Improving Health Care: National Policy and Local Practice

Abstract

¹Attention to quality and patient safety in health care has grown substantially over recent years. From 1982, I have been involved in advocating for efforts to improve quality and safety. Four years ago, I was given the opportunity to lead an academic health system - hospitals, doctors, and a medical school.

This article recounts the shift in perspective, from a focus solely on national policy, to one now of changing local practice. Both are important and needed.

The past 25 years have seen a large scale shift in the way the public at large and especially the medical community view the state of quality and safety in health care. I have been privileged to participate in this transformation at the national level in several roles, and I would like to describe that evolution.

Now, however, I have the job of leading an academic medical enterprise, and am challenged by the task of putting lofty national ideas into practice at the local level. I am very committed to this effort, but am sobered by the challenges we face.

BACKGROUND

During the late 1980s, I was administrator of the federal Health Care Financing Administration, with responsibility for the Medicare and Medicaid programs nationally. So much of my formative perspective on these matters is through those programs, especially Medicare.

When Medicare was enacted in 1965, the principal focus of the legislation was enhancing access to health care services for older Americans. The history of the legislation featured a major battle over the roles of government and of physicians in guiding health care - and the Medicare statute (¹) in 1965 includes the now quaint notion that decisions about medical care should be left entirely to doctors.

During the 1970s and early 1980s, widespread and growing concerns about the cost of care and the quality of services overtook the idea of further expansion of access, and became the dominate health care issues confronting the federal government.

Jack Wennberg's (²) seminal work showed wide geographic variation in the practice of medicine. Bob Brook (³) found that a large portion of medical services were judged to have been unnecessary by a panel of experts. And David Eddy (⁴) highlighted the lack of clear evidence for the effectiveness of many medical practices.

There was a major national debate over the cost of hospital services in the early 1980s, leading to the enactment of the hospital DRG payment system in 1985. By the time I came to head the Medicare program in mid-1986, the “quicker and sicker” issue was before the Congress - the concern that the new methodology for paying hospitals was leading to patients being discharged too soon from hospital stays, and to their detriment.

The Medicare agency was asked by the news media for information that we had assembled analyzing large scale patterns of use and outcomes. Instead of just releasing the data, we decided to publish it ourselves, as part of a major effort to improve the quality of care in Medicare.

And so from 1986 until 1991, HCFA published Medicare hospital mortality information (⁵). We sought and received help from experts in the field on how to improve the process and especially how to deal with the methodological challenges in producing the mortality statistics. Hospitals complained that our severity adjustments were not adequate and that our cut points for outliers were arbitrary.

But I am convinced that everyone, including the hospitals, learned a great deal about hospital performance, and began to explore how to evaluate health care. Shortly thereafter, we decided to launch a new effort, that we called HCFA's “Effectiveness Initiative,” that sought to use the Medicare data to improve health care. My colleagues and I had a paper in the NEJM in 1988, entitled, “Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice.” (⁶) And Bud Relman wrote an accompanying editorial, which he called “Assessment and Accountability: the Third Revolution in Medical Care.” (⁷)

We believed that information about health care effectiveness was a public good, and therefore, that the government should play a key role in data collection and evaluation of effectiveness. We sought funding for a research program to drive this process, and the following year the Congress established the Agency for Health Care Policy and Research, later renamed the Agency for Healthcare Research and Quality.

The Institute of Medicine, under Sam Their's and then Ken Shine's leadership, played a very important role across the decade of the 1990s, defining “quality” in health care, then pointing to problems in quality and patient safety. Bill Richardson led a multi-year IOM initiative that included the groundbreaking report, To Err is Human (⁸) in 1999, and then Crossing the Quality Chasm (⁹) in 2001. These reports were a clarion call for action - especially making the point that a systems approach was required to deal effectively with these issues.

In the past several years, a number of organizations have contributed mightily to this effort -including NCQA, the Joint Commission, the Institute for Healthcare Improvement, the Leapfrog Group, AHRQ, CMS, the Hospital Quality Alliance, the AQA, and the National Quality Forum, whose board I am now privileged to chair. I believe it is important to point out how far we have come in the past two decades, and especially since 1999.

We now take for granted that entities that do not directly deliver medical care - that is, government, private insurers, and employers - will routinely measure the performance of those who do provide the care - doctors, hospitals, and other practitioners. To be sure, many of the measures remain relatively crude, but we no longer debate whether this measuring and monitoring is a legitimate exercise.

Both patients and practitioners have also accepted the notion that we harm people in the course of trying to help them, and further, that many of these harms are preventable. The public's tolerance for these preventable harms is falling rapidly.

And finally, there is no controversy about the fact that in the case particularly of chronic conditions, many patients are not receiving care and treatment that is supported by scientific evidence - and this is independent of the problem of inadequate access to care for those who are uninsured or underinsured.

IMPLICATIONS

Because of these new realities, much energy is now devoted to meeting public desires for better care and for better ways to assess care. The looming challenge now is to integrate established improvement methods into health care. Americans increasingly receive health care services in organized settings, i.e. in organized systems. In other words, an individual's medical treatment rarely depends on the actions of one person, be it doctor or nurse. Even a private doctor's office includes one or more physicians, nurses, and usually a medical or nurse assistant. Obviously too, if a patient needs laboratory testing or x-rays, this is increasingly likely to be performed in some other place by some other people.

Because care is largely delivered in systems, it follows that improvements in performance and safety cannot rely on the impeccable behavior of individual practitioners alone, and we must therefore also focus on systems improvement. Systems improvement is driven by, among other things: teamwork, shared accountability, the universal use of data to assess performance, and establishing standardized processes and procedures to reduce variations in practice and therefore variations in quality.

People who work in health care organizations have by and large not been trained in systems improvement. This is certainly true of physicians. Doctors' training does not prepare us for a systems approach to improving medical care. Physicians are taught to be independent actors and solitary decision makers, with the occasional assistance from other physician consultants. Doctors have not traditionally had their daily practices monitored once they have received a license to practice. And while in training, doctors likely observe that their teachers may or may not be using the latest evidence to inform their decisions. In general, physicians have not had access to aggregate data to monitor the success of their interventions with patients. The doctor is meanwhile clearly compelled to function as the advocate for the individual patient, and not to be the agent for an organization.

Many doctors also view standardizing processes as a form of “cookbook medicine”, in which the physician's individual judgment is diminished or even excluded. To the extent that doctors are taught about using evidence to support medical care, the focus is on the traditional scientific method - randomizing patients and blinding caregivers to whom patients are receiving a treatment intervention or a placebo. Few medical schools teach other evidence driven methodologies, such as rapid cycle improvement to reduce potential harms to patients.

Finally, for doctors in the US, relinquishing decision making control and autonomy to a team or a standardized process is viewed as a high stakes gamble, because the physician's liability insurance and even license to practice ultimately depends on what happens to the patients for whom she provides care.

CONCLUSIONS

All of this together means physicians and hospitals will need to find common ground between standardization and autonomous practice, between group and individual accountability. At the same time, both individual certification and organizational accreditation will have to deal with this tension, because even as we push for predictability, we know that humans are complex organisms, and doctors must be allowed to apply their judgment in the care of individuals.

We will, all of us, also need to figure out how to do the work that it takes to collect information and implement change. As always, the devil is in the details, and for physicians at UNC and elsewhere, change is slow and sometimes painful. Doctors, nurses and staff are, of course, already fully deployed; in that context, we should expect conflict over who should be responsible for new steps in care (for example, screening a patient for vaccination while she is hospitalized), creating new documentation (of patient education, or why a practice deviated from a standard), and more detailed communication with patients and family members. We can continue to try to make the business case for quality, but the reality is that in general our financing system still pays “fee for episodes of service” and not for better outcomes; this limits hospitals' and doctors' willingness to shift dollars to those who do this work.

Another challenge that we face in translating national intent into local practice is getting good data to guide practice. Even when an organization and its practitioners are committed to efforts to measure and monitor outcomes and safety, good information can be difficult to come by. It is difficult to adjust doctor, nurse and staff workflow to accommodate additional specific data collection for this purpose. More to the point, these practitioners often lack good tools to collect data in the standardized fashion that would facilitate an evaluation of the care that they deliver. And unless they are documenting in elaborate and sophisticated electronic systems, the work of extracting and collating data from every individual patient record is expensive and time consuming.

One of the key benefits of using data to drive performance is reporting information back to the practitioners in a way that allows the practitioner to understand what is going on and to adjust his/her practice accordingly into the future. We are beginning to generate this kind of feedback, but if we want to fully meet the public's desire for reliable information about the quality and safety of health care, we will need even better ways to collect and report information to caregivers.

At UNC Health Care and the UNC School of Medicine, we are working intently on these issues. We now have an organization-wide electronic health record, with computerized provider order entry on all of our units. We are now moving to permit referring doctors to have access to their patients' records at UNC. We are soon going to be experimenting with patient access to their own records - and facilitating the health care process with such tools as online patient scheduling of clinic appointments.

We are proud of our record of performance in some measures of quality and safety - for example the Leapfrog Group's assessments. But in other areas we are disappointed in our results, and we are demanding much more of ourselves. We have appointed a “Chief Quality and Patient Safety Officer,” who is charged with leading all of our efforts in these areas. The board of directors of the UNC Health Care System has created a Quality Committee, and they (and the entire board) have taken a keen interest in pushing our progress.

But actual progress, on the ground, in local practice is very hard work. It is one thing to lead an initiative of a federal agency (HCFA and CDC), and to chair the board of a national coordinating group (the NQF) - it is quite another to really make this happen in a large (and supposedly) organized health care system.

I have already mentioned some of the key challenges we, at UNC, share with other systems. To these I would add a few more:

1. We must learn to trust and empower our people, and we must encourage them to make teamwork second nature.

2. We must relentlessly tell each other that it is everyone's job constantly to look for ways to improve care and to remove preventable patient harms.

3. Like other academic medical centers, we must more closely align the interests of our hospitals and our physicians.

Though some of these changes demand that we change our culture, we are determined to press ahead. It is the right thing to do, and our patients and families demand it of us, as does our professional commitment. But at a personal level, it would be a great embarrassment to me, personally, to have pushed this agenda so aggressively, for now more than twenty years, and not to be able to have UNC succeed in its practical application.

This is clearly a work in progress - stay tuned.

DISCUSSION

Powell, Galveston: The cost to move into quality management era with increasing information technology is really significant. How are we going to do this?

Roper, Chapel Hill: We are going to do it because we have to do it. A number of outside organizations, including the federal Medicare program and business purchasers as well demand this information of us. We, like other institutions, are moving to be able to present this information. I don't believe the federal government is going to give us a subsidy for the extra cost which is very substantial, but I trust that it will be a level playing field because all of us are going to have to do this.

Thorner, Charlottesville: Bill, that was a very illuminating and very important presentation. I guess the stress that I see is that what you are describing is monitoring scientific care and to steal from Abe's talk, this is about cure, not about healing. How are you going to monitor healing in this system?

Roper, Chapel Hill: That is a point very well made. We don't have a way of monitoring that, but I would just tell you we are focused intently at our institution on trying to make sure we treat patients and their families with compassion and care. It requires a much different, more subtle, more personal attention than the data-driven exercise that I was describing. Your point is very well made.

Ludmerer, St. Louis: I too would like to thank you for that excellent presentation and important work that you have been doing. You are a big part of what has been presented today and my question is, I think, on a similar vein as Michael's. The more that I personally looked into these issues, the more it seemed to me that a concern with safety and making systems work better is long overdue. On the other hand, with all the measures that we have today that are called quality, it seems to me that we are really talking about the floor of medical performance rather than the ceiling. There has to be something to quality beyond not making a mistake, and if you have a diabetic patient whose hemoglobin A1c hasn't been measured for three years, that's a mistake. If you have a patient with documented coronary artery disease not on a beta-blocker or an aspirin that is a mistake, but the higher practice of medicine aims toward the ceiling and it's not only the doctor/patient relationship as Michael was alluding to just now, but it is all the things that master clinicians from the very beginning do, beginning with the proper diagnosis. What good is it to follow an algorithm if you're on the wrong diagnosis, managing a difficult case, et cetera, et cetera? So I would appreciate your thoughts on this issue of teaching, stimulating, inspiring learners to learn the higher qualities of medicine, of inspiring physicians in practice to continue reaching for these levels as well as possibly developing useful measurements that will let us know if we are doing the job, looking upward rather than not trying to fall through the floor.

Roper, Chapel Hill: I would simply say I agree with everything you've said, and clearly we need to do all of those things. One of my takeaways from this meeting is to invite some of the speakers that we've had here to our medical school to talk to our medical students, because those are important messages, and I agree with your fundamental point that the essentials of care are floor, not ceiling, but it is profoundly discouraging, if I can be honest with you, to look at our institution and many others where we are falling regrettably far short of providing these services on a routine basis to everybody. Beth McGlynn and colleagues at RAND showed that for adult patients a couple of years ago and more recently for pediatric patients. We are well short of doing what doctors know to do. Many times, things are done and done well and appropriately but not documented, and so part of the problem is that we fall short on the bean counting, but if we don't document it, we don't get any credit for it.

Crowley, Boston: Bill, it was a great presentation. I agree with Michael, a very important one. My question is from a different perspective. At our institution, these are all the overwhelming operational mandates that we are facing at the same time as most major academics. My concern here is: there is a great opportunity here to generate new information in terms of clinical research, and you alluded to this as sort of a quality improvement kind of cycle which is sort of the operational motif that clinical research takes on when you are talking about operational people. But it strikes me that there is a really good opportunity here to rethink exactly how we are doing clinical research in a broad way that often gets lost in the shuffle of operational things. The mandates are so overwhelming, the challenges are so daunting, the financial commitments are exhaustive, that the bean counters, as you say, are in the room and there is nobody assigned to think about this, as we are doing this, given that we must expend this. How can we, value added it at the margin here, generate the most powerful tool we've ever seen for clinical research, not just individually but nationally? I am coming at this from the clinical research forms perspective, which I founded and shared at 62 academic health centers that are all focused on this, and, in fact, we are going to focus on this at our annual meeting. But it seems to me that with your national perspective, the ability to engage insurers in funding this as part of a clinical research engine, is unique if we start to speak up with one voice. That has not been the traditional relationship we've had with insurers. It is a different one. But is this the right moment to re-strike the balance, to seek support for these things that we are doing in a way because in many ways, the investments, we would call them, are rounding errors in all of our budgets, particularly theirs? Yet they have not been in a relationship that is anything more than adversarial or provider. Is this a tipping point where we can rethink the relationship and create a new marketplace for clinical research with them as funders?

Roper, Chapel Hill: I think it is. A couple of points I would make quickly, Bill. One is we, like most other academic medical centers, are building a data warehouse to permit much more real time research using our now fully-automated electronic health record to gather the information and then permit its use by researchers. If we are not high-minded enough to do it on our own, the CTSA process is requiring it of us, and so we are doing that as I trust everybody else is. The next step, as you are pointing out, is to aggregate that. Not in just a single institution but multi-institutions and maybe the whole country ultimately. I think that can be done given the things that I am sure Bill Stead understands, but I sure don't know about computers and their use in medicine.

Crowley, Boston: I am a little worried that the CTSA, which is so occupying everybody at the moment to make this painful transition, may be the rodeo clown in the arena, and the real bull and toreador here are these other relationships that we can build. Everybody's investing so much into the CTSA, which you have to and I understand it's five feet in front you, but that the real opportunity may be to use that to do other things.

Rounds, Providence: I very much enjoyed your presentation, and having grown up in the VA with the VA medical record, with all do respect, I would humbly suggest that perhaps the rest of organized medicine could learn a lot from the Department of Veterans Affairs. As a clinician, I first appreciated it as a way of making my life easier and not having to try to decipher someone's indecipherable handwriting, but I've grown to appreciate the sophisticated subtle complexities of this ranging from ease of the medical record to the realization that there is no better way to change physician behavior than to monitor their behavior and to report their behavior. That causes immense changes and the hemoglobin A1c suddenly becomes an important priority when the doctor realizes that someone there actually cares about it enough to monitor it and report it. Now the VA is going to use these systems to improve access to care in the clinics and also to improve patient flow through the hospitalization. So having the data is critical for all of these imperatives and I am wondering why doesn't the rest of organized medicine use the free CPRS system that is available from the Department of Veterans Affairs? It's been shown to be so effective.

Roper, Chapel Hill: First, let me just say I salute Ken Kaiser's leadership at the VA in creating this. It's a model for us all and there are efforts underway to spin off the VA system into other settings.

Barondess, New York: Bill, that was a masterful summary, and I thank you for it. I am concerned that we are focused in an era in which the main disorders of which we have to deal are chronic diseases at very late stage expressions of disorders that have been progressing silently and, in a sense below the clinical level. In fact, below the clinical level for years or even decades and what we are pleased to call healthcare is by in large not healthcare but disease care. I wonder what your thoughts would be about moving proximally in the course of the biological process–try to do something to apply what we know about risk factors and about prevention and about health preservation across the years before they come to the UNC Medical Center and how we disseminate and how we put some muscle into that. I would appreciate your thoughts.

Roper, Chapel Hill: It's something that my former colleagues, the CDC, are working on doing Jerry, and I would just say we, as a society, need to move much more upstream as you are saying.