BACKGROUND/RATIONALE:
Diabetes, hypertension, and dyslipidemia are chronic diseases that can lead to heart attack and stroke, and require costly interventions at patient and organizational levels to promote sustainable lifestyle and medication changes for cardiac risk reduction. Group intervention has emerged as a potentially cost-saving patient-centered approach to help achieve the necessary lifestyle and medication changes for the treatment of some chronic diseases, but its efficacy in absence of direct physician participation is not well demonstrated in diabetes.

OBJECTIVE(S):
To assess whether a non-physician-based, pharmacist-led group diabetes behavioral and pharmacotherapy intervention program for 13 months will: 1. improve cardiac risk as measured by the United Kingdom Prospective Diabestes Study (UKPDS) risk engine, 2. improve health-related quality-of-life, 3. add only minimal institutional cost; when compared to usual care in veterans with type 2 diabetes at Providence, Connecticut and the Pacific Islands VA Hospital systems.

METHODS:
We propose a multi-site randomized-controlled study to test the efficacy of a pharmacist-based, group diabetes behavioral and pharmacotherapy intervention program (treatment arm) for 13 months vs. usual care (control arm) in achieving cardiac risk reduction in type 2 diabetic patients with Hemoglobin A1c >7% and at least one other cardiac risk factor such as smoking, hyperlipidemia or hypertension not at national guideline recommended goals. The interventions in the treatment arm will consist of two phases. Phase 1 (intensive intervention) consists of weekly group sessions of education by a clinical pharmacist, nurse, a physical therapist, and/or a dietician; and behavioral modification and medication titration by a clinical pharmacist targeting the control of glycemia, smoking, blood pressure, and lipids for 4 weeks. Phase 2 consists of quarterly booster sessions for 1 year to prevent relapse. Patients in the control arm will continued on usual care. Our study endpoints will be the difference between the 2 groups after 13 months of study enrollment in: 1) the change from baseline in the UKPDS risk engine score (primary endpoint), 2) health-related quality of life (VR36) scores, and 3) healthcare costs from the VA perspective. 250 patients will be enrolled from the Providence, RI; West Haven, CT; and Honolulu VAMC sites and followed for 13 months. This sample will provide us with >90% power to detect an effect size of 0.50 in the primary endpoint, with a two-sided alpha of 5%, and assuming an attrition rate of 25%.

FINDINGS/RESULTS:
We compared change from baseline in A1C, total cholesterol/HDL ratio, systolic blood pressure (SBP), health-related quality of life and cost between the 2 study arms. Participants were similar in age and gender and baseline risk factors. After 13 months, both cases and controls had significant improvement from baseline in SBP and lipids, but only cases have significant reductions in A1c (mean change = -0.31, P = 0.02 vs. -0.16 for controls, P = 0.17). However, the difference in A1c change or the UKPDS risk score were not significantly different between the study arms. Health-related QOL trended towards greater improvement for the group visit intervention over usual care in both the physical (1.11 vs. -0.23; P = 0.18) and the mental (1.15 vs. 0.37; P = 0.53) health component. Health care system costs including provider time, medications, hospitalization, ER visits and other health service utilization costs was also computed. The intervention arm had a non-significant reduction of an average of $3263.1 (or 15.6%) per patient vs. $887.7 (or 6.3%) in controls in VA health service utilization costs compared to the year prior to the study.

IMPACT:
A pharmacist-led non-physician based group intervention program for Cardiovascular Risk Reduction in Type 2 DM added to usual care significantly improved glycemia from baseline without an additional increase in healthcare costs. However, differences between study arms were not significantly different. Health-related QOL was not adversely impacted by these added health care visits and the physical domains trended towards greater improvement for the group visit intervention over usual care. These data suggest that this additional layer of care is not additive in cost to the VHA. Further cost analyses are pending regarding the potential for cost reductions to the VHA.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Wu WC, Taveira TH, Jeffery S, Jiang L, Tokuda L, Musial J, Cohen LB, Uhrle F. Costs and effectiveness of pharmacist-led group medical visits for type-2 diabetes: A multi-center randomized controlled trial. PLoS ONE. 2018 Apr 19; 13(4):e0195898. [view]
2. Taveira TH, Pirraglia PA, Cohen LB, Wu WC. Efficacy of a pharmacist-led cardiovascular risk reduction clinic for diabetic patients with and without mental health conditions. Preventive Cardiology. 2008 Jan 1; 11(4):195-200. [view]

Conference Presentations

1. Lee DS, Jeffery S, de Rekeneire N, Hanlon JT, Gill JT, Bauer D, Meibohm B, Harris TB. Pharmacist-led Group Medical Visits for Cardiovascular Risk Reduction in Type 2 Diabetes. Poster session presented at: American Diabetes Association Annual Scientific Session; 2012 Jun 8; Philadelphia, PA. [view]

DRA: Diabetes and Other Endocrine Disorders
DRE: Treatment - Observational, Prevention, Treatment - Comparative Effectiveness
Keywords: Clinical practice guidelines, Diabetes, Primary care
MeSH Terms: none