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Critical Pathways as a Strategy for Improving Care

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ACADEMIA AND CLINIC Critical Pathways as a Strategy for Improving Care: Problems and Potential Steven D. Pearson, MD, MSc; Dorothy Goulart-Fisher, RN; and Thomas H. Lee, MD, MSc In an era of increasing competition in medical care, critical pathway guidelines have emerged as one of the most popular new initiatives intended to reduce costs while maintaining or even improving the quality of care. Developed primarily for high-volume hospital diag- noses, critical pathways display goals for patients and provide the corresponding ideal sequence and timing of staff actions for achieving those goals with optimal efficiency. Despite the rapid dissemination of critical pathway programs in hospitals throughout the United States, many uncertainties remain about their development, implementation, and evaluation. In addition, serious concerns have been raised about their effect on patient outcomes and satisfaction with care, physician auton- omy, malpractice risks, and the teaching and research missions of many hospitals. Underlying these concerns is the absence of data from controlled trials to evaluate the effects of critical pathways. Physicians should understand the potential benefits and problems associated with critical pathways be- cause physicians are increasingly being asked to pro- vide leadership for pathway programs. Physicians and other health service investigators should also develop methods to study pathways in evolving health care settings. Although the promise of reduced costs and improved quality is enticing, the gaps in our knowledge about critical pathways are extensive; therefore, like any new health care technology, pathway programs should be fully evaluated in order to understand the conditions under which that promise may be fulfilled. In recent years, intense pressures to reduce the costs of health care have led many health care organizations to seek strategies that reduce resource utilization while maintaining the quality of care (1-5). Among the most popular of the methods intended to meet this challenge are critical pathways. Critical pathways are management plans that display goals for patients and provide the cor- responding ideal sequence and timing of staff actions to achieve those goals with optimal efficiency (6-8). Interest in critical pathways has increased tremendously during the past several years as early anecdotal reports of their cost- saving potential have been disseminated, usually outside the peer-reviewed medical literature (7, 9, 10). The rapid push for critical pathway implementation comes from intense competitive pressures and the persis- tent evidence of unexplained variation in medical practice (11, 12). Many managed care organizations have added their weight to this process by mandating certain critical pathways or seeking partner hospitals that are willing to develop their own (7). However, no controlled study has shown a critical pathway to reduce the duration of hos- pital stay or to decrease resource use, nor has any study shown critical pathways to improve patient satisfaction or outcomes (13). Nevertheless, like other promising medical technologies, critical pathways are being disseminated be- fore controlled trials have been done to evaluate their effectiveness. Despite the lack of data, an increasing number of phy- sicians will be asked to participate in critical pathway development. Even more will find that their hospitalized patients are already "on" pathways that they may or may not have endorsed. To enhance the effectiveness of criti- cal pathways—and minimize the disruption to the patient- physician relationship—physicians and other caregivers must understand the origin, potential benefits, and poten- tial pitfalls of this new method. Critical Pathways: A New Form of Clinical Guideline Critical pathways have varying formats and are known by many names, including critical paths, clinical pathways, and care paths. Interpreted formally, a critical pathway is the sequence of events in a process that takes the greatest length of time. Like the techniques of continuous quality improvement, critical pathway techniques were first devel- oped for use in industry as a tool to identify and manage the rate-limiting steps in production processes (14-17). First developed in the 1950s, the Critical Path Method was frequently linked with a similar approach, the Pro- gram Evaluation and Review Technique, to coordinate multiple contractors or persons in a project by identifying the key sequence of events, or "critical path," the require- ments of which would drive the timeline of the overall project (18, 19). Critical pathway techniques have subse- Ann Intern Med. 1995;123:941-948. From Brigham and Women's Hospital, Harvard Medical School, Harvard Pilgrim Health Care, and Partners Community Health- Care, Inc., Boston, Massachusetts. For current author addresses, see end of text. © 1995 American College of Physicians 941
Transcript
Page 1: Critical Pathways as a Strategy for Improving Care

A C A D E M I A A N D C L I N I C

Critical Pathways as a Strategy for Improving Care: Problems and Potential Steven D. Pearson, MD, MSc; Dorothy Goulart-Fisher, RN; and Thomas H. Lee, MD, MSc

• In an era of increasing competition in medical care, critical pathway guidelines have emerged as one of the most popular new initiatives intended to reduce costs while maintaining or even improving the quality of care. Developed primarily for high-volume hospital diag­noses, critical pathways display goals for patients and provide the corresponding ideal sequence and timing of staff actions for achieving those goals with optimal efficiency.

Despite the rapid dissemination of critical pathway programs in hospitals throughout the United States, many uncertainties remain about their development, implementation, and evaluation. In addition, serious concerns have been raised about their effect on patient outcomes and satisfaction with care, physician auton­omy, malpractice risks, and the teaching and research missions of many hospitals. Underlying these concerns is the absence of data from controlled trials to evaluate the effects of critical pathways.

Physicians should understand the potential benefits and problems associated with critical pathways be­cause physicians are increasingly being asked to pro­vide leadership for pathway programs. Physicians and other health service investigators should also develop methods to study pathways in evolving health care settings. Although the promise of reduced costs and improved quality is enticing, the gaps in our knowledge about critical pathways are extensive; therefore, like any new health care technology, pathway programs should be fully evaluated in order to understand the conditions under which that promise may be fulfilled.

I n recent years, intense pressures to reduce the costs of health care have led many health care organizations to seek strategies that reduce resource utilization while maintaining the quality of care (1-5). Among the most popular of the methods intended to meet this challenge are critical pathways. Critical pathways are management plans that display goals for patients and provide the cor­responding ideal sequence and timing of staff actions to achieve those goals with optimal efficiency (6-8). Interest in critical pathways has increased tremendously during the past several years as early anecdotal reports of their cost-saving potential have been disseminated, usually outside the peer-reviewed medical literature (7, 9, 10).

The rapid push for critical pathway implementation comes from intense competitive pressures and the persis­tent evidence of unexplained variation in medical practice (11, 12). Many managed care organizations have added their weight to this process by mandating certain critical pathways or seeking partner hospitals that are willing to develop their own (7). However, no controlled study has shown a critical pathway to reduce the duration of hos­pital stay or to decrease resource use, nor has any study shown critical pathways to improve patient satisfaction or outcomes (13). Nevertheless, like other promising medical technologies, critical pathways are being disseminated be­fore controlled trials have been done to evaluate their effectiveness.

Despite the lack of data, an increasing number of phy­sicians will be asked to participate in critical pathway development. Even more will find that their hospitalized patients are already "on" pathways that they may or may not have endorsed. To enhance the effectiveness of criti­cal pathways—and minimize the disruption to the patient-physician relationship—physicians and other caregivers must understand the origin, potential benefits, and poten­tial pitfalls of this new method.

Critical Pathways: A New Form of Clinical Guideline

Critical pathways have varying formats and are known by many names, including critical paths, clinical pathways, and care paths. Interpreted formally, a critical pathway is the sequence of events in a process that takes the greatest length of time. Like the techniques of continuous quality improvement, critical pathway techniques were first devel­oped for use in industry as a tool to identify and manage the rate-limiting steps in production processes (14-17). First developed in the 1950s, the Critical Path Method was frequently linked with a similar approach, the Pro­gram Evaluation and Review Technique, to coordinate multiple contractors or persons in a project by identifying the key sequence of events, or "critical path," the require­ments of which would drive the timeline of the overall project (18, 19). Critical pathway techniques have subse-

Ann Intern Med. 1995;123:941-948.

From Brigham and Women's Hospital, Harvard Medical School, Harvard Pilgrim Health Care, and Partners Community Health-Care, Inc., Boston, Massachusetts. For current author addresses, see end of text.

© 1995 American College of Physicians 941

Page 2: Critical Pathways as a Strategy for Improving Care

Figure 1. The first 2 days of a sim­plified critical pathway for patients who have had cardiac surgery. This general time-task matrix format, also known as a Gantt chart, indi­cates for each day of care the cor­responding multidisciplinary staff actions and expected patient out­comes. CT = chest tube; CXR = chest radiograph; EKG = electro­cardiogram; ET = endotracheal tube; ICU = intensive care unit; MD = physician; PO = by mouth; POD1 = first postoperative day;

quently been applied to projects as diverse as construc­tion, civil engineering, town planning, marketing, ship building, product design, and equipment installation (6).

Critical pathways were first developed and applied to health care in the 1980s, when prospective payment sys­tems focused greater interest on potential methods to improve hospital efficiency (6). Most of the first critical pathways in hospitals were developed by nurses for nurs­ing care alone (20, 21), but multidisciplinary teams soon began developing pathways to encompass all aspects of care for hospitalized patients (22-24).

In general, efforts to develop critical pathways in health care have not incorporated the formal techniques used by industrial predecessors to identify the true "critical" path­way in any care process (18, 25). Instead, when critical pathways are used to plan medical care, the specific goals usually include the following:

1. Selecting a "best practice" when practice styles vary unnecessarily.

2. Defining standards for the expected duration of hos­pital stay and for the use of tests and treatments.

3. Examining the interrelations among the different steps in the care process to find ways to coordinate or decrease the time spent in the rate-limiting steps.

4. Giving all hospital staff a common "game plan" from which to view and understand their various roles in the overall care process.

5. Providing a framework for collecting data on the care process so that providers can learn how often and why patients do not follow an expected course during their hospitalization.

6. Decreasing nursing and physician documentation burdens.

7. Improving patient satisfaction with care by educating

patients and their families about the plan of care and involving them more fully in its implementation.

The general format of critical pathway guidelines is the Gantt chart, which outlines the suggested patient care process based on a time-task matrix, listing the compo­nents of care in one column and cross-aligning these entries with columns pertaining to time (8). Figure 1 is an example of such a chart for a critical pathway for patients who have had coronary artery bypass graft surgery. Cat­egories of multidisciplinary staff actions are listed in the first column of the pathway, with specific actions for each day of hospitalization. As indicated in Figure 1, a pa­tient's diet is expected to progress successfully from ice chips to clear liquids on the first day after surgery. For all other categories of patient care, critical pathways likewise explicitly mark the transition points of patient progress and lay out a coordinated "map" of staff activities to achieve those transitions in the most efficient way possi­ble.

Critical pathways differ from most clinical guidelines, protocols, and algorithms in several key respects. First, clinical guidelines often address the appropriateness of care by delineating the indications for tests or treatments. Critical pathways, on the other hand, have almost always focused on the quality and efficiency of care after deci­sions have already been made to admit the patient or perform the procedure. Another way in which critical pathways differ from most clinical guidelines is that they are multidisciplinary in their development and in the scope of their implementation. Critical pathways are also designed along specific timelines, sometimes even in hour-by-hour detail, for indicated actions, and pathways not only spell out these specific actions but also enumerate expected intermediate patient outcomes that serve as

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checkpoints for the performance of both the patient and the pathway.

Yet another distinguishing feature of critical pathways is that their comprehensive design allows them to be used as a part of the patient record, often replacing other documentation entirely (6, 24). All staff interventions and intermediate clinical outcomes that occur as expected can be simply initialed on the critical pathway document. If staff actions or intermediate patient outcomes do not occur as expected, however, a "variance" from the path­way is said to have occurred (26). Variances, too, can be noted on the document, along with an explanation of their cause or causes, and, if needed, a plan can be described to return the patient to the expected course of treatment and outcomes.

Critical Pathway Development

Topic Selection

Critical pathways are typically developed for the hospi­tal care associated with high-volume, high-cost diagnoses and procedures, particularly those for which inefficient variation in the process of care is thought to exist (6). Surgical procedures, such as coronary artery bypass graft surgery and total hip replacement, lend themselves par­ticularly well to critical pathways because the care process differs relatively little from patient to patient. For this same reason, obstetric procedures such as normal vaginal delivery and cesarean section have also been subjects of pathways in many institutions (24).

For most medical diagnoses, however, patient care has proved more difficult to translate successfully into critical pathways because of the greater heterogeneity among pa­tients and problems (6, 27). Some institutions have re­ported that pathways fail when used for medical patients who have either multiple problems and therefore multiple relevant pathways or a problem that does not fit neatly within any single standardized pathway (27-29). Despite these concerns, however, pathways have been designed and implemented at many institutions for medical diag­noses such as myocardial infarction, stroke, and deep venous thrombosis (23).

Team Composition

The group that is organized to develop a critical path­way should be multidisciplinary in order to bring to the table the knowledge and perspectives that are necessary to view the care process in its entirety. Although many institutions have appointed nurses as the leaders of crit­ical pathway teams (6), we have found that having a physician-expert lead each team lends credibility to the pathways and builds a foundation of support among all clinicians. Each pathway team should also have a group facilitator from the hospital administration, a housestaff physician, a member of the quality management depart­ment who has expertise in critical pathway methods, and a community-based primary care physician, whose per­spective on inpatient care is likely to differ from that of hospital-based physicians.

The lack of active involvement by physician-experts is cited as a key reason for the failure of pathway programs;

critical pathways that are developed without physician input have ended up sequestered in a part of the medical record where physicians do not often look (27, 30). Sim­ply gathering physicians, nurses, and other staff around the same table, however, may not be enough to generate the level of teamwork and communication necessary for success. It is an important challenge, especially for physi­cians trained in an individualistic ethic, to learn how to participate in and lead these teams effectively (31, 32).

The Pathway Development Process

The key steps in developing critical pathways vary from institution to institution and from diagnosis to diagnosis. Nevertheless, two steps common to all pathway develop­ment processes have been described (6, 8, 29).

Step 1. Evaluate the current process of care. The manner and extent to which critical pathway programs evaluate the current care process vary widely (6, 9, 18, 25). All authors urge that chart review be done to identify current variations in care and to understand the complex and interdependent actions of all staff. Another goal of eval­uating the current care process is to identify specific out­come criteria for discharge and for reaching intermediate patient goals so that these criteria can be made key elements of the pathway. However, to truly delineate the time-limiting path and key precedent relations among var­ious activities, some authors have also stressed moving beyond simple chart review and brainstorming to the use of formal critical pathway techniques, including Critical Path Method and Program Evaluation and Review Tech­nique, activity and precedent tables, flowcharts, and slack time determinations (18, 25). Although a full description of these methods in pathway development is beyond the scope of this article, good descriptions can now be found in the medical literature (18, 25, 33).

At our institution, we have found that critical pathway teams benefit from a breakdown of the costs of hospital­ization. Team members are often surprised to learn the relative importance of certain costs, such as pharmacy costs, in the overall cost of care for their patients. Know­ing the relative significance of different types of costs has helped our teams ask new questions about the care pro­cess, and the answers have helped them develop critical pathways with targeted innovations and changes to im­prove efficiency.

Step 2. Evaluate medical evidence and external practices. In evaluating the current care process, critical pathway teams discover variations and may find that the medical literature can help inform clinical debates about the ef­fectiveness and appropriateness of tests and treatments. We have let members of each critical pathway team de­cide, in the course of their discussions, when and how to evaluate the literature.

However, for many teams, the medical literature has been of limited importance in pathway development. Many of the questions of immediate importance to a pathway team, questions relating to the most effective execution of care, have rarely been topics of well-con­trolled studies. For example, solid evidence on the effect of different durations of hospital stay on clinical outcomes or patient satisfaction is uncommon (34).

Given the dearth of evidence in the medical literature,

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Figure 2. Documentation of ex­pected actions and outcomes. A simplified version of a page from a critical pathway for patients who have had coronary artery bypass surgery. This page shows some of the actions and intermediate out­comes that are expected to occur on the day of surgery. A level of detail suitable for nursing documen­tation is included, but, to encourage physicians to participate, only the two elements that are the most im­portant to them are indicated in bold print: 1) ordering an anesthe­sia consult as part of an early extu­bation protocol and 2) adequate pain control with analgesics. D = day nursing shift; E = evening nurs­ing shift; N = night nursing shift; VAR = variance.

anecdotal evidence, or "benchmarking," can be helpful to critical pathway teams (6). Many of our critical pathway teams have benefited from discussions on the care process with colleagues at other institutions or from examinations of critical pathways already in use at other sites. We know of no collaborative efforts to develop critical pathways at the regional or national level, but such efforts might offer the opportunity to build a broader-based consensus on controversial issues such as suggested durations of hospi­tal stay for various conditions. However, although it would be less costly to adopt critical pathways directly from consensus groups or other institutions, we share the impression of others that the active participation of local physicians, nurses, and other staff in designing their own pathway is essential to the success of these programs (29, 35).

Critical Pathway Formats

Although the basic format of critical pathways is that of the task-time matrix, the document itself can be format­ted in several different ways (8, 25). Some pathways are constructed as continuous, multipaged foldouts with space left for pathway documentation alongside standard progress notes. Other pathways are formatted as single-paged educational tools, without space for direct docu­mentation (23, 26). Some institutions are now experiment­ing with the computerization of pathways, linking them to laboratory test and pharmacy ordering systems, with the goal of eliminating the paper chart entirely (28, 36).

Having critical pathways serve as nursing documenta­tion tools often competes with the goal of involving phy­sicians in these programs, as is shown by the variety of formats (27, 37). Some critical pathways try to account for nearly every action that would occur in the care process so that nurses can simply check off boxes when these actions take place. However, the level of detail such doc­umentation necessitates makes daily critical pathways dif­

ficult for physicians to review, because they may list hun­dreds of specific tasks and patient outcomes.

Creating a format that will be used as part of the permanent medical record and that will be accepted and used by physicians has been noted as the chief hurdle faced by critical pathway programs (27, 29). One author has suggested that the time-task matrix common to most critical pathway formats is too foreign to physicians and that pathways formatted as standardized order sets may have the best chance at winning physician acceptance (27).

At our institution, we use a format that not only lists all patient actions for nursing documentation purposes but also identifies certain "key" elements in bold print that have been selected by the critical pathway team as most relevant to the physician. An example of this format is shown in Figure 2, a simplified version of a page from our cardiac surgery pathway. In this format, both nurses and physicians document on the same sheet. Physicians are encouraged to view the critical pathway as a whole, but if they prefer, they can focus rapidly on the key highlighted steps in the patient care process. The critical pathway document is kept in the "physician" section of the med­ical record, and physicians continue to write their own notes in sections of the critical pathway set aside for that purpose, while nurses document the achievement of all actions or expected outcomes by signing their initials in the appropriate box for their shift ("D" for day, "E" for evening, and "N" for night). If actions or outcomes do not occur as expected, nurses sign instead in the variance ("VAR") box, and in their written notes indicate an ac­tion plan for the variance.

Although our strategies for balancing documentation needs and physician involvement continue to evolve, our experience with this format has been favorable. We have no formal measure of staff acceptance, but it is our sub­jective impression that this format has allowed our phy­sicians and nurses to work comfortably together within the same critical pathway document.

944 15 December 1995 • Annals of Internal Medicine • Volume 123 • Number 12

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Documenting and Analyzing Variances

Another difficult challenge in pathway development is designing an effective method for documenting and ana­lyzing variance data (28). Variances are patient outcomes or staff actions that do not meet the expectations of the critical pathway. Variances in staff actions are usually considered omissions from what was suggested in the pathway, but they can also be "extra" actions that may represent overutilization. Nevertheless, perhaps because first-generation critical pathways usually focus on acceler­ating the pace of staff actions, most systems of variance analysis have evaluated only actions or outcomes that are expected but do not occur on time (26-28).

Variance data provide the essential tool that places critical pathways squarely within the tradition of continu­ous quality improvement. However, because every step in a critical pathway can be considered a source of variance if not completed or achieved within the time frame pro­posed by the pathway, many hospitals have found their data collection efforts overwhelmed with variances, most of which are not even important for evaluating clinical outcomes, patient satisfaction, or resource use (27-29).

To overcome this difficulty, institutions have developed many different strategies to identify and measure vari­ances, and these strategies continue to evolve (28, 38-41). Computer versions of critical pathways offer the ad­vantage of being able to gather and analyze variance data without human intervention, although the interpretation of large amounts of such data remains time-intensive (36). At our institution, we are testing an approach in which variances are defined and measured only at key transition points, or "gateways," within each pathway (18). Each critical pathway team uses a combination of intuitive and quantitative methods to select several key points at which a patient outcome that does not occur as expected indi­cates a significant risk for not meeting future time goals and ultimately for not meeting the goal for duration of hospitalization. Failure to "pass through" a gateway at the expected time serves as a signal that a significant variance

from the expected course has occurred, and the reason for that variance and a plan to address it is then docu­mented by the patient's nurse.

An example of this gateway variance method is shown in Figure 3. The gateway identified here is the anticipated transfer of a patient who has had cardiac surgery from an intensive care unit to an intermediate care ward within 24 hours after surgery. If the patient reaches and passes through this gateway at the expected time, no variance data are generated, even if other specific actions of the pathway are not completed. However, if the patient is not transferred from the intensive care unit within the ex­pected time and needs to stay in the intensive care unit for an additional day, then a gateway variance is recorded in a large box at the top of the critical pathway page for that day. Whenever a gateway variance is recorded, the nurse also notes the reason or reasons the patient did not "pass through" the gateway on time. These data on gate­way variance "causes," although subjective, can help one evaluate current hypotheses and even gain new insights into the care process. By focusing on the frequency of gateway failures and their underlying causes, the goal of our variance system is to provide clinicians with insights into critical steps in the care process without inundating them with less relevant process data.

Critical Pathway Implementation

The early experience in the implementation of critical pathways has been mixed. Enthusiastic qualitative reports have described benefits for patient empowerment and physician-nurse interactions (9). Many case studies and uncontrolled comparisons have also cited reductions in duration of hospital stays of 5% to 40%; cost reductions of as much as 33%; significant improvements in readmis-sion rates, wound infections, and other clinical outcomes; and significant increases in the rate of compliance with generally accepted standards of care (10, 21-23, 42).

However, other reports have not been as favorable. A

Figure 3. Variance documentation. This figure shows a simplified ver­sion of the page of a critical path­way for patients who had had cor­onary artery bypass surgery that is used if a patient does not achieve the "gateway" of expected transfer from the intensive care unit to an intermediate care bed within 24 hours after surgery. Reasons for the variance are documented by the nurse who is caring for the patient at the beginning of the patient's second day in the intensive care unit, and these data are used in on­going evaluations of the pathway and the care process. D = day nurs­ing shift; E = evening nursing shift; ECG = electrocardiogram; N = night nursing shift; VAR = vari-

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well-controlled study of a critical pathway for patients with stroke showed no significant effect on costs or clin­ical outcomes (13). Also, according to some recent anec­dotal reports, many critical pathway programs have met with physician resistance, and, in several cases, hundreds of pathways created by flourishing programs fell quickly into disuse and even disregard, despite their early success (27-29).

From both the successes and the failures, several themes emerge regarding pathway implementation. Strong support from hospital leaders is important to communi­cate the commitment of the institution to the pathways. Piloting each critical pathway in a subset of patients helps identify areas in which the pathway may need to be changed and builds trust among hospital staff (27).

Before pathway programs are implemented, education of all hospital staff who will be involved is vital (29). Nurses, physicians, and other care providers who have not been directly involved in the development of the pathway should understand and accept the goals of the pathway and the justification for the suggested duration of the hospital stay and care process as a whole. This educa­tional effort should include discussion of the methods for collection and analysis of data on variance from the crit­ical pathway. Clinicians may be concerned that they will be punished in some way if they do not manage their patients such that they meet all patient outcome and action goals proposed by the pathway. Because fear tends to accompany any significant change, these concerns should be discussed openly.

A central part of pathway implementation is the defi­nition of roles and responsibilities on a day-to-day basis. Will physicians document on the pathway? Will nurses and physicians indicate variances from the pathway, and who will have the responsibility for creating the plans to address the variances? Should a case manager manage variance data collection? Will case managers have a clin­ical role in managing patients' progress on the pathway? Although the answers to these questions have varied among successful pathway programs, most authors urge that physicians be as involved as possible, and all authors of reports on critical pathways have noted the importance of clearly defining staff roles before the pathways are implemented (23, 27-29).

Autonomy versus Standardization

A common response of physicians to critical pathways is to view them as another manifestation of "cookbook medicine" (43-45). However, although critical pathways encourage standardization as a strategy to improve quality and efficiency, physicians may gain even greater control over the care of their patients by helping define these standards.

Most institutions rely on the physician to judge when the individual needs of a patient require a different course of action. At any time, physicians at our institution can and do write orders that change the pathway for a patient or remove a patient from a pathway completely. Critical pathways are thus used as tools to increase con-

trol over patient care rather than as blunt instruments to constrain clinical judgment in an effort to control costs.

Finding the proper balance between autonomy and standardization may prove to be elusive. An open search for this balance, however, involving a continuing dialogue among clinicians and the institution, should lie at the heart of any successful critical pathways program.

Malpractice Risk

Another frequently voiced concern is that physicians may be more vulnerable to malpractice suits if they do not comply with a critical pathway and a patient has a complication. Practice guidelines have been used more often to implicate than to exonerate defendant physicians, and institutions may incur greater liability when they au­thorize the use of a critical pathway (46, 47). However, the use of critical pathways cuts both ways: Attorneys surveyed in one study reported that the existence of guidelines in certain cases had induced them not to bring suit in the first place (48), and other attorneys have described several ways in which critical pathways can de­crease overall malpractice risk (47). Many malpractice suits reach trial because of disagreement over what the standard of care should have been for the patient. Such disagreement is less likely to occur with critical pathways. By establishing a management protocol that has been reviewed by local opinion leaders, a critical pathway iden­tifies the appropriate standard of care and helps keep the caregivers' attention focused on the most vital steps. Fur­thermore, because documentation is such an important aspect of pathways, if the physicians' management devi­ates from that suggested by the pathway, the reason be­hind the deviation is also carefully documented.

Research and Education

The research and educational missions of teaching hos­pitals are already in jeopardy, and critical pathways may seem to further undermine training by discouraging ex­perimentation and independent thinking by trainees. Those responsible for housestaff education may feel that critical pathways set forth given processes of care that stifle the questioning through which residents learn.

On the other hand, medical training may be well served by incorporating methods such as critical pathways to teach students about cost-effective practice. At our insti­tution, we have incorporated critical pathways into our teaching programs by involving housestaff in all phases of pathway development and implementation. We have also used the pathways themselves as teaching instruments in lectures that explore the clinical controversies of path­ways. These activities have helped many members of the housestaff overcome the natural resistance they have for clinical "protocols" and have smoothed the integration of pathways into our teaching hospital.

Physicians who do clinical research may be concerned that strong institutional support will create an atmosphere in which patients will be steered away from clinical re­search studies into treatment according to critical path­ways. Critical pathways, however, are not meant to sup­plant clinical research but rather to improve the "usual care" that is delivered. For example, one critical pathway

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Concerns about Critical Pathways

Page 7: Critical Pathways as a Strategy for Improving Care

at our institution includes explicit instructions to consider patients for a clinical research protocol and to contact the research team when appropriate. We have also encour­aged the pathway development teams to think of research questions that may be embedded within their pathways, the answers for which may be discovered during the im­plementation of the pathway—for example, during vari­ance analysis.

Effectiveness of Critical Pathways

Despite the rapid implementation of critical pathway programs, uncertainty persists about their effectiveness. As mentioned previously, the only published controlled study on a critical pathway found that pathways have no effect on the duration of the hospital stay or on patient outcomes (13). In addition, we are aware of no studies that have attempted to measure the costs of pathway development, implementation, and maintenance. It has also been suggested that the improvements that some authors have attributed to critical pathways could have been achieved just as easily by simply instructing clinicians to manage their patients within a specified target duration of stay (27).

However, many hospitals have concluded that the com­petitive environment will not allow them to wait for the results of rigorous trials before pursuing critical pathways. Furthermore, performing controlled trials may prove to be difficult because of "contamination" of any control group with knowledge of the intervention. Studies in which patients or physicians are randomly assigned to either a pathway or conventional management are there­fore not likely to be undertaken.

To measure the effectiveness of pathways in reducing costs, one must also measure costs for the entire episode of care, including not only the hospital phase but also any prehospital or posthospital care associated with the con­dition. Critical pathways that reduce hospital costs by merely shifting equal or more costs into the outpatient setting do not meet the true needs of patients or the health care system.

Even if valid data on resource use, patient satisfaction, and outcomes can be gathered, the effectiveness of critical pathways at an institution may remain a value judgment. What would happen, for instance, if a hospital imple­mented a pathway for acute chest pain and found out that duration of the hospital stay and overall costs were re­duced, but that patients were now more likely to return to the emergency department with recurrent pain, or were less satisfied with their care? Would the hospital change its pathway, and if so, how? Unfortunately, the cost, qual­ity, and satisfaction vectors may not always point neatly in the same direction. What values are placed on these different outcomes of critical pathways is an issue each institution needs to consider closely, with physicians as active participants in all such decision making.

Conclusion

Critical pathway initiatives are being launched through­out the United States. As a potential tool of quality improvement, critical pathways have tremendous appeal because of their multidisciplinary methods, their focus on

process and on reducing unnecessary variation, and their attention to patient outcomes—all in a package that also offers a tangible way to reduce the duration of hospital stays and resource use. However, despite the appealing logic of this approach to quality improvement, serious concerns and questions remain about the development, implementation, and costs of critical pathways, as well as about their true potential to reduce costs or improve quality.

Methods to develop critical pathways remain unstudied and are still evolving, with wide variations seen among institutions in their approach to topic selection, team composition, documentation of current care processes, and the evaluation of the medical literature and other external benchmarks. Differences in the pathway develop­ment process underscore the striking differences reported among critical pathway formats and the strategies to im­plement pathways and gather variance data. Considerable research is needed to explore which methods of pathway development and implementation are most likely to pro­vide benefits. Measuring the costs of critical pathways and their impact on outpatient resources is essential to help­ing physicians and health care organizations determine whether such programs are truly worth the effort. As the technology of critical pathways and their setting evolve, an important challenge for investigators will be to develop methods to evaluate pathway techniques and their impact.

While future research is pursued, critical pathway pro­grams are in place today, affecting the care of thousands of patients daily. An important current challenge for phy­sicians is to participate in pathway development and im­plementation so that the management protocols reflect their beliefs about care. Although critical pathways clearly hold the promise of reduced costs and improved quality, the fulfillment of this promise requires the full and in­formed participation of physicians.

Grant Support: Dr. Lee is an Established Investigator (900119) of the American Heart Association.

Requests for Reprints: Thomas H. Lee, MD, Partners Community Health­care, Inc., Prudential Tower, Suite 1150, 800 Boylston Street, Boston, MA 02199-8001.

Current Author Addresses: Dr. Pearson: Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care, 126 Brookline Avenue, Boston, MA 02215. Ms. Goulart-Fisher: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115. Dr. Lee: Partners Community Healthcare, Inc., Prudential Tower, Suite 1150, 800 Boylston Street, Boston, MA 02199-8001.

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