BACKGROUND/RATIONALE:
Diabetes, hypertension, and dyslipidemia are chronic diseases that can lead to heart attack and stroke, and require interventions at patient and organizational levels to promote sustainable lifestyle and medication changes for cardiac risk reduction that are costly. 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. Our preliminary data have shown that our pharmacist-based, group diabetes management program at the Providence VAMC has achieved significant improvements in glycemic control and variable success toward improvement in blood pressure and lipid control in type 2 diabetic patients, through education, behavioral intervention and aggressive pharmacotherapy in 4 weekly group sessions. However, we do not know the long-term sustainability of this intervention, the exportability, the costs to the VA and the health-related quality-of-life implications of patients enrolled in our programs.
OBJECTIVE(S):
To assess whether a non-physician-based, pharmacist-led group diabetes behavioral and pharmacotherapy intervention program for 12 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 and Connecticut VA Hospital systems.
METHODS:
We propose a 2-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 nurse, a physical therapist, and 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 (SF-36V) scores, and 3) healthcare costs from the VA perspective. 220 patients will be enrolled from the Providence, RI, and West Haven, CT, 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:
No results at this time.
IMPACT:
Diabetes is a major epidemic in the US and especially among veterans. We anticipate this pharmacist-led group intervention will improve the outcome of patients with type 2 diabetes at a minimal added institutional cost.
PUBLICATIONS:
Journal Articles
- Pirraglia PA, Taveira TH, Cohen LB, Wu WC`. The moderating effect of depression diagnosis on the effectiveness of a multi-factorial cardiovascular risk reduction clinic. Preventing Chronic Disease. 2008.
- Pirraglia PA, Taveira TH, Cohen LB, Dooley A, Wu WC. Maintenance of cardiovascular risk goals in veterans with diabetes after discharge from a cardiovascular risk reduction clinic. Preventive Cardiology. 2008.
- Pirraglia PA, Gupta S. The interaction of depression and diabetes: a review. Current Diabetes Reports. 2007; 3(4): 249-51.
