David Edelman, MD; Sonja K. Fredrickson, MD; Stephanie D. Melnyk, PharmD; Cynthia J. Coffman, PhD; Amy S. Jeffreys, MStat; Santanu Datta, PhD; George L. Jackson, PhD; Amy C. Harris, BA; Natia S. Hamilton, BS; Helen Stewart, RN; Jeannette Stein, MD; Morris Weinberger, PhD
Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited.
To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension.
Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741)
2 Veterans Affairs Medical Centers in North Carolina and Virginia.
239 patients with poorly controlled diabetes (hemoglobin A1c [HbA1c] level â‰¥7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg).
Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patient's HbA1c level and blood pressure.
Hemoglobin A1c level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA1c levels and systolic blood pressure between the intervention and control groups.
Mean baseline systolic blood pressure and HbA1c level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (PÂ = 0.011 by linear mixed model), whereas mean HbA1c level improved by 0.8% in the GMC group and 0.5% in the usual care group (PÂ = 0.159).
Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention.
Group medical clinics are a potent strategy for improving blood pressure but not HbA1c level in diabetic patients.
U.S. Department of Veterans Affairs Health Services Research and Development Service.
Many practices lack the resources to train patients with chronic diseases to be active participants in their own care. Group visits during which multiple patients with the same disease receive training could be an efficient way to provide such training.
Among 239 patients with poorly controlled hypertension and diabetes who received either usual care or care that involved group visits, patients who participated in group visits had better blood pressure control than, but similar diabetes control to, patients who received usual care.
Group visits are feasible and can improve outcomes for some, but not all, chronic diseases.
* Developed exclusion criterion (cirrhosis).
The corresponding estimates and 95% CIs from the midpoint of the study were systolic blood pressure, 5.7 mm Hg (CI, 11.4 to 0.1 mm Hg); diastolic blood pressure, 3.8 mm Hg (CI, 6.9 to 0.8 mm Hg); and HbA1c, 0.20% (CI, 0.66% to 0.25%). The corresponding estimates and CIs from the end of the study were systolic blood pressure, 7.3 mm Hg (CI, 12.8 to 1.7 mm Hg); diastolic blood pressure, 3.8 mm Hg (CI, 6.9 to 0.8 mm Hg); and HbA1c, 0.33% (CI, 0.80% to 0.13%). HbA1c = hemoglobin A1c.
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Center for Health Outcomes and Pharmacoeconomic Research, College of Pharmacy, University of Arizona
June 1, 2010
Integrating blood pressure and HbA1c outcomes into total cardiovascular risk as a treatment outcome
Edelman et al. report critical findings on medical clinics versus usual care in patients with both hypertension and diabetes in a carefully designed and analyzed randomized trial. Blood pressure improved but this was not the case for HbA1c. Question is whether medical clinics might have had an impact on a composite endpoint of these two outcomes: total cardiovascular risk.
The tradition of treating separately such conditions as hypertension, diabetes, and dyslipidemia is making way to integrated approaches that recognize the interdependencies in etiology and treatment approaches among them. These conditions have also been integrated into the concept of total (or global) cardiovascular risk, one definition of which has been proposed jointly by the European Society of Hypertension and the European Society of Cardiology . It cross-classifies blood pressure levels by risk factors (e.g. smoking, dyslipidemia), metabolic syndrome, diabetes, and established CV disease (myocardial infarction [MI], coronary artery disease, heart failure, cerebrovascular conditions, peripheral arterial disease) or renal disease. It yields five risk levels for mortality from coronary artery disease: average risk; low added risk; moderate added risk; high added risk; and very high added risk.
Typically, such risk models are used as predictors of cardiovascular mortality and therefore as determinants of treatment outcome. As my colleagues and I have reported in a poster and three submitted manuscripts, total cardiovascular risk can also be used as an outcome variable [2,3,4,5]. Subtracting baseline from follow-up total CV risk yields possible scores from -4 (greatest improvement in total CV risk) to 4 (greatest worsening of total CV risk).
Admittedly, these manuscripts have not yet passed the test of peer review - in addition to being limited to antihypertensive treatment and not the dual outcomes focus of the Edelman et al. study. However, we want to bring the notion of (improvement in) total cardiovascular risk as a treatment outcome to the attention of Edelman et al. as a possible follow- on analysis of their trial results. Several patient outcomes scenarios are possible, best summarized as a two-by-two table of reduction in blood pressure (achieved vs. not achieved) and reduction in HbA1c (achieved vs. not achieved). Thus there may be patients with reductions achieved in both outcomes, in neither outcome, in blood pressure alone, and in HbA1c alone. Each of these is associated with total cardiovascular risk. One could reasonably assume that patients in the Edelman et al. would fall into one of these four possible outcome combinations.
Testing the hypothesis of a reduction in total cardiovascular risk in a medical clinic versus usual care might prove to be an important endeavor in itself, while also providing differential evidence about the inconsistently observed reductions in HbA1c. Our group would certainly be prepared to share its experiences in studying experiences in total cardiovascular risk.
 Guidelines Committee. 2007 European Society of Hypertension / European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2007;25:1105-1187.
 Lins R, Brie H, Hermans C, Aerts A, MacDonald K, Shen Y-M, Coen N, Lee C,Vancayzeele S, Mecum N, Abraham I. Hierarchical modeling of blood pressure and total cardiovascular risk in patients with hypertension treated with amlodipine-valsartan single-pill combinations (EXCELLENT study). Poster presented at the 3rd Annual Meeting of the Belgian Association of Pharmaceutical Physicians, Brussels, Belgium 18 March 2010.
 Lins R, Coen N, Aerts A, MacDonald K, Brie H, Hermans C, Shen Y- M, Lee CS, Vancayzeele S, Mecum N, Abraham, I. Modeling of blood pressure and total cardiovascular risk outcomes after 2nd-line valsartan therapy (B -SCORE study). Submitted.
 Lins R, Aerts A, Coen N, Hermans C, MacDonald K, Lee C, Shen Y-M, Vancayzeele S, Mecum N, Abraham I. Hierarchical modeling of blood pressure and total cardiovascular risk in patients with hypertension treated with amlodipine-valsartan single-pill combination (EXCELLENT Study). Submitted.
 Verpooten G, Aerts A, Coen N, Brie H, Vancayzeele S, Hermans C, Bowles J, MacDonald K, Abraham I, Lee C. Anti-hypertensive effectiveness of aliskiren for the real-world management of hypertension: multi-level modeling of blood pressure outcomes (the DRIVER study). Submitted.
The use of total cardiovascular risk as a treatment outcome, rather than only a determinant of treatment outcome, has been funded by grants and contracts from Novartis.
French League against Hypertension
June 7, 2010
What GMCs really improve?
In a recent article, Edelman et al. (1) seem to show that attending group medical clinics (GMCs) improve blood pressure control but not glucose control in hypertensive patients with diabetes. As far as treatment adherence was not improved in the GMCs group, the hypothesis of a decrease in therapeutic inertia must be considered. Recent studies have demonstrated that this kind of intervention, a priority dedicated to improve adherence and knowledge of the patient, have in fact only promoted treatment intensification by physicians (2). Finally, in African-American patients,who represent the majority of inclusions, behavioral factors related to physicians could explain a large part of uncontrolled blood pressure (3). It could be of importance that authors include in their analysis those factors and provide also the evolution of the number of antihypertensive drugs in both groups to better clarify the role of GMCs in the global care of this growing population .
1) Edelman D, Fredrickson SK, Melnyk S, et al. Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension: A Randomized Trial. Ann Intern Med , 2010 152:689-696
2) Green BB, Cook AJ, Ralston JD, et al. Effectiveness of Home Blood Pressure Monitoring, Web Communication, and Pharmacist Care on Hypertension Control. JAMA. 2008;299(24):2857-2867
3) Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Safran DG, Ayanian JZ. Physician performance and racial disparities in diabetes mellitus care. Arch Intern Med. 2008;168:1145-51
Department of Internal Medicine, University of Turin, Italy
June 16, 2010
Time of exposure and type of diabetes may determine treatment outcome of group clinics.
Edelman and colleagues report encouraging clinical results of Group Medical Clinics in patients with diabetes and hypertension (1). However, they observed that benefits of the group approach were confined to improved blood pressure, rather than better control of glycated haemoglobin. We would like to offer an alternative interpretation for their failure to improve metabolic control.
In an early randomised controlled clinical trial, Ref. 15 in Edelman paper, we were able to improve HbA1c together with quality of life and health behaviours using a similar Group Care approach (7 visits, lasting 60 min, 3 months apart, 8-10 patients per group). Subsequently, we described the 5-year time course of clinical and psychological variables in patients on Group Care and found that it takes at least 2 years to achieve significant advantages compared to controls on usual care (2).
Secondly, we had concentrated on patients with non insulin-treated Type 2 diabetes. When the group approach was applied to patients with type 1 diabetes, we observed no bettering of HbA1c over 3 years despite, again, improved quality of life and it took the addition of a specific carbohydrate counting programme to improve metabolic control (3). We are not told whether the patients seen by Edelman and colleagues had type 1 or 2 diabetes nor, assuming that most had type 2, how many were on insulin.
Third, we were able to confirm that group visits improve metabolic control, and insulin resistance, in the hands of nurses and dieticians (4) and, finally, that training of operators results in the full applicability of the model to other clinics. A recently published multicentre trial in Italy resulted in significantly more patients on Group Care achieving HbA1c <7%, systolic and diastolic blood pressure <130/80 mmHg and LDL cholesterol <100 mg/dl (2.6 mmol/l) (5).
We submit that the group clinic model experimented by Edelman and colleagues might result in improved HbA1c if the observation period were prolonged to at least 2 years, and that patients with type 2 diabetes on diet alone and/or oral agents are more likely to benefit.
Massimo Porta and Marina Trento, Laboratory of Clinical Pedagogy, Department of Internal Medicine, University of Turin, Italy.
1) Edelman D, Fredrickson SK, Melnyk SD, Coffman CJ, Jeffreys AS, Datta S, et al. Medical clinics versus usual care for patients with both diabetes and hypertension. A randomised trial. Ann. Int. Med. 2010; 152:689-696.
2) Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, Porta M. A 5-year randomized controlled study of learning, problem solving ability and quality of life modifications in people with type 2 diabetes managed by group care. Diabetes Care 2004; 27:670-675.
3) Trento M, Borgo E, Kucich C, Passera P, Trinetta A, Charrier L, et al. Quality of life, coping ability, and metabolic control in patients with type 1 diabetes managed by group care and a carbohydrate counting program. Diabetes Care 2009; 32:e134.
4) Trento M, Basile M, E. Borgo, Grassi G, Scuntero P, Trinetta A, et al. A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of type 2 diabetes. J Endocrinol Invest 2008; 31:1038-1042.
5) Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, et al. ROMEO: Rethink Organization To Improve Education And Outcomes. A Multicentre Randomised Trial Of Lifestyle Intervention By Group Care To Manage Type 2 Diabetes. Diabetes Care 2010; 33:745-747.
Durham VA Medical Center
July 22, 2010
Re:Time of exposure and type of diabetes may determine treatment outcome of group clinics.
We appreciate the thoughtful response from Trento et.al. regarding our article (1). We considered the possibility that Hemoglobin A1c (A1c) might be more slowly reactive to interventions than blood pressure as a possible explanation for the fact that our group medical clinic intervention, when compared to usual care, improved systolic blood pressure but not A1c. Because we did not follow patients for more than one year, we cannot exclude Trento et.al.'s hypothesis that we might have seen significant differences between study arms had we continued the intervention longer. However, our leading hypothesis was that there was more available support, and therefore stronger "usual care" for blood sugar management than blood pressure management. This hypothesis is also indirectly supported by the two trials (2, 3) performed by Trento's group. In both trials cited by Trento there was a dramatic worsening in A1c in the usual care comparison group (1.7% over 5 years and 1.0% over 4 years, respectively), with a modest improvement in A1c in the intervention arm (0.1% over 5 years and 0.5% over 4 years in their two trials, respectively); in ours there was a moderate improvement in A1c (0.6% over one year) among usual care patients, with an only slightly greater (0.9%) improvement among patients in the group medical clinics. These findings suggest it is at least plausible that patients in their clinical population were in clinical settings with relatively modest support for glycemic management, and that our intervention may, conversely, have failed to compete successfully with well-supported usual care.
2) Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, et al. ROMEO: Rethink Organization To Improve Education And Outcomes. A Multicentre Randomised Trial Of Lifestyle Intervention By Group Care To Manage Type 2 Diabetes. Diabetes Care 2010; 33:745-747.
3) Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, Porta M. A 5-year randomized controlled study of learning, problem solving ability and quality of life modifications in people with type 2 diabetes managed by group care. Diabetes Care 2004; 27:670-675.
David Edelman, Sonja K. Fredrickson, Stephanie D. Melnyk, Cynthia J. Coffman, Amy S. Jeffreys, Santanu Datta, et al. Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension: A Randomized Trial. Ann Intern Med. 2010;152:689–696. doi: 10.7326/0003-4819-152-11-201006010-00001
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Published: Ann Intern Med. 2010;152(11):689-696.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism, Hypertension.
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