Matt Stiefel, Kendra Rothert, Robert Crane, William Caplan, and Helen Pettay
EXECUTIVE SUMMARY
Kaiser Permanente's investment in a national, evidence-based population care management approach for adults with diabetes has yielded significant improvements in clinical processes and outcomes. In general, this success is based on the strategy of "making the right thing easier to do." Specific success factors include collaborative development and deployment of the policy; rigorous evidence basis; a focus on and adequate support for implementation, including clinical information technology; and comprehensive measurement systems for processes and outcomes.
Barriers
Facilitators
Lessons Learned
INTRODUCTION
Unlike most developed countries, the United States does not have a national health care system. Instead, our "system" is a patchwork of public and private organizations and services. The United States, with a population of 276.4 million (U.S. Census Bureau Nov. 2000), is governed under the principles of federalism, meaning that any powers not specifically given to the federal government (in the Constitution) are reserved for the 50 states. Two reasons often cited for the failure of the United States to implement a national health care system are: (1) a relatively weak or "decentralized" federal government that often deferred to states to protect the social welfare of citizens (Starr 1983); and (2) the enormous power (particularly in the first half of the 1900s) of the American Medical Association, which opposed any attempt by the government to interfere in physicians' fees or practice.
Responsibility for the provision of health care services to the U.S. population is shared by
While Medicare, Medicaid, private insurance, and direct-pay account for the vast majority of medical expenditures in the United States (83 percent) (Levit, Cown, Lazenby, et al. 2000), there are many people without insurance of any kind; in 1999, 42.5 million people, or 15.5 percent of the population, were uninsured (U.S. Census Bureau Sept. 2000). Such individuals often receive care in hospital emergency rooms or publicly financed health centers and clinics. Funding for such clinics comes from the federal, state, county, and sometimes city governments. Many also receive private charitable funds.
In 1998, the United States (all payers) spent $1.1 trillion, or 13.5 percent of the Gross Domestic Product, on health care (Levit et al. 2000). Because the health care system is made up of so many different payers, health care policymaking is done on a number of different levels and in a multiplicity of ways. Decisions about what to cover and for whom (i.e., implicit "rationing") are not centralized for the nation. The federal government sets policies for Medicare. (Because Medicare is such a large portion of the health care market—18.9 percent—such policies often "spill over" into private-sector activities.) State and local governments also develop policies for the programs over which they have jurisdiction. Finally, private payers also make decisions about coverage and care effectiveness. This is a case study about how one of them, Kaiser Permanente, links research and policy.
INTEGRATION OF CLINICAL RESEARCH, POLICY, AND IMPLEMENTATION AT KAISER PERMANENTE
In the late 1990s, Kaiser Permanente leaders and policymakers faced a problem common to the rest of the health care industry: The literature and best practices within our program suggested huge opportunities to improve health care and outcomes for our members with chronic conditions, but how could we make it happen? How could we bridge the gap between this knowledge, the policy arising from it, and the implementation of the policy?
The Care Management Institute
This thinking spawned the creation of the Care Management Institute (CMI), jointly sponsored by the Kaiser Foundation Health Plan and the Federation of Permanente Medical Groups in 1997. The vision and mission of CMI are:
Vision: The Care Management Institute, on a national level, will synthesize knowledge about the best clinical approaches and create, implement, and evaluate effective and efficient health care programs.
Mission: The Care Management Institute will be a nationally consistent, evidence-based, cost-effective approach to the delivery of health care that improves the health of all Kaiser Permanente members.
Simply stated, the unifying theme of CMI is "to make the right thing easier to do."
The Right Thing
CMI's objectives feature complementary and integrated efforts to identify the "right" things that will best support the delivery of evidence-based, cost-effective, population-based care. Examples include using the rigor of evidence-based medicine and results from Kaiser Permanente's three major research centers to create and maintain care management programs; identifying and transplanting successful practices; and supporting the identification and maintenance of enterprise-wide content for embedding into Kaiser Permanente's Clinical Information System (CIS).
Making It Easier
Making the right thing easier to do includes fostering implementation by engaging and supporting individuals and groups, and by developing and improving systems to support care. Examples include the work of an Implementation Network; collaboration with regional and national leadership; development of a Fund for Implementation Assistance; and the creation and management of a clinical knowledge repository Web site (the Permanente Knowledge Connection). Making the right thing easier also means ensuring that the scope of CMI's work is aligned with emerging technologies, including CIS, our member Web site (KP Online), and technologies to support population care management.
CMI as Nexus
CMI serves as the nexus for coordination between research and policymakers in the development and implementation of evidence-based care management programs, as depicted in Figure 1.
The following sequence of steps outlines the general process for development and implementation of a national care management program through CMI:
- Research. From the evidence in the literature and experience within Kaiser Permanente, CMI staff develops the rationale for a select set of care management programs for priority populations. Kaiser Permanente's three major research centers—the Department of Research in Northern California, the Center for Health Research in the Northwest and Hawaii, and the Research and Evaluation Center in Southern California—are important sources of clinical evidence.
- Policy. The CMI Board of Directors, comprising medical group and health plan leaders from across KP, establishes a subset of priority populations for national care management program development based on the materials presented.
- Research. CMI staff coordinates the development of the care management program with a team of clinical and operational experts and champions from the KP program, based on evidence from the literature and experience within Kaiser Permanente. Evidence is reviewed in two areas: clinical management and successful implementation practices. CMI's biomathematical simulation model, "Archimedes," enables us to test the impact of alternative clinical policies and guidelines prior to implementation and to extrapolate the results from process improvements into longer-term clinical and financial outcomes.
- Policy. The CMI board reviews and approves the care management program.
- Implementation. CMI contracts with each Region to fund implementation and analytic network support to achieve targeted performance improvement in clinical effectiveness and efficiency.
- Measurement. CMI staff coordinates the development of a measurement system, again with a team of clinical and measurement experts from across KP. Elements of the measurement system include common specifications, clinical registries for population-based care management, and national outcomes studies for benchmarking and program evaluation. The CMI Analytic Network, composed of staff in each Region, develops the registries or cohorts for clinician feedback and population care management, as well as providing the data for the national outcomes reports. CMI staff produces the national outcomes reports on an annual basis, providing comparisons of performance over time and across Regions and the basis for program evaluation of successful practices and the impact of interventions.
- Implementation. The CMI Implementation Network, composed of physicians and project managers in each Region, supports the local implementation of the care management programs.
- Implementation. CMI hosts quarterly national users' group calls to discuss implementation issues and new clinical developments.
- Measurement. The CMI Analytic Network prepares quarterly performance reports of regional progress against targeted performance improvement.
- Research and Policy. CMI staff coordinates the review and update of the care management programs at least biennially, as described in step 3, for review and approval by the CMI Board.
Practical Implementation of Care Management Programs
The rest of this report uses the KP Integrated Diabetes Care (IDC) Management Program as a case study to illustrate the practical implementation of the conceptual approach described above, as well as to show the results achieved and lessons learned.
In summary, in the four years since the inception of the IDC program, we have achieved dramatic improvements in care management performance for our 330,000 members with diabetes. For example:
- From 1996 to 1999, Hemoglobin A1c (HbA1c) screening rose from 71 percent to 80 percent, and the percentage of members with diabetes with good glycemic control (HbA1c <8%) also increased, from 33 percent to 48 percent. This translates into 31,000 more members screened and 51,000 more members in good glycemic control in 1999 compared to 1996. The projected impact of this improvement over a ten-year period includes: 1,000 averted cases of retinopathy, 1,200 averted microvascular events, and 5,000 averted cardiovascular events.
- Lipid testing and control increased from 39 percent in 1996 to 51 percent in 1999 (tested), and from 25 percent in 1998 to 29 percent in 1999 (good control). That means 12,500 more members had good lipid control.
- The combined total rate of recommended eye exams was 75 percent in 1999. This exceeded the Health Plan Employer Data and Information Set (HEDIS) 90th percentile benchmark of 57 percent and the Healthy People 2000 goal of 70 percent.
- There has been dramatic improvement in renal screening and treatment for renal disease, from 59 percent in 1997 to 72 percent in 1999. This means that 47,000 more members were receiving appropriate screening or preventive therapy for renal disease in 1999 than in 1997.
In addition, although Kaiser Permanente's size and integrated financing and delivery system are unique, we have learned a number of lessons along the way that may prove to be instructive to other organizations in their development of care management programs. The key success elements include collaborative development and deployment of the policy, a focus on implementation, and measurement, each of which is described below.
Collaborative Development and Deployment of the Policy
KP's organizational structure is unique and somewhat complex, including the following key elements relevant to the collaboration between research and policymakers:
- Partnership management between the national Health Plan and the Federation (of eight Permanente Medical Groups) as well as between each regional Health Plan and the associated Permanente Medical Group
- Physician partnership in the Permanente Medical Groups
- Salaried physicians, with no fee-for-service incentives
These structural features require collaborative development and deployment of clinical policies and guidelines. The health plan does not and cannot impose such policies and guidelines, and the Federation and individual Permanente Medical Groups choose not to impose them. Examples of collaborative development include:
- Designating a well-regarded KP expert as the "clinical lead" for each care management program
- Convening clinicians and operational managers identified by regional leadership to serve on the development work groups
- Sticking closely to the evidence in the development of our programs
- Providing financial support for implementation and measurement
- Maintaining a network of champions and program "users" across the KP organization
This collaboration in development and deployment results ultimately in a much stronger and more flexible program. The objective is to support, not dictate, the medical practice of Permanente physicians.
Focus on Implementation: Making the Right Thing Easier to Do
We have learned that clinical content and policies (the right things) have no value without effective implementation, and that effective implementation is much more difficult than policy development. Binders with clinical policies and programs sit on the shelf (or worse) and quickly become outdated. Our care management programs focus on implementation and provide implementation support. Listening to physicians and designing the programs around what they need is important for implementation success. For example, physicians in KP-Southern California felt that requiring members to fast before lipid tests created a barrier, so a nonfasting test was implemented. We find that clinicians are often too overwhelmed to add even minor things to short office visits, but they are more cooperative if they feel that they have been listened to and that their needs and constraints are being taken into account.
Information technology—in the form of automated prompts, orders, reminders, documentation, and feedback at the point of care—is a key factor in making the right thing easier to do. Setting up such systems is difficult, time-consuming, and costly. Also, if the registry information is incorrect, the systems quickly lose credibility and are not used.
Measurement: "You Manage What You Measure"
Measurement systems are essential to the success of our care management programs. Clinical registries and cohorts provide the basis for clinician, care manager, and member feedback and reminders; identify successful practices and common problems; and enable comparisons across Regions and over time.
Key areas for continued development in the future for Kaiser Permanente's care management programs include:
- Clinical information technology. This is the key to making the right thing easier, through automated order entry, prompts, reminders, and feedback; a clinical knowledge repository with advanced search-and-retrieval and decision support; and a member Web site, which facilitates self-management.
- Patient-centered outcomes data. Our administrative data systems are limited primarily to process measures. We need to establish broad-scale mechanisms to gather functional status and outcomes data directly from our members and to provide better measures of the effectiveness and value of our care management programs.
- Program evaluation. Our data reporting systems currently focus primarily on descriptive information about the care management programs, across Regions and over time. While this descriptive information is valuable, we need to invest in research and program evaluation to better understand the relationship between interventions and outcomes, differences in performance across Regions, and cost-effectiveness of alternative approaches. Our "Archimedes" simulation modeling capability will be utilized to test alternative policies and guidelines and to project longer-term health and financial outcomes of process improvements, thus helping to bridge the gaps between research, policy, and implementation.
- Hospital utilization. Contrary to expectations from the literature, we have not yet achieved reductions throughout KP in hospital utilization among diabetics as a result of our programs, even though we have achieved substantial process improvements. While a lag is expected between improvements in glucose and lipid control and hospital utilization, a key test of our program's success will be demonstrating utilization improvements as a result of our program. There is some evidence of reduction in hospital utilization in those Regions that have had diabetes care management programs in place the longest. For example, Group Health Cooperative (GHC) of Puget Sound (an affiliated member of KP) recently documented in a retrospective cohort study reductions in utilization and cost as a result of improved glucose control (Wagner, Sandhu, Newton, et al. 2001).
CASE STUDY: KAISER PERMANENTE'S INTEGRATED DIABETES CARE MANAGEMENT PROGRAM
Background Information about the Care Management Institute
Care management, also commonly referred to as "disease management," has been widely acclaimed by forward-looking health care experts as the next major evolutionary step beyond the cost-focused innovations of "managed care." Care management's promised impacts on future health outcomes and on the care delivery system itself are expected to be profound, given its potential to improve the management of chronic diseases, which account for nearly 60 percent of all medical costs in the United States.
Kaiser Permanente, which pioneered the population-based preventive care revolution more than 50 years ago, sees population management as the next level of innovation. In 1997, a national partnership agreement between the Health Plan and the Permanente Federation started the Care Management Institute (CMI), giving it a mandate to drive, fund, and catalyze care management activities throughout our health maintenance organization.
Care management as CMI defines it is coordinated health care, for logical groupings of members, intended to prospectively improve, maintain, or limit the degradation of their functional status. Terms are defined as follows:
- Coordinated care: Care that is delivered by a multidisciplinary health care team. Usually, a "care manager" oversees the treatment to ensure that the care is, indeed, coordinated.
- Logical groupings: Condition-specific populations of members, such as all those with diabetes, asthma, or depression, or with demographic/physical conditions such as the frail elderly or pregnant women.
- Prospective and forward-looking prevention and/or health maintenance: Strategies are aggressively pursued for each individual patient on the basis of customized care plans, with health status monitored longitudinally so that any deterioration can be addressed early.
Through systematic coordination, population grouping, and prevention, care management can improve the health and functional status of millions of individuals by keeping patients with chronic conditions healthier and more engaged in managing their own care. In addition, prospective, preventive care management can greatly reduce the growing, ever more costly demand for acute care to patients with chronic diseases. According to a 1995 study by the Institute for Health and Aging at the University of California at San Francisco, treatment for chronic disease populations accounts for nearly half of total national health expenditures, including 55 percent of all emergency-room visits and about 80 percent of hospital days. If a significant fraction of those acute-care episodes can be reduced through prospective care management, the savings could translate into better and more affordable care for virtually all people.
The populations that can benefit most from care management are those with conditions that share certain characteristics: high treatment costs, high prevalence in the general population, and the availability of effective, evidence-based treatments. Thus, diseases like diabetes, asthma, depression, heart failure, and coronary artery disease are the initial, major candidates for care management. CMI has developed comprehensive, integrated management programs and annual outcomes studies for each of these populations. These five clinical priority areas affect approximately one million Kaiser Permanente members and account for more than $3 billion in incremental costs (above and beyond the costs for members without these conditions) per year (Care Management Institute 1996–2001; Ray, Collin, Lieu, et al. 2000). Implementing programs based on the most current medical research for these conditions results in improved quality of life for a significant portion of members, greater employee productivity, more affordable health care for all members, and enhanced medical expertise.
CMI, as one of Kaiser Permanente's Program Offices (corporate office) departments, is funded by the Health Plan's Regions. The Institute works through a small national staff in Oakland, California, and an extensive network of implementation physicians, project managers, and analysts/programmers in each of the program's Regions. The current $12.3 million CMI budget is a very small percentage of Kaiser Permanente's overall budget of $17 billion. More than half of CMI's budget is returned to the Regions in implementation and analytic support. The balance of the CMI budget is used to develop care management programs and provide infrastructure support, such as the Kaiser Permanente national clinical Web site, the Permanente Knowledge Connection.
CMI funds Regional implementation and analytic support to achieve performance targets in clinical effectiveness and efficiency for CMI's priority populations. In exchange for funding, Regions target improvements in performance greater in value than the investment, formalized as Memoranda of Understanding agreements (MOUs). The Regions provide quarterly reports of progress against the MOU performance targets. This process:
- Establishes accountability for the CMI investment
- Provides concise documentation of the investment and resulting benefits
- Focuses attention on initiatives with greatest potential benefits
- Provides a framework for regular review of progress
- Is relatively simple and easy to administer
The Market
Purchasers
Purchasers are still quite focused on costs; however, for larger, national purchasers, health plan value has become defined more broadly than by low cost. These purchasers are requiring evidence of customer satisfaction, clinical outcomes, and improved productivity in the workplace.
Consumers
Members of Kaiser Permanente, like other health care consumers, are becoming increasingly interested in participating in decision making regarding their own health and are turning to the Internet for assistance.
Competitors and Other Players
These include other national managed care organizations, for-profit disease management companies, and pharmaceutical companies. They are responding to the increased consumer power in health care by developing systems for them to share in their own health care. However, they are limited in their ability to manage care jointly with consumers due to lack of truly integrated delivery and financing systems.
Accreditors and Government
The National Committee for Quality Assurance (NCQA) is an independent, nonprofit organization whose mission is to evaluate and report on the quality of the nation's managed care organizations. NCQA evaluates health plans through:
- Accreditation: A rigorous review of key clinical and administrative systems and of a health plan's performance on several important aspects of care and service
- Health Plan Employer Data and Information Set (HEDIS): A set of standardized performance measures
- Consumer Assessment of Health Plans Survey (CAHPS): A comprehensive survey of member satisfaction
Although the accreditation program is voluntary and rigorous, more than half the nation's HMOs currently participate. HEDIS scores are now widely used by consumer groups, government agencies, and employers to evaluate the quality of managed care organizations. While HEDIS performance scores are very important for purchasers and consumers, they are necessarily limited to the common denominator of what managed care plans around the country can report. Kaiser Permanente supplements HEDIS clinical performance metrics with CMI measures that are more closely linked to health care outcomes.
The Centers for Medicare & Medicaid Services (CMS, formerly the Health Care Financing Administration, or HCFA) and state governments both purchase care and set regulatory frameworks for providing benefits, including what is covered.
Diabetes Program Overview
The Integrated Diabetes Care (IDC) Program was the first in a portfolio of high-priority care management programs developed by CMI. The planning, development, and implementation of the IDC program has spanned four years. The project-planning phase was launched in the spring of 1996 with the establishment of national sponsorship from Permanente Medical Group and Health Plan leaders. The fall of 1996 marked the beginning of interregional collaboration on program development. In 1997, work groups were established to create the core components of the initial IDC program. In addition, the measurement and evaluation system was launched in 1997, producing the first outcomes report (1996 data) and conducting a patient survey.
The full IDC program was distributed throughout the organization in January 1998. Following the release of the program, efforts focused on dissemination and implementation, as well as ongoing measurement and evaluation work. The second outcomes report was published in January 1999 (1997 data). Also early in 1999, interregional work groups reconvened to revise the IDC program, focusing on grading the evidence basis for each clinical practice recommendation, guidelines, expansion of the model of care (how to organize the delivery system to maximize clinical care and outcomes), and inclusion of change management strategies. The revised program was reviewed in summer 1999 and the final revision was distributed in December 1999. Ongoing measurement and evaluation work resulted in the publication of the third outcomes report in December 1999 (1998 data) and the fourth report in August 2000 (1999 data). The overall focus in 2000 was implementation of the IDC program throughout the Permanente Medical Groups and Health Plan.
To obtain sponsorship from Kaiser Permanente leaders, a business case was made by the department that preceded CMI and initially investigated how best to develop a national initiative in care management. The advantages of an interregional approach were articulated as
- Elimination of duplicate efforts to develop disease management programs in multiple Regions
- Prevention of added post hoc work that occurs after Regions have adopted alternative approaches or measurements that then must be reconciled with others in the organization
- Rapid dissemination and transfer of innovations across Regions, leading to increased speed to market
- Availability of similar outcomes data from different practice environments for comparative purposes
- Greater consistency of clinical care across KP
- Enhanced national reputation of Kaiser Permanente
–Provides convincing response to purchasers' demand for integrated programs
to care for major chronic diseases
–Promotes improved results on HEDIS and other outcomes measurements
–Enables partnerships with influential national diabetes groups (e.g.,
American Diabetes Association)
The overriding objective of the IDC is to enhance the health of our members with diabetes, control disease progression, and prevent disability. Supporting objectives include:
- To promote the application of the latest medical evidence and national standards in clinical practice
- To disseminate components of proven diabetes care approaches by integrating them into the IDC program
- To equip our members with diabetes to be effective self-managers of their health and care, in partnership with their health care team
- To recommend proven strategies for successful implementation of diabetes interventions by clinicians
- To measurably demonstrate improvements in care through assessment of key outcomes measures
The IDC program is population based, utilizing economies of scale and intellectual capital. The program addresses the challenges of providing consistent, high-quality care to Kaiser Permanente members with diabetes. The IDC program is strongly grounded in medical evidence for treatment of diabetes. This focus on the evidence extends to many aspects of our comprehensive care management program, including:
- National, evidence-based clinical practice guidelines
- Model of care, including patient registries, stratification methodologies, commitment to a team approach, and evaluation of care
- Clinician resource materials
- Patient resource materials
- A measurement system
- Implementation support, including technology tools
These elements of our diabetes care management program are described in more detail in Appendix A.
Stakeholder Involvement and Communication
Internal
CMI provides overall process facilitation, but involves Kaiser Permanente's many clinical and operational experts to inform the substance of its programs. Development follows an evidence-based approach, particularly in evaluating the available medical literature. Policy is developed by:
- Designating a well-regarded KP clinical expert as the "clinical lead"
- Convening clinicians and operational managers identified by regional leadership to serve on the development work groups
- Sticking closely to the evidence in the development of our content
- Utilizing a broad "review and comment" process before finalizing our products
- Maintaining lots of flexibility in the "how to do" pieces, including first trying to adapt existing local programs to new protocols rather than imposing new ones
- Relying on our "deployed network" to lead implementation
The strength of our diabetes care management program is based in large part on the involvement of a broad spectrum of people and groups across Kaiser Permanente, including:
- National Health Plan and Federation leadership: Provides endorsement and funding for CMI
- CMI Board: Selects, reviews, approves, and endorses the diabetes program and national outcomes reports
- CMI national staff: Develops and updates the program and outcomes reports, negotiates performance improvement targets with the Regions
- Diabetes program clinical leads: Provide expertise and lend credibility to the program and outcomes reports
- Diabetes program national work groups: Build consensus for clinical guidelines and create acceptance and support by clinicians
- Diabetes program outcomes advisory group: Develops and sanctions consistent national measurement specifications and reviews outcomes reports
- CMI implementation network:Provides Regional implementation support
- CMI analytic network: Develops and maintains registries and cohorts, and uses them to produce feedback reports and regional data for the national outcomes reports
- Regional leadership: Funds and endorses care management programs, negotiates performance improvement targets with CMI
- National users' group: Clinicians and operating managers implementing care management programs meet regularly to share successful practices and new clinical information
- Care managers: Support clinicians in the management of panels of diabetic members through such activities as registry maintenance, in-reach and outreach, health education, and group visits
- Clinicians: Deliver diabetes care to members
- Members: Ultimately, provide the bulk of their own care, guided by Kaiser Permanente resources, including personal physicians, care managers, self-management tools, the member Web site (KP Online), health education classes, and advice nurses
The diabetes care management program and performance is communicated internally through a variety of mechanisms, including:
- Integrated Diabetes Care Program binder
- National annual outcomes reports
- Web site (Permanente Knowledge Connection)
- Online Continuing Medical Education
- Quarterly reports from Regions on progress against performance targets
- CMI Implementation Network meetings
- National Users' Group quarterly conference calls
- Bimonthly newsletter (CMIdeas) and CMI annual reports
External
The primary external stakeholders include major purchasers, the NCQA, CMS, the American Diabetes Association (ADA), the Foundation for Accountability (FACCT), and the Diabetes Quality Improvement Project (DQIP).
- Major purchasers: CMI has produced a brochure for national employers that includes general information about our care management programs and processes and inserts about each program, including diabetes, that include outcomes information. Major purchasers are becoming increasingly interested in our care management programs and their impact on their employees. For example, Pitney Bowes distributes our diabetes program patient resource materials to its employees.
- NCQA: A portion of the NCQA accreditation for managed care organizations is determined by their Health Plan Employer Data Information Set (HEDIS) scores. Among the Effectiveness of Care measures in HEDIS 2000 is Comprehensive Diabetes Care, which addresses blood sugar, lipids, retinopathy, and nephropathy.
- CMS: CMS (formerly HCFA), which oversees federal Medicare funding for older adults, is interested in diabetes care management as both a major purchaser and a regulator. HCFA funded and led the Diabetes Quality Improvement Project (see below).
- ADA: The ADA produces clinical guidelines and sponsors a voluntary Provider Recognition Program for physicians, which includes a set of key performance and outcomes measures to assess the care provided to diabetic patients.
- FACCT: This not-for-profit organization has focused on the development of consumer/patient perceptions of care, and on making information about quality accessible and more easily used by consumers and purchasers of health care services.
- DQIP: A collaboration of HCFA, the ADA, NCQA, FACCT, the American Academy of Physicians, the American College of Physicians, and the Veterans Administration. The intention of DQIP was to develop a single set of measures to relieve health plans of the burden of dealing with different sets of measures for the various regulatory organizations. The measures they developed were the origin of the HEDIS and ADA measures.
Evidence
Evidence for Choosing Diabetes
Diabetes was selected for the inaugural CMI care management program based on a number of factors, including the high prevalence of the disease, the risk of complications and mortality, the cost of treating patients with diabetes, and the opportunity for improving health outcomes through care management.
Diabetes affects a large number of Kaiser Permanente members. In 1999 more than 330,000 adult members, 6.1 percent of our adult membership, were identified as having diabetes. These rates are consistent with the prevalence of diabetes in the United States; the American Diabetes Association estimates that 16 million (5.9 percent) of Americans have diabetes (Harris, Flegel, Cowie, et al. 1998).
In addition to affecting a significant number of our members, the burden of disease for diabetes is very high. Diabetes can involve serious health risks and complications and can affect nearly every organ system of the body. Complications of diabetes can include microvascular disorders such as blindness, kidney disease, and lower-limb amputation. In the United States diabetes is the leading cause of new cases of blindness among adults (CDC 1998). Diabetes is also the leading cause of end-stage renal disease, accounting for 40 percent of new cases (CDC 1998). Although only 6 percent of Americans have diabetes, more than half of lower-limb amputations in the United States occur among people with diabetes (CDC 1998). Diabetes is also associated with an increased risk of macrovascular disorders, such as heart disease and stroke (National Diabetes Data Group 1995). Finally, diabetes entails an increased risk of mortality. In the United States, diabetes is the seventh leading cause of death (CDC 1998).
In addition to the health and quality of life costs associated with diabetes, there are significant economic costs. In the United States the estimated cost of diabetes (direct and indirect costs) totals $98 billion per year. Within Kaiser Permanente, the cost of treating a member with diabetes was estimated at $4,150 per year (Ray, Collin, Lieu, et al. 2000), which represents an excess cost of $3,500 compared to members without diabetes (Selby, Ray, Zhang, et al. 1997). The cost of treating members with diabetes was approximately 2.4 times higher than the cost of caring for matched controls without diabetes (Selby et al. 1997).
Effective treatment of diabetes has been shown to prevent and/or delay the onset of many of the associated complications (Diabetes Control and Complications Trial Research Group 1993). Diabetes represents a key opportunity for care management because there is wide variation in practice and the natural opportunity for a population-based approach, including stratification of the population and coordination of care across care teams. Care management has been shown to be effective in improving outcomes and reducing costs among patients with diabetes.
Evidence for Diabetes Clinical Guidelines
The CMI guidelines are predicated on formal evidence from either evidence-based guidelines (Group Health Cooperative of Puget Sound, Kaiser Permanente-Southern California, Kaiser Permanente-Northern California) or standardized literature reviews (Cochrane Collaboration). When evidence reviews did not include the relevant, most up-to-date literature, CMI conducted evidence reviews to fill the gaps.
The evidence grades for our recommendations are strong (A rating), fair (B rating), weak (C rating), and expert opinion. In cases where multiple studies supported different conclusions, the evidence rating is based upon the strongest studies (i.e., large, well-designed randomized controlled trials).
- Strong (A rating): A recommendation needs to be supported by at least two well-designed randomized controlled trials in relevant populations.
- Fair (B rating): A recommendation needs to be supported by a single randomized controlled trial or well-designed non-randomized controlled trials (RCT), or well-designed case-control studies.
- Weak (C rating): A recommendation needs to be supported by a single non-RCT or multiple small studies using quasi-experimental designs.
- Expert opinion: All other recommendations in the guidelines are in this category, which indicates that insufficient evidence is available; the recommendations are guided by diabetes content experts.
The Kaiser Permanente diabetes clinical guidelines and evidence in support of them are presented in Appendix B.
Continuing Impact of Evidence
To maintain an up-to-date evidence basis, our program is reviewed and revised regularly. The program, including clinical guidelines, is reviewed at least biennially. The first edition was produced in 1997; the second edition was issued in 1999. In addition, two new clinical practice recommendations have been added to the guidelines in 2000 based on new evidence from recently published clinical trials. As described above, the outcomes measures are reviewed and revised annually. Outcomes data are also utilized as evidence to identify successful practices, as well as areas requiring a focused improvement effort.
Evaluation: Current Efforts
National Outcomes Reports
The evaluation of the CMI IDC program is conducted through annual National Outcomes Reports. These studies, which began in 1996, identify more than 330,000 Kaiser Permanente members with diabetes (6.1 percent of our adult membership) and report on numerous clinical and process outcomes for these members, including case identification, glycemic screening and control, lipid screening and control, eye examination, renal screening and treatment, and hospital utilization.
For each report, CMI convenes an advisory group of clinical and measurement experts in diabetes from across KP to determine the measures for the outcomes report. CMI analysts in each Region collect data for these measures, which are summarized to calculate Kaiser Permanente totals. One unique aspect of these studies is the consistent use of the same measurement specifications across Regions, yielding a large cohort of members with diabetes with comparably measured outcomes, despite differences in data and care delivery systems across Regions.
CMI recently has completed the fourth diabetes outcomes report (data for 1999), which illustrates the improvement in diabetes care across KP from 1996 to 1999 (see Table 1). For example, HbA1c screening rose from 71 percent in 1996 to 80 percent in 1999, and the percentage of members with diabetes with good glycemic control (HbA1c <8%) also increased, from 33 percent to 48 percent. Lipid testing and control, a primary focus in the IDC program, also increased from 39 percent in 1996 to 51 percent in 1999 (tested), and from 25 percent in 1998 to 29 percent in 1999 (good control). There was also dramatic improvement in renal screening and treatment for renal disease, from 59 percent in 1997 to 72 percent in 1999. Improvements have also been shown in eye exams and hospital discharges and days.
Between 1996 and 1999, 51,000 more members with diabetes had good glycemic control.1 Although these are aggregate data that do not include individual-level information on changes in glycemic control or other risk factors, using some simple assumptions based on randomized clinical studies, we can estimate the impact of our diabetes care management programs. The United Kingdom Prospective Diabetes Study (UKPDS) compared intensive metformin treatment for glycemic control to conventional treatment (diet, clinic visits, nonintensive pharmacology) among overweight diabetes patients in the United Kingdom (UK Prospective Diabetes Study 1998). Results from the UKPDS suggest that the number needed to treat (NNT) for intensive glycemic therapy over a ten-year period is 49 for microvascular events, 43 for retinal photocoagulation, and 10 for major coronary events (fatal and nonfatal myocardial infarction, sudden death, heart failure, fatal and nonfatal stroke). The NNT is a powerful conversion to estimate how many patients must receive a therapy to see a result in one patient. An NNT of 50 estimates that 50 patients need to receive treatment to result in one good outcome during a specified time period.
We estimated the effect of better glycemic control in the Kaiser Permanente population based on the UKPDS findings. We assumed the effect of conventional compared to intensive treatment in the UKPDS was equivalent to the change from HbA1c levels >8% to HbA1c levels <8% in our cohort. We also assumed that the improvement in control in our cohort would be maintained over ten years, the duration of the UKPDS. Under these assumptions, we can expect to see 1,000 averted microvascular events, 1,200 averted cases of retinal photocoagulation, and 5,000 averted major coronary events over a decade as a result of this improvement in glycemic control.2
Using the results for randomized clinical trials, we can also estimate the impact of our programwide improvement in lipid control among our members with diabetes between 1998 and 1999. Between 1998 and 1999, 12,500 more KP members
with diabetes had good lipid control.3 Results from the West of Scotland Coronary Prevention Study (WOSCPS) (Shepard, Cobb, Ford, et al. 1995) suggest an NNT of 42 for primary prevention of myocardial infarction, stroke, and death over five years.4 For secondary prevention of myocardial infarction, stroke, and death, the Scandinavian Simvastatin Survival Study (4S) (Pyorala, Pederson, Kjekshus, et al. 1997) subgroup analysis of diabetic patients suggested an NNT of 5 over six years, while the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) (LIPID Study Group 1998) suggested an NNT of 17 over five years.5
Our data suggest that 16 percent of our members with diabetes also have coronary artery disease (eligible for secondary prevention of cardiovascular events). If we assume that our improvements in lipid control among our diabetic population were comparable to those attained in the above-noted studies, and that our improvements were to be sustained for five to six years, we can estimate the impact of our improvements in lipid control. Among the 12,500 more members with good lipid control in 1999 compared to 1998, we could expect to see between 260 and 650 averted cardiovascular events (myocardial infarction, stroke, death) over five to six years.6
Our significant process improvements, however, have not yet had an impact on hospital utilization rates as the literature suggests. In fact, both the discharge and day rates increased from 1997 to 1999.
These evaluation results help achieve the program objectives described above by focusing on key clinical areas of diabetes care and reflecting CMI's evidence-based clinical guidelines. They promote a national effort and allow for interregional comparisons and lessons, another key objective of the IDC program. The results are used to improve and enhance the intervention by highlighting both successful Regions as well as Regions facing challenges. This enables shared learning and problem solving across Regions. The national outcomes reports also enable identification of common barriers across the organization that may require a national effort or study to address and solve. Finally, successful practices and key clinical focus areas can be built into other KP enterprise-wide initiatives, such as the clinical information system.
Member Survey
In addition to the annual outcomes reports, CMI conducts surveys of our members with chronic conditions. Member surveys complement the outcomes reports by providing information on self-management, satisfaction with care, self-reported health status, and other health measures not easily obtained from administrative sources.
CMI conducted our first survey of a random sample of members with diabetes in 1997 (Roblin, Ni, Solomon, et al. 1998). Overall, 12,075 members were surveyed across 21 member service areas. The overall response rate was approximately 60 percent (7,123 completed surveys). The survey included information on demographic characteristics (age, duration of diabetes, race/ethnicity), health care services (foot care, vaccinations, administration of aspirin, smoking cessation counseling), self-management, satisfaction with care, and self-reported health status (including smoking status).
In 2001 we plan to repeat our survey of members with diabetes. In addition to analyzing the data for distributions and trends, we also intend to link the survey data to our administrative measures to enable a richer exploration and analysis of the health status of our diabetic population.
Memorandum of Understanding Reporting
In addition to the annual diabetes outcomes reports, CMI supports quarterly reporting against selected measures in diabetes care. Reporting of these measures is specified in the Memorandum of Understanding (MOU) between CMI and each Region. The measures are linked to specific investments in care management programs, and reporting is conducted on a quarterly basis.
Case Study of Diabetes Care Management: KP Northwest Region
Beginning in 1988, the Kaiser Permanente–Northwest (KPNW) Region implemented a comprehensive diabetes care management program. Although the KPNW program preceded the creation of the CMI IDC, the programs are very similar in their approach to population-based care management of members with diabetes. Like the IDC program, some key components of the KPNW diabetes care management program include a functioning registry of diabetic patients, evidence-based clinical guidelines, focus on patient self-management, and diabetes "expert teams" composed of clinicians, nurses, and pharmacists (see Brown, Nichols, and Glauber 2000).
The relationship between the CMI IDC and KPNW programs has been mutually beneficial. In the creation of the IDC, CMI built on existing diabetes care management programs within Kaiser Permanente, including KPNW, by incorporating successful practices and lessons into our program. The KPNW program benefited from the CMI work through exposure to successful practices from other Regions as well as financial support and sponsorship for population-based care initiatives from the KP leadership.
The findings from the KPNW experience suggest the potential impact of a comprehensive diabetes care management program within the KP health system. The findings from this study conclude that "this centrally organized program, based in a primary care setting and utilizing a register of patients with diabetes, was associated with substantial improvements in the process and outcomes of care in a large population" (Brown, Nichols, and Glauber 2000). Substantial improvements were found in annual retinal screening, from 50 percent to 68 percent within two years; and in immunizations, from 40 percent to 60 percent within four years. Over the study period (1987 to 1996), significant improvements were also seen in testing for glycemic control, from 22 percent to 83 percent; nephropathy screening, from 1 percent to 43 percent; and lipid testing, from 37 percent to 56 percent (Brown, Nichols, and Glauber 2000).
External Performance Reporting
In addition to the reporting of clinical, process, and health outcomes measures for the annual CMI Diabetes Outcomes Reports, each Region is required to report on measures of diabetes care to the National Committee for Quality Assurance (NCQA) for the Health Plan Employer Data and Information Set (HEDIS). These data, which cover a broad range of health care areas, are used by NCQA for health plan accreditation and performance measurement. HEDIS has required reporting of eye examinations among diabetes patients for several years. In 2000 (for 1999 data), HEDIS also required reporting of a set of comprehensive diabetes measures. These measures included HbA1c testing and control, eye examination, lipid profile and control, and monitoring for diabetic nephropathy. Overall, KP performed well in all of these measures.7 In addition to HEDIS measures, the American Diabetes Association (ADA) has developed target measures for its Provider Recognition Program (PRP). These measures are intended to be applied to the performance of individual physicians to assess their care of diabetic patients (see Table 2).
While the CMI diabetes measurement set includes measures that correspond to these HEDIS measures, the specifications for these two sets differ in meaningful ways that make direct comparisons between them impossible. Generally, the CMI measures leverage KP's access to higher-quality data compared to other health plans and/or capture outcomes with more clinical relevance than the HEDIS measures.
Future Evaluation
Archimedes Simulation Modeling
An important component of the evaluation of IDC programs in the future is Archimedes, a biomathematical simulation model developed by Kaiser Permanente that models both disease and care processes. By creating a population with diabetes and simulating the progression of diabetes as well as its complications, this model can estimate the impact of various care management investments and interventions. The estimates produced by Archimedes can be projected over an extended time frame, better capturing the true impact of care management investments. This model can aid in decision making and in evaluating alternative programs and interventions.
Program Evaluation
Following the establishment of case identification criteria and outcomes measures, CMI is now well positioned to expand our program evaluation activities. Four years of outcomes data allow for identification of time-based trends as well as successful practices in the Regions. In addition, CMI is moving toward creating an outcomes information system that includes member-level data. These data will enable testing of risk stratification methodologies, investigation of the impact of interventions on outcomes, correlation analysis between outcomes, and linking to member surveys.
Reflection and Generalization: Success Factors and Challenges
We have demonstrated that investment in an evidence-based population care management approach for adults with diabetes yields improvements in clinical processes and outcomes. The generalized success factors articulated at the beginning of this paper apply specifically to the success of our diabetes care management program.
Process (Collaborative Development and Deployment of the Policy)
To be successful, an improvement initiative needs to be sponsored actively and visibly by key leaders within the organization. Recognized experts need to lead and participate in the work. Finally, to create a viable program, those responsible for implementation must be included in the development process.
An inclusive, collaborative model has been used in all stages of developing the diabetes care management program. National, interdisciplinary teams have collaborated in the development of the care management program as well as the national outcomes studies. Well-regarded clinical experts have been designated as project leaders.
The clinical guidelines are not mandatory. They are, however, strongly evidence-based and are being incorporated into clinical information systems to make the right thing easier to do.
Policy ("The Right Thing")
Applying the rigor of evidence-based medicine optimizes the organization's ability to define and achieve desired clinical outcomes. It also dramatically facilitates clinician acceptance and support, enabling more rapid and successful implementation.
In the first version of our IDC program (published in 1997), we failed to grade the strength of each clinical practice recommendation for the diabetes guidelines strictly on the basis of the quality of the existing evidence. Having gained additional appreciation for the importance of this rigor after the initial guidelines development effort, we added this information to the diabetes guidelines in the 1999 revision. The current clinical guidelines are strongly evidence-based. As the principles of evidence-based medicine become more ingrained in the fabric of Kaiser Permanente, guidelines based on solid clinical evidence are more readily accepted.
New clinical evidence in diabetes care emerges continually. For example, the Heart Outcomes Prevention Evaluation (HOPE) study was terminated early because of the dramatic reduction in relative risk of cardiovascular events, nephropathy, and retinopathy associated with the use of ramipiril, an ACE (angiotension converting enzyme)-inhibitor. Through the following mechanisms, the national care management program is well suited to quickly incorporating new clinical knowledge as it becomes available:
CMI is currently creating a national "content network" of all the Kaiser Permanente groups involved in creating clinical policy, to provide a coordinated pipeline for clinical content to fuel our national clinical information system (see below).
Implementation ("Making the Right Thing Easier")
Program development is the simple part; sustainable improvements require ongoing sponsorship, leadership, and implementation support. The optimal pace of sustainable change can be achieved only through active engagement and support of stakeholders. The integrated diabetes care management program consists of much more than a collection of clinical guidelines. Implementation support materials include feedback reports, in-reach reminders, patient-driven reminders, clinician educational resources, and patient education resources. Financial support is provided to each Region for implementation. A national users' group meets quarterly to discuss implementation strategies and review new developments.
Information technology (IT) is the most powerful lever to make the right thing easier to do. Such support includes automated orders, reminders, feedback, registries, charting, and other decision support. Current IT systems support varies substantially across the KP Regions, and those with greater capabilities demonstrate superior performance.
The best clinical policy is not of value unless it is put into practice. The initial IDC program was published in binders and distributed to clinicians. This distribution method had the obvious shortcomings associated with a static paper system, including getting lost on the shelf and difficulty of updating.
KP is developing a clinical information system (CIS), technology tools to support care management such as a population-care registry (PCR), and an Internet- and Intranet-based clinical information Web site, Permanente Knowledge Connection (PKC). In addition, a Web site for members, KP Online, has been developed. It not only provides health information but also makes it possible to refill prescriptions and make appointments with physicians. This information technology provides the foundation for a powerful suite of clinical decision support tools for our clinicians, as well as for members with diabetes and other chronic conditions.
Publication of CMI's care management programs, including guidelines and tools, on the Permanente Knowledge Connection improved access and enabled efficient updating of content. PKC supports implementation in the following ways:
Currently the national content network is working to embed diabetes care management guidelines into Kaiser Permanente's national clinical information system (CIS). This puts the preferred clinical content into the daily operating practice of our clinicians in the form of automated orders for tests, procedures and prescriptions, outreach and in-reach to members, chart notes, and other decision support. Embedding clinical content into the CIS is ultimately the most powerful lever in making the right thing easier to do.
Kaiser Permanente's national automated population-care registry (PCR) has been implemented in two Regions to date. PCR provides an interface to regional legacy information systems and includes a variety of information on members with chronic illnesses, including diabetes. PCR enables care managers to generate automated feedback and in-reach and outreach reminders to clinicians and members. Compliance with various process measures, such as HbA1c screening, has increased significantly with the implementation of PCR.
KP Online, our national member Web site, allows diabetic members to automate appointment making and prescription refills and to access medical advice. It also is a convenient source of self-management information and tools for members, including reference materials and discussion groups. Tools under development include direct member access to medical record information, messaging between members and clinicians, and home glucose monitors linked to the clinical information system.
The rapid deployment of clinical information technology remains our single largest challenge and opportunity. Other implementation challenges include
Measurement ("You Manage What You Measure")
Measurement informs and motivates change. Many improvements in care management are long-term, difficult to achieve, and hard to measure. Nevertheless, it is important to quantify improvements in objective measures of performance and clinical outcomes. Outcomes measurement informs progress, identifies issues, builds momentum, and serves as a powerful communication vehicle for clinicians and operational managers as well as senior leadership. The current KP national diabetes measurement system is a resource unique in the health care industry, with multiple applications. Challenges and opportunities remain:
EPILOGUE
In an effort to assist Kaiser Permanente Regions in improving the care provided to members with diabetes, the Care Management Institute has undertaken a number of initiatives to support implementation of the Integrated Diabetes Care Program.
Users' Group Calls
Each quarter, CMI convenes and facilitates a users' group call of diabetes experts and practitioners across the program. In November 2000, the diabetes users' group call focused on reducing hospital admissions and length of stay among members with diabetes. Dr. Resa Levetan from Washington Hospital and Dr. Harry Glauber from Kaiser Permanente Northwest spoke on approaches to this crucial issue in diabetes care. Their presentations covered the rates and costs of hospital admissions, as well as strategies to reduce admissions and length of stay. Specific topics included the use of IV insulin to achieve glycemic control of diabetic patients in the hospital, prevention of admissions through a revised advice nurse protocol, consultation with a diabetes practitioner prior to admission from the emergency department, and prevention of admission through patient and physician outreach on lipid control, smoking cessation, blood pressure control, and aspirin therapy.
During the call, the users' group agreed that there was sufficient evidence to support each KP Region having a program in place to decrease hospital days and/or control in-hospital glucose levels among patients with diabetes. The priorities identified for these programs included:
While the users' group calls have been valuable, we still have less than half of the clinical champions involved, in part due to the constraint that clinicians are not allowed any additional time out of schedule to attend.
Quarterly Reporting of Core Diabetes Measures
Each year, CMI develops a memorandum of understanding (MOU) with each Region specifying the allocation of care management resources and targeted achievement on clinical effectiveness and efficiency goals. The MOU process includes quarterly reporting on progress toward these effectiveness and efficiency goals. For 2001, CMI instituted reporting on core measures in key disease areas, including diabetes. Reporting on core measures will enable improved comparisons across Regions, as well as facilitate identification of both successful and struggling programs across KP. The core measures for diabetes are:
Physician-Based Decision Making for Formulary Selection
Kaiser Permanente employs a physician-based decision-making process for the selection of medications for formulary inclusion. Regional- and facility-based pharmacy and therapeutic committees have been established to conduct reviews of FDA-approved drugs for formulary addition or deletion. Drugs are evaluated based on safety, efficacy, quality, member convenience, and, where appropriate, cost.
In Northern California, for example, evaluations may be initiated at the request of any Permanente Medical Group physician, facility, or Regional pharmacy and therapeutic committee, chiefs of service committees, or Drug Information Services, a division of Pharmacy Services. Subsequently, an elaborate assessment and approval process is initiated, including an evidence-based analysis of the drug under consideration in relationship to similar formulary products. A drug monograph is prepared, including a preliminary recommendation regarding formulary inclusion. Subsequently, additional reviews are obtained from Regional chiefs of service committees, task forces, and advisory panels. In addition, the advice of individual subspecialists or selected physician groups may be solicited. Consensus recommendations are obtained from the various clinical expert groups.
The Regional pharmacy and therapeutic committee, after reviewing the many expert opinions and recommendations, votes for inclusion in the formulary. In some instances the Regional pharmacy and therapeutic committee may restrict the drug to physician specialist usage. Typically, these are drugs with a narrow safety margin, significant potential for inappropriate use, or a condition requiring specialty expertise. It should be noted that the voting members of the Regional pharmacy and therapeutic committee are physicians, with the exception of the vice president of pharmacy strategy and operations. Decisions are broadly and rapidly communicated to all physicians, utilizing email, newsletters, and the Kaiser Permanente Intranet site.
Each of the drugs used to treat our diabetic patients has been subject to this process prior to formulary approval. It should be noted, however, that when in the opinion of the treating physician a non-formulary drug is medically necessary, that drug may be prescribed without prior authorization. The intent is clearly not to construct barriers to the provision of optimal medical care.
Award-Winning Diabetes Programs
Three programs in the Kaiser Permanente network—Hawaii, Group Health Cooperative (GHC), and the Northwest—earned the top three spots on the National Committee for Quality Assurance's list of the leading managed care organizations for people with diabetes in 2000. The Programwide IDC also earned the American Association of Health Plans' Exemplary Practice Award for Diabetes in 2000.
GLOSSARY
ADA Archimedes CAD CAHPS CIS CME CMI CMS DQIP FACCT 4S GHC HCFA HEDIS HMO HOPE IDC IT KP KFH (Kaiser Foundation Hospitals), KFHP (Kaiser Foundation Health Plan), and KPNW KP Online LDL-C LIPID Medicaid/Medicare MOU NCQA NNT PCR PKC PRP RCT Region UK UKPDS WOSCPS REFERENCES
Brown, J.B., G.A. Nichols, and H.S. Glauber. 2000. Case-Control Study of 10 Years of Comprehensive Diabetes Care. Western Journal of Medicine 172:85–90.
Care Management Institute. 1996-2001. Kaiser Permanente National Outcomes Reports. Oakland, Calif.: Kaiser Permanente Care Management Institute.
Centers for Disease Control and Prevention (CDC). 1998. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes in the United States. Rev. ed. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
Diabetes Control and Complications Trial Research Group. 1993. The Effect of Intensive Treatment of Diabetes on Development and Progression of Long-term Complications in Insulin-Dependent Diabetes Mellitus. New England Journal of Medicine 329:977–86.
Harris, M.I., K.M. Flegal, C.C. Cowie, et al. 1998. Prevalence of Diabetes, Impaired Fasting Glucose, and Impaired Glucose Tolerance in U.S. Adults. The Third National Health and Nutrition Examination Survey, 1988–1994. Diabetes Care 21(4): 518–24.
Levit, K., C. Cown, H. Lazenby, et al. 2000. Health Spending in 1998: Signals of Change. Health Affairs 19(1):124–32.
Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. 1998. Prevention of Cardiovascular Events and Death with Pravastatin in Patients with Coronary Heart Disease and a Broad Range of Initial Cholesterol Levels. New England Journal of Medicine 339(19):1349–57.
National Diabetes Data Group (U.S.). 1995. Diabetes in America. 2nd ed. Bethesda, Md.: National Institutes of Health, National Institute of Diabetes, Digestive and Kidney Diseases.
Pyorala K., T.R. Pederson, J. Kjekshus, et al. 1997. Cholesterol Lowering with Simvastatin Improves Prognosis of Diabetic Patients with Coronary Heart Disease: A Subgroup Analysis of the Scandinavin Simvastatin Survival Study (4S). Diabetes Care 20(4):614–20.
Ray, G.T., F. Collin, T. Lieu, et al. 2000. The Cost of Health Conditions in a Health Maintenance Organization. Medical Care Research and Review 57(1):92–109.
Roblin, D., B. Ni, N. Solomon, P. Juhn, and the Diabetes Survey Design Group. 1998 (June). 1997 Kaiser Permanente Survey of Adults with Diabetes. Oakland, Calif.: Kaiser Permanente Care Management Institute.
Selby, J.V., G.T. Ray, D. Zhang, and C.J. Colby. 1997. Excess Costs of Medical Care for Patients with Diabetes in a Managed Care Population. Diabetes Care 20(9):1396.
Shepard, J., S.M. Cobbe, I. Ford, et al. 1995. Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia. New England Journal of Medicine 333(20):1301–7.
Starr, P. 1983. The Social Transformation of American Medicine. New York: Basic Books.
United Kingdom Prospective Diabetes Study 34. 1998. Effect of Intensive Blood Glucose Control with Metformin on Complications in Overweight Patients with Type 2 Diabetes. Lancet 352:854–65.
U.S. Census Bureau. 2000 (September). Health Insurance Coverage—1999. Washington, DC: U.S. Department of Commerce.
U.S. Census Bureau. 2000 (November). Monthly population estimate.
Wagner, E.H., N. Sandhu, K.M. Newton, D.K. McCulloch, S.D. Ramsey, and L.C. Grothaus. 2001. Effect of Improved Glycemic Control on Health Care Costs and Utilization. Journal of the American Medical Association 285:182–9.
APPENDICES
Appendix A. Overview of KP-CMI's Integrated Diabetes Care Program
Evidence-Based Clinical Guidelines
Clinical practice guidelines for adult diabetes care are the core of the IDC program and consist of a series of evidence-based algorithms and protocols to assist in screening, treating, and referring patients depending on their specific circumstances. The guidelines are written in a concise, instructive style designed to enable primary care physicians and other clinicians to use the IDC materials easily. National guidelines also increase the consistency of care across the organization and reduce the need for local guideline development. Key components include recommendations for glycemic screening and control, renal screening, and screening and referral guidelines for retinopathy.
To remain current, new evidence is reviewed and our guidelines are updated and revised biennially. To facilitate our clinicians' ability to incorporate these evidence-based clinical recommendations into practice, our guidelines are widely distributed in paper and electronic form. In addition, guideline recommendations are incorporated into clinical technology tools, including point of service reminders, in-reach and outreach tools, our population care registry, and our clinical information system.
Model of Care
The model of care is the infrastructure and process for managing and delivering patient care. The model of care has four important components: population identification through a registry; stratification of patients; commitment to a team approach; and evaluation of care. In addition to descriptions of key components, our recommendations for models of care include examples of models being used within Kaiser Permanente. The inclusion of a variety of models enables our program managers to select models or combine elements of models to best adapt ideas to their local environment.
Population Identification through a Registry
The main purposes of a diabetes registry are to identify and sort the diabetes cohort, track services, target the patient population whose care is to be coordinated, and evaluate treatment outcomes. A registry can also be used to generate targeted mailings or clinical feedback reports and for other quality improvement projects. Reports also can be generated to show employers the care that their at-risk employees are receiving from Kaiser Permanente.
Stratification of Patients
Stratification is used to identify subgroups of members with common sets of needs and resource requirements and to segment the population into groups most likely to benefit from different levels of intervention. The stratification methodology used for a given population is determined by size of the population, local leadership's program objectives, staffing expectations, and the extent to which enabling technologies can be used to serve larger numbers of patients.
The stratification methodology is intended to be coupled with other aspects of the IDC program (i.e., patient education, group visits, and programs for self-management of chronic disease) that provide direct service to patients. The stratification methodology creates three tiers of patients with diabetes. The patients with the least severe disease are well controlled and usually have no evidence of end-stage organ damage. These patients will continue to receive most services in the usual way from their primary care physician or health care professional. Patients with the most severe disease have major, multiple complications and often require subspecialty services. These patients are potential candidates for "case management." Between these two extremes is a sizable cohort of patients who have clinically significant diabetes care needs but whose care management can be handled well through a care coordination system.
Commitment to a Team Approach
The model of care is a team approach in which specific responsibilities are assigned to different clinicians (e.g., a care coordinator, diabetes educator, primary care physician, or eye-care specialist). The care coordinator's role is particularly noteworthy, as it is central to the management of diabetic members.
Care coordinators rely on treatment algorithms and on feedback from supervising physicians to manage their patient panel. Typically, the care coordinator will follow approximately 1,000 patients, but will actively manage the care of 100 to 150. During the period of active management, patients are interviewed to evaluate their personal barriers to self-management, coached to set and follow up on specific, attainable behavior change goals, have their key clinical parameters actively managed, and are then discharged back to their primary care providers with explicit follow-up instructions.
Care coordination is intended to enhance the primary care for patients with diabetes by addressing the critical aspects of management for those patients most in need. Because it focuses attention on the patients most likely to encounter significant and expensive complications, and because it addresses the aspects of care that are likely to have the greatest impact, care coordination is a cost-effective approach to managing diabetes.
Evaluation of Care
All implementation should be evaluated to determine what is working and what really makes a difference. Evaluation at local sites focuses on
Clinician Resources
Clinician resources include pocket cards, screening tools, a risk calculator, and electronic reminders. In addition, to help clinicians remain at the forefront of diabetes care, we also developed an online continuing medical education (CME) module for diabetes care. This is founded on our evidence-based clinical guidelines and allows clinicians to test their knowledge of current diabetes care recommendations while earning CME credit. Our diabetes program also includes a significant section focused on change management. This module of our program is based on behavior change theory and targets enabling and sustaining positive change for both clinicians and patients.
Patient Resources
Patient resources in the IDC include tip sheets, a diabetes action plan, a personal care and testing record, and Web-based tools for self-management. Patient self-management is a critical component of any diabetes care management program. Because diabetes is a complex and lifelong disease, empowering patients and involving them in their own care is critical to achieving and sustaining positive outcomes and quality care. Our patient self-management tools, like our clinical guidelines and models of care, are based on evidence in this field and represent the best tools available.
Another key component of the IDC program is integrated patient education. The patient education component of the IDC encourages members with diabetes to participate in group visits. The groups give members an opportunity to talk with others who face similar problems and to increase the number of educational encounters they have with Kaiser Permanente.
To change the traditional, didactic method of diabetes education, patients are asked to set and pursue specific, attainable goals and to develop individual self-management skills. Educational messages are tailored to each patient's readiness for change and to each clinician so that they are continually reinforced.
Measurement System
The measurement system of the IDC enables demonstration of results achieved, identification of areas for improvement, and evaluation of the success of the program across Kaiser Permanente, in addition to allowing interregional comparison and identification and sharing of successful practices across Regions.
Our measurement work is focused primarily on annual national outcomes reports. These national studies include data from all Regions on clinical, process, and health outcomes among our 330,000 members with diabetes. The measures for these reports are aligned with our clinical guidelines and with evidence in the literature on relevant outcomes for diabetes care. These reports are produced annually, allowing for identification and tracking of trends.
As a component of this process, the measures included in the report are reviewed each year by an interregional advisory group of clinical and measurement experts in diabetes care. Measures are evaluated for their evidence basis, relevance, feasibility, value, and degree to which they can be acted on. For example, measures that cannot be captured through administrative data sources do not meet the "feasibility" criterion and are therefore not included in the measurement set. Likewise, measures can be added to the measurement set based on advances in the field or advances in our ability to capture data.
In addition, CMI regularly surveys members with diabetes to collect data available only from patients (e.g., self-perceived health) or that cannot be measured reliably from other data sources (e.g., foot examinations by physicians). The patient data survey summarizes measures of medical care interventions, self-care attitudes and behaviors, satisfaction with medical care, and patient perceptions of health status.
Implementation
The primary strategies used to effect successful implementation of the IDC include
Technology is also a key aspect in effective implementation. Technology tools for population management are essential for care coordination. These tools make it possible to quickly identify patients in trouble—for example, those who are not filling prescriptions or whose blood glucose levels are becoming dangerously high—and to remind care coordinators about scheduled follow-up care. Technology tools are also used to send messages to care providers and to patients.
In the absence of technology, other tools can assist in care management. For example, CMI has developed a template for a paper version of "speed charting" for patients with diabetes. The speed-charting template allows clinicians to easily check and record pertinent clinical data at routine scheduled visits. A personal diabetes record is another paper-based way to monitor the health status and treatment history of diabetic patients in the absence of technology tools. Patients are encouraged to use a wallet-size card to record their medical visits and laboratory test results. They take the wallet card with them when they visit their physician or other member of the diabetes care team, using it to discuss aspects of their care.
The IDC provides an opportunity to improve health status and outcomes for thousands of Kaiser Permanente members while assisting physicians and other health care professionals. The program provides tools and templates to help physicians manage their desk work and gives opportunities to focus on care, instead of cure. Over the past four years, the IDC has become a mature national Kaiser Permanente care management program and has served as the model for other successful national care management programs, including cardiovascular care, asthma, depression, and elder care. New programs are under development for chronic pain and cancer care.
Appendix B: CMI Diabetes Guidelines
The guidelines can be accessed via the Permanente Knowledge Connection, KP's clinical information Web site, at http://pkc.kp.org.
Appendix C: Kaiser Permanente: A Legacy Born of Challenges
The ideas that shaped Kaiser Permanente emerged from a series of environmental challenges. While thousands of men sought to meet the challenge of bringing Colorado River water to Los Angeles during the Great Depression with the 240-mile-long aqueduct across the Mojave Desert, a Kaiser Permanente founder wrestled with how to provide these workers with quality health care. As huge numbers of workers tackled the challenge of constructing the Grand Coulee, the largest dam in the history of the world, the organization that would become Kaiser Permanente tackled the challenge of making prepaid health care work to the benefit of these men and their families. When World War II demanded that the shipyards in Richmond, California, and Vancouver, Washington, construct ships in record time, Kaiser Permanente was meeting the demands of caring for the workers and battling for legitimacy among our peers and our critics.
Sidney Garfield, the physician founder of Kaiser Permanente, developed an idea that reversed the economics of medicine and changed American health care financing forever: prepayment for comprehensive medical coverage. Harold Hatch, an engineer-turned-insurance agent, suggested to Garfield that insurance companies agree to pay the doctor 5 cents a day for each worker covered. For a payroll deduction of another 5 cents a day, a worker could receive coverage for non-job-related medical problems. With thousands of workers enrolled, Garfield's health care idea soon became a financial success.
The introduction of prepayment enabled Garfield to encourage safety and health activities rather than just treating the ill and injured. He persuaded contractors to have their men pound down nails, and he inspected tunnels to combat the two most common injuries—nail punctures through rubber-soled boots and head injuries caused by falling rocks or protruding shoring.
This focus on prevention changed the economics of medicine by focusing on keeping the patient healthy rather than treating the illness. Prevention, partnership between medicine and management, integration of all of the elements of health care services, provision of comprehensive benefits, and choice of physicians have remained defining principles for Kaiser Permanente.
Kaiser Permanente continues to be shaped by the challenges confronting the country's health care environment. The birth and continued existence of the Care Management Institute, for example, have coincided with major environmental shifts that are influencing the way medical care will be delivered in the 21st century. The number of people with chronic diseases is growing, with expectations that by 2010, 40 percent of the American population will be living with one or more chronic conditions. New and costly therapeutic interventions are forcing Kaiser Permanente to ensure that there is a sound evidence basis for changes in medical practice. Advances in information technology have fostered members' demand for substantive clinical information and active participation in their medical decisions. The rising cost of providing health care and the corresponding increase in members' dues have challenged Kaiser Permanente to be a better steward of its resources and to develop new ways of delivering high-quality, cost-effective care to populations.
Since its inception in 1997, the Care Management Institute has been committed to responding to these external forces in the context of the principles and practices of Permanente Medicine. CMI's primary focus has been to establish the infrastructure and relationships necessary to support the delivery of high-quality, evidence-based medicine for priority populations in an integrated delivery system. In a practical sense, CMI leverages the resources and intellectual capital possessed by Kaiser Permanente physicians and health care professionals and helps to distribute it throughout the organization. At the same time, CMI serves as a bridge between the Permanente Medical Groups and the Kaiser Foundation Health Plan, catalyzing the types of discussions that ensure alignment between medical values and management realities.
This ability to respond to environmental shifts has made Kaiser Permanente America's oldest and largest private, nonprofit, integrated health care delivery and financing system. Founded in 1945, the group-practice prepayment program has its headquarters in Oakland, California. Today, Kaiser Permanente serves the health care needs of 8.2 million members in 10 states and the District of Columbia. It encompasses Kaiser Foundation Health Plan Inc., Kaiser Foundation Hospitals and their subsidiaries, and the Permanente Medical Groups. Kaiser Permanente also has an affiliation with Group Health Cooperative (GHC), based in Seattle, Washington. Nationwide, Kaiser Permanente includes about 90,000 technical, administrative, and clerical employees and about 11,000 physicians representing all specialties.
American Diabetes Association
CMI's biomathematical simulation model (see CMI, below)
coronary artery disease
Consumer Assessment of Health Plans Survey
clinical information system
continuing medical education
Care Management Institute (of KP)
Centers for Medicare & Medicaid Services (formerly the Health Care Financing Administration, or HCFA)
Diabetes Quality Improvement Project
Foundation for Accountability
Scandinavian Simvastatin Survival Study
Group Health Cooperative (affiliated with KP)
Health Care Financing Administration (renamed the Centers for Medicare & Medicaid Services, or CMS)
Health Plan Employer Data and Information Set
Health Maintenance Organization
Heart Outcomes Prevention Evaluation
Integrated Diabetes Care
information technology
Kaiser Permanente, comprising
PMGs (Permanente Medical Groups)
KP's Northwest Region (encompassing chiefly the Portland, Ore., and Vancouver, Wash., areas of Oregon and Washington states)
national KP member Web site
low-density lipoprotein cholesterol
Long-term Intervention with Pravastatin in Ischaemic Disease
(see Appendix C)
Memorandum/Memoranda of Understanding
National Committee for Quality Assurance
numbers needed to treat
population-care registry (of KP)
Permanente Knowledge Connection (national KP clinical Web site)
Provider Recognition Program (of the ADA)
randomized controlled trial
areas of the United States in which KP physicians practice (e.g., see KPNW)
United Kingdom
United Kingdom Prospective Diabetes Study
West of Scotland Coronary Prevention Study