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Improving glycemic control in adults with diabetes mellitus: shared responsibility in primary care practices.

ABSTRACT

Background Primary care physicians provide care for most patients with diabetes mellitus, but few have the resources to achieve the level of glycemic control needed to avert complications

Methods. Primary care physicians referred patients with unsatisfactory glycemic control, frequent hypoglycemia, or inadequate self-management to an endocrinologist-directed team of nurse and dietitian educators for a 3-month program of intensive diabetes care. Patients had at least weekly contact with a diabetes educator and received changes in insulin and/or other medication, coupled with extensive individualized instruction. The main outcome measurement was change in glycosylated hemoglobin ([HbA.sub.1c]) level at 3 months.

Results. The first 350 patients who completed the program had overall mean decrease in [HbA.sub.1c] level of 1.7% (95% CI 1.4%-1.9%).

Conclusions. Barriers to improving glycemic control may be overcome by establishment of a system of collaboration between primary care providers and endocrinologist-directed diabetes educators.

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PRIMARY CARE PHYSICIANS provide clinical care for most patients with diabetes mellitus. (1) physicians have the availability of resources that were pivotal to the success of clinical trials such as the Diabetes Control and Complications Trial (DCCT), the Stockholm Diabetes Intervention Study, the Kumamoto Study, and the United Kingdom Prospective Diabetes Study. (2-5) Intensive management in the DCCT and other clinical trials was successfully carried out in patient volunteers by specialty teams of diabetologists, nurses, dietitians, and behavioral specialists, requiring considerable time, effort, and cost. In the absence of such support, it is difficult for primary care physicians to achieve the level of glycemic control that is needed to avert complications. (6-8) In fact, mean [HbA.sub.1c] levels for most patients remain high, despite adequate frequency of visits to primary care physicians. (9-15) Since the resources used in the clinical trials are not widely available, new strategies are needed to fashion methods for the attainment and maintenance of acceptable glycemic control in clinical practice in the general community. (2)

The purpose of this study is to evaluate the effectiveness of a new program to improve the control of patients with diabetes cared for in the primary care setting, without the program's assuming ongoing long-term management of these patients. An initial "pulse" of intensive outpatient care, followed by subsequent surveillance to determine the long-term benefits of this pulse, is examined as an alternative to the long-term continuous care used in the clinical trials. This study analyzes the initial pulse to determine which variables are associated with initial improvement in [HbA.sub.1c] levels. Furthermore, we characterize this collaborative model between primary care and endocrinology that leads to improved glycemic control.

MATERIALS AND METHODS

Patient Enrollment

A total of 568 consecutive unselected adult patients with diabetes mellitus were referred by their primary care physicians to this program at an academic medical center. Of these, 260 patients were referred by 36 primary care physicians in the Vanderbilt Department of Internal Medicine, and 308 patients were referred by 216 community primary care physicians. Patients were referred because of lack of knowledge of diabetes self-management skills, inadequate self-management practices, hyperglycemia refractory to efforts by their primary care physicians, recurrent or severe hypoglycemia, the need to initiate insulin or insulin pump therapy, or for psychosocial situations expected to benefit from patient-empowerment skills provided by diabetes educators. (16) All patients signed an agreement that they would participate in the program for the next 12 weeks. One hundred seven patients (19%) dropped out before completing the program. The most frequent reason cited for dropping out was a financial or health insurance barrier in payment for the clinic visits with the educators. The patients who dropped out did not differ significantly from those who completed the program with regard to mean entry level of [HbA.sub.1c] or duration of diabetes, though they were younger and a higher proportion were male. No grant support was used to aid patient participation. At the time of this analysis, 111 patients had not completed the program and are not part of this report. The first 350 patients who completed the program are the subjects of this report (Table 1). For the purpose of establishing a registry and monitoring personal information, the program was approved by the Institutional Review Board of Vanderbilt University Medical Center.

Establishing Shared Responsibility

During the course of a year-long dialogue involving a primary care physician, an endocrinologist, and a quality improvement professional, the concerns and resources of the primary care physicians and of endocrinology were assessed for the purpose of establishing a model of care that emphasizes shared as opposed to competing responsibilities for a population of individuals with diabetes. (17) Initial concerns among the primary care physicians included the perceived loss of control of their patients, fragmentation of care, inadequate communication about medication changes, and hypoglycemia resulting from intensive insulin administration. As these concerns were raised, solutions were sought. The nurse educators used electronic mail (e-mail) liberally to communicate about medication changes during the program, and the patients returned to the care of the primary physician after completing the program. As the dialogue and interaction progressed, a set of practice patterns evolved into a functional model (Fig 1). Stratification of the patient population with regard to [HbA.sub.jc] level, need for improved self-management practices, and comorbid conditions resulted in agreement for referral criteria and clarification of roles for primary care physicians, diabetes educators, and the endocrinologist.

Outpatient Program

A 12-week intensive outpatient program, consisting of instruction and support in diabetes self-management coupled with adjustment of insulin arid oral hypoglycemic medications, was provided by the educators and supervised by the endocrinologist. Each patient had an initial hour clinic visit with both a nurse diabetes educator and a dietitian, after which subsequent clinic visits were scheduled according to individualized needs. The educational intervention method included the dissemination of information, negotiated behavioral prescriptive efforts, and situational problem-solving that targeted the individual circumstances of the patient The educational intervention content included diet, exercise, self-monitoring of blood glucose, and medication adherence, as well as preventive measures such as foot care and screening for complications. One of the educators, usually the nurse, had at least weekly contact with the patient to recommend changes in insulin dose and/or other diabetes medications. The weekly conta ct was either a clinic visit, a telephone call, or an exchange of e-mall or faxed messages regarding home blood glucose results. The program was intended to last for 12 weeks but was occasionally extended up to a maximum of 12 additional weeks by mutual agreement between the patient and educator, when it was thought that additional intensive contact was necessary to optimize self-management.

Protocols for insulin and oral medication use were developed and supervised by the edocrinologist. Patients who had type 1 diabetes were switched either to a regimen of basal insulin (long or intermediate duration insulin) twice daily and insulin lispro, a rapid-acting human insulin analog, before meals, or to insulin pump therapy, as permitted by their individual circumstances. Obese patients with type 2 diabetes were started on metformin, either alone or added to previous sulfonylurea therapy, unless it was contraindicated or not tolerated. The pharmacologic treatment protocol for type 2 diabetes was similar to that published by DeFronozo. (18) Direct consultation with an endocrinologist was added when there were clinical problems such as comorbid illnesses complicating glycemic control, extreme insulin resistance or sensitivity, or refractory hyperlipidemia. The educators and supervising endocrinologist met at least weekly to review program and patient progress, ensure appropriate medication administratio n, and promote a consistent approach.

Measures

The main outcome variable was the change in [HbA.sub.1c] from entry, using the difference between the value at program entry and the [HbA.sub.1c] value obtained at 3 months after entry into the study. Hemoglobin [A.sub.1c] was measured by high performance liquid chromatography, with a normal range of 4.0% to 6.1%. We monitored hypoglycemia frequency weight, insulin and/or medication dose, number of daily insulin injections, adherence with home blood glucose monitoring, exercise, and activity at entry and at the end of the program. Self-reported episodes of mild hypoglycemia (not requiring assistance of others) were counted as number of episodes per week; episodes of severe hypoglycemia (coma or requiring assistance of others) were counted as number of episodes per year. Clinically important hypoglycemia was defined as two or more episodes of mild hypoglycemia per week or two or more episodes of severe hypoglycemia per year. Adherence with instructions for home capillary blood glucose monitoring was expressed as a ratio of the number of blood glucose tests done per week divided by the number assigned per week. Self-reported exercise habits were counted as minutes of exercise per week. Self-reported daily activity pattern (job) was categorized as sedentary, active, or very active.

Analysis

All data were analyzed using STATA 5.0 (STATA Corp, College Station, Tex). To determine which variables were associated with improvement in [HbA.sub.1c] levels ([HbA.sub.1c] value at the start minus the value at 12 weeks), univariate analysis was done, using the following independent variables: patient characteristics at entry (eg, race, age, body mass index), program-related variables (changes in weight and/or exercise during the program, adherence with instructions for home blood glucose monitoring, starting insulin or insulin pump), and provider-related variables (number of visits and total contacts with educators). Two-sample t tests were used as well as Pearson's product moment correlation in the univariate analysis, with a Sidak correction method to adjust for the "multiple comparison fallacy." Independent variables identified with an association at the P < .25 level in the univariate analysis were included in the multiple regression analysis.

RESULTS

Patient Characteristics

The first 350 consecutive participants included 29% (n = 100) with type 1 diabetes, 27% (n = 94) with type 2 diabetes and previous insulin therapy, and 44% (n = 156) with type 2 diabetes without previous insulin therapy. The mean (SD) [HbA.sub.1c] value at entry was 9.4% (1.9) and was similar in the aforementioned three groups. At entry, the mean duration of diabetes was 10.3 (10.0) years and was lowest in patients without previous insulin therapy. Patients with type 1 diabetes reported a mean of 2.7 mild hypoglycemic reactions per week and a mean of 2.7 hypoglycemic episodes requiring assistance per year. Patients with type 2 diabetes for which they previously received insulin therapy had a mean of 0.8 mild hypoglycemic reactions per week and a mean of 0.6 episodes requiring assistance per year (Table 1).

The mean number of nurse-educator clinic visits was 3.8 (1.7) and the mean number of dietitian clinic visits was 1.7 (1.1), so that the mean total of nurse and dietitian clinic visits was 5.5 (2.3). In addition to clinic visits, each patient had a mean number of telephone and/or e-mail or fax contacts of 3.5 (3.6), so that the mean number of total contacts with the educators was 9.0 (4.6), over an average duration of 14.6 (5.5) weeks in the program. The average individual adhered to recommended self-monitoring of blood glucose, with a ratio of 1 (ie, number of tests done per week equaled number assigned).

Changes During Program

Overall, there was a mean decrease in Hb[A.sub.1c] of 1.7% (95% CI, 1.4%-1.9%). Individuals with type 1 diabetes had the least amount of Hb[A.sub.1c] change, a mean decrease of 1.1% (95% CI, 0.7%-1.6%). Individuals with type 2 diabetes who were taking insulin at the start of the program had a decrease of 1.4% (95% CI, 1.0%-1.7%), while individuals with type 2 diabetes who were not taking insulin at the start had the greatest decrease in Hb[A.sub.1c], a mean decrease of 2.3% (95% CI, 1.9%-2.7%) (Fig 2).

Among patients who used insulin at entry, 69 had episodes of mild hypoglycemia 2 or more times per week, episodes of severe hypoglycemia requiring assistance 2 or more times per year, or both. These patients had a decrease in frequency of mild hypoglycemia from a mean of 3.9 per week at entry to 2.3 per week by the end of the program (P < .01). Only 2 patients had an episode of hypoglycemia requiring assistance during the program.

There was no significant mean weight change in any of the three groups during the program, despite the decrease in Hb[A.sub.1c]. Although increased exercise was uniformly recommended and some patients began exercise programs or increased their activity, no mean change in self-reported dally exercise was documented.

The multiple regression analysis included only those variables with a P < .25 in the univariate analysis (Table 2). The final model had an [R.sup.2] of 0.61, with the Hb[A.sub.1c] value at entry, type of diabetes, duration of diabetes, and sex all contributing significantly to the final predictive model. A high Hb[A.sub.1c] level at entry was the variable most highly correlated with change in Hb[A.sub.1c]. Sex was a significant predictor of change in Hb[A.sub.1c], with men having a greater change in Hb[A.sub.1c] (1.9% vs 1.4%). Race, presence of hypoglycemia, and change in exercise habits were not predictive of change in Hb[A.sub.1c] in the multiple regression analysis.

DISCUSSION

This report proposes a model that defines the interaction between the providers of diabetes care. It is based on the assumption that the primary care physician has ultimate responsibility for overall management but lacks resources and time to achieve desired glycemic outcomes for many patients. Differences between specialists and generalists in terms of knowledge, patterns of care, and clinical outcomes of care for a broad range of diseases have been reviewed. (19) Rather than debate whether primary care physicians or specialists (endocrinologists) provide better care for patients with diabetes, this model acknowledges that primary care physicians and endocrinologists share the responsibility for management of a population of patients with diabetes. It emphasizes that mutually accepted guidelines should outline the interaction between the providers for optimal management of the population (Fig 1). The model proposes a new role for the endocrinologist, not only as a consultant for patients with complex or refr actory disease, but also as a support for primary care physicians, with duties including the provision and maintenance of a computerized registry of the population of patients with diabetes, the direction of educational programs for both physicians and patients, and the supervision of nurse and dietitian educators.

The triangular interaction between diabetic patients, their primary care physicians, and specialists could be the dominant factor that ultimately determines the quality and the most appropriate type of care. (20) Primary care-based disease management programs that bolster rather than undermine primary care have the potential to improve outcomes for patients with chronic disease. (21) Although the need for expertise plays some role, the effect of the organized system plays the major role in responding to the needs of the chronically ill patient. (22) A Dutch study has shown that the implementation of a structured, shared care system in general practice, with the availability of a diabetologist-supervised diabetes support service, results in sustained good glycemic control (23)

The diverse characteristics and expectations of primary care physicians are important factors that can affect their interaction with specialty services. Some prefer the specialty service to manage the diabetes, while others expect only recommendations, having the patient return for ongoing care. (20) A system of shared care in Australia emphasized the complementarity of primary and secondary care, encouraging primary care physicians to manage the patients in the community, while facilitating access to specialized services for patients who required them. (24) A system of "integrated" care in Aberdeen, Scotland, where diabetic patients were seen in general practice every 3 or 4 months and in a specialist hospital clinic annually, had coordination of all appointments and recall of patients facilitated by a computer-based record system, run by the specialist clinic. Patients were sent computer-generated letters reminding them of routine appointments with their general practitioner, and the general practitioner r eceived a computer-generated reminder letter that the patient was due, together with the most recent clinical data. Thirty percent of the cost of integrated care was due to maintaining the clinical database and operating the appointment-prompting system. (25) Prospective studies of shared care are needed that take into account complexities and interactions of setting, provider interest, and patient preferences. (26)

Greenhalgh (27) reviewed all published reports of shared care initiatives in diabetes in the UK. He defined shared care as "the joint participation of hospital consultants and general practitioners in the planned delivery of care for patients with a chronic condition, informed by an enhanced information exchange over and above routine discharge and referral notices." He concluded that there was unequivocal failure to produce acceptable levels of process and outcome with unstructured care by general practitioners; but that there was potential for high standards' of diabetes care if structured care from a committed primary health care team was combined with a high degree of support and enthusiasm from a specialist. (27) Primary care physicians cite patient non-adherence to the treatment regimen as the most common barrier to care. (28) The primary care providers' attitudes toward diabetes, rather than knowledge, may constitute a significant barrier to effective diabetes care. (29)

This study attempts to overcome some of the barriers by developing a model to improve glycemic control in primary care practices and then analyzing the operation and results of the model. It shows that a 3-month "pulse" of intensive outpatient counseling and treatment, consisting of an average combination of 4 outpatient visits with a diabetes nurse-educator, 2 outpatient visits with a dietitian, and weekly contact by telephone, fax, or email, resulted in important improvement in [HbA.sub.1c] levels. The additional nurse and dietitian clinic visits cost an average of $319.70 per patient. The intervention was unique because diabetes nurse-educators combined standard patient education techniques with initiation of or changes in insulin and other medications, under supervision of an endocrinologist. Significant decreases in [HbA.sub.1c] were observed across the entire clinical spectrum of diabetes mellitus, including type 1 diabetes and type 2 diabetes with or without insulin therapy The magnitude of the observ ed initial fall in [HbA.sub.1c] was similar to that observed during the first 6 months of the DCCT intensive treatment cohort. (2)

The level of [HbA.sub.1c] at entry was the most significant predictor of the fall in [HbA.sub.1c] during the program. Thus, patients with the worst glycemic control at entry benefited most from this pulse of intervention. According to guidelines of the American Diabetes Association, further action should be taken when a patient's [HbA.sub.1c] level exceeds 8%. (30)

Another independent predictor of improvement in [HbA.sub.1c] was type 2 diabetes. Patients with type 2 diabetes had shorter duration of diabetes, particularly those who had not received insulin before this program. More options for medication changes exist in these patients than in those with type 1 diabetes.

Weight gain is a frequent accompaniment of improved glycemic control. (31) All patients were warned of the risk of weight gain at entry to the program, and dietary counseling emphasized caloric restriction and exercise to prevent it. It was surprising that no mean weight gain occurred in these patients during the period that Hb[A.sub.Ic] level improved, suggesting that some effective caloric restriction occurred. The addition of metformin in patients with type 2 diabetes and the inclusion of intensive and repeated dietary counseling as an integral part of the program may have been partly responsible for the lack of weight gain.

This study has several important limitations. Sampling consisted of consecutively referred patients, and thus the population from which they were drawn is poorly defined. It is likely that the referred patients were not representative of the entire population but represent patients who were refractory to the efforts of their primary care physicians and willing to participate in a diabetes improvement program. Second, the intervention was not controlled and represents a case series rather than a randomized trial. Before generalizing the impact of the intervention, it should be tested in a controlled setting. Notwithstanding, the effect is not likely the result of regression to the mean, since patients had refractory, sustained hyperglycemia before referral. Third, follow-up beyond 3 months was incomplete and will be the subject of a future report. We consider this initial 3-month "pulse" an initial treatment phase, with the duration of effect unknown. Long-term studies are needed to determine the necessity for repeated pulses and their optimal content, intensity, duration, and frequency required to maintain glycemic control.

[FIGURE 2 OMITTED]
TABLE 1

Patient Characteristics at Entry

 Type 2

 Previous Insulin
 Type 1 Therapy
 (N = 100) (N = 94)

Age * 39.0 (14.6) 57.0 (11.7)
Female (%) 53.0 59.0
Race
 White (%) 80.0 62.8
 African American (%) 5.0 21.3
 Other/unknown (%) 14.0 14.9
Years of diabetes * 16.2 (11.4) 12.8 (8.9)
[HbA.sub.1c] value at entry * 9.1 (1.8) 9.5 (1.6)
Body mass index * 26.1 (5.2) 34.0 (8.2)
Previous hypoglycemia
 Mild (episodes/wk) * + 2.7 (3.0) 0.8 (1.6)
 Severe (episodes/yr) * + 2.7 (11.4) 0.6 (4.2)
Daily insulin dose * 52.6 (37.0) 68.4 (43.9)
Insulin injections per day * 2.2 (1.4) 2.0 (0.8)
Sedentary job (%) + 25.0 58.5
No exercise (%) + 37.0 48.9
Insurance (%)
 Medicare 13.0 24.5
 Medicaid 13.0 13.8
 Commercial 57.0 54.3
 Other/unknown 17.0 7.4

 Type 2

 No Previous
 Insulin Therapy All
 (N = 156) (N = 350)

Age * 55.0 (12.8) 51.0 (15.2)
Female (%) 54.0 55.0
Race
 White (%) 65.2 68.9
 African American (%) 17.4 14.9
 Other/unknown (%) 14.1 14.4
Years of diabetes * 5.0 (6.3) 10.3 (10.0)
[HbA.sub.1c] value at entry * 9.6 (2.1) 9.4 (1.9)
Body mass index * 34.9 (9.3) 31.7 (8.8)
Previous hypoglycemia
 Mild (episodes/wk) * + 0.1 (0.4) 1.0 (2.1)
 Severe (episodes/yr) * + 0 0.9 (6.5)
Daily insulin dose * 0 33.4 (42.9)
Insulin injections per day * 0 1.2 (1.4)
Sedentary job (%) + 53.5 46.6
No exercise (%) + 54.8 48.0
Insurance (%)
 Medicare 22.6 20.6
 Medicaid 8.4 11.1
 Commercial 48.4 52.3
 Other/unknown 20.6 16.0

* Mean (SD).

+ Self-report.
TABLE 2

Predicting change in [HbA.sub.1c] by Multiple Regression Analysis

Variable Coefficient 95% CI P Value

[HbA.sub.1c] value at start 0.66 0.57 to 0.75 .000
Type of diabetes 0.38 0.10 to 0.66 .001
Sex -0.49 -0.83 to -0.15 .005
Duration of diabetes -0.02 -0.04 to -0.01 .018
Change in exercise 0.001 -0.00 to 0.00 .26
Hypoglycemia at start * 0.14 -0.34 to 0.63 .56
Race -0.08 -0.45 to 0.29 .66
Constant -4.98

* Either mild or severe hypoglycemia.

[R.sup.2] = 0.61.

N = 191.


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RELATED ARTICLE: KEY POINTS

* Primary care physicians provide clinical care for most patients with diabetes mellitus, but it is difficult for them to achieve desired levels of glycemic control.

* New strategies are needed to attain and maintain acceptable glycemic control in clinical practice.

* A model that defines the interaction between the clinical providers of diabetes care is proposed.

* An endocrinologist-directed team of nurse and dietitian diabetes specialists was able to improve glycemic control in a 3-month outpatient program of intensive diabetes care.

From the Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tenn.

Reprint requests to Alan L. Graber, MD, Vanderbilt University Medical Center, 2558 TVC, Nashville, TN 37232.
COPYRIGHT 2002 Southern Medical Association
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Author:Brown, Anne
Publication:Southern Medical Journal
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Date:Jul 1, 2002
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