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Trends in Complexity of Diabetes Care in the United States From 1991 to 2000
Richard W. Grant, MD, MPH;
Paul A. Pirraglia, MD, MPH;
James B. Meigs, MD, MPH;
Daniel E. Singer, MD
Arch Intern Med. 2004;164:1134-1139.
ABSTRACT
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Background During the decade from 1991 to 2000, the standard of care for diabetes mellitus evolved to require more intensive management of glycemia, blood pressure, and cholesterol levels.
Methods To assess changes in the complexity of outpatient management of diabetes, we used nationally representative data from the National Ambulatory Medical Care Survey. For 4708 primary care visits by patients with diabetes from 1991 to 2000, we characterized trends in the number of prescribed medicines, management of hyperglycemia, hypertension, and hyperlipidemia, provision of diabetes-related ambulatory services, and visit length.
Results From 1991 to 2000, the annual proportion of primary care visits listing at least 5 prescription medicines increased from 18.2% to 29.9% (P<.001). We found increases in visits listing oral medications for control of glucose levels (37.2% to 50.5%; P<.001), antihypertensive agents (35.9% to 42.3%; P<.001), and medications for lowering of lipid levels (4.1% to 17.3%; P<.001), whereas visits listing insulin treatment decreased from 25.3% in 1991 to 15.3% in 2000 (P<.001). Provision of diabetes-related ambulatory services remained stable (blood pressure measurement, cholesterol level testing, and dietary and smoking cessation counseling) or increased (exercise counseling; P = .01). The proportion of visits longer than 20 minutes increased from 17.8% in 1991 to 20.9% in 2000 (P = .02 for trend).
Conclusions Office-based management of diabetes has changed significantly during the study decade. We found a marked increase in medical regimen complexity, a modest increase in visit length, and stable or increased provision of diabetes-related screening and counseling services. The increasing complexity of medical care combined with limited time during clinic visits may represent a barrier to achieving evidence-based goals of diabetes care.
INTRODUCTION
During the decade from 1991 to 2000, results from clinical trials have expanded the evidence base for diabetes care1-10 and led to practice guidelines that emphasize the need for aggressive control of hyperglycemia, hypertension, and hyperlipidemia.11-19 As a result of these advances in our understanding of diabetes, patients now typically require multiple medications to reduce the risk for microvascular and macrovascular disease complications.20 In addition, diabetes self-care, smoking cessation, dietary and exercise counseling, and other preventive care services are now recognized as critical components of effective management.21-28
During this same time span, financial constraints have placed increased pressure on physicians to see more patients in less time.29-30 Indeed, several physician surveys have reported that clinicians feel increasingly pressed for time during clinic visits.31-35 Despite physician perceptions, Mechanic and colleagues36 found that the overall amount of time physicians spend with patients actually increased by 1 to 2 minutes from 1989 to 1998.
We tested the hypothesis that complexity of ambulatory care for patients with diabetes has increased in the decade from 1991 to 2000. Using the National Ambulatory Medical Care Survey (NAMCS), we analyzed data from the study decade to assess trends in patterns of medication prescription, provision of recommended diabetes-related preventive services, and visit length in patients with diabetes. We also stratified our sample and applied regression models controlling for visit length to determine whether increases in complexity of care occurred independent of visit duration.
METHODS
The NAMCS, conducted by the National Center for Health Statistics (NCHS), collects data from US office-based physicians on an annual basis. For each year, a systematic sample of clinic visits to a participating physician during a single week is randomly chosen. For each visit, the physician or a member of the clinic staff provides information about patient characteristics, physician and practice characteristics, the reason for the visit, medications prescribed, diagnoses made, services provided, and visit duration. Visit duration is defined as time spent by the physician in face-to-face contact with the patient. Further details of the survey methods can be found at the NCHS Web site (available at: http://www.cdc.gov/nchs/about/major/ahcd/namcsdes.htm).
We restricted our analysis to visits by adult patients with diabetes mellitus (age, >18 years) to primary care physicians (internists, general practitioners, and family physicians) from 1991 to 2000. The NAMCS response rates varied from 65.7% to 73.3%. We selected all visits with diagnosis codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), ranging from 250.00 through 250.90 to identify patients with diabetes (excluding gestational diabetes). During the study years, the number of annual visits by patients with diabetes sampled each year ranged from 374 to 631, corresponding to a range of less than 15 million to greater than 26 million annual visits nationwide.
We used several measures of care complexity. The total number of medications that could be reported in the NAMCS survey increased from a maximum of 5 in 1991 to 1994 to a maximum of 6 in 1995 to 2000. We defined a complex medical regimen as consisting of at least 5 medications, and we determined the proportion of visits from 1991 to 2000 during which at least 5 medicines were listed. In subsidiary analyses, we also assessed trends in proportion of visits with at least 4 and at least 3 medicines listed.
To assess management of hyperglycemia, hypertension, and hyperlipidemia3 central components of the diabetes metabolic syndromewe categorized medicines used to treat each of these conditions and assessed the proportion of patient visits with these medicines listed each year. In addition, within the category of glycemic medicines, we assessed annual changes in visits listing insulin therapy and annual changes in visits listing more than 1 oral glycemic medicine. For hypertension, we also assessed annual changes in visits listing more than 1 antihypertensive medicine and visits listing angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.
Data on the following 5 diabetes-related ambulatory services were collected for most years from 1991 to 2000: blood pressure monitoring, cholesterol level testing, and counseling about diet, exercise, and smoking cessation. We assessed the proportion of visits during which each of these 5 diabetes-related services were provided and used data from available years to test trends during the decade in provision of these services. The survey did not assess hemoglobin A1c or glucose level testing, foot examinations, or referral for ophthalmologic examination.
We assessed trends from 1991 to 2000 in univariate analyses using the 2 test for trend for dichotomous variables and bivariate linear models for continuous variables. Because the distribution of data for visit duration was skewed, we analyzed mean and median visit duration and reported the proportion of visits longer than 20 minutes (corresponding to the highest quartile of visit length). In a subgroup analysis, we restricted our sample to visits by patients being seen by a physician who had seen them before (ie, an established patient visit rather than a new patient visit).
We constructed logistic regression models to determine the annual change in proportion of visits by diabetic patients that listed at least 5 medications, an agent to control glucose levels, an antihypertensive, or a medicine to lower lipid levels. The models controlled for age, sex, race/ethnicity (white vs nonwhite), insurance status, physician type (internist vs noninternist), type of diabetes, and visit duration. Diabetes was classified as type 2 vs type 1 or unspecified on the basis of the ICD-9-CM diagnosis codes.
We used the method by Potthoff et al37 of modified sample weights to calculate 95% confidence intervals (CIs) and generalized estimating equations in our models to take into account clustering effects by physician. Sampling variables to account for sampling design and clustering effects were publicly available from the NCHS only for the years 1995 to 2000. To validate our method of estimating standard error, we compared our results limited to the years 1995 to 2000 with those produced for these years through analysis in SAS-callable Sudaan (Release 8.0.1; Research Triangle Institute, Research Triangle Park, NC), a method that includes the sampling variables provided by the NCHS. The estimates and standard errors for both methods were nearly identical (point estimate and standard error variation of less than 4%), and thus we report the longer-term trends from 1991 to 2000. We used SAS software for all analyses (version 8.2; SAS Institute, Cary, NC), and P<.05 was taken to indicate statistical significance.
RESULTS
PATIENT CHARACTERISTICS
We analyzed 4708 primary care visits by patients with diabetes from 1991 to 2000, representing an average of 19.6 million visits per year. Overall, the mean ± SD patient age was 62.4 ± 12 years; 55.4% were women; 32.3% were of nonwhite race/ethnicity; and 87.2% had type 2 diabetes mellitus. There was a small but statistically significant trend of increasing proportion of visits by men and by patients with prepaid insurance from 1991 to 2000 (Table 1).
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Table 1. Characteristics of Patients With Diabetes With Clinic Visits From 1991 to 2000*
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CHANGES IN MEDICAL REGIMEN COMPLEXITY
There was a significant increase in the number of prescription medicines reported at office visits from 1991 to 2000. In an unadjusted analysis, the proportion of patients prescribed at least 5 medicines increased in a linear trend from 18.2% in 1991 to 29.9% in 2000 (P<.001 for trend). Significant annual increases were also seen for patients prescribed at least 4 medicines (25.9% to 43.9%; P<.001) or at least 3 medicines (40.4% to 55.2%; P<.001) (Figure 1).
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Figure 1. Trends in the total number of prescribed medicines, 1991-2000.
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Overall, the proportion of patients taking medicines for control of glucose levels (including insulin, sulfonylureas, metformin hydrochloride, thiazolidinediones, and -glycosidase inhibitors) remained stable (62.5% of sampled visits in 1991 vs 65.8% of sampled visits in 2000; P = .16 for annual trend). Within this category of glucose level control, however, there was a significant decline in annual visits with insulin listed (from 25.3% of visits in 1991 to 15.3% in 2001; P<.001 for annual trend) balanced by an increase in visits listing oral medicines (from 37.2% in 1991 to 50.5% in 2001; P<.001). Before 1995, less than 0.5% of visits listed more than 1 oral agent for control of glucose levels. With the approval of metformin use in the United States in 1995, the annual proportion of visits listing more than 1 agent for control of glucose levels climbed from 1.2% in 1995 to 17.1% in 2000.
We found a significant increase in the proportion of patient visits listing antihypertensive medicines (35.9% to 42.3%; P<.001) from 1991 to 2000. In particular, the proportion of visits listing angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers increased from 9.3% to 25.7% (P<.001). Most patients were receiving a single antihypertensive agent, with the proportion of visits that listed more than 1 antihypertensive agent remaining fairly stable (ranging from 8.7% in 1991 to 11.7% in 2000; P = .15 for trend). Visits that listed medicines to lower lipid levels (hydroxymethylglutarylcoenzyme A reductase inhibitors, fibrates, niacin, and resins) also increased significantly (from 4.1% in 1991 to 17.3% in 2000; P<.001) during the study decade (Figure 2).
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Figure 2. Trends in pharmaceutical treatment of hyperglycemia, hypertension, and hyperlipidemia, 1991-2000.
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After controlling for age, sex, race/ethnicity, insurance status, physician type, and diabetes type, the proportion of patient visits with 5 or more medicines listed increased by 10.6% per year from 1991 to 2000 (95% CI, 6.0%-15.0%; P<.001). Further controlling for visit duration did not significantly affect this relationship (10.1% annual increase in proportion of patient visits with 5 medicines listed; 95% CI, 6.6%-13.5%; P<.001). In similar regression models controlling for patient and physician characteristics and visit duration, the proportion of annual visits listing any agent for lowering of glucose levels, any antihypertensive medicines, or more than 1 antihypertensive agent did not change significantly (P>.05 for each medicine category). In contrast, there was a significant annual decrease in visits with insulin listed (6.3% decline per year; 95% CI, 10% to 2%; P = .002) and an increase in visits with angiotensin-converting enzyme inhibitors (12.9% increase per year; 95% CI, 9%-16.9%; P<.001) or medicines for lowering of lipid levels (19.1% increase per year; 95% CI, 14%-24%; P<.001) listed.
CHANGES IN PROVISION OF DIABETES-RELATED OFFICE-BASED SERVICES
To test whether visits by patients with increasingly complex medical regimens resulted in decreased time spent providing other diabetes-related services, we assessed trends in testing of blood pressure and cholesterol levels and lifestyle counseling during the study decade.
From 1991 to 2000, there were no significant changes in the annual proportion of visits with blood pressure measurement (84.3% of total visits, ranging from 78.2% of visits in 1992 to 93.8% in 1993; P = .16 for annual trend), testing of cholesterol levels (12.1% of total visits, ranging from 8.0% in 1996 to 18.4% in 2000; P = .57 for annual trend), diet counseling (48.3% of total visits, ranging from 42.8% in 1991 to 53.5% in 1997; P = .40 for annual trend), or smoking cessation advice (4.4% of total visits, ranging from 2.7% in 2000 to 7.2% in 1994; P = .38 for annual trend). The proportion of visits during which exercise counseling was provided increased from 22.1% in 1991 to 31.9% of visits in 2000 (P = .01; Table 2).
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Table 2. Proportion of Clinic Visits to Primary Care Physicians by Patients With Diabetes During Which Diabetes-Related Office-Based Services and Counseling Were Provided, 1991-2000*
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Established patients represented 93.5% to 98.7% of all visits for patients with diabetes; trends in regimen complexity and provision of diabetes-related office services were essentially the same in visits by established patients compared with all patient visits.
VISIT DURATION
Mean length of visits by patients with diabetes increased slightly during the study decade. Overall visit duration increased by 2.2 minutes, from a mean ± SD of 17.1 ± 8.0 minutes in 1991 to 19.3 ± 8.2 minutes in the year 2000 (P<.001). In a regression model controlling for age, sex, race/ethnicity, insurance status, physician type, and diabetes type, the trend of increasing visit length persisted (P<.001). The median visit length, 15 minutes, was unchanged from 1991 to 2000. In 1991, 17.8% of visits lasted more than 20 minutes, whereas in 2000, 20.9% of visits lasted more than 20 minutes (P = .02 for trend).
COMMENT
Using nationally sampled survey data, we found that from 1991 to 2000 there was a marked increase in the complexity of ambulatory medical management of diabetes. Increased use of multiple oral hypoglycemic agents and increased treatment of hypertension and hyperlipidemia were the major contributors to increased medical regimen complexity. The trend of increased numbers of prescribed medicines did not appear to result in a compensatory decrease in visits during which other major diabetes-related services were provided. Specifically, rates of blood pressure measurement, testing of cholesterol levels, and counseling about diet and smoking cessation remained stable, and there was an increase in the proportion of visits during which exercise counseling was provided. Because of the sampling design used, NAMCS data provide a representative view of national patterns of ambulatory care. To our knowledge, our analysis of medication number and type, provision of certain diabetes-related services, and visit duration represents a unique assessment of how ambulatory care in the United States has changed over time for patients with diabetes.
Landmark studies demonstrating the value of aggressive control of glycemia,1-2,38 blood pressure,3, 5 and cholesterol levels7-8 were published in the latter half of the 1990s. The marked increase in proportion of patients taking 5 or more medicines likely reflects the increased availability of new medicines to control cardiovascular risk factors and gradual translation of clinical trial data and practice guidelines to community practice. However, national data on rates of glycemic and cardiovascular risk factor control demonstrate a continuing need for even further intensification of therapy to reach the present evidence-based goals of control.39 In particular, the marked relative increase in visits that listed an agent for lowering of lipid levels reflects the very low prescription rates at the beginning of the decade. In 2000, cholesterol level testing and medicines for lowering of lipid levels were each still listed for less than 20% of visits, despite newer guidelines that recommended goals of even lower levels of low-density lipoprotein control for these patients.19 Given that hyperlipidemia is diagnosed in more than half of the diabetic patients who undergo testing,39-40 more aggressive management of this cardiovascular risk factor is clearly needed.
Similarly, previous studies have shown that national rates of effective blood pressure control remain low,41 and increases in therapy for patients with elevated blood pressure are often inadequate.42 We found that although there was a modest increase in the number of patients receiving any therapy for elevated blood pressure, the annual proportion of visits with more than 1 antihypertensive medicine remained persistently low. In clinical trials, most hypertensive patients typically require more than 1 medication and more than one third require 3 medications to achieve adequate control.5-6 Despite the high prevalence of hypertension in patients with diabetes,43-44 our data indicate that most patients are unlikely to be receiving this level of aggressive pharmacotherapy in community practice.
We found that although the annual proportion of visits listing therapy for control of glucose levels remained stable, there was a significant change in insulin use compared with oral therapy. The increase in oral therapy likely reflects the introduction of newer oral agents (particularly metformin45) that can be used in conjunction with other medicines to lower glucose levels. Unfortunately, this change in practice has not resulted in substantial improvement in nationwide levels of glycemic control, with less than half of patients with diabetes reaching current hemoglobin A1c goal levels according to recent survey data.39
The NAMCS samples visit-based information from a broad spectrum of US primary care providers annually, thereby allowing the characterization of nationwide trends in care over an extended period. This survey has several limitations. Because the total number of medicines that could be listed in the NAMCS survey form was capped, we dichotomized number of medicines at 5 or more rather than report trends in total numbers of prescribed medicines. Patients prescribed more than 5 medicines may have had treatment for hyperglycemia, hypertension, or hyperlipidemia that was not listed in the survey, and thus we may have slightly underestimated the proportion of visits during which these medicines were listed. In addition, because the NAMCS does not include visits with dieticians or certified diabetes educators, we may have underestimated the overall provision of preventive services to patients with diabetes.
The unit of analysis in the NAMCS is the clinic visit rather than the patient. Although care is clearly more complex on the basis of medication prescription, we do not know how many different visits an individual patient made in a given year. Our data do not address the possibility that patients are being seen more frequently in later years with the tasks of management spread out over more visits. In addition, because questionnaire-based surveys completed by physicians or by office staff are not a completely objective method of collecting clinical management information, our results need to be corroborated with other sources of outpatient practice data, such as national pharmacy claims. However, because any reporting biases in the survey are not likely to change over time, the trends we report are internally consistent and indicate a true transformation in the complexity of outpatient diabetes care.
We found that visit duration for patients with diabetes has increased modestly, confirming the overall trend reported by Mechanic et al.36 In the NAMCS, most visit lengths were coded in 5-minute increments and thus are imprecise estimates of actual time spent with patients. However, we believe that the significant increase in proportion of visits that were longer than 20 minutes represents a true change during the decade.
Primary care physicians who treat patients with diabetes mellitus are being asked to provide increasingly complex care while maintaining high levels of productivity. Lower goals for hemoglobin A1c levels, blood pressure, and LDL cholesterol levels require physicians to prescribe more medicines and make more frequent adjustments in dosages. In addition, the increased prevalence of polypharmacy requires effective patient-physician communication and patient motivation to maintain high levels of medication adherence. Difficulty in reaching evidence-based goals of diabetes care46 may be due in part to the increasing complexity of care and the limited time that patients and physicians have during clinic visits to address all aspects of this care. Fundamental changes in the way traditional visit-based ambulatory care is delivered to patients with diabetes may be required to translate the efficacy of treatment demonstrated in clinical trials into effective care in community practice.
AUTHOR INFORMATION
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Corresponding author and reprints: Richard W. Grant, MD, MPH, General Medicine Division, Massachusetts General Hospital, 50 Staniford St, Ninth Floor, Boston, MA 02114 (e-mail: rgrant{at}partners.org).
Accepted for publication June 30, 2003.
This study was supported by a Massachusetts General Hospital Primary Care Operations Improvement grant, Massachusetts General Hospital, Boston (Dr Grant); National Research Service Award 2-T321100114 from the National Institutes of Health, Bethesda, Md (Dr Pirraglia); and a career development grant from the American Diabetes Association, Alexandria, Va (Dr Meigs).
We thank David M. Nathan, MD, for his thoughtful comments on an earlier version of the manuscript.
From the General Medicine Division, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston. Dr Pirraglia is now with the Division of General Internal Medicine, Rhode Island Hospital and Brown University, Providence. The authors have no relevant financial interest in this article.
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Chronic Illness 2006;2:59-69.
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Reduced Screening Mammography Among Women With Diabetes
Lipscombe et al.
Arch Intern Med 2005;165:2090-2095.
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The Complexity of Diabetes Care
Childs
Diabetes Spectr. 2005;18:130-131.
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Effects of a medication assistance program on health outcomes in patients with type 2 diabetes mellitus
Strum et al.
Am J Health Syst Pharm 2005;62:1048-1052.
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Adherence to Statin Therapy and LDL Cholesterol Goal Attainment by Patients With Diabetes and Dyslipidemia
Parris et al.
Diabetes Care 2005;28:595-599.
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Quality of Diabetes Care in U.S. Academic Medical Centers: Low rates of medical regimen change
Grant et al.
Diabetes Care 2005;28:337-442.
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Impact of Concurrent Medication Use on Statin Adherence and Refill Persistence
Grant et al.
Arch Intern Med 2004;164:2343-2348.
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