Clinical trial NCT00554671: Pharmacist-led Group Medical Visits to Help With Diabetes Management
Official title: Group Intervention for DM Guideline Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Keywords: Diabetes Mellitus
Clinical pharmacists
guideline adherence
group medical visits
behavioral modification
pharmacotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-11-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
measure: Hemoglobin A1c
timeFrame: 13 months
Secondary outcomes:
measure: Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment
timeFrame: Baseline and 13 months
measure: Health-care Costs to the VHA
timeFrame: 13 months (during study) and 13 months (after the study) = 26 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
city: Honolulu
country: United States
facility: VA Pacific Islands Health Care System, Honolulu
state: Hawaii
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Wen-Chih H Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Prev Cardiol. 2008 Fall;11(4):195-200. doi: 10.1111/j.1751-7141.2008.00008.x.
citation: 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. doi: 10.1371/journal.pone.0195898. eCollection 2018.