Disease management (DM) is a comprehensive and evidence-based approach to caring for populations with chronic healthcare conditions. The concept of DM emerged over the past decade in response to growing concern about the quality and costs of healthcare for groups of individuals with common and expensive health problems such as diabetes or heart disease. Proponents of early DM programs believed that a more systematic and evidence-based approach to caring for populations of individuals with chronic conditions would not only improve clinical outcomes but would save significant dollars for healthcare plans, consumers, and providers. The recent growth and popularity of research-based practice guidelines has supported and propelled DM in many new directions (Box 1).
     
DM programs seek to create better systems of healthcare targeted for patients with chronic conditions. Based on current scientific knowledge about prevention and treatment of common health problems and their complications, these programs focus on improving processes of care to ensure that patients receive appropriate interventions at the appropriate time. For example, a diabetes DM program would include strategies for identifying patients at risk for developing diabetes and tools to increase the likelihood that patients with an established diagnosis of diabetes receive foot and eye examinations within recommended timeframes. A comprehensive diabetes DM program also would establish criteria for referring high-risk patients for case management services and would provide an infrastructure for the role of the case manager (Case Manager's Tip 1).
     
For case managers, DM programs can offer an effective structure and state-of-the-art tools for practice with high-risk patients. This chapter provides an overview of the evolution of current DM programs and their impact on the quality and costs of care. Current approaches to DM are described, including key strategies for success. The chapter concludes with a detailed example/case study of a DM program implemented in a clinic setting.

EVOLUTION OF CURRENT DISEASE MANAGEMENT PROGRAMS

During the 1990s the U.S. healthcare system experienced increased levels of financial risk for patient medical management. At the same time it was being held more accountable for providing appropriate, cost-effective, quality care (Rosenstein, 1999). These pressures mounted in an atmosphere characterized by a lack of skilled staff, increased consumer dissatisfaction with managed care, and constant turnover in clinical and administrative personnel. It was within this rapidly changing environment that DM programs came of age, emerging from outcomes research—a discipline that attempts to improve clinical practice and control costs through well-designed effectiveness studies.
     
DM programs have been implemented in managed care organizations (i.e., health maintenance organizations [HMOs]) and hospital and physician group practices. DM programs were initially developed and promoted by pharmacy benefits management organizations to address the inadequacies of the healthcare system. They focused on the small number of patients who consumed a large portion of resources, were complex cases to manage, or were patients with specific chronic conditions. The rationale for developing DM programs was that short-term costs in one specific disease arena would be offset by longerterm savings (Harris, 1996). Commercial companies were the first to develop DM programs and to sell them to HMOs, employer groups, and healthcare organizations. They provided mechanisms for identifying patients with chronic diseases and patient education materials and classes aimed at lifestyle modification and self-management skills, such as help with quitting smoking, nutrition/exercise for cholesterol reduction, and stress management. They also offered assistance with medication management through the tracking of pharmacy claims.
     
However, not all DM services were provided by commercial DM companies. At the same time these programs were growing, a number of leading healthcare organizations developed their own "in-house" programs (Wagner et al, 1999). These newer programs attempted to overcome some of the deficiencies of earlier programs by focusing on individuals with multiple chronic illnesses and integrating physicians into the process (Leider, 1999; Fernandez et al, 2001). They developed interventions that relied on multidisciplinary teams and care providers of varied specialties. They emphasized population-based care and included formalized treatment plans to assist patients in navigating the complexities of healthcare systems, self-management education, and continual follow-up (Wagner, 2000).
     
In the future, demographic trends can be expected to drive continued growth of team-based DM programs for chronically ill individuals. It is estimated that over 100 million Americans suffer from multiple chronic illnesses today (Hoffman, Rice, and Sung, 1996). With the aging of the population and the large baby boom generation, in particular, these numbers will continue to increase, as will the customers' expectations for improved systems of care (Bodenheimer, 1999). There will be increased demand to reduce wide variations in patterns of care for the same disease(s) and to implement and monitor best practices of care (Coye, 2002). Increased access to information via the Internet and growing familiarity with the various managed care structures also will propel consumer demand for innovative and effective programs for chronic illness management (Bazzoli et al, 2002; Coye, 2002). Case Manager's Tip 2 describes the issues that will drive future DM programs.

DISEASE MANAGEMENT AND CASE MANAGEMENT

Although current models of DM emerged after the rapid growth of case management in the 1980s and 1990s, they provide an important context for effective application of case management. Generally, DM programs address the full continuum of care for patients with targeted chronic and complex health conditions. They are concerned with health promotion and prevention of illness, as well as treatment of advanced complications of diseases. They consider the needs of patients at all levels of risk for adverse outcomes to ensure that patient needs are matched to an appropriate level of intervention.
     
Case managers fulfill an essential component of DM programs. Working at the high-risk end of the DM spectrum, case managers focus on the care of individuals and populations who are most likely to have complications and adverse health outcomes. In many practice settings, it is likely that it will be these high-risk patients who trigger the interest of healthcare providers in starting a DM program. Examination of service use patterns or expenses may reveal a population that is hospitalized more than expected or costs more than the norm. Once this pattern is discovered, it leads to discussions of how care for this population may be managed more effectively and efficiently. The case manager is in a pivotal position to help the team understand the usual trajectory of illness and care for high-risk members of the populations and to guide them in looking at strategies to prevent patients from becoming high risk or to reduce the risk once it occurs.
     
DM can provide a useful framework for case managers to explain their interventions and justify their value to the organization. If DM is described as the overarching approach to working with populations with one or more chronic conditions, it is relatively easy to show how and where case management fits into a DM process. That is, case managers are most concerned with assessment, planning, monitoring, coordination of care, and evaluation for patients at the high-risk end of the population (Case Manager's Tip 3). From there, case managers can further emphasize their importance in the DM process by highlighting the complexity and costs associated with providing healthcare for this group.
     
Not surprisingly, however, case managers have been in the forefront of developing DM programs. Armed with their perspective and experience with highly vulnerable and expensive populations, case managers have led the way in designing better systems of care for patients who are not yet at risk and can potentially avoid future complications and threats to their quality of life.

IMPACT OF DISEASE MANAGEMENT ON QUALITY AND COST

DM programs focus on the care and management of populations with a greater volume of high-cost, chronic health conditions. As outlined in Box 2, expected outcomes of these programs include a decrease in overall healthcare costs for the population, reductions in avoidable hospitalizations and emergency care, improvements in disease-specific clinical outcomes and patient satisfaction with care, as well as increased adherence to national treatment guidelines.
     
Numerous clinical trials testing diverse interventions have documented improvements in a number of selected outcomes for specific chronic illnesses, including patients with asthma (Homer, 1997), diabetes (Berger and Muhlhauser, 1999; Clark et al, 2001), and heart failure (McAlister et al, 2001; Rich, 2001). The literature describing DM programs' impact on outcomes and cost savings is less compelling. Initially, most of the reported benefits of DM programs were anecdotal and based on cursory evaluation of changes in outcomes before and after the program was implemented (Hunter and Fairfield, 1997; Todd and Ladon, 1998; Bodenheimer, 2000).
     
Typically, DM programs have been able to demonstrate reductions in acute care hospitalizations and/or emergency department visits in the short run, usually 6 to 12 months, and an increase in patient satisfaction. Despite their potential, they have not consistently documented overall cost savings, improved clinical outcomes, or quality of care indicators.
     
Recently, Mathematica Policy Research, Inc. (MPR), conducted a comprehensive review of best practices in chronic illness care coordination (Chen et al, 2000). Participants in their study were identified through an extensive process that included literature review, word-of-mouth recommendations, and invitations to share detailed program descriptions. Over 150 programs that met specified eligibility criteria volunteered information. To participate, programs needed to have

(1) published evidence of reductions in hospital admissions or total medical costs and
(2) services in place to coordinate care for adults with chronic conditions.

Two types of coordinated care programs emerged:

(1) DM programs that served patients with a specific disease or condition; and
(2) case management programs that served patients with multiple comorbidities.
     
The principal finding from this review showed no single potentially effective way of coordinating care. Characteristics of the successful programs included interventions that targeted specific disease(s), worked most effectively in integrated healthcare organizational structures, had staff resources and capabilities to conduct rigorous program evaluations, and willingness to share the stories of the programs with others.
     
Although each DM program was different, they had a number of common features that are outlined in Box 3. The DM interventions took a proactive outlook and viewed case management and care coordination as preventive activities (i.e., providing services to patients in the present to prevent adverse health outcomes and limiting hospitalizations in the future). For those readers who are interested in a more in-depth review of the programs MPR evaluated, refer to the report by Chen et al (2000). The report is accessible via the Internet.
     
One of the primary reasons DM programs have not demonstrated success is that many healthcare organizations do not have adequate internal resources necessary to evaluate program outcomes. As a result, the effectiveness of DM has either not been tested or has been shown to be minimally effective. Future programs will need to address this deficit (Case Manager's Tip 4).
     
Although DM programs might not have all of the resources necessary to conduct vigorous scientific research, there are some "rules of thumb" that should be considered.

Rule of Thumb #1
First, as noted previously, the "gold standard" for any evaluation strategy is to make comparisons between the tested intervention and usual care or alternative interventions.
     
Ideally, these comparisons include a treatment and control group based on patient randomization into each group. When randomization is not possible or feasible, program outcomes should be compared with some other type of group—a defined group of patients who resemble the treatment group but do not necessarily receive all aspects of the DM intervention. Another evaluation strategy can be the use of the same group; data can be collected before and after the DM intervention is implemented.

Rule of Thumb #2
It is important to build in a data collection strategy early in the process of designing a DM program.
     
Having credible data is essential to program sustainability. At a minimum, try to include data that describe the patients served in the DM program and a few key measures of outcomes. Descriptive information about the patients being served might include age, gender, race, marital status, education, and insurance, as well as living conditions (e.g., live with spouse, live alone, live with a relative, live in a retirement community), presence or absence of a caregiver, existing chronic health condition(s), functional status/limitations (e.g., activities of daily living [ADLs] and instrumental activities of daily living [IADLs] for establishing disability levels), and perceptions of overall health.

Rule of Thumb #3
Selection of outcome measures must be tied to the goals of the DM program.
     
Measurement of DM outcomes might include patient and provider satisfaction; targeted clinical outcomes; and service use patterns such as the number of hospitalizations, hospital bed days, emergency department visits, ambulatory care visits, and physician visits. This is discussed in greater detail in a later section of this chapter.

Rule of Thumb #4
Although it may not be feasible or practical to randomize patients or even have a comparison group, it is usually possible to collect the same information on all patients at different points in time.
     
Data can be collected on all patients when they enter the program (baseline measure) and then again at predetermined intervals (e.g., 6, 9, or 12 months) to evaluate changes in patient outcomes over time.

DESIGNING DISEASE MANAGEMENT PROGRAMS

The majority of DM programs include a number of common features. Increasingly, evidence-based practice guidelines and protocols are used as a framework for core program interventions. Interventions are selected to match the illness and care trajectory of the population and may include a unique mix of self-care education, prevention, medical management, and care coordination and case management components. DM programs rely on information systems capable of identifying potential program patients and providing detailed reports to track and monitor clinical, utilization, and cost outcomes. Continuous quality improvement (CQI) tools and processes are typically integrated into all aspects of the DM programs.
     
A systematic process may be used to design, implement, and evaluate programs that incorporate each of these core features of DM. Most commonly an interdisciplinary team is brought together to select the target population and to oversee the development of the program. The team works through a number of steps in setting up the program. Case Manager's Tip 5 outlines the key steps in the process, which are reviewed in detail.

Step 1: Defining the Target Population
The first step in designing a DM program is to define the target population. Typically this is done based on an analysis of the frequency and costs associated with various medical diagnoses in a practice or health plan. Initial programs usually focus on common diagnoses associated with high expenses, increased hospitalizations or emergency department use, and/or a high incidence of adverse outcomes. The diagnoses tend to include diseases that are chronic and complex.
      Selecting diagnoses that are associated with well-developed evidence-based guidelines facilitates the start-up process. Guidelines provide an important benchmark for gauging the effectiveness of changes in clinical practice that are part of DM programs. Some of the more common diagnoses chosen for DM are diabetes, asthma, and heart failure, each of which is common and associated with high service use, complications, and costs.
     
Increasingly, DM programs are designed to address comorbid conditions and health problems that tend to go along with major chronic illnesses. Examples of such conditions are hypercholesteremia, hypertension, and renal failure/insufficiency. Decisions about the scope of the program should be made during the initial planning phase.

Step 2: Establishing Goals and Outcome Indicators
The analysis of common diagnoses, practice patterns, and costs used to select the target group also should be used to establish the expected goals or outcomes for the program. Depending on the type of organization and its incentives, credentialing, and regulatory guidelines, expected outcomes will include a combination of clinical, service use, cost, and provider and patient satisfaction indicators. Reductions in cost per patient, emergency department visits, and hospitalizations are commonly tracked over time. Most settings also desire to achieve improvements in disease-specific clinical indicators targeted in current practice guidelines, such as blood glucose or blood pressure levels.
     
Selection of specific outcomes may be based on a combination of current outcomes and a plan for incrementally improving the outcomes to a target or benchmark level. For instance, a hospital-based clinical or quality improvement team identifies that one third of patients admitted with heart failure are readmitted within 30 days for the same problem. Review of current literature on heart failure indicates effective interventions that can diminish exacerbation of the disease and reduce the 30-day readmission rates. The team may set an initial goal of cutting readmissions by half during the first 6 months and then establish a plan for continuing to lower the readmission rate incrementally over the following year. At the same time, the team may identify other positive outcomes for this population that they want to track at the same time, such as the percentage of discharged patients on angiotensin-converting enzyme (ACE) inhibitor medications or the percentage of patients who can correctly identify when to contact their primary care provider.

Step 3: Identifying Key Stakeholders
At the same time that the target population and goals are being discussed, it is important to identify each of the key groups that are major participants in the care of the population and likely to influence reaching the desired goals. Common stakeholder groups include patients and their families, members of the health-care team, agency administrators, and health plan representatives. Although each of these groups may share common goals for a DM program, such as high patient satisfaction, there may be some differences in priorities based on individual or organizational viewpoints and financial incentives. As specific targets for each outcome are agreed upon, the perspectives of each group of stakeholders should be considered. Representatives of key stakeholder groups should be invited to participate in the design of the program and/or asked to review program plans as they emerge. The initial plan for developing the DM program needs to identify how and when the perspectives of each group will be incorporated in the design and outcomes of the program.
     
For example, a health plan considering the development of a comprehensive DM program for its members with diabetes identifies several influential groups involved in diabetes care. These include patients with diagnosed diabetes and their families, members in their plan who represent populations at high risk for developing diabetes, primary care providers, endocrinologists, diabetes educators, case managers, and community organizations focused on diabetes education and care. Initial discussions should consider the goals and priorities of each of these groups for diabetes management and how they will affect support for various program outcomes. The administrators of the health plan might be expected to emphasize member satisfaction and a reasonable return on investment. In addition to satisfaction and costs, primary care providers and diabetes educators can be expected to focus on improving clinical indicators linked to reducing severe complications of diabetes such as foot ulcers and diabetic neuropathy and retinopathy.
     
In contrast, a hospital-based team thinking about developing a program for community-acquired pneumonia might identify a different set of stakeholders. Key players for this condition might include pulmonologists, respiratory therapists, staff nurses, pharmacists, dieticians, and infection control staff. Regardless of group composition, a major challenge in designing DM programs is to keep stakeholder priorities and incentives in balance with the program goals and resources.

Step 4: Defining Core Interventions
Characteristics of the target population and desired outcomes will guide the selection of interventions and the scope of the DM program. Programs seeking to prevent the development of the condition or detect it in an early stage will, by necessity, be more comprehensive than programs focused on reducing complications and adverse events in already diagnosed populations. Expected timeframes and resources for achieving program outcomes will shape the priority placed on different services and interventions.
     
Today, most DM programs are concerned with chronic illnesses that commonly span several years between prevention, detection, treatment, complications, and death. Many of the triggers to these conditions may be found in early lifestyle choices, such as smoking and diet, or environmental factors. Once disease is detected and diagnosed, it may be several more years before complications are evident. Some of the most challenging decisions in designing DM programs are determining when and where the program will interact with the usual illness trajectory and how resources will be allocated to the various stages of disease development and its related care. Although it may be considered highly desirable to have interventions targeted to each stage, from prevention to life-threatening illness, realistic concerns about time and available reimbursement are likely to affect program design. For instance, health plans with high turnover rates may not be willing to invest heavily in prevention programs that can take several years to show an impact on cost savings. Low reimbursement for prevention and education activities may require creative problem-solving strategies to ensure that these activities are incorporated in ways that are not cost-prohibitive.
     
One practical way to craft DM programs is to begin by drawing out the disease trajectory for the targeted illness. Review of current and evidence-based literature will help to identify essential and state-of-the-art interventions for each stage of illness from prevention to managing life-threatening complications. Next, factor in the goals of the key stakeholders.

What are the key outcomes that major groups will use to determine the success and cost-effectiveness of the program?
Where in the illness trajectory are the interventions most likely to achieve the expected outcomes in the expected timeframe?

Answers to these questions will help determine where energy and resources may best be targeted, especially for the initial stages of program implementation. In general, prevention activities take longer to demonstrate significant cost savings than interventions targeted at reducing expensive outcomes (e.g., hospitalizations and emergency department use) in populations already found to be at high risk for these outcomes.
     
Clearly, there is no "one-size fits all" DM program for all organizations and stakeholders. Although the availability and standardization of evidence-based guidelines has improved the content and targeted interventions, there is considerable room for flexibility and creativity about how much, where, and when different interventions are applied. The program must be tailor-fit for the organization, the population to be served, the stakeholders, the timeframes, and the resources available. The growth in common processes and tools for DM make it much easier for program customization.
     
In sum, the initial stages of designing DM programs require considerable analysis and discussion. Key stakeholders must come to some agreement on the target group, goals, and primary services to be offered. Decisions need to be made about the scope of the program and the components of the illness trajectory that will take priority.
     
At this point, a planning team might summarize: "After considerable study, our program will focus on the population of people with heart failure in our system. Our goals are to

(1) reduce hospitalizations and emergency department visits for this population by 50%,
(2) increase the percentage of patients on ACE inhibitors by 25%, and
(3) reach 90% satisfaction rate of patients who receive services in the program.

Our initial focus will be on patients at high risk for hospital admission and emergency department visits."
     
Another planning team might conclude "Our program is aimed at improving outcomes for all patients in our system who have diabetes or are at-risk of developing diabetes. Our goals are to

(1) screen 100% of the patients in our clinic for their risk of developing diabetes,
(2) increase by 50% the percentage of patients who have a hemoglobin A_1c of less than or equal to 7%, and
(3) reduce by 25% the percentage of patients with high low-density lipoprotein (LDL) cholesterol."

Each of these examples requires interventions of different focus and scope. The first example emphasizes working with high-risk patients and is likely to incorporate case management as a key intervention. The second example encompasses early detection and screening, as well as treatment, and will likely include a range of interventions to assist patients in reaching clinical outcome targets.

Step 5: Implementing Disease Management: Tools and Strategies
After there is initial agreement on program focus and goals, attention then turns to plans for program implementation. Fortunately there are many resources available to assist with this, from descriptions of setting up programs to written tools and instruments to help stay on track.
     
Most DM programs are based on a common set of core processes that begin with identifying the target population and proceed through matching patients to appropriate interventions and evaluating the impact on outcomes. Underlying most of the descriptions of current DM programs are a sequence of steps that include risk screening, systematic application of evidence-based practice guidelines, mechanisms for communication and coordination of patient progress, evaluation, and process improvement.
     
One framework uses the acronym FAST to alert clinicians to essential steps in the DM process (Lamb and Zazworsky, 2000). FAST stands for Find, Assess, Stratify, Treat, Train, and Track. Once the target population for the program is determined, a variety of information sources are used to "Find" patients who meet the criteria for participating in the program once privacy regulations are met. Patients with various diagnoses or clinical experiences (e.g., readmission to the hospital, emergency department use, high expenses) may be identified by diagnostic codes, service use files, or financial information. Patients fitting the program criteria are then "Assessed" for their level of risk using standardized risk assessment tools. Risk assessment tools are available to identify the risk for hospitalization and the likelihood of experiencing clinical complications and other adverse events. Examples of risk tools are described in a later section of this chapter. Using the results of the risk assessments, patients are "Stratified" into low-, moderate-, or high-risk groups. Each group has a specific plan to "Treat," "Train" (educate), and "Track" (communication, coordination, evaluation) their progress based on their level of risk, complexity, and intensity of need.
     
There are a variety of tools that have been developed to support the core elements of the DM process. Risk assessment tools provide a standardized way of measuring a person's level of risk for experiencing adverse outcomes or further progression of the disease. CareMaps are used to track patient progress in achieving outcomes and reasons why there may be a difference between the expected and actual outcomes.

Risk Assessment Tools
The most extensively used screening tool to identify patients at risk for adverse outcomes is the Probability of Repeat Admissions (PRA) questionnaire (Boult et al, 1993). This eight-question survey has been found to be a valid and reliable indicator of future adverse health events in a variety of community-dwelling elderly populations (Pacala, Boult, and Boult, 1995; Pacala et al, 1997). The PRA was specifically designed to measure the probability of being hospitalized in the next 4 years.
     
A defined risk score identifies a patient as "high risk." A risk score of 0.50 or higher, based on the instrument's scoring algorithm, places the patient in the high-risk category. However, this "cut point" is somewhat arbitrary, and there are other ways to interpret the scores for classification purposes. A useful way of analyzing the risk scores is to examine their distribution from lowest to highest and then select those patients whose scores fall in certain percentiles. As an example, all patients whose scores are in the 70th percentile (70% to 100%) or 80th percentile (80% to 100%) could be identified as potential high-risk candidates. Those with scores in the 50th percentile (50% to 70%) could be of moderate risk, and those with scores that fall below the 50th percentile could be identified as low risk.
     
Another example of a screening tool is The Community Assessment Risk Screen (CARS) (Shelton, Sager, and Schraeder, 2000). The CARS is intended to identify elderly patients who are at increased risk of a hospitalization or emergency department visit in the next 12 months. The CARS consists of three questions that identify preexisting chronic illnesses (heart disease, diabetes, myocardial infarction, stroke, chronic obstructive pulmonary disease [COPD], or cancer), the number of prescription medications (five or more), and hospitalization or emergency department use in the preceding 6 to 12 months. Based on answers to these questions, patients are classified into either high- or low-risk groups.
     
Both the PRA and CARS were designed to be short, easily administered risk screening tools. They were developed to identify elderly (age 65 and older) populations at risk for future hospitalizations and increased healthcare costs. Data used to construct the instruments were collected from self-report mailed questionnaires. Mailed surveys used to collect health-related information should be used with caution. First, the response rate to mailed surveys generally achieves response rates of only 50% to 60%, and nonrespondents tend to be older and sicker than respondents. Second, low socioeconomic status and literacy rates can lead to even lower response rates. Third, administration and data entry for mailed surveys can be expensive, and these costs must be considered with any DM program (Vojta et al, 2001). Finally, all individuals who are categorized "at risk" by any screening tool or mechanism should undergo further evaluation and in-depth clinical assessment to reduce the incidence of false positives (i.e., identifying those patients who are identified as "at risk" but by clinical evaluation are not).
     
There are many other instruments that can be used to screen potential patients for DM programs. For a review of many of these instruments the reader should refer to the article by Ware (1994).

Use of Case Management Plans
Treatment recommendations usually find their way into DM programs in a variety of forms, including practice guidelines, clinical pathways or multidisciplinary action plans (MAPs), and specific practice protocols. Although providers may initially resist the use of these case management tools, guidelines, pathways, and protocols offer a template or framework to organize interventions and maximize the likelihood that patients receive effective treatment in a timely way.
     
Evidence-based guidelines are recommendations for desired elements of practice and outcomes for a specific population based on a compilation of research findings. Support for each recommendation is provided, including an analysis of the scientific merit of the studies underlying each recommendation. In recent years, federal healthcare agencies and professional associations have put considerable effort into developing consensus around outcomes and performance measurement for several chronic conditions, such as hypertension and diabetes.

Step 6: Overseeing the Evaluation and Process Improvement Activities
DM programs rely on systematic data collection and tracking to monitor and refine expected outcomes. Although program goals are identified early in the process of designing DM programs, it often requires considerable time and effort to develop and maintain reliable and valid systems of outcome measurement. Tracking outcomes may require complex linkages between financial, clinical, and service use data. Access to credible and timely data is the key to demonstrating program value and thus to the survival and sustainability of DM programs.
     
All team members must be committed to collecting complete and accurate information and making sure it is documented or entered into a computer database and in a timely way. Information systems personnel must be relied on to create user-friendly processes to track data and generate reports.

PUTTING IT ALL TOGETHER: THE DISEASE MANAGEMENT TEMPLATE

Planning and implementing DM programs requires that all of the steps come together in a coordinated and seamless process. Patients who meet the criteria for the program must be identified and matched to the right interventions and right quantity at the right time. Entry and exit of key stakeholders need to be closely orchestrated. Plans for outcome evaluation must be built into the earliest stages of program design and then implemented using reliable and valid tools.
     
The DM template provides a blueprint for action. It defines and operationalizes each of the components of the DM program (Case Manager's Tip 6). It specifies expected timelines and individual and team responsibilities. Some of the usual elements in a DM template are shown in Figure 1. Common issues and questions that drive template development are discussed as follows.

Risk Assessment
Each of the steps involved in selecting, implementing, and evaluating a risk assessment tool can be incorporated into the template. These steps might include the following:

Each of the decision steps should be reflected, including the following: Will the DM teams use a standardized tool, or will they design their own? Will the risk information be collected by chart review, patient interview, or both? Who will be responsible for designing and implementing the risk assessment process?

Patient Education
The team will evaluate the patient education materials necessary and their appropriateness for age, reading level, and culture. In addition, the method of delivery must be specified. For example, will the patients receive individual or group education in the hospital or community setting?

Staff Education
Preparation of staff for implementation of DM programs requires careful consideration and planning. Not only is it necessary to assess the level of knowledge about the disease being addressed, the staff must have a basic understanding of patient behavioral change processes and influencing factors, such as age, sensory deficits, and cultural beliefs. In addition, it is essential to provide staff members with an overview of the DM process and each of its components.

Evaluation and Reporting Structures
Identifying the clinical, quality, and financial outcomes will be the first goal in the evaluation plan. Next, a plan for the generation and distribution of reports may be outlined in this section. Decisions about the type and frequency of reports to various stakeholders should be included. In other words, what information does the executive team, medical staff, and/or DM administrative and practice team need to have and how often? As noted earlier, each stakeholder group may have different needs and priorities for information.

Information System Support
Demands for data tracking and management in DM require early involvement of information system (IS) experts. This section of the template should define the process and timeframes for development and testing of automated data collection tools and reports.

Physician Coordination
One of the earliest criticisms of DM programs was the lack of physician involvement. Ideally, one or more physicians are members of the development team. The physician coordination component of the template identifies how and where physician participation will be needed in the DM process. For example, in hospital-based DM programs there may be a need for standing orders guided by evidence-based protocols. In the outpatient setting it is common to see interdisciplinary practice guidelines for common chronic illnesses. Physician education on the DM process and tools also may be specified here (Case Manager's Tip 7).

Care Coordination
DM programs typically address the needs of patients who require integration of services across multiple settings and care providers. Plans for referrals and coordination across providers and settings are addressed in this component of the template. Team members integral to ensuring continuity and consistency of care are identified, and plans are put in place to ensure smooth transitions. This may involve case managers, social workers, staff nurses, utilization managers, and admitting personnel, as well as community resources and health plan representatives.

Communication Plan
Support of the public relations and marketing department may be enlisted to facilitate internal and external communication about the progress and outcomes of the DM program. Keeping major stakeholders informed is essential for program support and sustainability. The template should address how and when each stakeholder group will be contacted.

Community Referrals
This section of the template describes how community referrals will be documented, communicated, and tracked. Often, referrals are initiated, but very little is incorporated into the DM program to determine if the patient seeks and/or receives the intended services. Clear feedback loops and accountability for tracking and communicating of referrals should be delineated.

Patient and Caregiver Support
New support systems may be required for patients to achieve desired outcomes. In this component of the DM template, members of the team identify essential supports and resources for the target population. Strategies for overcoming barriers to care, such as lack of transportation or funds for medications, are included.

Pharmacy / Equipment
This element considers the medication and equipment needs specific to the targeted chronic conditions. In some cases it may address pharmacy protocols and how they will be managed across service settings. Equipment needs for various populations are included here. For example, in a congestive heart failure (CHF) program, plans typically are made to provide all participants with a scale for weighing themselves. Issues related to ordering and distributing scales may be included in this part of the template.
     
The DM template is best used as a working tool and blueprint for rolling out the DM program. Completing each component of the template ensures that both patient and programmatic needs will be identified and addressed. Potential gaps in key DM processes or available resources may be anticipated and prevented. An example of how to use the template is included in Case Study 1.

ST. ELIZABETH OF HUNGARY CLINIC'S DISEASE MANAGEMENT PROGRAM
Step 1: Defining the Target Population
In 1999 St. Elizabeth of Hungary Clinic (SEHC) brought together a multidisciplinary committee, the Clinical Care Support Committee, to oversee the process of identifying patient needs and improving patient care practices and outcomes. The committee established several objectives. To identify priorities for action, committee members decided as one of their first steps to conduct a comprehensive needs assessment, including surveys of both professionals and patients and a review of SEHC's database.
     
The results of the clinic needs assessment indicated that the most common health conditions of SEHC's patients were hypertension, acute infection, and pregnancy. For many of the visits associated with these conditions, diabetes was identified as a primary comorbidity. A random chart audit indicated that out of 5,000 patient records reviewed approximately 600 patients (12%) were diagnosed with and being treated for diabetes (adult onset or gestational). Limited information was available in the medical records on diabetes management, suggesting a significant opportunity for improvement.
     
As a result of the analysis of the clinic needs assessment, members of the Clinical Care Support Committee decided to target the population of individuals at SEHC at risk of developing diabetes and those already with a diagnosis of diabetes. Their broad objective was to identify at-risk individuals as early as possible and immediately implement core interventions to prevent the onset of diabetes. Another objective was to implement necessary interventions to reduce the incidence of complications for those who were already diagnosed with diabetes.

Step 2: Establishing Goals and Outcome Indicators
The objectives of the diabetes DM program were twofold:

(1) to improve diabetes clinical care and outcomes and
(2) to enhance patient and provider satisfaction.

Although there were a number of process objectives defined, these two goals reflect the ultimate outcomes that were important to the clinic.
     
Specific goals were to do the following: