the hospital had ever considered the full costs of waking elderly patients in the middle of the night. Rather than consider the costs of having elderly patients become sleep deprived, disoriented, and potentially depressed upon leaving the hospital, hospitals were evidently too focused on the potential legal ramifications if something had happened to her mother between 2 a.m. and 4 a.m.
The Missing Ingredient: Demand from Hospitals to Improve Safety
Dr. Feinstein concluded from this experience that reform efforts that rely on the application of research in the real-world setting are very difficult. Simply informing caregivers of findings certainly does not work. For change to occur, there has to be some "pull" or demand from health care organizations themselves. In other words, these organizations have to want to change and to be capable of change. The culture must support such change.
Unfortunately, most hospital units do not exhibit this desire to change. On most units it is not clear who the customer is or who is in charge. The financial incentives for change are also unclear, as most purchasing organizations do not encourage health systems to adopt best practices. While there are a few places where caregivers are demanding change by welcoming data collection, error investigation, and problem solving (Dr. Feinstein highlighted the Mayo Clinic's efforts to put the patient first and to promote teamwork, evidence-based medicine and on-the-spot problem solving), such situations are clearly the exception rather than the rule.
Steps to Create the Demand
To create a demand for patient safety within health care organizations, Dr. Feinstein called on purchasers and insurers to begin to share some of the savings from doing things right, and to be willing to pay more for higher quality and improved safety. Clinicians and hospitals that do things right today are rewarded for their efforts with declining revenues and falling profits. She also called on hospital board members and other leaders to step up to the plate and provide the type of visionary leadership necessary to change a culture and promote reform.
Focusing on the Message as Well as the Messenger
Richard Lilford, Ph.D., FRCOG, FRCP, MFPHM, professor of clinical epidemiology in the Department of Public Health and Epidemiology at the University of Birmingham in the United Kingdom, noted that the message being delivered may be very important in determining the rate at which the research is put into practice. In fact, the failure to incorporate research findings into practice is not primarily due to a lack of effort to make these findings known.
Dr. Lilford noted that there is an important distinction between the way that knowledge is transferred (the messenger) and the content of that knowledge (the message). He believes that focusing exclusively on the messenger without considering the message may be short-sighted. To illustrate his point, Dr. Lilford highlighted the wide variations in the rate at which different innovations diffuse. For example, X-rays diffused rapidly while regular washing of hands by caregivers has diffused slowly. In his view, two factors drove this difference. First, the evidence on the benefits of X-rays was very clear to anyone who examined it. But many practitioners were initially skeptical that hand washing truly mattered, even in the face of evidence to the contrary. (Dr. Lilford noted that caregivers' prior beliefs influence their willingness to act on evidence; many clinicians implicitly assumed that it did not matter if they washed their hands.) Second, X-rays were a new, add-on, revenue-producing procedure that could easily be adopted, while hand washing required a time-consuming change in practice that brought no new revenues.
Unfortunately, organizational research often does not produce clear-cut, yes-no results. Those relatively few findings that are clear are often adopted quickly on a national level. But the adoption of less clear-cut findings will depend upon organization-specific issues. Different organizations will absorb it in different ways. As a result, it is critical to build closer ties between the research and the organizations using it, to make sure that knowledge is "socially absorbed" into the culture of the institutions that deliver patient care.
Leveraging the Connectors and Salespeople to Promote Adoption
Paul Schyve, M.D., senior vice president of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), believes that the key to ensuring that research findings are translated into practice is for the "mavens" (the experts who develop the findings) to link with "connectors" (who spread the word on the findings) and "salesmen" (who take the ideas and get organizations to try them). This model is borrowed from a paper written by Molly Joel Coye of the Health Technology Center (presented at a January 2003 conference sponsored by AHRQ and the National Institute for Healthcare Management Foundation) that is based on the principles in Malcolm Gladwell's The Tipping Point.
Researchers are the mavens when it comes to identifying strategies for improving patient safety. The connectors include a whole host of organizations, including accrediting bodies like JCAHO, associations, large health care systems, purchasing coalitions, professional societies, and government agencies and regulators. The salesmen include the leaders within organizations, including CEOs, senior managers, boards of trustees, and physician leaders.
Dr. Schyve believes that the salesmen are the critical players in getting research translated into practice. As a result, the key issue revolves around giving the salespeople what they need to be effective salesmen. This is a two-step process, involving making the salesmen themselves believers and giving them the tools to sell these beliefs to others. Dr. Schyve laid out five critical questions that the mavens and connectors must answer to give the salesmen within institutions what they need to effectively promote change:
- Does our institution have a problem? Some leaders still do not believe they have a patient safety problem. Statistics alone will not convince them. Rather, stories are needed that supplement the statistics by reaching the hearts and minds of leaders.
- What is the right thing to do? The right solutions to a problem should come from evidence on best practices. Knowledge should be synthesized to ensure that the underlying course of action is clear.
- How should this be done? Dr. Schyve called for development of a "how-to" manual that includes recommendations tailored to the specific needs of organizations.
- What is the business case (not just the financial case) for implementation? The business case should include the ethical arguments as well as the financial case for action.
- What could go wrong? What unintended consequences might result? Failure analysis should detail what failures might occur and how they would affect the organization.
AHRQ's Role in Facilitating the Translation of Research Into Practice
Dr. Graham reviewed AHRQ's role in promoting the translation of research findings into the everyday practice of medicine. He began by sharing a question asked by Congressmen John Porter during a 1998 subcommittee meeting, directed to the late John Eisenberg, M.D. (AHRQ director at the time). The "Porter Question" (go to box below) emphasized the importance of ensuring that agency findings are used to benefit patients. It has become an important benchmark by which AHRQ has measured its work since that time.
|The Porter Question "What we really want to get at is not how many reports have been done, but how many people's lives are being bettered by what has been accomplished. In other words, is it being used, is it being followed, is it actually being given to patients?... [W]hat effect is it having on people?"— Congressman John Porter, 1998, Chairman, House Appropriations Subcommittee on Labor, HHS, and Education.|
How Does AHRQ Bridge the Chasm?
Dr. Graham highlighted a variety of ways in which AHRQ helps to bridge the chasm between research findings and the everyday practice of medicine. Through research grants and the development of important data, AHRQ engages in the following:
- Support and conduct of user-driven research that meets the needs of its customers.
- Translation of research and evidence into tools that can be used to improve health care.
- Work with users to ensure that research results in measurable improvements.
AHRQ prioritizes its efforts by considering the impact that research could have. There is a hierarchy of potential impact. At the lowest level of this hierarchy, research may help to improve other research (e.g., how other researchers conduct their investigations). At the second level, research improves policies and processes. At the third level, research can improve daily practice by changing behavior. And at the top level, research can lead to improvements in outcomes, access, and efficiency, which represents the ultimate goal and gets to the heart of the Porter Question. AHRQ uses this hierarchy to deliberately and systematically track the impact of AHRQ-funded research.
AHRQ serves a variety of customers in its efforts to reach this ambitious goal, including clinical decisionmakers, health system decisionmakers (purchasers, health plans, and provider organizations), and public policy decisionmakers. While the information provided to each customer type differs according to the roles they play, the primary objectives in serving each customer are the same—to improve outcomes, access, and quality, to encourage appropriate resource use, and to enhance cost-effectiveness.
The AHRQ research and knowledge transfer process focuses on first building the knowledge base by figuring out what works at a clinical and organizational level and then figuring out how to get people, systems, and policymakers to use or do what works. The next step is to support the widespread implementation of what works, and then to sustain the use of the evidence-based practice over time. Specific AHRQ strategies for transferring knowledge include the following:
- Involving users in the research cycle.
- Partnering for translation and dissemination.
- Partnering for implementation and evaluation.
- Forming research networks.
- Forming research collaboratives.
- Focusing on results by measuring the impact of research through systematic evaluation.
AHRQ is moving away from its "push" approach to transferring knowledge in which both research findings and the decision to use them are viewed as discrete events to a "push, pull, and partner" approach in which both steps are viewed as a process to be conducted in partnership with the users of research.
Dr. Graham concluded his remarks by urging researchers to work to ensure that their research makes its way to the top of the research hierarchy pyramid. To maximize success in this effort, he outlined seven roles for researchers in translating their work into practice:
- Ask users what they want to know.
- Partner with users in the research design phase.
- Include in research all the people who will be affected.
- Share findings with user partners.
- Know why the findings matter, and say so.
- Tell funders who is using the research and how, so they know when it is having an impact.
- Ask users what they need to know next; this step becomes the beginning of a new cycle.
Key Insights from Discussion
Following the presentations, attendees engaged in a general discussion of the issues surrounding translating research into practice. Key insights from this discussion are provided below:
- Putting a face on the statistics appears to be critical to getting research findings put into practice. At the same time, one must be careful not to rely too much on anecdote, as stories cannot serve as a replacement for statistics and hard data.
- There is a tension between a provider's need to do more (which is in part due to concerns about malpractice and the desire for increased profits) and the need to simplify by doing less. Several attendees expressed concerns that there might not be protection for those who do less. Others suggested that working in teams and focusing on the practice of evidence-based medicine could offer some protection.
- Several attendees suggested using the term "integrating research within practices" rather than "translating" research into practice." In their view, the term "translation" somehow implies a separation between research and practice, when in reality research should be a part of practice (and vice versa).
- While the phrase "integrating research within practice" may apply to clinicians, there was a general sense that research findings do need to be "translated" for policymakers. Consumer groups and other organizations need to get involved to make sure that public officials understand the policy implications of research findings. Several attendees suggested focusing on legislative staff, who tend to be knowledgeable about issues and pragmatic in finding solutions. Influencing these staff members requires a persuasive force of argument. In addition to sharing compelling, easy-to-understand statistics and anecdotes, it may make sense to walk legislative staff through the hospital so they can see problems first-hand.
- Research should be viewed as a tool to reach clearly articulated goals. An example of a goal might be to eliminate all deaths from hospital-acquired infections within two years. By articulating this goal, provider organizations have something tangible they can strive to achieve. As a result, they are more likely to use research findings that help to reach the goal.
- Research findings are more likely to be adopted quickly if they simplify tasks for clinicians.
Where Do We Go From Here?
With Dr. Stryer as moderator, the final session focused on the future, offering both "blue-sky" and practical strategies and suggestions for how to improve patient safety through research.
Next Steps for Manufacturers: Engineering Controls
Mark E. Bruley, B.Sc., vice president of accident and forensic investigation at ECRI, focused on the need for the development of engineering controls within medical devices and information technology to promote patient safety.
ECRI in Brief
A nonprofit health services research agency, ECRI has extensive experience in the patient safety arena. ECRI performs accident investigations at hospitals and facilities around the world, and its medical device safety reports provide a critical link between the research community and the manufacturers of medical devices and technologies. Approximately 15 percent of products reviewed by ECRI have been modified after the evaluation. In some cases, problems that could have caused great harm were addressed before the product's release.
The Need for Engineering Controls
Engineering controls provide barriers and forcing functions that prevent humans from making errors. A common example can be found in automobiles, where engineers have put in place controls that prevent cars from being started when not in the appropriate gear (i.e., in the "drive" position rather than "park"). Engineering controls can include physical barriers, software features, and human factors (e.g., controls, displays, alarms, connectors). Designing these controls requires an understanding of human factors and the clinical realities of the settings in which health care practitioners operate. Examples of engineering controls in health care include the following:
- Infusion pumps designed with dosing schedules that prevent errors.
- Resecting surgical staplers that prevent the firing of staples in certain circumstances.
- Electrosurgical unit/return electrode monitors designed to prevent patients from being burned.
- Ventilators that have a limited range of settings.
- Electric beds with controls designed to prevent a child from being injured or killed.
- Physiologic monitoring leads designed to prevent the electrocution of children.
- Medical gas connectors that cannot be plugged into the wrong type of gas.
Mr. Bruley believes that current researchers are not focused enough on investigating the potential of engineering controls to enhance patient safety. He sees an opportunity for researchers to promote safety by working more closely with the medical device community.
Recommendations for Increasing Use of Engineering Controls
Mr. Bruley shared four recommendations that collectively will enhance the ability to identify, research, and put into place engineering controls that can prevent errors in health care.
- Examine existing patient safety research to identify those that have a significant medical device or IT component: A review of 94 current AHRQ patient safety grants suggests that 21 have the potential for engineering controls.
- From those devices and technologies identified in step 1, determine which medical errors can be prevented by the application of engineering controls: For example, the use of databases with drug dictionaries helps to reduce voice recognition mistakes in transcription, as potential misinterpretations are flagged.
- Develop a clear means of disseminating research findings to the manufacturing community, so that engineering controls can be developed: There are few formal links today between the research community and the manufacturers of medical devices, particularly with respect to the potential for engineering controls to improve safety.
- Use IT and the Internet to relay recalls and safety alerts: The failure to inform technology users of recalls and safety alerts from manufacturers and health agencies in a timely manner has led to the continued use of recalled devices, with potentially deadly consequences. To improve this situation, ECRI sends out a weekly notice of safety alerts and recalls.
Next Steps for Researchers and AHRQ
Lucian L. Leape, M.D., adjunct professor of public health at the Harvard School of Public Health, focused on the next steps for researchers and AHRQ in the area of patient safety. Thanks to a flurry of activities, Dr. Leape believes there has been some progress in the area of patient safety over the last several years. But progress has been slower than many would like, and much more needs to be done to improve patient safety in the future.
To facilitate progress, Dr. Leape called on the research community to finish their projects, which will help to answer key questions and identify new research questions to be answered. Often the best research questions arise as a result of initial work in an area. Researchers should also share their results (both successes and failures) broadly. For its part, AHRQ should not focus its limited resources on basic knowledge about patient safety; enough is already known about how and why people make mistakes. He also believes that the existing list of effective practices for improving safety is long enough (at least for now). While some work should continue to establish the evidence base related to effective practices (i.e., proving that they work), the industry can not wait for definitive evidence before taking action. To that end, Dr. Leape called for AHRQ to focus its attention on implementation—that is, understanding how to make the adoption of effective safety practices happen within institutions. One critical issue is how to motivate institutional leaders to push for change.
Unlike in other countries, the U.S. health care system is attempting to achieve needed levels of safety voluntarily. Calling this approach a great social experiment, Dr. Leape noted that no safe industry has ever become safe in this manner. Industries such as airlines are highly regulated and exert strong administrative controls over personnel. Health care has neither of these characteristics. Dr. Leape is cautiously optimistic that this "bottom-up" approach can work. A growing cadre of people "get it" when it comes to patient safety. He is hopeful that this mass of people will soon become a "critical mass" that can eventually change the culture of medicine.
Next Steps in Medical Education
David P. Stevens, M.D., vice president of the Association of American Medical Colleges (AAMC), discussed the next steps in patient safety in the field of medical education.
Lessons from History
He reviewed what history teaches about change in health care, using three issues as illustrations:
- Genomics and proteomics are understood and well accepted within health care, largely because they are exciting and rooted in familiar territory—biology.
- Information sciences are only slowly being accepted, since the industry as a whole does not understand technology well.
- "Systems" approaches to patient safety are being accepted with great difficulty by the industry, as they run counter to the culture of medicine.
Dr. Stevens believes that individuals who go into health care learn in much the same manner that pilots learn to fly. Citing a stages of development model (The Dreyfus Model, developed in the 1970s and adapted to health care by Paul Batalden and David Leach), he noted that health care practitioners and students go through six stages of learning—the novice stage (characterized by memorization of rules), advanced beginner and competent stages (where rules are adapted to standard and then more complex situations), proficient and expert stages (where expertise is gained slowly over time), and finally the master stage (when a skill is completely mastered). Individuals follow the expected path with respect to learning the practice of medicine, with medical students being novices and practicing physicians and faculty being experts.
But not all aspects of learning in health care follow this particular path. For example, within the area of genomics and proteomics, faculty and practicing physicians may well be novices, having never received training in this relatively new field. And in the area of information science, medical students may well be the experts, with residents being only competent and practicing physicians being novices.
But within the area of patient safety, everyone is learning from each other. It is not clear who are the teachers and who are the learners. The traditional knowledge and authority gradient has been replaced by a knowledge and authority "equilibrium" where all parties learn from each other.
The Future: Redesigned Work for Care and Learning in Teaching Settings
Dr. Stevens described an AAMC project (funded by The Robert Wood Johnson Foundation) to develop a framework of explicit rules and principles that will support the redesign of patient care and resident and student learning within teaching settings. The project involves the bringing together of various groups, including physicians, nurses, pharmacists, and others to take a "30,000-foot view" of how work can be redesigned to improve both patient care and learning (the presumption is that these two functions should not be separated). Key goals include the following: enhancing patient safety; improving patient and learner satisfaction; preserving key relationships, including doctor-patient and teacher-learner; removing re-work; creating time for care and learning; and creating greater joy in work.
The project is not just a "pie-in-the-sky" evaluation. It includes practical on-the-ground components that focus on use of simulations and rehearsals, eliminating unnecessary redundancies while creating redundancies for safety, using IT systems to support care and learning, improving scheduling systems as well as communication during handoffs, and developing high-performance microsystems (e.g., in the doctor's office).
Action Steps for Next Tuesday
Dr. Stevens highlighted some immediate steps that teaching institutions can take to enhance patient care and learning through the creation of a safety culture that emphasizes new strategies and new partners. His suggestions for creating a culture of safety include the following:
- Pay constant attention to failures through a relentless focus on root-cause analysis of errors and discussions of near misses.
- Develop an "adaptive" authority structure that allows for flexible authority and learning gradients that recognize that the teacher and student may switch roles in given situations.
- Be mindful of the unexpected.
- Avoid quick fixes that require radical culture change.
To cultivate new partners, Dr. Stevens called for the following:
- Exploiting the continuum by expanding use of the six ACGME competencies, especially the practice-based learning and improvement and systems competencies.
- Re-thinking the concept of teams to incorporate high-performance microsystems and crews that emphasize what each person brings to a particular activity.
- Moving to patient-centered care; information sharing is a key part of this step.
- Aligning patient care and learning by committing to work redesign; patients and learners should no longer be put in settings that do not offer the best-possible care.
Next Steps for the Industry as a Whole
Dr. Graham concluded the panel presentations by emphasizing the next steps for the health care system as a whole. Basic organizational theory suggests that for the system to change, it must acknowledge the need to change. Within the Nation's medical care system, there is at least an acknowledgment today of the need to improve safety and quality. Yet because humans regard change (e.g., adopting new systems and values) as loss, resistance still exists. Changes that are additive and require less loss will be more readily adopted than those requiring fundamental modification of systems or individual behaviors. These changes will meet with fierce resistance, which must be understood if it is to be overcome. On a tactical level, Dr. Graham called on researchers to find ways to link, transfer, integrate, and migrate knowledge into those settings that can bring about the changes in behavior that will in turn lead to improved safety and outcomes. Researchers must identify points of leverage (e.g., change agents and salespeople) that can serve to maximize the impact of research findings.
Key Insights from Discussion
Following the presentations, attendees asked the panelists questions and engaged in a general discussion of the next steps in patient safety research. Key insights are provided below:
- The fact that patient safety depends upon both human factors and machines does not argue against a systems approach to safety, as the systems approach incorporates both factors. This reality enhances the role of human factor analysis in the evaluation of errors. Hospitals often lack expertise in human factor analysis and equipment engineering, and therefore may fail to identify safety problems and potential solutions. Fortunately, progress is being made; a recent FDA conference brought together human factor researchers and patient safety researchers.
- Attendees and panelists saw potential value in the creation of a federally funded, independent National Patient Safety Board to investigate and publicly release findings related to errors and accidents (similar to the National Transportation Safety Board). Dr. Leape noted that criteria would be needed to determine which errors and accidents the board would investigate. That said, the board need not investigate a huge number of accidents to provide value; often a single, well-investigated accident can yield important insights and recommendations.
- Because medical device companies are not well-funded or highly profitable (and thus are unlikely to develop engineering controls on their own), the development of safer devices will depend upon the creation of strong demand for them. Fortunately, the activities of organizations like the Leapfrog Group, combined with legal liability concerns, have served to heighten awareness of patient safety and therefore are beginning to create this demand.
- Getting information on patient safety published can be a difficult task, especially in better medical journals. While attendees had no specific solutions to this problem, there was general consensus that it was an issue worthy of further attention.
Dr. Graham concluded the meeting by agreeing with Dr. Clancy's view that the health care system today is probably not significantly safer than it was several years ago. But that fact does not mean that progress has not been made. The "mindset" of the health care system has changed; most acknowledge that patient safety is a huge problem and that the system must change to address it. While enthusiasm and the pace of change varies significantly across institutions, acknowledgment of the need for change does exist broadly.
Dr. Stryer built upon Dr. Graham's remarks by noting that the best gauge of the conference's success is what happens when everyone goes home. He urged attendees to work with their peers to promote change by shifting the conversation about patient safety to a new level and by cultivating leaders throughout the organization to act as catalysts for change. For its part, AHRQ will continue to play a leadership role in this effort, both through new programs such as the Patient Safety Improvement Corps and through efforts to work with the mavens and the connectors to identify and share evidence and stories that are so critical to achieving change.