Protocols, critical pathways, and clinical guidelines are sets of conditions, actions and rules that set guidelines for the delivery of health care. When presented at the time of treatment, protocols can greatly improve the quality and cost effectiveness of health care. Current protocol software is not flexible enough to be used in diverse health care settings and does not work effectively with existing medical software.

When protocols are maintained and enforced on an organization's primary or "live" data management system, users receive prompts regarding quality care standards and cost effective health care management when the care is provided or planned -- not after the fact. Currently, few small- to medium-sized physician offices and clinics have computerized protocol systems. Of those that do, most have systems which run independently of the facility's primary data gathering system and commonly cannot share its data. This combination greatly reduces the effectiveness of protocols.

Protocol management software closely integrated with the "live" data entry system ensures that medical staff get vital information when they need it most. Thus, the opportunity to reduce health care costs while improving the delivery of services is enormous.

CK Software, Inc. (CKSI), an innovator in the solution of health care software design problems, has set the design specifications for and begun work to develop a prototype "Protocol Engine" with the following features:

• Windows application designed for personal computers and computer networks.
• Allow protocols to be defined and customized to meet the specific needs of the organization.
• Link with or access data from other medical software packages.
• Facilitate timely monitoring of information.

CKSI will continue with the work needed to develop the protocol engine into a commercial software application that will be a valuable tool for health care clinics, insurance groups and other health software vendors. We believe that it has a tremendous market potential.

This project addresses the need to develop products which help all participants in health care to assess and monitor the quality and level of care furnished to patients. Pressures to limit costs and improve quality through standardization and managed care are coming from insurers, government agencies, health management organizations and payors of all types. Protocols, practice guidelines and/or standards of care are increasingly being discussed and implemented to control costs and improve care quality. Computer software designed to monitor health care data can provide vital assistance to this end. The computer can search for situations that do not meet quality standards and, where appropriate, suggest specific guidelines to be followed.

Clinical protocols, critical paths, practice guidelines, and standard orders are other terms used to describe approaches to standardizing and monitoring care. In this project the term protocols is used in its more general sense to describe all of these sets of conditions, actions and rules that set standards and guidelines for the delivery of health care and health management services.

In most small and medium-sized health care agencies, protocols exist on paper and are referenced well after the situations to which they apply have occurred. Consequently, they also are refined only sporadically and with minimal analytical material available on which to base the changes. However, when set up and enforced in concert with an organization's primary software management system, protocols have the potential to greatly improve the quality, efficiency and cost effectiveness of health care.

If designed and developed correctly, protocol software will:

• allow for triggering events, rules and enforcement of protocols to be defined.
• monitor health care data as it is entered.
• require or prompt for specific procedural guidelines to be followed.
• assure that providers and case managers are alerted immediately with the patient specific information (including chart notes) necessary to effect timely and careful follow-up with patients, guarantors and others involved in particular cases.
• help staff members analyze and review care outcomes to determine how protocols should be refined to improve patterns of service.
• be location and machine independent to allow case managers and guarantors anywhere in the country to be notified instantly.

Properly designed protocol software will provide primary assistance to an organization as it continually assesses patterns of service and refines protocols with an aim toward the improvement of the quality and cost effectiveness of care.

When protocols are maintained and enforced on an organization's primary or "live" data management system, users receive prompts regarding quality care standards and cost effective health care management when the care is provided or planned -- not after the fact. Currently, few small- to medium-sized physician offices and clinics have computerized protocol systems. Of those that do, most have systems which run independently of the facility's primary data gathering system and commonly cannot share it's data. This combination greatly reduces the effectiveness of protocols.

Protocol management software closely integrated with the "live" data entry system ensures that medical staff get vital information when they need it most. Thus, the opportunity to reduce health care costs while improving the delivery of services by employing automatic quality management techniques is clearly significant. If protocol software is available to clinicians and staff members in a user friendly and familiar context while they are working with the patient it will reduce human error and paperwork by automatically monitoring rules and standards and printing documents such as routing slips and standard orders with detailed instructions already filled in. Any additional data entry that is required to confirm activities that have been completed or to track variances can be minimized with predefined lists.

During the course of the Phase I grant, two major shifts occurred which altered the approach of this project. The first shift was a surprising and sudden growth in the popularity of the Internet. This shift was driven by the acceptance and possibilities presented by the popularity of the World Wide Web. The Web Browser has become the focal point of the desktop due to its power to integrate voice, e-mail, sound, images, and data into a single window in a platform independent application, and has greatly changed the way in which information could be handled. As a result of this trend we too modified our approach to take advantage of the location and platform independence demonstrated by the Web server and browser environment, with the opportunities to develop applications that allow data to easily be shared and accessed throughout organizations and communities.

The second shift is in the rate of restructuring in the health care industry as it prepares to respond to steadily increasing pressure to cut costs. The health care industry is in a state of flux. Alignments between clinics, hospitals, insurers, and employers are rapidly being formed, altered, and dissolved. In the year and a half since our phase I proposal was submitted less flexible and more traditional patient care software systems have struggled to make significant improvements in their ability to allow users to define, review, and monitor care guidelines. However, due to their platform and location specific nature, these systems tend to be extremely expensive, inflexible, and often require two or more groups to agree on a common standard. This is a significant problem. With the rapid realignment of the industry all physicians in one physical location may be members of different HMO's or provider groups. Our approach is designed to maximize and stimulate acceptance critical to success. It is a cost effective solution which is location and hardware independent and binds different health care systems into a virtual and continuous body capable of sharing transparently all health care related data. This is an absolute requisite needed to improve care quality and lower expense.

Private Health Care Intranets Can Be Set Up Using Internet Technologies

All of the technologies used on the Internet can be applied and implemented on private, low cost medical intranets. A local medical intranet could be composed of doctors, medical staff, laboratories, medical managers, and payors. It would work from off-site over a simple phone line and have the look, feel, and function of on-site network access. To isolated clinics or remote doctors, as well as to the payors and health care managers who need to keep in close contact with them, the benefit of data sharing with integrated functionality is very attractive from all perspectives.

Given the current need for a virtual network in which managed care and HMO's can form and prosper, the necessity for consolidating and sharing data from a variety of diverse sources and locations is squarely upon us. TCP/IP solutions i.e.: Web browsers and servers provide a low cost solution to a coalescing medical community. A solution with platform and location independence best serves to address the immediate need to share information between hospitals, insurers, management organizations, laboratories, clinics, and physicians, wherever they may be physically located. All health care organizations need ways to work with and add value to their legacy systems while making a smooth transition to more modern and robust data sharing solutions. Again, this is the focus, the underlying premise of the method we employ and wish to develop further with Phase II funds.

Future Development: a Unique Opportunity

As the health care industry realigns and repositions itself and works to improve its cost effectiveness and efficiency, the ability to transfer and integrate data from different systems, software, and sites is becoming essential. More and more, software vendors are converting to "open architecture" data storage, where data is stored in formats that can be accessed by other parties, independent of the original software system, or are providing secondary output of their data in documented and standardized formats such as HL-7.

Open architecture data storage and the rapidly improving technologies being developed for web/Internet environments now make it possible to successfully produce an application designed as an add-on to be used in concert with different software systems running at different locations. Thus, on a single desk-top with an open architecture database, it will be possible to run a data entry and billing system with the data and program stored and residing locally and a protocol system set up on a web server in a completely different geographic location which will be monitoring data entered on the local system, and initiating data transmissions and requests.

For the past twelve years, CK Software, Inc. (CKSI, aka CK Computer Consultants) has designed, developed, evaluated and supported DOS-based health care management software for physician offices, clinics, occupational health services, various other hospital departments and utilization review services. In all of these different settings, we have had first hand experience working closely with users to design and then support health care applications. We also have given a great deal of thought to the specifics of protocol implementation and understand how explicitly rules need to be defined if they are to work properly on a computer. In developing our prototype protocol engine with Phase I SBIR funding from HCFA we have conducted a detailed review of the different design elements needed to efficiently monitor and enforce rules that users can design themselves. In our prototype we have illustrated the way in which rules monitoring and enforcement can work efficiently in an environment with different data sources and locations. We have demonstrated how to separate protocol definitions from data definitions, so a protocol can be monitored and enforced on a variety of different types of systems running different kinds of software.

The challenge in medicine is cost reduction. To meet this challenge grants such as this one have been let with the hope of accelerating a marriage of creative solutions and new technologies. The ultimate goal is to extract relevant information from wherever it is gathered and use it to help make better medical decisions. Due to the diversity of clinics, hospitals, data types, and connectivity options, any viable solution must be open and flexible. It will be a solution that is platform independent, has a minimal support need, will work on older computer hardware and can bring physically separated organizations together electronically. We have such a solution under development. It uses the language of the Internet, TCP/IP; it works from home over a simple phone line exactly as it does over an Ethernet hospital LAN and can bind the isolated clinic or remote doctor into a wide area data sharing network for the cost of an extra phone line and modem.

Our solution allows a virtual network of data users and providers to function as one contiguous entity. Our methods insure the fastest access to information and a way to insure that the correct protocols reach the user. Our methods allow tightly controlled access to the data as well as a means with which to gather, process, and display information in a timely fashion using existing hardware with the barest minimum of personnel training or support.

Our method maximizes cost effectiveness by using well known and familiar software like the Netscape Browser, and Netscape's integrated POP3 e-mail client. Connection costs are reduced by the use of standard telephone lines and all information is distributed from a web server having a look and function with which users will already be familiar, dramatically cutting re­training costs.

Our methods engage the user, demanding their attention, and with this comes an increased willingness to input data and use the system regularly and as designed.

Our solution is a straight forward presentation backed by a powerful protocol engine and data collection strategy. Proactive warnings, trends, and irregular tendencies can be spotted, corrected, and monitored. An insurer in Virginia could be "notified" via e-mail by the efforts of our protocol engine if a trigger was defined. A cardiologist could see real time patient data in a small window on her office PC and automatically be paged, via e-mail, if vital signs drifted out of a normal range.

Our protocol engine dynamically analyzes data and reports back to involved or affected parties using methods that closely models today's Internet environment. With Phase II monies we will define protocol mechanisms explicitly targeted to the needs of those people who directly control medical expenses. Our system can be set up to work with data gathered from diverse environments. It then can be offered to both ends of the software market -- to software vendors as an add­on to their products or to software users as "middleware" that can run concurrently with their primary data entry system.

While there are technical challenges to overcome in order to develop a such a system, the rewards will be enormous. Once systems are configured properly to meet the needs of the practice and all necessary data entered, computers can monitor enormous amounts of information very efficiently and immediately draw attention to any care plans that fail to meet standards. Such a system also can provide the valuable analytical and historical information necessary to make decisions which improve service delivery and health care outcomes.