Clinical Practice Guidelines
As managed care matures and as competing plans become willing to accept a greater degree of uniformity in standards of care, the question of who will set those standards remains. New standards are easier to implement when they fill a gap than when they change existing behavior or when they call for more care. In turn, asking for less care may be a difficult proposition, particularly when patient satisfaction is an important issue for the purchaser of care. In some instances, patient satisfaction may be contingent upon receipt of a prescribed medication, such as an antibiotic. On the other hand, some plans implement telephone management of certain infections, which also receives high marks in terms of patient satisfaction.
Changes to existing clinical practice guidelines or implementation of new rules is most effective when these efforts are initiated from the ground up, overcoming both psychosocial and organizational barriers. The presentations described below examine the challenges and opportunities related to clinical practice guidelines, managed care, and emerging infections.
CLINICAL PRACTICE GUIDELINES FOR EMERGING INFECTIONS AND MANAGED CARE
Presented by Anne Schuchat, M.D.
Chief, Respiratory Diseases Branch, Centers for Disease Control and Prevention
The time interval between the emergence of new infectious agents and the formulation and implementation of clinical practice guidelines for their control is shrinking. An example of this is the emergence of the hanta pulmonary syn-
drome. The cause of the syndrome, the hanta virus, was quickly identified, followed by the rapid development and implementation of prevention guidelines. This development has encouraging implications for the prevention of emerging infections. Technological advances and greater community activism have contributed to this trend, as have improvements in behavioral science and medical communications. Managed care may also be a contributing factor, particularly as more of the at-risk populations for new and reemerging infections are included under managed Medicaid contracts.
The example of Group B streptococcal infection provides an illustration of ways in which managed care can provide new opportunities to implement and evaluate clinical practice guidelines for controlling infectious diseases. Twenty-five years ago, Group B streptococcus emerged as the principal cause of sepsis and meningitis among newborns in the United States, resulting in treatment costs of approximately $300 million per year. Clinical trials during the 1980s demonstrated that the use of antibiotics in high-risk mothers during labor was successful in preventing transmission of the streptococcus to neonates. However, this strategy was not implemented. Both logistical concerns and lack of public pressure accounted for this absence of a response. Cost-effectiveness studies conducted in the early 1990s provided further support for this approach. The formation of a parents' organization, the Group B Strep Association, placed pressure on the medical community to develop a new standard of care. In 1996, the Centers for Disease Control and Prevention collaborated with the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics to issue consensus guidelines for the prevention of neonatal Group B streptococcal infection. Evaluation of these new guidelines at the Group Health Cooperative of Puget Sound showed that changing the timing of prenatal screening and offering treatment to all carriers (i.e., the screening-based approach included in the consensus recommendations) was feasible and could be efficiently implemented. This approach significantly increased the proportion of women who received antibiotics during labor (Anne Schuchat, Chief, Respiratory Diseases Branch, CDC, personal communication, January 8, 1999). Adoption of Group B streptococcal prevention policies by hospitals throughout the United States has been accompanied by a significant decline in Group B streptococcal disease (CDC, 1998; Schuchat, 1999).
As managed care evolves it offers increased advantages for implementation and evaluation of clinical practice guidelines. Patient recruitment, systemwide implementation, and the surveillance and monitoring of infectious diseases with computerized databases are some of the tools available to managed care systems to help combat emerging infections. Information can be readily accessed when systems are well designed and integrated, allowing quicker responses to new recommendations. On the other hand, the challenges to be overcome are subscriber turnover, proprietary restrictions on access to data from managed care organizations, and the adoption of different guidelines across organizations. Until these challenges have been addressed for clinicians, patients, laboratory personnel, and public health officials, the systemwide implementation of standard
ized clinical practice guidelines may not be successful in addressing the threats of emerging infections.
REALITIES OF IMPLEMENTING GUIDELINES
Presented by Nora Morris, M.A.
Assistant Director/Senior Analyst, Healthcare Education and Research Foundation, Inc.
The implementation of standardized clinical practice guidelines in managed care systems is a difficult process that requires communitywide efforts, including participation from the purchasers of health care plans. Development and adoption of clinical practice guidelines will involve changes in the individual and organizational behaviors of physicians, nurses, health care administrators, patients, and individual health care facilities. Health care providers presented with clinical practice guidelines must consider them in light of the financial incentives of the managed care organization, professional incentives and culture, personal and professional beliefs and experiences, and what they consider to be in the best interest of the patient. Patients on the receiving end also bring to their treatment a health history, and personal beliefs and experiences. Broad participation in the development of guidelines will ensure that barriers to adoption are identified early.
An example of the successful implementation of clinical practice guidelines can be found in the managed care systems in the St. Paul-Minneapolis area. Since the early 1990s, managed care organizations in that region have worked together to institute standardized clinical practice guidelines. To accomplish this goal, participating organizations first targeted the audiences for such guidelines: physicians, nurses, health care administrators, and patients. Second, potential barriers to implementation were identified: knowledge and skills deficits and resource and organizational shortfalls. It was not until these issues were addressed that efforts were made to complete and implement the guidelines.
The barriers to implementation of standardized clinical practice guidelines may be found at many levels within a managed care setting. Knowledge and skills deficits have the ability to affect the decisions of all participants. For example, primary care physicians treating a patient with AIDS and lacking access to the most current data about courses of therapy may be daunted by sophisticated treatment guidelines. At the patient level, the degree of family support that a patient receives is a contributing factor to the acceptance or rejection of standardized guidelines, as is the degree of community and financial support available. These factors combine to influence a patient's decision about seeking and adhering to therapy. At the organizational level, ongoing conflicts within an organization may prevent members from learning about and adhering to proposed guidelines. This type of barrier can be more difficult to address since it involves changing the behaviors of many people simultaneously. Full imple
mentation of guidelines requires the cooperation of clinicians, health care administrators, public and private payers, patients, and patients' families.
MAKING GUIDELINES INSTRUMENTAL: THEORY VERSUS PRACTICE
Presented by Richard Dixon, M.D., FACP
Medical Director, National Independent Practice Association Coalition
The foundation of managed care is care management. Better outcomes and lower costs could materialize if the care for individual patients and populations is systematically organized. This can be accomplished by ensuring the use of available evidence-based best clinical practices and the implementation of reasonable standards, even when best practices have not been defined. Better care management, which has resulted from the spread of managed care nationwide, is expected to reduce the enormous variations in practices and outcomes that have been documented whenever patterns of practice and outcomes have been evaluated.
The promise of managed care to the better management of care has not yet been successfully fulfilled. With only a few exceptions, studies have shown that the outcomes achieved under managed care systems are at least as good as those achieved under the old, unmanaged fee-for-service systems. Although managed care has undoubtedly achieved actual improvements in the quality of care, those improvements appear to have been modest.
There are several reasons why managed care has not fulfilled its promise to standardize care, make care more cost-effective, and produce better outcomes. In large part, failure has occurred because it has been exceedingly difficult to change physicians' practice patterns. Clinical practice guidelines can influence a physician's decisions and actions. To affect clinicians' behaviors and decisions, clinical practice guidelines should satisfy five criteria. First, they must be clinically credible to clinicians and must be viewed as important. Unfortunately, patterns of practice vary considerably by geography, specialty, and practice setting, reflecting the likelihood that there is no common consensus about the best—or even the proper—clinical steps to be taken in the same clinical situation. The guidelines themselves contribute to this variation since many different guidelines that address the same conditions are available, and guidelines are occasionally contradictory. Many clinicians do not consider published guidelines to be applicable to their patients because those guidelines often come from research settings and academic centers, which are believed to be different from typical community settings. Additionally, some guidelines are not documented to be safe or effective, so clinicians are reluctant to accept them on faith.
Second, guidelines must provide clinicians with a single, coherent message. Clinicians are often under contract with many health plans and work in several
hospitals. If these plans and hospitals promote the use of different guidelines, clinicians are likely to reject all of them since it is difficult, if not impossible, to use different standards of care based on the hospital or insurance company responsible for the patient.
Third, most experts who have attempted to deploy clinical practice guidelines agree that physicians must ''buy into" the guidelines. This usually requires that the affected clinicians be involved in the construction of guideline elements. Although guidelines imposed from the top are typically poorly received, it is difficult to develop local guidelines. Because clinicians are busy and are increasingly required to meet productivity targets, they are reluctant to devote time to guideline development. Other resources are also scarce: good guidelines require systematic research, local assessments of variations in practice, considerable meeting time to develop consensus, and ongoing processes to monitor guideline effectiveness and to educate the clinicians.
Fourth, guidelines must be living documents. Best practices evolve over time, and a guideline that represented the evidence-based best practice several years ago may not be appropriate now. Therefore, guideline maintenance requires long-term investments.
Finally, and perhaps most importantly, physicians need incentives to change practices and adopt clinical practice guidelines. Financial incentives may not be the most important, but they cannot be ignored. If a physician is paid more not to follow a guideline, the guideline is unlikely to be adopted. In addition, if a guideline reduces a physician's efficiency and productivity, it will be resented. Positive financial rewards for compliance with guidelines hasten their adoption. Nonfinancial incentives must also be considered. Clinicians must be assured that by following the guideline they are providing care at least as good as that provided without following the guideline.
These five challenges are compelling and can be realized. Major purchasers of health care must recognize improvements occur when clinicians make decisions about patients. Those purchasers are in a good position to require health plans and hospitals to standardize the required guidelines and to reward those who comply with the guidelines. Hospitals and plans should also recognize that guidelines will make care more effective and more cost-effective, so they should provide resources to help with the development of local guidelines. Additionally, informed patients can pressure and encourage their doctors to use evidencebased best practices, which in turn can have a positive effect on clinicians. For example, an educated patient population that is knowledgeable about childhood immunization issues would most likely have improved rates of compliance with immunization guidelines. Finally, if quality of care is truly believed to be an important national value, society must begin to pay for quality. Higher-quality providers must be paid more than providers who provide lower-quality care, and the latter motivated to sharpen their expertise.
SUMMARY OF CHALLENGES AND OPPORTUNITIES
Jonathan R. Davis, Ph.D., Editor
The presentations described above and the discussion that followed during the workshop highlighted several challenges and opportunities related to clinical practice guidelines in a managed care setting. These are summarized below as Promoting Adoption and Use of Guidelines in Managed Care Organizations and Involving Clinicians in Guideline Development and Implementation.
Promoting Adoption and Use of Guidelines in Managed Care Organizations
Providing managed care organizations with opportunities to implement and evaluate clinical practice guidelines can control new and reemerging infectious diseases. This is especially important as more members of the populations at risk for these diseases are included in managed care plans. Systemwide clinical practice guidelines that address the various audiences likely to use them and that anticipate barriers to their implementation can be adopted. Each of the targeted audiences—clinicians, patients, laboratory personnel, administrators, and consumer groups—has an important role to play if communitywide efforts are to be successful. These efforts would likely involve changes to human and organizational behaviors, including not only the behaviors of the medical community but also those of patients and the individual health care facilities.
Many workshop participants discussed the fact that managed care is focused on prevention, populations, standardization, cost containment, and quality and is thus uniquely positioned to promote and use clinical practice guidelines. As discussed earlier in this chapter, however, some of the existing guidelines have not been validated, and others do not address the needs of clinicians, many of whom contract with multiple plans that have different and often contradictory guidelines. In addition, it is sometimes difficult to gather the data necessary to construct the guidelines, as competing managed care organizations are often unwilling to share proprietary data. Despite these obstacles, the adoption of clinical practice guidelines may be more easily accomplished for the treatment of emerging infectious diseases than for other subspecialties, in part because the label "emerging" conveys a need for the development and adoption of new guidelines.
The development of guidelines is challenged further by patterns of practice that vary considerably by geography, specialty, and practice setting, reflecting the likelihood that there is no common consensus about the best—or even the proper—clinical steps to be taken in the same clinical situation. Moreover, the guidelines themselves contribute to variations in patterns of practice since many different guidelines that address the same conditions are available and guidelines are occasionally contradictory.
Involving Clinicians in Guideline Development and Implementation
As discussed by the workshop participants, many clinicians do not view published guidelines as being applicable to their patients because those guidelines often come from research settings and academic centers believed to be different from typical community settings. Moreover, some clinical practice guidelines are not documented to be safe or effective, so clinicians are reluctant to accept them on faith. Because clinicians are busy and are increasingly required to meet productivity targets, they are reluctant to devote time to clinical practice guideline development.
Protected time and resources were discussed as essential needs of members of the medical community to become more knowledgeable on the latest medical advances in disease pathogenesis and current diagnosis and therapy, an important and integral component of maintaining high-quality medical care and adherence to guidelines. When hospitals and plans recognize that clinical practice guidelines will help make clinical care more effective and more cost-effective, they will be more likely to provide resources to help with the development of local guidelines.
The Need for Systemwide, Standardized Guidelines
Subscriber turnover and proprietary restrictions on access to managed care data, combined with the adoption of different clinical practice guidelines across managed care organizations, may compromise efforts to implement systemwide, standardized clinical practice guidelines. However, health care plan purchasers are in a good position to require health plans and hospitals to standardize the required guidelines and to reward those who comply with them.
Promoting Professional and Public Education
In addition to members of the health care profession, the public must also be better educated and informed about current information on disease states and treatments. Informed patients can encourage their doctors to use evidence-based best practices, which in turn can have a positive effect on clinicians.
A common thread throughout the discussion of clinical practice guidelines revolved around the extent to which managed care organizations should promote clinical practice guidelines. A common perception is that managed care fails to adhere to standardized clinical practice guidelines because many of these guidelines have not been validated under sustained clinical settings. Furthermore, it is
argued that the guidelines in use do not adequately address the needs of clinicians, many of whom contract with multiple plans that have different and often contradictory guidelines. Consequently, it was recognized that it may be difficult to change guidelines or implement new ones because effective change comes from the ground up and would need to overcome both psychosocial and organizational barriers. Nevertheless, initiatives to standardize clinical practice guidelines have involved successful collaborations among providers, mechanisms to standardize guidelines across plans, involvement and comments from physicians, and financial and other incentives from major purchasers. Opinion leaders and administrative champions play vital roles in implementing new guidelines.
Guidelines may be less of a problem in infectious diseases than in other subspecialties, as shown by the success of one health maintenance organization in achieving a 40 percent reduction in neonatal Group B streptococcus infections. Managed care organizations offer a number of advantages for evaluating this kind of initiative, including patient recruitment, systemwide implementation and monitoring, and a computerized database. Industry and professional organizations can also play an important role in developing and disseminating new guidelines.
The adoption of clinical practice guidelines may be more easily accomplished for the treatment of emerging infectious diseases than for other subspecialties, in part because the label "emerging" conveys a need for the development and adoption of new guidelines. Even here, however, guidelines should be flexible and dynamic, allowing treatment to change in response to comments on compliance and results. In addition, there may be a need to reassess these data on a regular basis and revise the guidelines as required.