Pharmacist-led Group Medical Visits to Help With Diabetes Management

Project Background: 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.

Project Objectives: To assess whether a non-physician-based, group diabetes behavioral and
pharmacotherapy intervention program for 12 months will: 1. improve cardiac risk factors, 2.
improve health-related quality-of-life, 3. add only minimal institutional cost; when compared
to usual care in veterans with type 2 diabetes.

Project Methods: We propose a 3-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 continue on usual care. Our study endpoints will be the
difference between the 2 groups after 13 months of study enrollment in: 1) hemoglobin a1c,
blood pressure, LDL cholesterol and smoking 2) health-related quality of life (SF-36V)
scores, and 3) healthcare costs from the VA perspective. A total of 250 patients will be
enrolled from 3 VAMC sites and followed for 13 months.

Inclusion Criteria:

Diabetic veterans with HbA1c >7.0% and at least one of the following:

- being a smoker (any cigarette smoking < 30 days)

- having an LDL >100 mg/dl or a blood pressure >130/80 mm Hg documented in at least two
occasions within the last 6 months

- able to participate and discuss their DM and cardiac risk control in a group setting
and sign informed consent

Exclusion Criteria:

- patients without eligible cardiac risk factors within the last 6 months

- those who are unable to attend the group sessions

- or disease conditions such as psychiatric instability (acutely suicidal, psychotic) or
organic brain injury that preclude them from performing DM self-care

- patients with conditions that would preclude them from standard algorithm-based
medication dose titrations such as those who are pregnant or with complex
co-morbidities as defined by New York Heart Association Class 3 or 4 heart failure,
liver cirrhosis, end-stage renal disease on dialysis and end-stage cancer will be
excluded from the study

- all women of childbearing age will have a pregnancy test before study enrollment