Chronic diseases including heart disease, stroke, arthritis, high blood pressure, diabetes, cancer, and kidney disease account for 70% of deaths, and consume 75% of the US $2 trillion annual medical care costs. Chronic disease patients require lifetime medical care, from many caregivers in several medical disciplines. Many require care in several sites under various administrative umbrellas.

Conceived medically and designed technically to address these needs, MIQSs Disease Manager Plus differs strikingly from traditional, inadequate, medical records because it focuses on patients as the center of interest. Current health care records are designed to serve institution, department or software user, not patients (Appendix 1). 

Our mission was to create and implement a completely new medical record providing information tools to care optimally for chronic disease patients over their lifetimes. Our success derives from making this new record so effective. 

Disease Manager Plus increases clinical effectiveness by helping physicians and caregivers maintain complete, analyzable medical histories of each patient, immediately available anytime anywhere. It helps identify and manage clinical problems in patients and patient groups, reorganizes and communicates patient records, and displays trends among any combination of clinical data to understand the connection between treatments and outcomes at the point-of-care.

The solution contains complete, coded, lifetime patient data. Users can therefore collect, process and analyze comprehensive arrays of data including symptoms, diagnoses, procedures, medications, hospitalizations, and treatments. Immediately available reports tuned to particular patient needs enable physicians to know all details of the patient when he walks in the door, freeing time to examine and talk with the patient. 

In a published 9-year study, use of Disease Manager Plus improved patient outcomes and decreased mortality significantly when used by physicians to help manage chronic kidney disease patients treated by dialysis. Combining electronic medical records, practice management, and decision-support within an integrated and analyzable application, it also substantially reduced costs and increased revenues. 

Disease Manager Plus also helps the business of healthcare organizations by facilitating compliance with ever-changing complex regulations and healthcare reporting requirements. For billing, it extracts patient-specific clinical data automatically from medical records for inclusion on bills.

Key technology design features of Disease Manager Plus are that the data are patient-centered and extensively coded, and therefore immediately analyzable. The software employs a unitary data model, extensible architecture, a centralized configuration and automated data exchange (Appendix 2). It features bandwidth independence and allows healthcare organizations to manage patient care at many sites.

For the end-user, Disease Manager Plus is easy-to-use and enables collaboration of multiple users. The flexible data model allows users to run reports to analyze information from many perspectives on single patients or selected patient groups, using the integrated patient selection engine and report writer. At the same time, the multi-tiered security protects patient confidentiality and limits data access to authorized users only. 
    
But the ultimate benefits of Disease Manager Plus are those delivered to physicians to enable more effective patient care. The software contains powerful decision-support reporting capabilities that give physicians the relevant information at the point-of-care to help decide on treatment plans because it provides:

o	Fast, flexible data collection and retrieval
o	Organized lifetime patient history
o	Tracking relationships between treatments and outcomes
o	Identification of patients that need intervention or follow-up action
o	Extensive tabular and graphic reporting capabilities
o	Data selection based on any combination of variables
o	Dynamic reporting and analysis of data from any domain
o	Incorporation of statistical feedback into reports 
o	Generation of exception reports for each payer 
o	Management of clinical trials and daily practice 
o	Comparison of performance within or between medical practices

MIQS built Disease Manager Plus on the premise that physicians and other healthcare providers who have the relevant information at the point-of-care at the right point in time will generally make appropriate decisions and diagnoses. Creating an environment in which all these conditions are met is a major technological challenge to healthcare organizations. 

Personal information on patients, along with data on the various types of care patients receive from multiple healthcare providers needs to be collected from many sources. The data then has to be transformed so that all components can be compiled. Lastly, the resulting information must be made available to caregivers in various formats and reports that can be run or altered on an ad-hoc basis so that physicians can view information in the best way to diagnose patient conditions and determine proper treatments. The data must be organized flexibly enough so that physicians can drill down for details or retrieve summary views when needed.

To accomplish this, the latest application development and database platform technology are required. Physicians must be able to collect data from multiple, disparate sources. To help them address the patients problems and their treatment they must then analyze the information in myriad ways using spreadsheets, charts and graphs.

The first key technology component of the Disease Manager Plus solution was created by our internal application developers using a development tool allowing deployment on both Windows® and Macintosh® workstations. It combines electronic medical records, practice management, and decision-support functions within a completely integrated and analyzable application infrastructure. The software allows integration of clinical processes and business operations: diagnosis, treatment, laboratory data, billing, communications and resource deployment.

The second key technology component of Disease Manager Plus was the database platform on which it was built: Sybase® Adaptive Server Enterprise (ASE). To ensure Disease Manager Plus would run properly and consistently 24 hours per day, we needed to integrate our front-end software with a reliable relational database like Sybase ASE. Our application processes data sets are wide but not deep, which means the data are very complex to analyze. Physicians using our software might need to analyze thousands of pieces of data in many different ways, and some of our customers gather as many as 25,000 discreet bits of information per year on each patient.

Another reason we needed a reliable relational database is the inherent nature of chronic diseases such as diabetes and kidney failure. Patients receive treatments on a regular basis, so information and conditions constantly change. To treat patients properly, physicians have to assess how things change over time by viewing trends, improvements and deterioration. If the technology allows the data to be organized so physicians can see exactly that someone is getting better or worse, and why, physicians can treat patients more effectively and in less time. In addition to improving overall care, they can see more patients  which allows the practice to do a better job while operating more profitably. Finding and structuring a reliable database was a major key towards ensuring our solution would work optimally over the long-term.

Importantly, Disease Manager Plus required adherence to the practices of continuous improvement. To address the evolving needs of chronic care, the database, workstation toolset, and MIQSs custom programming had to enable continuous improvement of care and business processes. In a typical year, more than 500 enhancements are added. In practice, initial deployment and all upgrades of Disease Manager Plus at customer sites have been seamless. Based on our success, MIQS continues to believe that any truly acceptable EMR must operate without the need for specialized IT resources. 

Yes

Yes

Physicians, nurses, dietitians, other caregivers and billers need to know many details of the past and present condition of each patient at the time of each patient visit. It is not enough only to have the data available. The data must be presented and displayed in ways that make it easy for physicians to evaluate the wellbeing of patients, and the effects of treatments; and make it easy to detect both adverse effects of treatments and unanticipated events. Disease Manager Plus organizes and displays this information without delay, and makes it available for physicians on the computer screen or on paper. The patient with diabetes illustrates the point. Physicians need to know the relationship between the blood sugar and dose of insulin and/or other drugs. But even this seemingly simple problem is more complex. The insulin required varies not only with the blood sugar, but also with exercise and food intake. The information system should accommodate these variables, and display them over time in a way permitting interpretation. Disease Manager Plus does this. Many diabetics develop complications over 5 to 20 or more years. These problems affect the kidney and blood pressure, peripheral nerves, brain, eyes, heart, and blood vessels in many parts of the body including legs and feet. Disease Manager Plus is designed to accommodate all these elements of the medical record, and to rearrange them flexibly in reports that are available immediately when patients visit their physicians. Several advantages flow from the way data are stored and organized in reports: 

o The time needed to get the data together for the visit is minimized. 

o There is no need to search multiple databases as all data are in one place. 

o The physician has more time to talk to and advise the patient. 

o Physician, nurse, dietitian, social worker and other caregivers can easily cooperate in patient care a major need in chronic disease where cooperation of these caregivers is essential for patient wellbeing.

o Makes it easy to check for important facts, forgotten because they happened a long time ago a possible allergic reaction to an antibiotic ten years earlier. o Makes communication with referring physicians easy, organized, and complete. 

o Makes all relevant information available for billing without any duplicate entries. 

o Eliminates/minimizes billing errors, and thereby improves financial performance. 

o Whereas paper may be useful during a patient visit, storage of paper records can be eliminated completely. 

o Greatly improves the experience for patients and caregivers, and increases the satisfaction of both. 

The way data are stored and organized encourages application of rules based alerts and reminders. For women, Disease Manager Plus can remind physicians that a mammogram is due at the required intervals. It can alert, automatically and without delay, when the result of a laboratory test indicates a potential danger for the patient. To summarize: Use of Disease Manager Plus eliminates the hassle; ensures that physicians have all relevant information, from all sources, available at the point-of-care; makes it easier to draw correct conclusions; and enables better decisions and better care. Disease Manager Plus also makes it easy for physicians, administrators, and healthcare providers to gather and analyze data on groups of patients, all diabetics for example. This enables research on outcomes, and makes continuous quality improvement a reality in the physicians practice. In turn, this promotes further improvement in the quality of care.

The Rogosin Institute, affiliated with Cornell University Medical College and New York-Presbyterian Hospital, has used Disease Manager Plus since 1998. Benefits for the organization include managing: o 950 dialysis patients treated at sites in Manhattan, Brooklyn, and Queens. 

o 25 patients who dialyze alone at home while asleep and are monitored remotely in real-time. 

o 2400 patients who have received a kidney transplant, including 260 new transplants per year o 2000 patients with kidney disease not yet requiring dialysis or transplant 

o 500 patients with lipid disorders

o scheduling office/outpatient visits at 7 sites, including almost 100 per day at the main site o bills for dialysis treatments, sent to payers on the first business day of each month 

o FDA mandated drug trials Some advantages for staff:
 
o For physicians, patients are followed without discontinuity through chronic kidney disease, dialysis, transplant, and back on dialysis if the transplant fails. o For schedulers, integration reduces the workload.
 
o For billers, there is no duplicate entry, errors are eliminated, claims are clean, and workload is much reduced.
 
o For all caregivers, time spent chasing missing data is eliminated. 

o For investigators, studies are done with minimal hassle and elimination of paperwork.
 
o For the organization, compliance with ever-changing federal and state mandates is facilitated.
 
How well Disease Manager Plus works was shown in a study MIQS conducted with Rogosin to measure the impact of Disease Manager Plus on dialysis patient mortality at the 3 NYC clinics. Initially, in 1998-2000, the 22-23% yearly mortality was similar to the US national average (23.7%) for dialysis patients. Mortality decreased from the third year after deployment of the software to 13-14%. In the same period US mortality did not decrease significantly. Had mortality continued at the same rate as the US mortality, some 50-70 additional patients would likely have died each year. Because 25% fewer staff were required to care for these patients than the US average, the software had a very favorable effect on the cost of care. Personal quotes from two individuals: Jonathan A Lorch, MD, Associate Professor of Clinical Medicine, Weill Cornell Medical College, Director of Medical Informatics, The Rogosin Institute, New York, NY 10021 Contributes a tale of 2 EMRs, a widely used hospital EMR and Disease Manager Plus: One of my renal failure patients, a complex 38 year old with 3 major underlying diseases was admitted to hospital with respiratory failure. After 2 weeks in hospital someone notes that, among the lab results, is an iron saturation of only 9%. Everyone ignores it its just a single value among a myriad of other tests done in hospital. So we look to the Disease Manager Plus record where we keep all in-patient and out-patient medical information. There, you can see that the iron saturation had gone into free fall. I tell the attending physician the patient is having a GI bleed. I get a quizzical look. They check for blood in the intestinal tract and, sure enough, a GI bleed. Lisa Pantaleone, RN, Director of Renal Services, Provena St. Mary's Hospital Dialysis Center, Kankakee, IL 60901 Using MIQS has fundamentally changed how we provide care to patients. Where we spent days accumulating data and minutes with patients using the data, we now spend minutes managing data and staff can spend time with the patient improving outcomes. The real time quality assessment aspect has been the single most important tool in managing patient care especially for identifying the patients most at risk quickly and efficiently. MIQS is used in every aspect of unit management from patient care, supply management and analysis, billing, budgeting, regulatory compliance, communication, and financial analysis.

Common current computerized records used in medicine are concerned with:  administrative and billing functions, sometimes with an add-on medical record; separate individual functions such as laboratory tests, medications, or X-ray reports; computer order entry for medications; organ based specialties or subspecialties; communication of data in disparate data systems.

These do not integrate needed information in a manner optimal for patient care; nor do they display information in reports that allow physicians to view patient data over time and with treatment  a quality essential for long-term care of patients with chronic disease(s). Applications that integrate all aspects of chronic disease care have rarely been attempted.

Disease Manager Plus was designed primarily to accommodate the needs of complex patients with diseases affecting any and all organ systems, and to track and analyze information on individual patients at the point-of-care. Analysis, sorting, and clinically effective display of data, as well as complex security, were key design features. 

Disease Manager Plus provides a large range of reports for use by physicians, and built-in tools that enable immediate creation of new and ad hoc reports. This plays an important role in giving physicians new ways of addressing their patients problems  which, in turn, improves patient care and outcomes. We are not aware of any other technology solution that approaches electronic medical records (EMR) in this way.

Another unique feature is that Disease Manager Plus was designed to enable generation of new patient-specific knowledge while facilitating day-to-day patient care (Appendix 3).  Results documented in peer-reviewed medical journals substantiate the claim that Disease Manager Plus is the best and most effective application of its kind. We cite two such studies.

First: Of dialysis units in the US over 85% use EMRs with a primary administrative and billing focus. From 1998 to 2006, US national mortality changed little. By contrast, mortality in the 3 study units deploying Disease Manager Plus decreased dramatically over the same 9-year period from 22-23% to 13-14%. Uniquely, also, the software design made possible the detailed analysis of data collected over many years of clinical practice. 

Second: Anemia is an almost universal problem in dialysis patients. Associated with considerable morbidity, its causes are complex, and treatment difficult and costly. Widely publicized guidelines, based on clinical trials of select patient groups, have influenced clinical practice. With Disease Manager Plus, analysis of data for over 4000 patient years demonstrated which treatments affect survival both favorably and unfavorably.  They also showed that guidelines used by physicians (and regulators) for the past 10 years need radical revision. The traditional medical records structure handicaps guideline development in complicated chronic disease. 

Complete integration of billing and administrative with clinical functions is another exceptional software feature. Errors and omissions in data for billing are corrected in most systems by billers communicating with clinical staff when, days later, bills are prepared. With Disease Manager Plus errors and omissions are detected and corrected, when or immediately after they occur, at the point-of-care. Billers simply compile the stored data when monthly bills are prepared, so that monthly bills are out the door on the first business day each month. This translates into improved financial performance since charge-capture is improved and accounts receivable reduced. It also leads to improved revenue, faster and more accurate claims filing, fewer billing errors. and improved clinical and clerical staff efficiency. 

Addressing business issues in this way enables healthcare providers to focus more attention on treating patients, with two important long-term benefits: improved patient outcomes and reduced mortality rates. They can also reduce administrative clinical staff and simplify the regulatory compliance process.

Like most technological innovations, Disease Manager Pluss success depends on the compatibility and congruence of social and institutional as well as technological factors. Whereas the analytic approach to medical practice has clear benefits for patient well-being, two important factors have limited its wide acceptance: differences in problem definition and professional inertia.

First, Disease Manager Plus defines the problem of healthcare delivery differently from the current mainstream view. Healthcare organizations and planners have focused on managed care, disease management and evidence-based medicine, approaches that assume little clinical variability surrounding the notion of an average patient and often seek to establish target treatment values. They call for clinical judgments based on best evidence available from randomized or controlled clinical studies which include a group of carefully selected patients, and exclude large numbers who do not fit. Ultimately, they see the central problem of clinical practice as the development and dissemination of generalized protocols or guidelines that in effect limit discretion for physicians who care for patients many or most of whom differ from those selected for clinical trials.

Adults with kidney failure treated by dialysis range to over 90 years of age; 40% have diabetes, some have cancer, others have AIDS. Almost all develop anemia and various forms of bone disease, to say nothing of high blood pressure, heart disease, and disease of blood vessels to the brain and limbs. Clinical protocols and guidelines, generally developed for single problems in defined patient groups, do not readily fit this very diverse group of patients.

By contrast, Disease Manager Plus defines the central problem of clinical practice as the need to enhance the physicians ability to develop and apply knowledge and experience to each patients unique circumstances and co-morbid conditions. It assumes great clinical variability from patient to patient, and within the same patient over time. It therefore recognizes that best-practice clinical procedures may vary from one patient to another, and displays data in ways tuned to take advantage of the physicians knowledge and experience.

Professional inertia is the second factor that slows acceptance of Disease Manager Plus. Like any new technology, realizing the full potential benefits of new software involves re-engineering the context in which it is applied. New technology almost invariably requires new ways of doing things. Disease Manager Plus places much emphasis on thorough collection of reliable clinical data during routine clinical practice, and facilitates it. Data omissions can create holes in the medical record and reports that undermine its clinical value. Although the main beneficiaries and most critical contributors of data, physicians are often resistant to adopt changes which they view as another stress in their busy lives. Physicians have, for many years, been promised that successive new computerized information systems would help them care for their patients, a promise rarely fulfilled. Perhaps it is no wonder they resist using computers in their practice. 

Fortunately, Disease Manager Plus was designed by physicians sensitive to the need to improve work flow in clinical practice, who promoted a design that could operate in both paperless and paper modes. The designers also realized that physicians will buy into Disease Manager Plus only if the link between data output and input is clearly evident in day-to-day clinical practice. The result is a conundrum of sorts: it takes time to accumulate enough data to generate meaningful reports but the clinicians participation is needed to generate such data in the first place. 

Physicians, trained on paper charts, unfamiliar with the advantages of coding, modern process control and management, and continuous quality improvement are particularly resistant to change. Computers, it was once believed, had no place in patient care other than to render the bills. That effective medical record computerization can conserve physician time and improve practice is a hard sell. We had to gain acceptance of the concept of a patient-centered, coded, analyzable medical record, with full integration of billing and administrative functions - and fund its development. Repeated and persistent badgering for many years enabled funding from unconventional sources to get the project off the ground.   Entering medical data into a new computer system demands organization and discipline difficult to find in hospitals and medical practice. This obstacle was overcome by 

(1) choosing as the test site a free standing dialysis unit, controlled by a dedicated physician director who ensured complete data entry and development of clinically useful reports;

(2) getting unit staff to buy in by demonstrating time saving, effectiveness, and improved patient care; and 

(3) publishing results in medical literature.    

These obstacles persist as challenges for wide acceptance of Disease Manager Plus, although medical records computerization is now a national objective. The healthcare industry is loath to finance IT, which is viewed as an add-on cost, and averse to spending time and funds for training for effective IT implementation. Implementation of Disease Manager Plus, with integration of clinical, billing and administrative functions, provides the template to reduce costs and improve financial performance. Publication of results associated with its implementation is important to overcome this objection. A recent peer reviewed study covering nearly 4000 patient years of experience showed a stunning outcome improvement, a 40% decrease in mortality, with spectacular cost reduction, 25% fewer staff than the national average.

Exceeded

Chronic diseases account for 75% of healthcare costs in developed countries. Prevalence is accelerating worldwide. Because IT is believed necessary to improve outcomes and decrease cost, governments have appropriated vast sums of money for healthcare IT. Many of these efforts have failed. The basic problem is the error of computerizing traditional paper records rather than adopting a new paradigm to unleash ITs power to address these intractable problems.

Disease Manager Pluss success in patients treated by dialysis opens the door to wider use in chronic diseases, to enable better outcomes, improve practice efficiency and decrease costs. Success depends on having the proper software tool, Disease Manager Plus and serious organizational commitment, key person(s) taking charge, learning the software capabilities and orderly re-engineering practice to capitalize on its power. Both tools and commitment are essential. 

Current institution-based and hopelessly fragmented medical records are a major impediment to chronic disease care. A complete, patient-centered, analyzable medical record available to all caregivers is essential. Although Disease Manager Plus provides such a record, difficult political and institutional change is needed to effect this change.

Skilled healthcare personnel are expensive and in short supply. The shortage is poised to worsen. Physicians and nurses spend 40-50% of time on paper work.  Reducing this modestly to 10-15% allows these skilled caregivers to care for 25-30% more patients, saves money, and slows growing personnel shortages. Disease Manager Plus has been shown to effect this.

Advances in molecular biology and therapeutics are rapidly moving medical practice to a more personalized level, where treatment decisions will depend significantly on atomized knowledge of details of patient biology and genetics. The design of Disease Manager Plus accommodates these new details in the database, while its strengths in lifetime data analysis enable the needed outcome analyses.

New users must begin the software use with a patient database as complete as possible. Essential core data are gathered from paper and other computerized systems, and entered in Disease Manager Plus. Patient demographics, diagnoses, procedures, medications, laboratory test results, rules and data for billing are entered before go live, in effect creating a coded medical record for each patient. All interfaces are functional. That caregivers have available an excellent account of the patient data on day one facilitates acceptance of the software. The speed with which the software is embraced varies, dependent in part on the practical organization and commitment of the client. 

For one organized and committed nurse manager the result was:
Disease Manager Plus was almost instantly embraced by even our most computer phobic staff due to the ease of use, time, and work savings. After about 6 months the power of the tool was being embraced with staff actively looking for ways to use the tool for more than data management but interpretation of data to improve outcomes and communication among care providers. I believe every day staff are evaluating how they can use Disease Manager Plus to streamline processes and improve outcomes in new ways.
 
Led by a committed physician, the software was effectively used in dialysis without delay. Financial benefits were evident within 3 months. A year later a large medical practice, including computer phobic physicians, was using it. Paper storage became a thing of the past. A large kidney transplant program was next. Tracking transplant patients, transplant candidates, and organs for transplant improved dramatically. Transplant coordinators with the time and mission critical assignment of finding a recipient for a donor organ now complete their mission without delay even when caught in traffic traveling home by automobile or bus.