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Dr. Dan Murtagh and Dr. Neil Baum

Whenever the words protocol and guidelines are mentioned to physicians, they become defensive, resist the concept, and argue emotionally that the quality of medicine will decrease. That was the perception of protocols. Today protocols are a tool that can clearly enhance the quality of care that you provide your patients, and serve as method of communicating that quality to managed care organizations in a scientific and valid fashion. In this article, we will describe the value of protocols, techniques for developing protocols that are unique for your practice and your community, and how to implement them into your practice.

Why protocols are important?
Protocols are designed for the primary purpose to improve the quality of care that you and your practice delivers to your patients. If you ask a doctor or group of doctors, "Do you have a quality practice?" every hand goes up and every doctor feels that heshe offers the best quality of health care. If you ask the doctors to prove it or demonstrate that quality, few are able to do so with objective data. Protocols provide that methodology to clearly, statistically, and scientifically offer proof of the quality of the practice.

Other business and industries have adopted a total quality management (TQM) process to improve the quality of their products and services. Now health care can apply those same techniques by implementing a continuous practice improvement (CPI) process that results in improving the quality of care. Using protocols you can clearly demonstrate to others that you deliver a better product.

The common goals and objectives of managed care organizations and physicians are improving outcomes, improving patient satisfaction and reducing costs. Using protocols will result in satisfying all of those goals and objectives for both physicians and managed care organizations.

Let's be honest. Few of us treat enough patients to develop our own mortality statistics or outcomes. Also few of us have enough experience to draw conclusions regarding the use of perioperative antibiotics for penile prosthesis surgery. However, if you combine your experience with that of your colleagues in your practice or your network, you can accumulate useful data that will help make better clinical decisions for your patients that ultimately improve outcomes and reduce costs.

Protocols Reduce Variation
Until recently there have been few standards of care based on statistically sound data. As a result most practices have unnecessary variation in the practice patterns of the physicians. For example an eight manwoman group, trained at different institutions and at different times, may have eight different approaches to the very same clinical condition. It is not unusual for one physician to have several options or approaches for the same diagnosis or disease process. With so many choices and options it is difficult to analyze your outcomes or to determine which tests or treatments add value and which do not. This multitude of approaches and treatment options results in variation. And variations are the anathema and bane of any practice. Variation in practice patterns increases costs and decrease the efficiency of all practices.

Protocols are a process that if properly created and implemented decreases variation in your practice.. Protocols are based on the principle that the fundamental knowledge of a group of doctors is usually better than any single doctor alone. When you ask a group of doctors what is the best way to treat a certain condition or diagnosis, you tap into their individual experiences and get a result that is better than any single doctor alone. Consequently as a result of using the consensus of opinion, you can now deliver a higher quality product to your patient.

Advantages of Protocols
Not only do protocols reduce, and hopefully eliminate, variation, but it also improves the efficiency of the practice. Without protocols there is a "waffling effect" which is the time interval that takes place to make a clinical decision. When protocols are in place the waffling effect is reduced or even eliminated. For example, if you have a patient with recurrent nephrolithiasis and are about to institute a metabolic evaluation you don't have to pause and try to remember which urine and blood tests need to be ordered. Similarly a patient with prostate cancer that is to have a metastatic workup can have the same workup that is agreed upon by all the members of the group. A first generation protocol by one of us (DM) tracked patients being worked up for metastatic prostate cancer with PSAs <10. After one year the protocol identified that patients with a PSA less than 10.ng/ml do not require a bone scan as none of the patients that were monitored in the early protocol had a positive bone scan when the PSA was less than 10.0. Now none of the physicians order a bone scan in a patient with a PSA <10 since they have statistically sound data to justify the exclusion of that test from the work-up.

Effective protocols are based on studies reported in the urologic literature. Each protocol should be created with the careful evaluation and refinement by urologists that are seeing patients in clinical practice in your community. Often times protocols that are developed on the national level by our colleagues do not allow the practicing physicians the feeling of ownership that is essential to the successful implementation of protocols.

Protocols and Costs
Protocols identify which tests or treatments add value and which do not. Using protocols make it possible to determine which tests and treatments are useful or which can be eliminated. Using the previous example of eliminating the bone scan in patients with a PSA < 10 in a large group practice or in a network of urologists, can save hundreds of thousands of dollars

Another example is the use of a metabolic stone work up. The standard evaluation recommended in the urologic literature is expensive and often does not add any value to the workup. Protocols demonstrate that many conventional workups are acceptable from an academic or conceptual standpoint but from a practical standpoint cannot be justified from a cost-benefit analysis.

In order to get physicians to stop ordering tests, they have to be comfortable in knowing that the test does not decrease the quality of care. If you generate statistical data that shows physicians that they can make a clinical decision, you are providing them with the comfort that they need in order to change their practice patterns. Protocols also determine which tests are useful. In some protocols you may be adding additional tests and thus increasing the front end costs but decreasing the overall cost of care. An example occurred when one (DM) of our partners wanted to add Propulsid to radical prostatectomy post-op orders. A trial of this addition to the post- operative protocol resulted in a decrease in the post-op ileus. Once the data was made available and all the urologists added this to the post-op orders it increased the initial cost of that protocol. However this change enabled the radical prostatectomy patient to leave the hospital sooner and reduced the overall cost of patient care.

Getting Started.
Implementing protocols is hard work and success usually requires a physician to champion or lead the process. It takes a visionary physician that wants to demonstrate better quality outcomes in the office practice and to objectively prove to HMOs, third party payors, or to any one that wants a contract with the practice that you have a cost effective practice and are able to provide quality and patient satisfaction. One of us (DM) spent a month with Dr. Brent James, the father of Continuous Practice Improvement (CPI), at Intermoutain Health Care in Salt Lake City, Utah, learning principles of continuous practice improvement (CPI). Dr. James' work was based on hospital protocols. We felt that he was missing an opportunity by not applying the same principle to the office practice since physicians generate tremendous costs by ordering tests in the office setting. We have demonstrated that the same principles used in the hospital can be just as effective in reducing costs and improving the outcomes and the quality in the office practice. The reality is that it is easier to implement protocols in the office environment because you avoid the arduous bureaucracy and committee process of the hospital.

Upon completion of the first protocols you have a greater chance of convincing your associates of their value. You can anticipate a snowball effect after the first few protocols as everyone in the office, including nurses and technicians, will be offering ideas that can be added or subtracted from existing protocols.

As a result of using protocols you can anticipate a positive impact on your staff. Ultimately protocols make their job a lot easier. Now your staff won't have to "read the minds" of the physicians. For example, the nurse or patient coordinator knows exactly what tests to order. No more guess work or interrupting the physician to ask questions about the orders. The nurse knows what information needs to be obtained. Also every doctor in the practice or the group knows what every other doctor is doing, thinking, and even ordering.

You can count on mistakes being made in the beginning of the protocol implementation process. The first protocol will probably take a long time to create and will be met with obstacles and discouragement from the physicians and the staff. The physicians need to know that they have the option of deviating from the protocol any time they want or when they feel it is in the best interest of the patient not to adhere to the protocol. Successful protocols are based on voluntary participation by the doctors. However, if the urologists do not participate in the protocol, their actions will be tracked and their outcomes and data will serve as a control. Protocols are an appeal to the physicians basic science training. Protocols are nothing more than applying the scientific method to the day to day practice of medicine. Once physicians understand the philosophy of protocols (voluntary and applies the scientific method), most will be agreeable to a 3-6 month trial period.

We suggest that you start with a very small focused protocol and that you begin with a single protocol. Even after you are comfortable with the protocol implementation process, we recommend only using two to three protocols at a time. Don't take an entire disease entity. Begin by focusing on a single decision point. We also suggest that you consider conducting a patient satisfaction survey. This is part of every CPI process. Remember, you are already being surveyed by managed care plans (MCPs). Without patient surveys you have no objective data to argue, agree or disagree with the MCPs. Now you can compare your date with data given to you by MCPs.

We suggest that you use a form that triples as a progress note, an order sheet, and a data collection form. The form should be color-coded so that it can be easily identified by the physicians and the staff. You will also need to obtain the services of statistician to collate the data and make the interpretations. Often times you can hire a statistician from one of the universities in your area who will appreciate the extra income and will input the data into the computer program and create the summaries at a very reasonable cost, $50 per hour for data tabulation and $250 per protocol development. Other than the statistician you can anticipate very little additional expenses.

Encouraging your associates to participate in the protocol process.
Every urologist is convinced that they deliver the best care with the highest quality. Many physicians that have been in practice for 20-30 years are unlikely to accept the concept of protocols or to be told how to practice medicine. Older colleagues may perceive protocols as cookbook medicine or that the protocols take away their intellectual freedom. Ultimately some physicians perceive protocols as loss of control. The reality is that protocols are exactly the opposite of that perception.

You might begin by asking a key question, "Does any one want to improve the practice of medicine that we offer our patients?" Every doctor wants to improve hisher services and the care that we give our patients. When the doctors realize that only physicians develop the protocols, they are likely to buy in to the process and develop and ownership in the implementation of this CPI.

Certainly the American Urologic Association has helped us in creating guidelines for various diseases such as prostate cancer, impotence and staghorn calculi but nationally crated protocols usually won't meet with universal acceptance on a local level. Often these national protocols are too broad and don't include the local physician input. Also national protocols don't track the data or the outcomes and return that information back to the practice.

In order to make the protocols acceptable to your colleagues, you will need to assure your colleagues that the protocols are not punitive. They need to know that the purpose of the protocols is not to identify the bad apples. It is just the opposite. These protocols are collegial in nature and designed to identify those physicians that are practicing more effectively and what can be done to transfer their behavior to others in the practice or the network. .

In order to avoid punitive measures, the data is tracked blindly. No other physicians knows what another physician is doing or what their data is demonstrating. Each physician would see only their data and the results of the rest of the group. Each physician could then compare their results with the group. In a collaborative fashion, the group compares the results and then came up with the best of the breed. You will soon find that the doctors will soon enjoy these discussions of the data and if this done properly, everyone leaves each meeting with a pretty good feeling.

What Motivates Practices to Develop Protocols
In most situations protocols are developed as a result of increased competition. When the managed care plans present contracts requesting deeper discounts for our services, it is necessary to demonstrate that we are delivering better quality. The managed care plans will respond with "show me." As a result of institution protocols you can show a high patient satisfaction, better quality, and all provided at a reasonable cost. The protocol process allow you to demonstrate to others what you are dong.

What was previously created out of fear and a defensive mood, results in demonstrating the positive aspects of your practice and group to the managed care plans. Now when you are approached for discounts and you can respond with a demonstration of increased quality and patient satisfaction. You can show the managed care plans that you are cost conscious, are eliminating unnecessary tests, and improving quality while maintaining patient satisfaction. Ultimately this strategy of implementing protocols moves the payors out of the cost arena into the quality and outcomes arena.

Summary
No practice can be successful in this era of transition from fee for service to managed care without access to data and information. A practice that does not start to track outcomes, patient satisfaction and costs will be a practice that does not get contracts and will see an erosion of their bottom line. Information and data will provide your practice with unparalleled power in the managed care market place. One of the best, easiest and least expensive ways to get started is to implement the protocol process into your practice.

For those that are interested in additional reading on this topic we recommend Clinical Practice Improvement: A New Technology For Developing Cost Effective Quality Health Care by Susan Horn and David Hopkins.( Faulkner and Gray publishers 1994)