(Circulation. 2000;101:461.)
© 2000 American Heart Association, Inc.
AHA Scientific Statement |
Critical Pathways
A Review
Key Words: AHA Scientific Statements • critical pathways • clinical protocols
Critical pathways, also known as critical paths, clinical pathways, or care paths, are management plans that display goals for patients and provide the sequence and timing of actions necessary to achieve these goals with optimal efficiency.1 As competition in the healthcare industry has increased, managers have embraced critical pathways as a method to reduce variation in care, decrease resource utilization, and potentially improve healthcare quality. Cardiovascular medicine in particular is an area in which critical pathways have been embraced. This is due in part to the high volume and high cost associated with cardiovascular diseases and procedures. In addition, the relatively mature guideline process has also contributed to the growth in use of critical pathways in cardiology.
Although anchored in clinical guidelines, the critical pathway is a distinct tool that details processes of care and highlights inefficiencies regardless of whether there is evidence to warrant changes in those processes. Clinical guidelines, on the other hand, are consensus statements that are systematically developed to assist practitioners in making patient management decisions related to specific clinical circumstances.2 Although clinical guidelines can and should be used in pathway development, the majority of processes included in a pathway have not been rigorously tested and are generally not addressed in guidelines. Another term that should also be distinguished from critical pathways is clinical protocols. Protocols are treatment recommendations that are often based on guidelines. Like the critical pathway, the goal of the clinical protocol may be to decrease treatment variation. However, protocols are most often focused on guideline compliance rather than the identification of rate-limiting steps in the patient care process. In further contrast to critical pathways, protocols may or may not include a continuous monitoring and data-evaluation component.
Critical pathway techniques were first developed for use in industry as a tool to identify and manage the rate-limiting steps in production processes.3 4 5 6 In industry, any variation in production process is suboptimal. Thus, by defining the processes and timing of these processes, managers could target areas that were critical, measure variation, and try to make improvements. Once steps were taken to improve the process, there would be a remeasurement. In time, variation would decrease, the time it took to complete the pathway would decrease, costs would decrease, and quality of production would improve.
When applied to health care, the technique of critical pathways has obvious concerns. First, unlike in manufacturing, not all variation in patient care is negative. Individual patient factors may contribute to variation that cannot and should not be controlled by the system. For example, if postoperative extubation occurred within a prespecified time period based on a pathway, there would be early extubations with potential for harm. Also unlike in manufacturing, in which the products are standardized, patients are different and may not fit within a pathway. Second, there exists concern that streamlining care may have a negative impact on patient outcomes. For example, if a care pathway suggests a 2-day stay in the cardiac care unit, a provider may alter care against his or her best judgment to stay within the plan. Finally, physicians have objected to "cookbook medicine" and have felt an erosion of professional autonomy with the critical pathways. Without physician support of the pathway, it is unlikely to achieve any of the stated cost-saving or quality goals.
Despite these obvious limitations, the use of critical pathways is being embraced in many systems. Although designed as a tool for both cost savings and improved quality of care, it is the former that has been emphasized by managers. Interest in critical pathways has increased because anecdotal reports of cost savings have been disseminated. These reports are best described as case studies and in general have not followed careful study designs. Implementation of the care pathways has not been tested in a scientific or controlled fashion.7 8 9 No controlled study has shown a critical pathway to reduce length of stay, decrease resource use, or improve patient satisfaction. Most importantly, no controlled study has shown improvements in patient outcome.3
Lack of careful evaluation has not limited the development and
implementation of critical pathways in multiple healthcare settings. It
is important for cardiovascular
practitioners to understand the goals, development, and
implementation of critical pathways. In addition, physicians must take
an active role in the development of critical pathways. By
understanding the strengths and limitations of the critical pathway
process, physicians and other practitioners can ensure
appropriate use of these methods. In a review of critical pathways,
Pearson et al1 examined the goals of critical pathways,
optimal pathway development, and implementation strategies (Table 1
).
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Critical Pathway Development
Select a Topic
Topic selection in general should concentrate on high-volume,
high-cost diagnoses and procedures. Critical pathway development has
focused on several cardiovascular diseases and
procedures because of volume and costs. These include bypass surgery,
diagnostic catheterization,
coronary angioplasty, acute myocardial infarction, and unstable
angina. These diagnoses and procedures tend to be more suitable for
critical pathway development because of the predictable course of
events that occur during the hospitalization. In addition, marked
variation in care has been observed in these conditions, which makes
the goal of decreased variation and reduction in resource utilization
possible. Furthermore, there has been evidence of noncompliance with
guideline recommendations. In this case, the pathways might improve
guideline compliance and potentially improve quality of care.
Select a Team
It is important to develop a multidisciplinary team for critical
pathway development. Historically, critical pathway development has
been a nursing initiative. Although this has been a successful model in
some institutions, one fault of this process is lack of physician
commitment to the pathway. Active physician participation and
leadership is crucial to the development and implementation of the
pathway. In addition, it is important to include
representatives from all groups that would be affected
by the pathway, for example, house staff, physical therapy personnel,
and dietary personnel. The lack of involvement of physicians has been
cited as a reason for failure of a pathway.10 11
Evaluate the Current Process of Care
In this step, data, rather than anecdotal reports, are key to
understanding current variation. For systems with electronic medical
records, this process may be more automated. For other systems, a
careful review of medical records is necessary to identify the
critical intermediate outcomes, rate-limiting steps, and high-cost
areas on which to focus.
Evaluate Medical Evidence and External Practices
After key rate-limiting steps have been identified, the critical
pathway team must evaluate the literature to identify evidence of best
practices. For most rate-limiting steps, there are few data available
to define optimal processes of care. The critical pathway development
team will often lack answers to specific questions such as appropriate
observation period or length of stay. In the absence of evidence,
comparison with other institutions, or "benchmarking," is the most
reasonable method to use.
Determine the Critical Pathway Format
The format of the pathway may vary widely. Important features
include a task-time matrix in which specific tasks are specified along
a timeline. There is a spectrum of pathways that range from a form that
takes the place of the medical record to a simple checklist. A
reduction in charting that may occur with more complicated pathways is
a benefit. However, if the pathway format is too difficult to follow,
it will not be used. Critical pathways have become widely available in
electronic format, where electronic charting and pathway compliance are
obtained simultaneously. One disadvantage to this method is
the absence of a standard medical record. This may result in
duplication of efforts and possible noncompliance with the pathway.
This is particularly true among physicians who are likely to be
resistant to novel charting methods. For some systems, a simple
checklist at the front of the paper chart may be an optimal method for
implementing the pathway. These checklists would have areas to be
filled in by different staff members active in patient care.
Document and Analyze Variance
Variances are patient outcomes or staff actions that do not meet
the expectation of the pathway. In general, variance in clinical
pathways is a result of the omission of an action or the
performance of an action at an inappropriate (often, a late)
time period. Because the critical pathway is a series of
time-associated actions, this analysis of variance can be
overwhelmed by multiple data points. Computer-assisted pathway
analysis can help with this issue. Another approach is for the
pathway team to concentrate on a few critical items in the pathway that
have been identified in advance, such as extubation time after cardiac
surgery or length of stay in the intensive care unit. These are
critical intermediate outcomes that may have a substantial number of
important contributory factors. Arguably, the selection of areas to
analyze and the analysis of variance are among the most
important processes in the critical pathway. Identification of factors
that contribute to variance and interventions to improve those factors
are the key features in process improvement.
Critical Pathways in Cardiovascular Medicine
Table 2 highlights the published
experience with critical pathways in cardiovascular
medicine. As with critical pathways in general, most published reports
are best described as case series.
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Pathway Implementation
Critical pathway implementation can be a challenge, and if not handled well, it can generate major obstacles. Factors critical in implementation include education of all staff members who will be involved in any component of the pathway. This is particularly true of nonparticipants in pathway development. Concerns and misconceptions about the pathway should be addressed. One obvious concern would be repercussions of failure to follow the clinical pathway. Another key issue in implementation is to define the roles within the pathway: Will there be a case manager? Who will collect data? Who will analyze variance within the pathway? The simple implementation of the pathway is only the first action of the critical pathway. Data must be collected and analyzed, and processes must be improved to achieve the goals of resource savings with improvement in outcomes.
Clinical Protocols in Cardiovascular Medicine
In contrast to the relatively limited data and review of critical
pathways, there has been more careful appraisal of clinical protocols
in the medical literature. Recent examples of protocol implementation
and evaluation are included in Table 3. Grines and
colleagues24 developed and tested a protocol for
identification of low-risk myocardial infarction patients for early
discharge after primary angioplasty. Low-risk patients randomized to
accelerated care had similar outcomes and substantially lower costs
than patients in the usual-care group. Clinical protocols were also
evaluated in several recent observational studies and randomized trials
that evaluated chest pain observation units. Overall, these studies
have shown that the use of the chest pain evaluation unit with
standardized risk stratification and diagnostic and
treatment protocol is associated with similar or improved quality of
care as well as lower costs than the standard hospital workup of chest
pain patients.22 Standardized treatment protocols have
also been successfully implemented in the care of patients receiving
thrombolytic therapy and primary angioplasty, as well
as in the generalized care of patients with acute coronary
syndromes.26 27
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As a group, these studies are somewhat underpowered to evaluate the safety of the specific clinical protocol; however, the overall experience has been promising. Clinical protocols as applied to patients with cardiovascular disease tend to decrease treatment variation, improve guideline compliance, and reduce costs. Although similar in some respects, the experience with these treatment protocols cannot be generalized to the use of critical pathways. This is because much of the focus in critical pathway development has been in the area of cost savings. Although decreasing variation in these areas may be cost saving, these interventions in general have not been clinically evaluated and are often not addressed by clinical guidelines. Clinicians may be more supportive of the implementation of treatment protocols than critical pathways. This may be due to the perception that critical pathways are a management tool for cost reduction, whereas protocols are clinician-driven quality-improvement measures.
Issues With Critical Pathways
There are many issues in critical pathway development and implementation that are of concern to practitioners who care for patients with cardiovascular disease. The first issue is that critical pathways address processes in the "ideal" patient and in some cases do not address issues in the majority of patients who enter the path.12 Identification of appropriate patients to enter the pathway is an important issue in implementation. In general, critical pathways are more applicable to patients with uncomplicated illnesses who are undergoing procedures or surgery. For patients treated with medical conditions such as acute coronary syndromes, it is difficult to define "appropriate" treatment for the majority of patients. Therefore, critical pathways will tend to identify a great deal of variance in the care of these patients that may or may not be wasteful or potentially harmful. The goal of placing most patients within pathways may not benefit the individual patient.
A second issue is how to evaluate critical pathways as an effective tool in improving patient care. As we have mentioned, little controlled research has been performed on the effectiveness of pathways. One reason for this is that at any one medical center, "pathway" care cannot be easily differentiated from "usual" care because of contamination from the pathway intervention. Randomized trials with the unit of randomization at the medical center would be the optimal evaluation method.
The cost of pathway development and implementation has not been evaluated. Although the pathway may save 0.5 days in length-of-stay resources for path development, analysis and the possible need for case managers for implementation must be included in any evaluation of the cost-effectiveness of this process. The issue of who will pay for the development and implementation of the pathway should also be addressed. Although hospitals have in general supported this activity, additional support from managed care organizations and payors would also be appropriate.
Finally, it is important that physicians and practitioners be key players in any pathway development and implementation. There is a real danger when critical pathways are brought in from external sources and implemented on the basis of administrative attempts to reduce costs.
The real impact of critical pathways and appropriateness protocols is their use as tools for collection of information. Pathways can serve as a screening test for inefficient care. The danger is that a pathway with too many critical areas under review will be too sensitive, resulting in the review of a large number of marginally appropriate cases.28 Review of critical pathway data should be focused on the highest-impact areas in terms of either cost, quality of care, or, preferably, both.
Conclusions
- Critical pathways are being implemented in a broad range of patients
with cardiovascular disease.
Although cost savings can and should be evaluated with the critical pathway, the goal of improving guideline compliance and overall quality of care should be the primary focus.
Additional rigorous research into the cost of pathway development and implementation, as well as the outcomes of critical pathway use, is essential before further dissemination of this tool.
Clinical protocols can and should be used to decrease variation in care, improve guideline compliance, and potentially improve overall quality of care in patients with cardiovascular disease.
Practitioners and administrators should work together to incorporate similar and compatible features of clinical protocols and critical pathways. This may result in improved quality and reduced costs.
Footnotes
This statement was approved by the American Heart Association Science Advisory and Coordinating Committee in October 1999. A single reprint is available by calling 800-242-8721 (US only) or writing the American Heart Association, Public Information, 7272 Greenville Ave, Dallas, TX 75231-4596. Ask for reprint No. 71-0182. To purchase additional reprints: up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 214-706-1466, fax 214-691-6342, or
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