Medical Device Daily Washington Editor

WASHINGTON - To even the casual observer, the U.S. healthcare tab might by now be the stuff of urban legend, so it was no surprise that presenters at the third day of this year's Heart Failure Society of America (HFSA; St. Paul, Minnesota) meeting tackled quality of care and pay-for-performance, or P4P.

However, the presenter on P4P exuded anything but affection for the idea, and while discussions of quality of care (QOC) were more optimistic, even this paradigm for healthcare reform is viewed as, at best, an unfinished product.

Gregg Fonarow, MD, the co-director of the preventive cardiology program at the David Geffen School of Medicine at the University of California at Los Angeles (Los Angeles), said that QOC is "a huge public health problem" because a "large number of patients are receiving other than optimal care."

Fonarow said that the mere act of defining QOC is an issue, however. the Institute of Medicine (IOM; Washington), for instance, defines quality of care as:

"The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."

Fonarow also said many observers might be inclined to define quality care as that which is provided by clinicians with excellent training, or the care provided at centers with national recognition. Others would define it via appropriateness measures, while still others, when pressed to define quality care, might respond "I'm not sure what it is, but I know it when I see it."

Fonarow pointed out that HFSA has a set of guidelines published more or less as consensus documents on quality care, "describing a range of generally accepted approaches for diagnosis, management or prevention." But the level of detail, while important, is also a bit daunting.

"There are actually 230 domains of recommendations" for heart failure, but "only about 16% have been firmly established by RCTs."

Another part of the difficulty is in figuring out how to translate the established best practices to clinical practice, let alone cases that don't fall into these established groups. He described briefly the case of a patient in his sixties who received "defect-free care," but had a cardiac arrest at day 31 and died.

Due to these and other dilemmas, Fonarow said, "measuring quality of care is important, but we must continually evaluate whether measures are valid and positively impact patient outcome."

As any manager can testify, inducing behavioral change in an organization is a huge task, but Edward Havranek, MD, a professor of medicine in the division of cardiology at the Denver Health Medical Center (Denver), nonetheless gave attendees a few approaches to implementing quality initiatives.

There are two classes of initiatives, those that arise within organizations and those that come into being due to interaction between organizations.

In the case of the intra-organizational quality initiative, Havranek said, success may hinge on the presence of a "local opinion leader," which is "someone who is willing to champion an idea." He said that the presence of such a person "in and of itself can lead to improved care, but the effect is small." The studies that Havranek cited averaged a 10% decrease in non-compliance with quality standards across 12 studies.

Quality audits and feedback also have some effect, Havranek said, which "a large number of studies show," but the impact is generally restricted to a small number of measures.

Another approach, albeit one that promises to be rather labor-intensive, is academic detailing, which consists of one-on-one academic discussions. "Having someone you know and respect coming to you and saying you should do something is significantly effective in the preponderance of studies," Havranek said, an assertion he said was supported by 12 of 13 studies.

On the other side of this coin, however, Havranek said that continuing medical education and grand rounds do not change behavior.

To effect lasting change, "the organization has to have a shared goal for improvement," Havranek said, as well as "substantial administrative support."

"It has to come from that corner office," and if the members of the executive suite buy in, "it tends to drive the rest of the organization."

As for change induced by external organizations, Havranek referred to the standard motivators, the carrot and the stick. He said that P4P is one of the more obvious financial carrots, and the Joint Commission for Accreditation of Healthcare Organizations (JCAHO; Oak Brook Terrace, Illinois) is the stick because an accreditation failure can lead to loss of business.

Havranek said that social motivators still count in hospitals, clinics and doctors' offices. "Some argue these are as important or even more important" than economic incentives due to the ethic that motivates participation in healthcare in the first place.

Will public quality reporting change practices? "I think it's really not known yet," Havranek said, but "its important to know that public reporting" does not seem to prompt changes in hospital behavior due to "little economic incentive."

A presentation made by Daniel Mark, PhD, professor of medicine at the Duke University School of Medicine (Durham, North Carolina), was titled "P4P; Boon or Bane?" By the end of his talk, it was clear that he saw little boon in P4P.

Mark said that there are currently more than 100 P4P programs in force in private care and that most of the impetus is because Congress "is looking for value-based purchasing." He said that a 2006 IOM report "strongly recommends moving forward cautiously" to roll out performance measures, and Mark noted the tension inherent in a strong recommendation to move cautiously.

Mark said that in one analysis of 17 studies of P4P that had concluded by the end of 2005, several were at the level of a hospital system and several were of doctor's offices, but effects were small in all the studies. "The interesting thing about all this evidence is that ... eight of the nine had an effective sample size of less than 100," which would generate scathing criticism if that sample size was used as a clinical trial.

One of the unintended consequences of P4P, Mark said, was that physicians sometimes game the baseline illness, and some institutions have allegedly developed an aversion to sicker patients. Marks also said that there is currently no data on the persistence of the impact on performance.

According to Mark, "the UK has led the charge," in P4P. He noted that several years ago, the British government committed the equivalent of $3.2 billion over three years for practicing physicians to boost performance. Doctors who maxed out their scores on all categories stood to pull in about $140,000 per year in additional income, but this program involved no penalty for poor performers. In the first year, 83% of key indicators were largely achieved, but data from 6% of patients was excluded.

Mark said that the average increase in pay was $40,000 a year, but this better performance also increased the debt of the National Health Service. He also said that some data suggested that performance indicators were going up before the program, "so its not clear how much of the achievements can be attributed to the program itself."

As a consequence, Mark said, "the government has made it significantly harder to get the money."

Mark said that the Premier P4P project funded by the Centers for Medicare & Medicaid Services was the subject of a claim of 1,300 fewer deaths for myocardial infarction, but that at least one researcher, Peter Lindenauer, MD, of the Baystate Medical Center (Springfield, Massachusetts), is of the opinion that "for acute MI, and heart failure, generally speaking, there was no overall difference." Lindenauer's research, which appeared in the Feb. 1 edition of the New England Journal of Medicine, demonstrated a "very small incremental effect, if any," Mark said.

In the end, "what you measure generally improves," Mark said, hinting at the notorious Hawthorne effect - a phenomenon which is thought to occur when people observed during a research study temporarily change their behavior or performance, adding that "what gets measured is usually what's easiest to measure." But ease of measurement is not the same as the relevance of those measures. He posed several additional questions, including "what are the unintended consequences of these programs?" He also asked, "What is the cost of the program?"

Mark also wondered at the enthusiasm for a program that is backed by little evidence, but posited that "the pressure to take action can overwhelm" evidence-based approaches.

"I think you could argue that it's a social experiment," but he urged doctors to "wear your helmet and keep your eyes open."

Mark told Medical Device Daily that "we don't really understand what [P4P programs] cost," and the salaries of those who are paid to handle these programs are not necessarily accounted for. As to whether preventive medicine is the only realistic hope for healthcare cost containment, he said that this might be the case, but that "it probably takes a generation or more to pay off."

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