For years, healthcare providers, purchasers and policymakers have been grappling with the challenge of cutting costs while providing quality care.
One solution many have found is the use of clinical pathways. While it's not a new solution--HHS' Agency for Health Care Policy and Research, the U.S. Preventive Services Task Force (organized through HHS) and the American College of Physicians have been developing pathways for years--the continuing reign of managed care has sparked new interest.
Hospitals and healthcare systems, HMOs and other managed-care organizations, medical specialty societies, insurance companies and even various proprietary groups are among those formulating pathways for a range of services, from childhood immunizations to cataract surgery.
About 75 organizations have developed more than 2,000 guidelines to date, according to the American Medical Association. The AMA had about 700 guidelines on record just five years ago.
Clinical pathways, also known as practice guidelines or care protocols, provide a road map for physicians making decisions about care. Typically, panels of healthcare experts, including physicians and nurses, write guidelines based on reviews of medical literature and scientific evidence.
"An increasing concern with cost and a general concern with quality has been the impetus behind guidelines proliferation," says Douglas Kamerow, M.D., director of the AHCPR's Office of the Forum for Quality and Effectiveness in Health Care, Rockville, Md. "We want to channel money in the most appropriate direction. Guidelines can tell us what's appropriate and what's not."
Recent national surveys show that a majority of managed-care plans have adopted guidelines, according to a May 1996 report by the General Accounting Office, Congress' investigative arm. The report cites a 1994 survey by the Physician Payment Review Commission that found 63% of managed-care plans reported using written practice guidelines.
Many managed-care organizations believe guidelines give them a competitive advantage with employers, other healthcare purchasers and in the accreditation process.
"The real fire for making this happen (developing pathways) is managed care," says Brent C. James, M.D., executive director of the Institute for Health Care Delivery Research and vice president of medical research and continuing medical education at Intermountain Health Care in Salt Lake City. "It's something we should have been doing years ago," James says. Intermountain is an integrated system of 24 hospitals, more than 30 clinics and a 500,000-enrollee HMO/PPO.
There is good data to show practice guidelines can improve quality of care and increase organizational efficiency, James says. At Intermountain's LDS Hospital in Salt Lake City, the postsurgical infection rate was cut in half after clinical data was used to determine the best time to introduce prophylactic antibiotics during surgery. A research team found that, for the majority of patients, antibiotics are most effective when started about two hours before a procedure.
Preventing a postoperative deep-wound infection can slice an average of $14,000 off a patient's healthcare tab, according to hospital estimates. At LDS, the use of clinical guidelines to control these infections has saved nearly $750,000 a year.
Intermountain, which has won national recognition for its pioneering efforts in the areas of healthcare quality and continuous quality improvement, is in the midst of about 60 clinical improvement projects, James says. The projects address issues ranging from reducing waiting times at clinics and providing faster lab results to improving health services for women and newborns.
Despite the expense of developing clinical pathways, it makes sense financially to use them to modify physician decisionmaking: Industry estimates show that physician decisions control between 70% and 80% of all healthcare expenditures.
Encouraging physicians to change their behavior has never been an easy task, and convincing them to accept and use guidelines is no exception. Accordingly, proponents of clinical guidelines need to make sure physician executives understand that involving their medical staffs in the development of guidelines is critical to achieving staff buy-in.
"Practicing doctors have to be able to understand how guidelines were developed," says Robert Bargar, M.D., vice president and chief medical officer at Optimed Physician Review, a private quality management company in Lexington, Mass. "Otherwise, the guidelines won't have support in the (physician) community."
The importance of building consensus among physicians and other healthcare professionals whose work will be affected by guidelines can't be overstated, Bargar says. As a contributor to the new book, Tools With A Task, Bargar has outlined the components of a successful guideline (see chart on page 18).
Who does it help?
It is common for physicians to be skeptical about the integrity of data chosen to develop guidelines-the source of the data, its reliability and its objectivity. Physicians want to ensure that any guidelines they use reflect values and clinical decisions that match their own.
At Bucks County Physician Hospital Alliance in Doylestown, Pa., primary-care physicians and specialists alike are intimately involved in developing and adapting guidelines, according to Patricia Vida, a registered nurse and director of critical care and emergency services for the 180-member independent practice association.
"Finding a group to be committed to (guidelines) is very important because their ownership of it is what creates success," Vida says. To encourage that kind of commitment, Alliance compensates physicians for the chunk of time they spend serving on medical management committees developing guidelines.
For some doctors, the main problem with guidelines is the possibility that they weaken a physician's position in the event of a lawsuit.
"Doctors are afraid if they use guidelines they'll get sued, and if they don't use guidelines they'll get sued," says Philip Boyle, senior vice president and editor-in-chief at Chicago's Park Ridge Center for the Study of Health, Faith and Ethics, a not-for-profit research and education organization.
In fact, guidelines sometimes serve as a defense in medical malpractice cases, experts say. "If you comply with guidelines, you have a strong defense in medical malpractice litigation," says Troyen Brennan, M.D., executive director of Brigham and Women's Physician Hospital Organization in Boston.
Yet Brennan, who holds a law degree, also says, "(Although) judges will integrate guidelines into their decisionmaking process, practice guidelines probably will not revolutionize the procedures courts use to determine negligence."
A more common complaint physicians voice is that practice guidelines undermine their decisionmaking authority. They argue that written guidelines lead to the practice of "cookbook" medicine, which they say compromises clinical autonomy and creativity and fails to account for patients' unique health circumstances or choices about their care.
"The standard cookbook approach has been met with great resistance by doctors, probably for the right reasons," Vida says. The alliance initially heard all the "standard arguments" against the use of guidelines, she says.
"It's true that guidelines shouldn't substitute for individualized patient workup. However, medicine has to look at the evidence to see if there's a better way to approach conditions."
Concerns about "cookbook medicine" were even greater more than a decade ago when the Harvard Pilgrim Health Plan of New England in Providence, R.I., first developed guidelines, says Stephen Schoenbaum, M.D., the plan's medical director.
One of the main challenges, he says, "was trying to break down the assumption that guidelines were a bad cookbook, rather than an excellent recipe--tried and tested by clinicians--that led to good results. We involved physicians and other clinicians in the development of guidelines and the adaptation process so they could understand how guidelines were developed and that they weren't being imposed by some arbitrary outside party but, rather, by themselves.
"In truth, winning acceptance is always a problem," Schoenbaum says. "To the degree that guidelines are evidence-based, it's much easier to get physicians to buy into them."
To move physicians away from the "cookbook medicine" mentality, Vida says she likens guidelines to a pilot checklist.
"You want a pilot to go through a checklist each time a plane takes off regardless of how many times he's flown," she says. Even though a pilot may do things differently on different flights, a basic checklist still is essential.
On the downside, if used improperly, guidelines can become a straitjacket or a mandate, says Intermountain's James.
"Guidelines never will replace clinical judgment," he says. "They just standardize about 80% to 90% of patient care."
Ironically, a certain amount of standardization can allow physicians more flexibility in exercising clinical judgment, James says. It liberates them to focus on problems that can't be standardized.
The intention behind "evidence-based healthcare" is that it uses the best available evidence to support decisions about the healthcare of groups of patients.
The AHCPR-which is redirecting its efforts away from writing guidelines-recently selected 12 institutions to serve as evidence-based practice centers in a five-year program designed to improve the implementation of guidelines and to evaluate medical technology.
Each of the 12 centers has been assigned a specific topic--for example, geriatrics--on which it will review all relevant scientific literature and then generate a written report digesting the best of what it finds. All 12 reports will be published on the Internet. Collaborating with the AHCPR on the new project are the AMA and the American Association of Health Plans.
In addition, the AMA is taking steps to address the concerns of its members about the misuse of guidelines by insurers, pharmaceutical companies and others, and the proliferation of proprietary guidelines of questionable
To help identify "good" and "bad" guidelines, the AMA has launched a new "clinical practice guideline recognition program," which uses scientifically based criteria to measure guideline integrity.
The AMA developed the criteria in partnership with the AHCPR, the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association and a cross section of national medical specialty groups.
How it works
Once physicians accept the idea of using guidelines, it's important that the guidelines be easily accessible. Otherwise they'll likely be ignored. "Once you have the guidelines, you need the tools to implement them easily," Schoenbaum says. "A lot of guidelines exist on paper. And a lot of paper gets stuffed into notebooks and put on shelves."
Guidelines are more widely used when there is a system in place to disseminate and implement them, he says. These days, many guidelines are published online. Many hospitals and managed-care organizations have automated data systems, so it's easier than it used to be to provide physicians with clinical information quickly.
"We automate data collection-doctors can get patient information as well as research information at a moment's notice," says June Buckle, senior director for care management and outcomes evaluation at Johns Hopkins Bayview Medical Center in Baltimore.
Buckle suggests the reason many guidelines programs fail is because it is too difficult to get the data or results. Results include both positive and negative information, which is reflected in outcomes, utilization and cost data.
At Bayview, medical center staff track patient outcomes from hospital admission to rehabilitation and home healthcare.
"Physicians like to know the functional status of a knee replacement six weeks out," Buckle says. They also like the fact that someone is providing continuity in patient care and smoothing the transitions from care team to care team-for example, coordinating care from the surgical team to the rehabilitation team.
Program and department heads review guideline reports biannually and measure their physicians' performance against that of all physicians statewide.
A healthcare institution has to decide early on "how to align human and technological resources" to make a guidelines program successful, Buckle says.
Bayview was able to enjoy early success with its 2-year-old guidelines program by "getting results out-that's what doctors want."
Many Bayview physicians protested when the guidelines were first introduced, before they realized the guidelines eliminated a lot of late-night phone calls, Buckle says. "Now they don't want to live without them."
Will all clinical practice guidelines save money and improve quality? The answer depends on several variables:
Like the successful practice of medicine, the successful development and use of clinical pathways appears to be a combination of science and art--a willingness to dig up all of the evidence and to use it in a creative way.
Anne Wright is a Falls Church, Va.-based freelance writer specializing in healthcare topics.