Slide Lecture with Audio
This activity is based on a 45-minute slide lecture presented Barry J. Goldstein, MD, PhD, FACE and William J. Cardarelli, PharmD. This program is available as read only and with accompanying audio.
*Scroll to read lecture and/or follow along with audio.
Slides 1, 2 and 3: Welcome to the teleconference, “Integrating Quality Measures in Type 2 Diabetes Management: Opportunities to Improve Macrovascular Outcomes.” This program is jointly sponsored by the Medical Education Collaborative, Inc (MEC) and Princeton CME; and is supported by an educational grant from Takeda Pharmaceuticals North America, Inc.
This educational activity is designed to educate the target audience of managed markets physicians, pharmacists, and nurses on the implementation and execution of quality measures to assist clinicians in improving management of type 2 diabetes and prevention of macrovascular disease.
After completing this activity, participants should be able to:
- Describe the prevalence and clinical and cost burden of type 2 diabetes and the impact of macrovascular complications
- Summarize data on the safety and efficacy of pharmacologic approaches for the management of type 2 diabetes and prevention of macrovascular disease
- Outline strategies to assist patients and providers in increasing compliance with type 2 diabetes management approaches
- Integrate quality measures into managed markets practice to improve outcomes related to type 2 diabetes and macrovascular complications
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of MEC and Princeton CME. MEC is accredited by the ACCME to provide continuing medical education for physicians.
MEC designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
For questions regarding the ACCME accreditation of this activity, please contact MEC at 866-420-3252
MEC is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
This continuing nursing education activity for 1.0 contact hour is provided by MEC.
MEC is approved by the California Board of Registered Nursing, Provider Number 129909 for 1.0 contact hour.
Princeton CME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (ACPE Provider #452) and complies with the Criteria for Quality and Interpretive Guidelines. This activity is approved for 1 contact hour, or 0.1 CEU, of continuing pharmacy education. The Universal Program Number for this activity is 452-999-08-014-H01-P.
Faculty disclosures for this activity are as follows—
Dr. Goldstein receives grant/research support from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co, Inc, Novo Nordisk, sanofi-aventis U.S., and Takeda Pharmaceuticals North America, Inc; he is a consultant for GlaxoSmithKline and Merck & Co, Inc; and a speaker for GlaxoSmithKline, Merck & Co, Inc, and sanofi-aventis U.S.
Dr. Cardarelli and Dr. Simmons disclosed no relevant financial relationships with any commercial interests.
Presenting today is Barry J. Goldstein, MD, PhD, FACE, Professor of Medicine, Biochemistry and Molecular Pharmacology, and Director, Division of Endocrinology, Diabetes, and Metabolic Diseases at Jefferson Medical College of Thomas Jefferson University in Philadelphia, Pennsylvania.
A pay-for-performance case study applying the data to a real-world scenario will be presented by William J. Cardarelli, PharmD, Director of Pharmacy at Atrius Health, Harvard Vanguard Medical Associates in Watertown, Massachusetts.
Please remember that to receive continuing education credit following the conclusion of this activity, each participant must complete the post-test and evaluation form. These forms can be easily completed online at www.princetoncme.com.
Thank you again for joining us. Dr. Goldstein will now begin his presentation.
Slide 4: Thank you. I am Dr. Goldstein, and I would like to begin the presentation today with an overview of the clinical and economic burden of type 2 diabetes.
Slide 5: In the United States, diabetes accounts for more than 20 million people. Type 2 diabetes is about 90% to 95% of all diagnosed cases and clearly accounts for the largest burden of diabetes on the healthcare system. About 30% of patients with type 2 diabetes are undiagnosed, and that is the reason why we need to be vigilant about screening to identify this large population that does not know that they have diabetes.
Slide 6: Disease-related complications are widespread in the body. There are what we call microvascular complications, affecting the eyes and kidney function as well as nerve function, and vascular complications, which contribute to heart disease and stroke. And, it is important to recognize that cardiovascular events account for about 80% of the morbidity and ultimate mortality of patients with type 2 diabetes.
Slide 7: The data on the slide that says Type 2 Diabetes Increases the Risk of CVD is taken from the Framingham Study—and this is almost 20 years ago—which showed clearly that in males there is an increase in all cardiovascular risk factors in patients with diabetes compared to nondiabetics. And, in females, especially, there is an increased relative risk of CVD, and this was highlighted in their extensive review of that data.
Slide 8: The economic impact of diabetes is important to recognize. Indirect costs include time loss from work and disability from complications associated with diabetes. And, it is also important for this presentation to note that the oral antidiabetic agents only account for a small percentage of the total cost breakdown. A lot of the cost is due to hospitalization, which includes worse outcomes in patients who are poorly controlled at the time of hospitalization and during their hospital stay.
Slide 9: The medical costs of diabetes-related comorbidities are dominated by cardiovascular disease, as shown in this bar graph. Other complications account for literally billions of dollars; but, cardiovascular burden is about $18 billion.
Slide 10: When we look at quality measures, they have provided guidelines for management of type 2 diabetes, especially in the primary care arena.
Slides 11 and 12: Evidence-based measures have been developed, and there are expert bodies that have provided guidance—the American Diabetes Association, the American College of Endocrinology, and the American Association of Clinical Endocrinologists—and working with government and other oversight bodies, the NCQA and the HEDIS measures that have been developed, largely stemming from guidelines as those shown on the table for diabetes management. The ACE guidelines and the ADA guidelines are largely in agreement; the hemoglobin A1c is slightly lower in the ACE guidelines. And, the American Diabetes Association often quotes less than 7% because they are really looking at all patients with diabetes—including type 1 and type 2—and are giving more of a global recommendation in terms of care management. The ACE guidelines are more focused on type 2 diabetes.
Slide 13: We have a number of different therapies that we can use for managing type 2 diabetes.
Slide 14: Enhancing insulin sensitivity is very important, since more than 90% of the patients with type 2 diabetes have insulin resistance associated with their obesity and sedentary lifestyles. Medical-nutrition therapy tries to work with the patient to establish caloric restriction and weight loss. And, exercise is key to maintain muscle mass and promote insulin-independent glucose uptake.
Slide 15: We have many different types of medications available for pharmacologic therapy, as shown in this slide. There are different actions that we can use to a great benefit in combining different mechanisms so that we can try to get at the underlying cause of type 2 diabetes, working on both the insulin resistance at the liver and muscle, and then separately in the pancreas to increase insulin secretion. And, other related mechanisms can give us good control of blood sugar in most patients, but requires combination therapy.
Slide 16: The ADA Consensus Treatment Algorithm was generated along with the European Diabetes Association; so, this is more or less a global view of how diabetes should be managed. The change that was put into this algorithm in 2006 was the earlier use of metformin along with lifestyle changes at the time of diagnosis, because it was recognized that most patients cannot achieve adequate glycemic goals with lifestyle intervention alone.
The algorithm points out, clearly, that every 3 months the A1c should be checked, and if patients are not at goal, then further intervention should be undertaken. You can see that there is certainly no linear path toward glycemic control and that many choices exist with combinations of oral agents—adding to the metformin a glitazone or sulfonylurea or even insulin, when it is used, is usually added to oral agents. Again, these various combinations should be employed to get patients to A1c at least less than 7%. This should be accomplished within the first 6 to 9 months of diagnosis and then for the duration of the patient's lifetime.
Slide 17: Insulin is, of course, an important agent for the management of type 2 diabetes. Many patients eventually need insulin because they lack sufficient insulin secretion from the pancreas. About 40% or 50% of well-controlled patients will need insulin supplementation. Insulin is problematic in several ways in that it needs to be injected, can cause hypoglycemia, often leads to weight gain, and requires more resources from a primary care office with titration of the dose and trying to avoid some of the problems that I just mentioned.
Slide 18: The Treat-to-Target Trial showed efficacy of glargine compared to NPH insulin. This was a large study that essentially was able to show that glargine—having a peakless pharmacokinetic profile—was associated with less nocturnal hypoglycemia, and also they showed that there was less weight gain even though the patients were controlled to about the same A1c. So, there are clinical advantages of using some of the newer basal analogues, such as glargine.
Slide 19: The oral antihyperglycemic agents have—what is shown in this bar graph—a range of efficacies in lowering A1c, although these data are taken from a variety of studies that are summarized for you on the citations on this slide. Often when patients are starting with a high A1c, they will show a greater reduction in a clinical trial. Essentially, all of these agents show somewhere between a 0.8% and a 1.5% reduction in A1c, on average. It is also impossible to predict how an individual patient might do when given 1 of these medications. So, really all of the agents are useful. The ones that seem to have the smallest effect on A1c are the short-acting secretion enhancers—nateglinide and repaglinide in particular—but they do provide postprandial glycemic control.
Slide 20: We recognize the benefits of glycemic control on both microvascular disease and myocardial infarction, as shown here from the UKPDS, a large study done in type 2 diabetes patients about a decade-and-a-half ago. Here you can see in this epidemiologic analysis, the lower the A1c, a reduced risk was seen for both microvascular complications as well as cardiovascular complications. These data help support the aggressive glycemic targets that I mentioned a few minutes ago.
Slide 21: Metformin is the only agent in the biguanide class of drugs that is used orally in type 2 diabetes. It has no hypoglycemia, because it works independently of the pancreas. It has been used for decades, and there is a very good safety margin with metformin. And, importantly, it limits weight gain and in any combination—even with agents that increase weight, including sulfonylureas, insulin, and the thiazolidinediones—metformin can be very helpful.
Slide 22: The insulin secretion enhancers—the sulfonylureas, the long-acting agents, and the short-acting agents are what are called meglitinides—are also important when patients no longer have enough endogenous insulin response to support the action of oral agents that rely on this insulin response, and those would include metformin and the thiazolidinediones. So, increasing insulin secretion with a pill is often preferable prior to starting insulin therapy. The problems with increasing insulin secretion are that you can get hypoglycemia and there is also often weight gain.
Slide 23: The UKPDS also looked at results in the intensive therapy group overall, comparing conventional treatment with intensive treatment. One group had their A1c lowered to 7% from an average in the conventional group of 7.9%. This maneuver alone was associated with a 16% reduction in MI, but this was marginally statistically significant, just missing the .05 P value.
A substudy of the UKPDS—done with overweight subjects taking metformin as opposed to the conventional group, comparing A1c with metformin at 7.4% to conventional treatment at 8%— showed a 39% reduction in MI, and this was highly significant. So, even though this was a small subset—only 342 patients—it does provide guidance on the potential benefit of metformin in preventing myocardial infarction in type 2 diabetes.
Slide 24: The TZDs, the glitazones or thiazolidinediones, are the insulin sensitizers that have a unique mechanism of action working through the PPAR-gamma system. They have been associated, unfortunately, with weight gain, fluid retention, peripheral edema, and a few percentage of patients are also susceptible to congestive heart failure. And, more recently, it has been recognized that there are some distal fractures in postmenopausal women with these agents. Nevertheless, they are good at lowering glucose and they have, for many years, been hoped to have positive effects in vascular outcomes, and long-term trials are still looking at this possibility.
Slide 25: One of the studies that investigated this was called the PROactive study, which used pioglitazone and studied over 5000 patients for 3 years. This study had a very complex primary composite end point that included peripheral amputation and peripheral vascular disease as well as other more typical cardiovascular end points. And, it just missed its primary end point’s statistical significance; there was a 10% reduction that was not statistically significant. On the other hand, there was a secondary end point, which was more limited—looking at all-cause mortality, nonfatal MI, and stroke—and this showed a 16% reduction in the secondary end point.
So it looks as though the reduction in events is going in the right direction. We are not sure if the reason for the small difference might have been the aggressive treatment, in general, or that many patients in these studies are receiving lipid-lowering therapy and antihypertensive therapy, which by itself will reduce the number of events in both groups.
Slide 26: Last year there were concerns raised about rosiglitazone in a meta-analysis done by Dr. Nissan as well as by the FDA, raising the possibility in a number of short-term trials that there was an increase in ischemic events with rosiglitazone. However, the FDA, in their full analysis, determined that the data are inconclusive and, although there is a warning in the package insert, they are still relying on a number of ongoing clinical trials with rosiglitazone to determine this issue.
Slide 27: In the process of thinking about the thiazolidinediones and aggressive treatment of type 2 diabetes, the ACCORD study—which is a very aggressive glycemic control study that is being done by the NIH in patients with type 2 diabetes with cardiovascular outcomes as the main end point—was suspended because the investigators in the Data Safety Monitoring Board noted that there was a 20% higher incidence of death in the group receiving intensive treatment. Now, this intensive treatment in ACCORD was different than what we would normally do in clinical practice. For the sake of this clinical trial, they were trying to get A1c less than 6% versus the standard treatment where they hoped the average would be about an A1c of 7.5%. So, we are not sure exactly the reason for this; it is being analyzed currently. There is a similar study in Australia that did not show increased mortality in the intensively treated group. And, hopefully we will see more data at the ADA meeting this June, which will help clarify this important issue.
Slide 28: Several newer agents, the oral DPP-4 inhibitors, work by a unique mechanism through what is called the incretin system. They increase insulin secretion in a glucose-dependent way without causing hypoglycemia and they block glucagon secretion. Their cardiovascular effects have not been determined, but it is anticipated that they will probably not have a big effect on cardiovascular outcomes, per se.
Slide 29: Other incretin-related therapies include injectable agents, such as exenatide, which is a GLP-1 agonist. It works in a way similar to the DPP-4 inhibitors, since the DPP-4s block the enzyme in the body that degrades GLP-1 and then, secondarily, they increase the endogenous level of GLP-1. Exenatide is associated with some weight loss, which is an advantage, but it does need to be injected twice daily.
Slide 30: The table compares the effects that I just described for the oral agents and gives you some data to look at in more detail.
Slide 31: Now, to prevent cardiovascular risk in type 2 diabetes, macrovascular risk certainly has to be targeted.
Slide 32: We want to make sure that the audience appreciates the role of glycemic control overall, as I showed you from the UKPDS study, certainly controlling blood pressure and lipids, and we will look at some data from clinical trials that have shown efficacy in type 2 diabetes. And again, no oral antidiabetic agent has really been conclusively shown to reduce CV risk. This is going to be mentioned in the package insert according to a recommendation by the FDA, but we still use them to control glucose along with these other modalities.
Slide 33: It was noted in the Steno-2 study, which is another landmark trial that was exploring how multifactorial intervention can help reduce CV outcomes. Here you can see in this bar graph, control of glucose, lipids, and blood pressure and the goal attainment in these different categories. Even though it looks like only a few percent of patients reach their A1c goals of less than 6.5%, there still was a significant difference between the intensively treated group and the conventional group.
Slide 34: These data in controlling these multiple risk factors showed a dramatic reduction in death from any cause as well as death from CV events in the Steno-2 study from the initial trial, which was published in 2003 in the New England Journal of Medicine, and this follow-up study, where the patients were treated for a mean of almost 8 years, further substantiating the long-term control of these multiple risk factors in helping to reduce CV mortality.
Slide 35: The relative risk reduction with ACE inhibitors versus other antihypertensives has been studied in a number of different trials. And, here you are seeing a meta-analysis of 3 large studies showing the benefit, especially ACE inhibitors versus calcium channel blockers. We generally believe that calcium channel blockers are helpful in combination therapy, but they seem to lack the special efficacy of the ACE inhibitors in preventing cardiovascular events.
Slide 36: The HOPE and MICRO-HOPE studies looked at ramipril versus placebo. They showed that ramipril—the ACE inhibitor—was also associated with a significant reduction in risk associated with its blood pressure lowering and probably other effects that these agents have, including the blocking of inflammation and oxidative stress in the microvasculature.
Slide 37: ARB therapy, with the angiotensin receptor blockers, has been studied in a number of different trials, and 1 study, for example, the LIFE study, showed losartan was more effective at preventing CV events and mortality compared with the beta-blocker, atenolol. Not all studies have reached this conclusion, but the general recommendation from the American Diabetes Association is that antihypertensive therapy should be initiated with ACE inhibitors or ARBs.
Slide 38: The statins have been studied in a number of CHD prevention trials. Shown here, the subgroup analyses coming from the larger primary studies with a relatively small number of patients, but still showing overall significant reduction in risk in the diabetes subgroups of these large studies, anywhere from 20% to 55%.
Slide 39: This slide shows you the definition of these different acronyms from that table.
Slide 40: One of the important studies done in patients with type 2 diabetes with atorvastatin is called the CARDS study, and it showed that by giving everyone in the study atorvastatin—despite their lipid levels—there was a significant reduction of major CV events, stroke, and death.
Slide 41: The VA-HIT trial is an older study but looked at gemfibrozil, the fibrate, on CV events in patients with diabetes and showed a 24% risk reduction. However, other studies with fenofibrates and other ongoing studies have really not given as much confidence in the benefit of fibrate therapy in patients with type 2 diabetes.
Slide 42: The effectiveness of aspirin has been looked at in very large trials. This is one of the basic recommendations of the American Diabetes Association, to use aspirin as an antiplatelet agent, because of its experience in reduction of CV events.
Slide 43: How do we increase compliance in the management of type 2 diabetes?
Slide 44: Well, there are quality measure initiatives that have identified large practices in managed care where goals are not being achieved. So, certainly getting the information to the doctors about their patient populations. Pay-for-performance initiatives encourage performance on the part of the physician and work to try to encourage patient compliance.
Slide 45: The Diabetes Physician Recognition Program—as you can see here between 1997 and 2003—there is an increased level of achievement in looking at these multirisk factors, including glycemic control, blood pressure, LDL levels, and also measuring a urine albumin excretion as a nephrology assessment. Although there is certainly measurable improvement, there are still many patients that are not getting these assessments in terms of percentage of total patient population.
Slide 46: Combination therapy—we know we can improve patient outcomes, and this applies to glycemic control as well as blood pressure control. In terms of the oral antidiabetic agents—as I showed you—there are many different mechanisms. And, using the drugs that provide complementary mechanisms—and there are many examples—gives a better therapeutic effect. There are fixed-combination pills available that have been shown to improve compliance and are less costly to the patient. We do believe that aggressive early glycemic control may actually go a long way in preserving function in the pancreas and certainly helping to prevent long-term complications.
Slide 47: This study showed that compliance with combination therapies can go down. This was a study done by Dr. Dailey, which looked at patients taking either metformin or sulfonylureas. When they had to take both medications, as is often done in combination therapy, you can see the compliance days on the left-hand side went down by about 40% to 45%. And, on the right-hand side, the compliance rate also was significantly reduced by about 40% in the patients that had to take the 2 medications.
Slide 48: The next slide shows the converse, that compliance improved with single-tablet combination agents. These are the fixed-combination ratio pills. And, patients who were taking separately metformin and glyburide, had a 54% adherence rate; when they were given metformin/ glyburide combination tablets, that adherence rate went up to 77%. On the right-hand side, you are seeing patients that were switched from metformin and glyburide that was coadministered to metformin and glyburide combination pill, with their adherence rate going up from 71% to 87%.
Slide 49: Patient education is important so they understand why they have diabetes, some of the underlying mechanisms, and how their medications are working. They need to understand their lab tests and follow along with, what is the hemoglobin A1c? What does the finger stick blood sugar mean? And, their lipid values. And, comprehensive treatments clearly have provided guidance for patients and physicians in terms of the long-term management of this chronic illness.
Slide 50: So, in conclusion, cardiovascular complications account for a large portion of the morbidity and mortality as well as the cost burden in type 2 diabetes. Quality measures provide guidelines for physicians and also patients for their consideration of how their diabetes and preventive complications should be managed. There are many drug approaches to the glycemic management as well as combinations with blood pressure medicines and lipid-lowering medications. And, compliance can be improved by incorporating programs based on quality measures, fixed-combination agents, and patient education into treatment regimens.
Thank you very much for your attention, and now I would like to turn it over to Dr. Cardarelli, who is going to present his organization's pay-for-performance initiative. Thank you, Dr. Cardarelli.
Slide 51: Thank you, Dr. Goldstein. I am going to speak today about developing a chronic care program for diabetes.
Slide 52: There can be little debate over whether diabetes is a very challenging disease to treat.
It is an insidious disease, has a number of comorbidities, and presents an enormous financial burden to both patients and insurer. Dr. Goldstein has already done an excellent job of detailing the expenses associated with diabetes, and you can see the numbers on the slide. One fact that is important to remember is that the prevalence of diabetes increases with age. If diabetes prevalence rates were to remain constant over time, the number of patients would grow to an estimated 17.4 million patients by the year 2020.
Slide 53: Diabetes is a chronic disease and requires a systematic approach to care. This approach can be enhanced by the managed care company in many ways. First, the MCO can implement many of the HEDIS 2008 measures into a pay-for-performance program to incent the physician network to work toward quality goals. Secondly, the MCO has access to the data that is necessary to assist the practice and clinician in dealing with the multifocal components of the disease. Of all chronic diseases, diabetes might be best suited for a structured approach to provide care. This approach requires that the physician have access to all the patient's history, labs, and prescriptions. The goal of this effort is to allow the physician to develop a treatment plan and then monitor this plan for persistence and adherence.
Slide 54: The concept of pay-for-performance in diabetes is an intriguing one. The concept depends on the ability to measure certain specific end points of care, and that these end points can translate into improved care for patients with diabetes. Under pay-for-performance contracts, providers would be financially rewarded when their patients meet the applicable guidelines. The overall intent of this program is to improve the health status of the general population.
These models are often based on externally developed practice guidelines. There are several nationally recognized practice guidelines available. I have listed some of them on the slide. One of the most commonly used measures of care is the Healthcare Effectiveness Data and Information Set from the National Committee for Quality Assurance. HEDIS has a comprehensive diabetes care measure that includes hemoglobin A1c control, blood pressure control, LDL screening, and use of ACE or ARBs for medical attention to nephropathy.
Slide 55: Design and development of pay-for-performance initiatives has to address several elements in order to be successful. It has to be completely transparent so the clinicians will fully participate. It has to include goals that are attainable within the general population. It has to be both evidence-based and consistent with a standard of practice within the community, and it has to be accompanied by a formulary design that allows for clinician flexibility in the prescribing of drugs. One attribute that pay-for-performance programs cannot have, is that it cannot encourage the exclusion of the more challenging or difficult-to-treat patients with diabetes.
Slide 56: Harvard Vanguard Medical Associates is an integrated multispecialty ambulatory physician group practice based in Boston, Massachusetts. Across its 15 practice locations, Harvard Vanguard has 160 primary care internists caring for over 300,000 adult patients and accepts full risk, both medical and pharmacy, on its patients. True to its ancestry as one of the original staff model HMOs, it continues to operate freestanding clinics.
Primary care internal medicine is structured into care teams, including physicians, advanced practice clinicians, such as nurse practitioners or physician assistants, registered nurses, and dedicated medical assistants. All Harvard Vanguard primary and specialty clinicians use EpiCare Electronic Medical Record. This system is used for visit documentation, order entry, patient referrals, prescriptions, and test results review. In addition, Harvard Vanguard maintains an internally developed data warehouse that integrates patient-level EMR clinical information with insurer claims data and operational scheduling data through unique patient identifiers.
Slide 57: In 2003, Harvard Vanguard Medical Associates recognized an opportunity to improve patient care by designing and implementing a chronic complex care model across its primary care practices. This model was loosely based on a theoretical model originally developed by the McColl Institute in the 1990s, then implemented in several practices in the early 2000s. At the bottom of this slide, there are a couple of excellent references that describe this in detail. The inspiration for this practice design was the desire to improve the quality of care received by their patients and to improve performance on clinical measures in response to the trend towards increased transparency and consumerism.
Slide 58: Another benefit was that increased performance would yield enhanced pay-for-performance bonuses. The model was designed to identify several major components of an ideal delivery system that is better equipped to care for chronically ill patients. The transition from acute care to chronic care requires fundamental changes in the structure and processes of primary care. Population management, system-based practice, and planned chronic illness care represents potential core components for 21st-century primary care. Population management leverages clinical informatics for patient registries and involves the application of continuous quality improvement concepts to chronic illness care. In a system-based practice, clinicians do not work by themselves, but rather learn to collaborate and use organizational resources for patient care. Finally, planned care for chronic conditions has been effective in freeing up physician time, improving patient access, and providing some level of predictability to the daily physician's workload.
Under pay-for-performance contracts, providers would be financially rewarded when their patients meet the applicable guidelines. The overall intent of these programs is to improve the health status of the general population. In this specific example, bonus dollars are used to support investments in new equipment or technology. The program I am describing here leverages the efficiency of its staff model design and its integrated electronic medical record system.
Slide 59: Harvard Vanguard has assembled a complex chronic care team to improve the care of their patients. The team consists of the following components: a primary care team composed of a physician, advanced practice clinician, registered nurse, medical assistant, and medical secretary. These staff represents the core team responsible for providing efficient, high-quality care across the spectrum of treatment, including preventive care, chronic disease management, complex-care treatment, facility-based care, and end-of-life care. This primary care team is supported by an elaborate system of specialists, each available to consult on difficult cases.
Atrius Health Harvard Vanguard Pharmacy and Therapeutics Committee is charged with reviewing the available guidelines, performing focused literature reviews, and the customization of guidelines into a format compatible with the organization. This committee is made up of physicians, nurses, pharmacists, and administrators. They are responsible for development of cost-effective, evidence-based, clinically appropriate treatment strategies designed to improve care for all their patients.
Slide 60: Clinical informatics specialists support this team by working within the electronic medical record system to design decision-support tools that facilitate the flow of information to clinical decision makers. A fully integrated EMR allows clinicians to view the patient's chart, lab results, radiology, and pharmacy record. It is linked so that any specialist within the system has access to and can input into a patient's unique medical record. The care team also has access to disease management specialists who can assist in coordinating care outside of the practice setting, as well as social workers who can assist patients with financial issues relating to care.
The care team itself has clearly defined roles and responsibilities. They follow work flows designed to optimize the care provided to patients while minimizing administrative burden on physicians. The ultimate goal is to provide population management and improve the overall health of patients with diabetes. Additionally, Harvard Vanguard relies on its care teams to understand and deal effectively with any cultural or health literacy needs of its patients.
Slide 61: The patient is a critical part of this team as well. The importance of their role in this process cannot be understated. In this model, patients must take responsibility for managing their health, as all patients engage in behaviors that affect their health. The care team is responsible for educating patients on behavioral modifications that promote well-being. It is important to realize that both control of disease and patient outcomes are dependent to a significant degree on the effectiveness of patients’ self-management.
Slide 62: All Harvard Vanguard patients who require complex chronic care are automatically enrolled in the chronic care program. Eligibility is determined by patient rosters created within the EMR or by claims data. Prior to their first visit, eligible patients are provided with a health assessment questionnaire to complete and bring with them at the time of their consultation. This questionnaire solicits current healthcare treatments, self-reported comorbidities, self-assessment of current status of diabetes control, and level of knowledge about diabetes care.
Slide 63: The first visit is considerably longer than a standard follow-up appointment and is usually scheduled for 45 minutes or more. Although it could be conducted by the primary care physician, it is generally conducted by an advanced practice clinician. The visit begins with a detailed review of the patient's medical history and current therapies. The particularly complex patients have clinical pharmacists available to review the patient's medication history. This might include a detailed medication therapy management encounter, where the clinical pharmacist makes recommendations for changes in the patient's drug therapy. These changes could be to simplify the drug regimen, obtain clinical goal attainment, or reduce the patient's cost burden.
Slide 64: At the conclusion of this visit, the treatment plan is developed and documented for the patient, and a follow-up visit is scheduled as determined by the patient's morbidity. During the time between these scheduled visits, the patient may access any member of the care team to follow up with questions or concerns. Urgent care visits are scheduled and handled separately from the chronic complex care visits.
Slide 65: At the end of 2006, a 3-year retrospective study was conducted to estimate the impact of this program. The results of the survey showed a steady improvement of quality measures from 2004 to 2006. Composite screening rates improved from 51% to 58%, and composite intermediate outcome goal attainment measures increased from 13% to 17%. A secondary analysis of this population showed that the improved quality was attained without increased average visit rates. Clinical processes in intermediate outcome measures were used. Process measures included screening for hemoglobin A1c, LDL, and blood pressure over a 12-month period.
Slide 66: Although there was no direct financial analysis performed on this group, it does make a strong case for using performance incentives to drive innovation and delivery system change. Because this is a staff model design, the organization benefits because of increased capitation fees and pay-for-performance bonuses; the individual physicians are salaried staff. If you look into the literature, then you can find similar incentives that show an effectiveness ratio of about $33,000 per quality-adjusted life-year.
Slide 67: Despite all the clinical and financial upside to pay-for-performance, Harvard Vanguard did encounter several challenges during development and initiation. Many clinicians were reluctant and slow to change practices. This required a large amount of education to support the planned initiative. A diabetes-specific screen within the electronic medical record had to be created, and the data available on the screen had to be current, accurate, and easy-to-read. We focused on the 3 most recent labs as well as blood pressure and body mass measurements. This required significant use of our IT resources to design and program these changes.
The ongoing maturation of medical informatics now enables frontline clinicians to adopt disease management capabilities previously reserved for specialized programs. Data can now be leveraged at the frontlines for patient care improvement. As the fundamental structure and process of primary care begin to change, active engagement of frontline clinicians and clinical performance improvement is critical to sustainable change in improvement.
Slide 68: In conclusion, diabetes is a very complex, difficult-to-treat disease. It requires a disciplined, structured approach to successfully treat patients. This treatment approach requires both patience and persistence on the caregiver's side and compliance and adherence on the patient’s. Managed care organizations can contribute to improving the care of its members with diabetes by using pay-for-performance programs to provide incentives to their physicians to meet realistic quality standards of care. They can also assist their physicians in this task by providing the infrastructure necessary to acquire, sort, and display the types of utilization information that assists physicians in making good therapy choices.
This concludes my presentation. Thank you very much for your attention.
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