Do clinical pathways improve efficiency?

Do Clinical Pathways Improve Efficiency? D. M. Glenn and Alex Macario

O NE WOULD HAVE to be a total recluse (or have been shipwrecked on a deserted island)

for the past 20 years not to have heard time and time again that the cost of medical care in the United States is too high and getting higher. Whether one believes health care costs are truly increasing--no matter how much we would like to discover some day that it all has been an evil plot designed and perpetrated by a faceless secret organization-providers who practice medicine in the present world must deal with the present reality. And that present reality is managed care medicine.

Perhaps the managed care conspiracy theorist may one day have the last laugh. The health main- tenance organization (HMO) in its present incar- nation has as its origins a number of influential nonmedical economic scholars and lawmakers who saw it as their crusade to solve uncontrolled health care expenditures, "fragmentation, and lack of accountability. ''1 They successfully sponsored the HMO Act of 1973, which provided grant fund- ing and a regulatory structure for HMO development, opening the floodgates for what we all live with today.

The final nail in the coffin of traditional fee-for- service followed with the 1975 Supreme Court Decision rejecting the exemption of the "learned professions" from antitrust laws and the enactment of a law in California in 1982 that legalized pre- ferred provider insurance. Naturally, these changes had the overt and covert support from the HMO industry.

In its most essential definition, managed care can be characterized as selective health care pro-

viders contracting f o r prespecified health care benefits. In other words, the integration of the f inancing of health care with the delivery of health

From the Department of Anesthesiology, Stanford Univer- sity, Stanford, CA.

Address correspondence to Alex Macario, MD, MBA, De- partment of Anesthesiology, Stanford University, Stanford, CA 94305-5640.

Copyright �9 1999 by W.B. Saunders Company 0277-0326/99/1804-0003510.00/0

care. Consequently, this has resulted in the grow- ing "corporate" nature of the delivery of health care, and it has brought with it new challenges. The most significant challenge is the financial risk of patient care being placed both on our patient care institutions (ie, our hospitals) and ourselves as individual physicians. No longer can we practice medical care without considering the cost of the care we provide. This obviously impacts the type and quality of care we provide as well as the economic compensation we receive for for our services. In fact, the two have become inextricably intertwined.

Specifically for the anesthesiologist, this has come to mean increasing constraints on choice of pharmaceuticals, equipment, and procedures; increased pressure to perform anesthesia with more time-efficiency (in other words, in less time); and even pressure to accept less compensation for services provided or, at the very least, to justify the compensation demanded.

It is this last issue--the justification of desired compensation for services that may yet prove to be the most significant driving force for anesthesiologist involvement in clinical pathway development. The creation of mechanisms that reliably measure and control the quality, quantity, and con- tent of our practices is a priority. This is where clinical pathways play a significant role. Not only can clinical pathways reduce hospital costs of quality care, but they also serve as a mechanism for the measurement of costs and savings. Such quantita- tive data can be indispensable in negotiating reim- bursement contracts.

Besides the economics, what about the quality of care we strive to provide? How can clinical pathways maintain and hopefully improve the quality of care? This very legitimate question deserves more than the typical market-strategic propagan- dized answer. The Institute of Medicine defines quality as "the degree to which health services for individuals increase the likelihood of desired health outcomes and are consistent with current professional knowledge. ''2 The question of whether or not clinical pathways can achieve im-

Seminars in Anesthesia, Perioperative Medicine and Pain, Vol 18, No 4 (December), 1999: pp 281-288 281

282

Table I. Examples af Consensus Practices Defined by the Clinical Pathway for Knee Replacement Surgery at

Stanford University Medical Center

Preoperative Standardization of preoperative laboratory analyses Standardization to 2 U autologous blood donation

Surgery admission unit Epidural catheter inserted by anesthesiologist in surgery

admission unit Correct epidural catheter placement of the catheter

confirmed before incision Standardization of antibiotic usage

Operating room Variety and number of instruments reduced Number of basins reduced Change from general total joint pack to specific total

knee pack Standardized times for room set-up, procedure, and

turnover Autologous blood retrieval system eliminated Criteria set for use of reinfusion drain Standardization of implants

Postanesthesia care unit Standardized time and criteria for postanesthesia care

unit stay

Data from Macario et al. 9

proved desired health outcomes has been the sub- ject of much recent debate. To such an appropriate a question, there are answers that go beyond market strategic propaganda. The discussion that follows considers the answers.

DEFINITION OF CLINICAL PATHWAYS

All providers have experienced the frustration brought on by the paperwork and protocols involved in patient care. Commonly, we find ourselves resolved to tolerate and work in a seemingly illogical environment of redundant processes left over from some prehistoric hospital tradition. The thought, "There must be an easier way to do this," has crossed all of our minds. In its purest sense, clinical pathways attempt to accomplish this task. Clinical pathways outline recommended tests and therapies that are based on a combination of clinical practice consensus and evidence from the scientific literature. Applied to the patient care delivery process, clinical pathways define a timeline of the expected flow of services for a group of patients with a particular diagnosis or undergoing a particular procedure (Table 1). Unlike practice pa- rameters, which are generated by governmental agencies or national specialty societies, clinical

GLENN A N D MACARIO

pathways are, by definition, developed by a multidisciplinary group of providers to create an optimal regimen of care in their own institution. Clinical pathways aim, as much as possible, to standardize practice within the unique culture and environment of the individual hospital. Clinical pathways address variability in practice (eg, use of hospital support systems and resources for patients with similar conditions) by having providers agree pro- spectively on a common regimen of clinical interventions.

THE ESSENTIAL LINK BETWEEN QUALITY AND CLINICAL PATHWAYS

Admittedly, standardization does not automati- cally ensure quality. Many components constitute a system of health care that befits the stamp of quality. So from its most early structural development, a clinical pathway should pursue quality with awareness of three possible avoidable uses of health care services: underuse, overuse, and misuse. 3

�9 Underuse is failure to provide a service when it would have produced a favorable outcome. Missing a childhood polio immunization is an example of underuse.

�9 Overuse occurs when care is provided in which its potential benefit is lower than the potential harm. Prescribing antibiotics for a viral illness is an example of overuse.

�9 Misuse occurs when appropriate service is provided, but a preventable complication occurs. An example of misuse is a patient who suffers a rash after receiving penicillin despite having a known allergy.

This clever categorization of the term "use" pro- vides a quick and easy "Swiss army knife" rough guide to gauge the quality of an intervention. One only need add into the equation the concept of cost-efficiency to arrive at a measure of value. Clinical pathways that reduce these "wrong" aspects of health care delivery while at the same time eliminating costly redundancy and variability are inarguably valuable contributions.

EFFICIENCY IN THE PERIOPERATIVE SEVI'ING

Economic Incentives, or Whose Money Is It and

Where Should It Go?

As Albert Einstein once said, "Everything should be made as simple as possible, but no

DO CLINICAL PATHWAYS IMPROVE EFFICIENCY? 283

simpler." So, too, would we be well advised to have as a goal simple, rational efficiency. This is especially important in common capitated systems in which both the numbers of patients treated and how they are treated influence the financial outcomes of the organization and the anesthesiology department. Hence, reducing unnecessary variation in care may be essential to maintaining cost-efficiency. The key is to remember that as clinical pathways reduce the portion of financial risk re- suiting from provider variability, the risk to cost- efficiency will be limited to accurately forecasting the numbers of procedures performed for a given number of covered lives. For the anesthesiology department, this can translate into more reliable scheduling, fiscal planning, and better informed, and therefore improved, negotiating positions.

The vast array of methods attempted by health care systems to control costs and manage variability in clinical care seems to have no limits: volun- tary practice guidelines, case management programs, postoperative nursing protocols, quality improvement initiatives, clinical restrictions, and benchmarking (ie, providing information on the practice patterns of peers). These, as well as financial incentives and educational programs, have had variable success in changing physicians' clinical decision making to those behaviors that will control costs. 4-8

Because most hospital administrators lack medical training, they often have a difficult time understanding why apparently similar patients are treated in different ways. Some variability is expected and necessary because of individual patient conditions--patients are not in fact similar. But some of it comes from physician differences (ie, differences in training, skills, and habits). For example, length of stay (LOS) for patients having knee replacement surgery may vary significantly depending on the surgeon's choice of surgical or rehabilitation technique. 8 Severity of illness and comorbidities are not necessarily good predictors of utilization of resources, costs, and lengths of stay. 9 The fact that the patient has undergone elective surgery usually means that coexisting illnesses are stable enough to proceed with surgery. There- fore, this issue is not typically the cause of ex- tended hospital stays and use of resources. This is especially true for elective, relatively tow-risk procedures, such as orthopedic and otolaryngologic surgery. It is the severity of the condition for which

the patient is coming to surgery and the consequent complications, however, that are the usual culprit in increasing COSTS. 9

Sometimes, the medical care that physicians de- liver is based on personal anecdotal experience and on how they incorporate patients' values (versus the physicians' own values) into decision making. For example, anesthesiologists may interpret patient concerns about avoiding postoperative nausea (PONV) differently and therefore choose varying prophylactic regimens. At our hospital, each fac- ulty anesthesiologist has his own strategy for anti- emetic prophylaxis.

Another source of variability occurs from "style- of-practice" differences, which arise from how physicians handle uncertainty. For example, because it is impossible to know a priori which patients will experience PONV, some physicians may choose not to pretreat any patient. This would avoid giving prophylactic drugs to patients who did not require them because they were not going to develop PONV anyway. Others assume that the cost in patient satisfaction by having to use "res- cue" medication for PONV is not worth the nom- inal cost savings achieved by withholding prophylaxis and reflects badly on the anesthesiologist's skill. As a result, patients with a common condition are treated differently by different physicians, thus producing differing outcomes. Hence the questions arise: Is this variability necessary and, if not, would reducing it cut costs?

In the industrial world, simplification and standardization of production processes and the elimination of waste and duplication of effort has long succeeded in delivering a quality product at the lowest possible cost. In medicine, cost-reduction strategies based on responsible standardization can allow certain costs to be taken out of the old system without compromising the quality of the care delivered.

A fundamental principle of industrial quality management science is that unnecessary variation can erode quality.l~ Though fraught with debate about the appropriateness of applying techniques borrowed from an industrial setting to medical care, such methods are among the newer ap- proaches being adapted to the management of health care systems. 12 Such an adaptation and application of this and other principles to medical care are what clinical pathways aim to accomplish.

284 GLENN AND MACARIO

Recent studies have demonstrated cost reduction (1) for patients with various types of problems (ie, chest pain) without changing patient outcomes, 13 (2) decreased hospital and intensive care unit LOSs for patients treated for congenital heart disease, 13 and (3) anesthesia drug costs. 14 At our own institution, clinical pathways reduced hospital costs for knee replacement surgery from $21,709 to $17,618. Fifty percent of these savings resulted from operative times (18 minutes) and resource utilization reduction (eg, instruments, blood retrieval systems) and 16% from reduction in hospital LOS. Fifty-four percent of the total hospital cost savings after pathway implementation resulted from decreasing operating room costs by 22%. Pestotnik et a115 published their experience in reducing adverse drug events caused by antibiotics. Computer-based guidelines assisted physicians in giving prophylactic antibiotics preoperatively. This produced a 30% decrease in patient injuries due to antibiotics and a 58% decrease in antibiotic costs per patient.

EFFECTS OF CLINICAL PATHWAYS Positives Effects

Until recently in medicine there has been little incentive to develop consistently standardized processes of care with which to measure devia- tions in process or cost. The reasons for this are numerous. However, a significant contributing factor is the compartmentalization of the patient care delivery process (ie, nursing, separate physician specialties, physical therapy, social services, admissions, etc).

Physicians, nurses, and other staff have little knowledge of the practice patterns of others. 16 Clinical pathways that effectively standardize the patient care process not only simplify the process but also facilitate communication between providers, data collection and analysis, and feedback for the providers. 7"17"1s

The advantage of cost savings speaks for itself. The cost savings of a well-designed clinical pathway will have been calculated in advance of its implementation. The method of measurement of these cost savings must, of course, be included in the plan as well if reliable feedback is to be as- sured.

Quality improvement manifests itself as a reduction of unnecessary variability and elimination of rework (eg, asking the patient if they have any

allergies multiple times during the presurgical admission process). In that sense, improving quality will also reduce cost. Many industries know that quality is free if rework is reduced, but most of the health care industry is just now realizing this.

Negatives Effects

Who and what is needed for hospital-based clinical pathway development may depend on the surgical procedure and the hospital. A physician leader trained in total quality management may be necessary.ll The cost savings related to pathways depend on doing a minimum, or threshold, number of procedures and are most likely to yield cost savings for high-volume, high-risk (ie, high resource consumption, high associated morbidity and cost) procedures.

The fact that truly achievable cost savings de- pends on the number of cases (volume) is illus- trated in the following example. Suppose that once a year a hospital treats one patient with a tropical illness that lasts 30 days, and chest roentgenograms are ordered each day. If a newly developed clinical pathway recommends that all but one chest roent- genogram per week be eliminated and that the hospital stay be cut in half, then a total of 15 days • one patient = 15 bed-days saved. Also, -----8 roentgenograms (1/d for 28 days) are saved. How- ever, the major costs of care are fixed (ie, do not change according to volume of care) and are labor- related; it is unlikely that either nurse or x-ray technician labor cost will change due to the clinical pathway. Because a hospital bed (=365 bed days) will not be closed, most hospital costs are unlikely to be affected. TM

On the other hand, let us examine a clinical pathway for a more common procedure, cholecystectomies. Suppose the clinical pathway recommends reducing a 1-day admission to 0 days (am- bulatory surgery v a 23-hour admit), and the health system performs 1,500 cholecystectomies/y. The hospital would save 1,500 bed days, which trans- lates into closure or reallocation of 4 beds. If the nurse-patient ratio on the floor equals one to four, approximately five nursing positions may be reas- signed (around-the-clock coverage for 365 d/y in- cluding vacation yields approximately five full- time equivalents to cover those beds). The high volume of cases allows the cumulative effect of the reduction in LOS to influence staffing and associ-

DO CLINICAL PATHWAYS IMPROVE EFFICIENCY?

Table 2. The Definition of Quality of Anesthesia Services Means Different Things to Different People

285

The "Customer" of the Anesthesiologist Definition of Quality of Anesthesia Services

Patient Surgeon Hospital administration

Payor JCAHO

Safely, no PONV, pain control, bedside manner, convenient access to hospital and clinics Early case start times, speedy turnover, 24-hour-a-day availability, PONV control Efficient minimal resource utilization of hospital resources fie, blood bank), 24-hour-a-day labor

and delivery coverage, satisfied surgeons Low price, capitation, excellent care at a low price, few patient complaints Doing the right thing and doing it well: efficacy, appropriateness and availability, timeliness,

effectiveness, continuity, safety, efficiency, respect, and caring

Abbreviations: PONV, postoperative nausea and vomiting; JCAHO, Joint Commission of Accreditation of Healthcare Organi- zations.

ated labor costs. In business and economic circles, this would be referred to as an "economy of scale."

It is to be expected that some may feel certain quality aspects of care are lost in the implementation of clinical pathways. This will most likely be due to the differences in the way quality is defined by different people. For example, in addition to their patients, the anesthesiologist must answer to several different "customers," each with a different definition of quality anesthetic service. These in- clude surgeons, hospital administrators, payers, even the Joint Commission of Accreditation of Healthcare Organizations (Table 2). For this rea- son, as stated previously, clinical practice consensus and evidence from the scientific literature are essential steps in the clinical pathway development process. As the saying goes, you can please some of the people all of the time and all of the people some of the time, but you can't please all of the people all of the time.

A recent study by Dexter and Macario 19 showed the important realization that cost savings due to clinical pathways may be greater than the potential for increased revenue generation. Their computer simulation showed that even though clinical pathways can decrease operative times, the cumulative time savings is not reliable enough to allow additional cases to be scheduled within the normal working hours of the day.

Probably the most important lesson to learn from clinical pathways is that there are, in fact, lessons to be learned. Clinical pathways are not meant to be a statically designed and implemented single event. Instead they are a dynamic beast constantly evolving with the changing times. Con- tinual feedback, reevaluation, and readjustment are

fundamental characteristics that enhance their value over time.

BEHAVIORAL ASPECTS AND IMPLICATIONS OF CLINICAL PATHWAYS

A Threat to Physician Autonomy ?

Many physicians react to pathways with skepti- cism. The reasons for this are numerous and com- plex. Unlike in the manufacturing industry, physicians in most hospitals are not employees but independent agents operating within a contractual arrangement with the hospital and/or health care system. This vital difference creates a very different culture, power, and responsibility structure from manufacturing industry. Physicians, being ul- timately responsible for the care of their patients, understandably question a medical care "recipe." They perceive clinical pathways to be a possible threat to their ability to vary care to meet the needs of individual patients and their freedom to inno- vate. However, because clinical pathways represent a consensus on the most uniform and efficient process of implementation of the most current clinical methods, they bring accountability to care.

Another legitimate concern about clinical pathways is that if they prove successful, the parame- ters of clinical decision making could become fundamentally rigid. The slippery slope could eventually result in scorn for free thinking and, misuse of the data by HMOs and other adminis- trative entities to create a system of performance scrutiny and accountability. The flip side of this scenario is that if correctly designed and main- tained by physicians themselves, clinical pathways can be the physician's best tool and ally. They can offer powerful information about the correct meth-


ods to care for patients and the obstacles to efficient care, and they can be early indicators of changes in patient needs. In this way, clinical pathways can help serve as a basis for the development of new practices. As long as the development and application of clinical pathways continues to be controlled by physicians, the "home-court advantage" will remain with physicians. Unfortunately, physicians traditionally have not dedicated significant time to these types of endeavors. Continuing lack of commitment of time and effort by physicians will likely result in nonphysicians administrators taking increasing degrees of control of medical care.

USEFUL METHODS FOR THE DEVELOPMENT OF CLINICAL PATHWAYS: THE NUTS

AND BOLTS

Assumptions in the Application of Clinical Pathways

Just as certain environmental conditions must be assumed and accepted in thinking about a physics problem, certain conditions must exist in the clinical environment in which effective clinical pathways are to be developed.

�9 First, a clinical pathway's purpose must be to optimize the utilization of the resources and services consumed in reaching a predetermined, consensually accepted high standard of care. (A clinical pathway is not a standard of care in and of itself.) It follows, therefore, that clinical pathways function well in an environment of "predetermined" resources, namely a capitated system.

�9 Second, the clinical pathways environment requires a sufficient volume of cases and should be designed for the relatively "rou- tine" and more common procedures, processes, and tasks undertaken in the operating room. A certain "threshold" number of cases is necessary to economically justify the clinical pathway's development (explained in de- tail below).

�9 Third, these common procedures, processes, and tasks should be ones that can tolerate relatively minimal patient variability. If the differences in the physical conditions and vital characteristics of the patients that enter the clinical pathways are too great, then the criteria for simplification will necessarily need

to be broad. In this scenario, the clinical pathway's purpose of standardization is defeated.

Elements of a Viable Clinical Pathway,

1. A good problem: First, there must be identification of a problem that would have significant impact (either monetary or with patient outcomes) if improved. There must be a substantial benefit to convince practitioners to follow a clinical pathway guideline.

2. Multidisciplinary consensus: Grassroots development of the pathway must take into account the published literature and the practice patterns of physicians and other members of the health care provider team. Implementation of a clinical pathway from the top down is doomed. The entire care team must be allowed input for "buy-in" and adherence to the pathway. Nursing colleagues, anesthesia techni- cians, and others implement physician or- ders. Their insight may help a particular clinical pathway work better and contrib- ute crucial practical considerations. A multidisciplinary team consisting of surgeons, anesthesiologists, and nurses develops flow charts of treatment processes for patients undergoing a particular surgery. The team collects clinical and cost data on existing practice patterns. Experts in related specialties join the team on an ad hoc basis to provide special expertise. The final pathway requires consensus by team members on a written, reproducible, day-by-day clinical care plan. A clinical pathway defines multiple interventions in the perioperative period (Table 1). After the pathway is initiated, monthly meetings should be held to as- sess performance and make adjustments.

3. Communication: Nonambiguous language is essential. The written pathway should be easily understood.

4. "Point of practice" reminders: A mechanism to remind providers of the pathway is necessary to increase adherence. What- ever practice one is trying to change requires constant reminders as close to the planned medical service as possible. For

DO CLINICAL PATHWAYS IMPROVE EFFICIENCY? 287

example, for pharmaceutical prescribing guidelines in the OR, guidelines should be reinforced at the point where drugs are supplied. If guidelines exist for pulmo- nary artery (PA) catheters, the anesthesia technician can remind the physician about the guideline, or it can be attached to the PA catheter package. In the computerized medical record of the future, as tests are ordered for patients, prompts will be vi- sualized on the computer screen about which tests are on the relevant pathway.

5. Feedback: Measuring the effect of the pathway on outcomes, cost, and patient satisfaction is essential to evaluate the impact of the pathway (ie, quality control feedback, etc). This is especially true as new pharmaceuticals and technologies become available that have the potential to improve pathway outcomes.

6. Incentives: Although important, incentives do not have to be a monetary re- ward. Recognition and demonstrated ap- preciation for a job well done can serve as a good incentive. Money, though, is the most commonly used incentive. It is usually distributed by the hospital to the health care team via a predefined cost- savings sharing program.

7. Flexibility: Physician flexibility to over- ride the pathway when deemed necessary is essential. This is important not only for the benefit of the patient but also to iden- tify basis and justification for improve- ments to the pathway's structure. Opti- mally, clinical pathways should have an inherent plasticity, ie, multiple "paths," or overlapping layers, to account for common patient variabilities that would oth- erwise cause their exclusion from the clinical pathways. A feedback mechanism to ensure follow-up on variation from the pathway also is an essential component.

8. Compliance: Adherence to the pathway should be monitored for two reasons. First, the effectiveness of a pathway can be determined only if it is authentically implemented. Second, because physicians are attentive to colleague practice pattems and outcomes, providing performance measures encourages discussion on inno-

vations and improving practice, thereby "fine-tuning" the pathways.

CONCLUSION: THE FUSION OF CLINICAL PATHWAYS AND QUALITY--BREAKING THE

COST-QUALITY LINK

As alluded to in the beginning of this article, it must be a principal concern in the construction of clinical pathways to incorporate as a primary goal the quality of care. This is in fact not as counter- intuitive as it may appear on the surface. The concepts and science of total quality management is based on the very idea that to target quality as the main objective in the control of a process will at the end of the day create great cost savings.

Our "customers" (patients, hospitals, and insur- ers) expect medical providers to increase quality and reduce costs at the same t ime--an unrealistic combination unless the positive dependency between quality and costs can somehow be halted or even reversed. To do so requires a transformation in approach from quality control to process improvement. Analytical methods developed and long used in industrial settings have been able to cut costs and increase quality simultaneously. These methods are part of the schools of total quality management and continuous process improvement that use statistical process analysis and control. This involves the use of statistics to mon- itor and maintain a state of statistical control and thereby improve the capability of the process. The sound of these methods often confuses and disturbs physicians because the phrase "quality control" smacks of the ominous "Big Brother" and the erosion of the patient-doctor relationship. This principle, however, is the exact approach that clinical pathways represent, the aspects of which need not be misunderstood nor feared. Statistical process analysis is simply a tool in understanding the nature of a system (ie, operating room) and causes of variation (eg, turnover times).

Quality improvement manifests itself as a reduction of unnecessary variability and elimination of "rework." I f clinical pathways succeed in this en- deavor, then whatever the costs, the overall value perceived by all involved will be enhanced. In this sense, improving quality will reduce cost because as the health-care industry is just now realizing, quality is free if rework is reduced.


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Do clinical pathways improve efficiency?