Pharmacist-led Group Medical Visits to Help With Diabetes Management (MEDIC-1 year)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554671
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : December 31, 2014
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Cardiovascular Diseases Other: Algorithm driven medication titration Behavioral: Monitoring Behavioral: Group support Behavioral: Self efficacy Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Intervention for DM Guideline Implementation
Study Start Date : May 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Pharmacist-led Group Visits
Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Other: Algorithm driven medication titration
Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes

Behavioral: Monitoring
Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals

Behavioral: Group support
Peer support are provided in the group setting

Behavioral: Self efficacy
Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision

No Intervention: Usual Care
Patients continued on usual care without pharmacist-led group medical visits

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months ]
  2. Hemoglobin A1c [ Time Frame: 13 months ]
    hemoglobin A1c

Secondary Outcome Measures :
  1. Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment [ Time Frame: 13 months ]
  2. Health-care Costs to the VHA [ Time Frame: 13 months (during study) and 13 months (after the study) = 26 months ]
    Institutional costs from health service utilization on the study patients during and 13 months after the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554671

United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Hawaii
VA Pacific Islands Health Care System, Honolulu
Honolulu, Hawaii, United States, 96819-1522
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Wen-Chih Hank Wu, MD Providence VA Medical Center, Providence, RI

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00554671     History of Changes
Other Study ID Numbers: IAB 06-269
First Posted: November 7, 2007    Key Record Dates
Results First Posted: December 31, 2014
Last Update Posted: April 24, 2015
Last Verified: October 2014

Keywords provided by VA Office of Research and Development:
Diabetes Mellitus
Clinical pharmacists
guideline adherence
group medical visits
behavioral modification

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases