To be successful in the future, academic medical centers must find methods of fulfilling their research missions in a fashion compatible with the fiscal atmosphere created by managed care.

If ever there were two unlikely companions, they would be managed care and scientific medical research. By all appearances, the two are pushing medical practice in opposite directions: the former, toward conserving limited resources and the latter, toward expanding technological frontiers. Both, however, are vitally important to the passage of today’s academic medical centers into the next millennium. RCPs are well positioned to lead the way in these efforts.

It is difficult to find anything pleasant in what has been written or spoken by medical researchers about the fiscal restraints put on clinical research by managed care. For its part, managed care may approve of medical research funded by someone else, but appears loath to allow its resources to be used to support research directly or indirectly.

Managed Care’s Impact
The recent impact that managed care has had on medical research is, in large part, reflected by a shift in the leadership focus of academic medical institutions. Historically, academic authorities controlled the policies of university medical centers. Fiscal support was reasonably plentiful, and medical leaders were free to determine the goals of the institution on the basis of academic values. A typical hospital “business plan” would consist almost exclusively of efforts to be regarded as a pioneer of medical progress. For this reason, medical centers prized and supported their own research groups. Successful research was recognized as a way of enhancing the status (and therefore the referral volume) of the hospitals and clinics. Establish an excellent reputation, to paraphrase an old saying, “and the world will beat a path to your door.”

The past several years have been witness to a revolution in health care finances. The managed care market has been exerting increasing pressure on medical centers to reduce costs. Institutions slow to respond have risked losing large portions of their health care market share. The basis of competition in the health care market has been shifting from academic success to the ability to provide care at the lowest cost. Even the most highly regarded academic medical centers have been imperiled if their costs were not competitive with those of community hospitals; many have not survived the insult intact.

Under these pressures, the focus of leadership in academic medical centers is shifting toward cost reduction. “Reorganization,” by one name or another, is the battle cry and resource conservation is an important goal. Along with many other industries in the late 1990s, medical centers ask their employees to do more with less. Hospital administrations scrutinize individual procedures, processes, and even employees to determine if their functions justify continued financial support. Administrators, facing these tough decisions each day, are often reluctant to allocate limited hospital resources to activities that produce primarily research results, even results of the highest quality.

Managed care operates similarly to many other corporations. Its leadership is primarily responsible to the organization’s stockholders and trustees for its financial success. In addition, it has ethical and regulatory responsibilities to those covered by its health care plans. It has no specific responsibility for advancing medical knowledge or technology, beyond what is expedient to meet its major goal: to maximize the shareholders’ earnings by reducing costs, while still meeting its obligations to provide health care to its current participants.

Medical Research
Medical research comes from an entirely different perspective. The goal of research is to answer questions by gathering facts. Medical research concerns answering those questions that may, in some way, lead to improved health care. The approach to research, by its very nature, must be unbiased and driven exclusively by the need to answer the questions accurately.

When most people think of research, they think of the “pure” form, which is directed toward understanding the mechanisms of health and disease. This type of research forms the scientific basis of all other medical research (and, in fact, all medical practice). Because of its enormous potential for influencing the future of medical care across populations, “pure” research is very highly valued in academic communities. However, as medical center leadership is influenced more by the priorities of managed care, the universal nature of research paradoxically becomes a liability. Expending limited hospital resources to support research is deemed inappropriate during times when most institutions are scrambling to find ways to fund clinical activities. Administrators perceive responsibility for the hospital’s financial well-being, not for the advancement of medical science.

However, the scientific and fiscal responsibilities of academic medical centers may share more common ground than is commonly perceived. If hospitals and clinics are to view themselves increasingly as businesses, they must adopt business-like approaches to new technology and practices. A major corporation without an aggressive approach to research and development in its field of interest is not likely to survive. The same fate awaits medical centers that have poorly supported mechanisms for adopting new techniques and practices.

The challenge for academic medical centers is to identify and/or create research programs that complement their financial goals. In this respect, medical center administrations have recognized the value of cost-effective strategies for providing health care. Indeed, medical centers pay millions of dollars annually to the cottage industry of “expert medical consultants” in exchange for advice on these strategies. While their administrative advice may be useful, those of us who have devoted our lives to patient care generally regard the clinical recommendations of these “experts” with a mixture of amusement and alarm. Clinical recommendations should come from those who perform clinical work.

Interestingly, the medical research community has also become interested in the cost-effectiveness of care. Whether it is called “evidence-based medicine” or “clinical outcomes research,” a movement is afoot in academic medicine to define which clinical strategies are the most likely to benefit the health of entire populations in the most cost-effective manner. Indeed, a rigorously controlled clinical trial is as likely to headline a current major medical journal as a breakthrough discovery in molecular biology.

Respiratory care departments are in an especially advantageous position to address both the investigative and financial goals of academic medicine. A substantial portion of medical resources is consumed in the provision of respiratory care, and the potential for developing cost-effective strategies is enormous. Respiratory care is at the center of rapidly changing technologies and practices. Properly evaluated and employed, they could expedite recovery from respiratory illness and reduce overall medical cost. Without the proper attention, however, the opposite could occur. Under the fiscal constraints of managed care, medical centers have much to gain from properly conducted research in respiratory care
.

Randomized Controlled Trial
It is appropriate at this point to briefly discuss methods of research. The current state-of-the-art method for clinical research is the randomized controlled trial (RCT). An RCT is a rigorously controlled clinical experiment that compares the outcome of a group treated by one method with a similar group treated by another method. In order to ensure that any observed differences in outcomes reflect differences in the treatments themselves, the two treatment groups should be as similar as possible. The subjects are randomly assigned to one of the treatment groups and typically neither the patients nor the investigators know which group the patients are assigned to until the trial is over.

RCTs are very expensive and require a great deal of time and effort to accomplish. Perhaps because of these limitations, much of medical care is based on research performed in other, less expensive ways. Similarly, few present-day academic medical centers have the resources to perform RCTs. Most, however, have an interest in supporting alternative methods of investigating cost-effective solutions to clinical problems. For example, there may be value in reporting the favorable outcomes experienced by a group of patients who had received a new type of treatment, even if they were not part of an RCT. The group could be reported alone (a case series) or could be compared to another (nonrandomized) group with similar characteristics, which had not received the new treatment (cohort study). Purists may prefer to call these less rigorous investigations “technology development/application,” but they are essentially research, performed in a more affordable fashion than RCTs. They may be conclusive enough to change medical practice themselves, or they may provide enough preliminary data to foster an actual RCT.

Clinical Outcomes
A number of clinical outcome questions are especially suited to research by RCPs. This article will highlight three general areas of inquiry relevant to cost-effective delivery of respiratory care, and give examples of how the respiratory care department at UCSD performs specific investigative projects in each area. The questions are: 1) Which, among several currently accepted methods of providing respiratory care, is the most cost-effective and the most likely to provide long-term benefits? 2) Which new methods of using existing technology optimize the benefits and minimize wasted efforts on the part of both physicians and respiratory therapists? 3) Which new technologies are likely to solve important clinical problems (and, conversely, which ones represent technology for its own sake)?

The first research area concerns choosing among several accepted methods of administering care. The optimal choice is, of course, the method that provides the highest therapeutic benefit at the lowest cost. At our center, we observed inconsistencies among clinicians in the method of bronchodilator administration to patients with obstructive airways disease. While the inhaled forms of these drugs have largely replaced other routes of administration, practices vary regarding the use of metered dose inhalers (MDIs) versus the more labor-intensive wet nebulization. Clinicians at our center expressed the opinion that the “low tech” MDIs were appropriate for outpatients and stable inpatients. However, they used nebulizers for the sicker obstructed patients because of their impression that the nebulizers delivered more of the drug to the airways in patients with more severe obstruction. Because of the importance of this question, our department devoted significant resources to determine which strategy was more cost-effective and to implement its use.

An extensive literature review disclosed no significant benefits to the nebulization method in most clinical situations. In mechanical models of airway medication delivery, MDIs delivered a more consistent pattern of medication-containing small particles than nebulizers.1-3 Furthermore, in clinical studies of patients with severe airways obstruction, beta-agonists delivered using MDIs were at least as effective as the same medications delivered using nebulizers.4,5 Finally, our own preliminary data disclosed that nebulization of bronchodilators incurred a significantly greater labor and material cost than the delivery of equivalent doses administered by MDI.

On the basis of these data, our center is compiling a large series of patients with obstructive disease (even severe obstructive disease) in whom bronchodilators have been delivered exclusively by MDIs. In comparison to historical controls, we have observed no increase in adverse effects, but have observed a marked reduction in resource utilization from this change in practice. Although the program was met initially with resistance on the part of some clinicians, the clinical success documented in our ongoing series won them over and convinced our leadership to adopt this practice as a matter of policy.

Ventilator Weaning
The next area of investigation suggested for respiratory care is to develop highly efficient methods of using existing technology to optimize benefits and minimize waste. At our center, these efforts were focused on our respiratory care protocol program.6 As a specific example of our program, we will examine the newest addition to the protocol: ventilator weaning.

A great deal of scientific research has already been performed on weaning from mechanical ventilation. However, few processes are performed with as much variability and confusion. In large part, this is due to the fact that weaning is a dynamic process; it is rare that one set of orders in the morning will be sufficient to guide the process throughout the day. Physicians must therefore write out elaborate sets of instructions with multiple layers of contingencies on a daily basis, or return to the bedside several times in order to guide each step personally. The first option is so complex that the process is fraught with miscommunication and error. The second wastes valuable time and is often neglected when critically ill patients compete for a physician’s attention. The result is unnecessarily prolonged mechanical ventilation, increasing medical costs, and the risk of further complications.

At our center, we formed a team of RCPs who extensively reviewed the literature regarding ventilator weaning and formulated a comprehensive protocol that was practical and evidence-based. The team obtained suggestions and, more important, buy-in from the critical care staff. The staff was extensively trained in the protocols and a senior therapist was assigned to guide the initiation of the process into clinical practice.

The protocol has been described in detail in the UCSD Respiratory Care Protocol Manual (available through the American Association for Respiratory Care). Briefly, patients are placed into the protocol at the beginning of mechanical ventilation, often well before weaning is indicated. The RCP will then evaluate the patients daily using predetermined criteria to decide whether the patients are too unstable to wean (Class 4 patients) or whether weaning may begin. Weaning begins with a trial of minimum support, and patients who successfully complete this “sprint trial” (Class 1 patients) are soon extubated. Those requiring more gradual reduction in support (Class 2 patients) are put into a standard program of increasingly challenging “sprints” until they develop into (Class 1) “extubatable” patients. Those who do not steadily progress along the standard protocol (Class 3) a
re systematically identified so they may receive the appropriate diagnostic and therapeutic attention in a timely fashion.

This innovation, like the one described above, met with some initial resistance. However, as the case series of patients successfully weaned grew larger, there was growing recognition of the safety and efficacy of the new protocol. As the popularity of the program increases, a cohort study will be done to compare the cost-effectiveness of the weaning protocol, compared to standard practice.

In addition to their clinical acumen, RCPs possess highly specialized knowledge of the mechanics of advanced respiratory care technology. Expertise both in the problems faced by respiratory patients and in the inner workings of respiratory apparatus makes the RCP in an academic center the ideal person to evaluate new technology. From a fiscal perspective, the RCP who can identify and prioritize the technology necessary to solve specific clinical problems in respiratory patients could realize enormous cost savings for a medical center.

In our center, specialized RCPs are responsible for evaluating and applying new respiratory devices. Often, the information gathered by intricate physical experiments with the devices is of interest to (and supported by) the technology manufacturers. More important, extensive bench testing and careful clinical observation ensure that our center prioritizes its resources on technology helpful to its specific clinical population.

A specific example of this process at our center is in the evaluation of new mechanical ventilation technology. The technology is focused, in large part, on microprocessor-driven control of exhalation valves, resulting in rapid, precise control over airway pressure and flow under a variety of conditions. Our specialized RCPs performed detailed experiments to compare the performance of exhalation valves from a variety of newer ventilators. We constructed mechanical models to simulate clinical scenarios, such as lung injury and ventilator “bucking,” and tested the ability of the ventilators to accommodate these situations. Finally, after making informed purchasing decisions, we introduced the new technology into clinically indicated situations and painstakingly documented the “battle performance” of the new technology.

Conclusion
In summary, it is apparent that the fiscal constraints introduced by managed care have jeopardized many of the functions of academic medical centers, including clinical research. However, the financial situation is unlikely to improve in the near future and adaptation is much more palatable than resignation. Respiratory care research has enormous potential, not only for advancing its own discipline, but also for showing hospitals systematic ways to optimize patient care in a financially responsible manner. The programs briefly described in this article serve as examples of how academic respiratory therapy-driven investigation can be combined with actual cost-control processes.

Timothy Morris, MD, is the assistant professor of medicine in the Division of Pulmonary and Critical Care Medicine at University California, San Diego Medical Center—Hillcrest.

References
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2. Dahlback M. Behavior of nebulizing solutions and suspensions. J Aerosol Med. 1994;7:S13-18.
3. Hess D, Fisher D, Williams P, et al. Medication nebulizer performance. Effects of diluent volume, nebulizer flow, and nebulizer brand [see comments]. Chest. 1996;110:498-505.
4. Hess D. Aerosol bronchodilator delivery during mechanical ventilation: nebulizer or inhaler? Chest. 1991;100:1103-1104.
5. Zanen P, Go LT, Lammers JW. Optimal particle size for beta 2 agonist and anticholinergic aerosols in patients with severe airflow obstruction. Thorax. 1996;51:977-980.
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