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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00554671
First received: November 5, 2007
Last updated: April 15, 2014
Last verified: April 2014

November 5, 2007
April 15, 2014
May 2008
December 2011   (final data collection date for primary outcome measure)
1 year coronary event risk as measured by the UK Prospective Diabetes Study risk engine [ Time Frame: 13 months ] [ Designated as safety issue: No ]
the ratio of the future coronary event risk at 13 months / baseline as measured by the UK Prospective Diabetes Study risk engine [ Time Frame: 13 months ]
Complete list of historical versions of study NCT00554671 on ClinicalTrials.gov Archive Site
change from the baseline in the hr-QOL as assessed by SF-36V at 13 months of study enrollment [ Time Frame: 13 months ] [ Designated as safety issue: No ]
change from the baseline in the hr-QOL as assessed by SF-36V at 13 months of study enrollment [ Time Frame: 13 months ]
Not Provided
Not Provided
 
Pharmacist-led Group Medical Visits to Help With Diabetes Management
Group Intervention for DM Guideline Implementation

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

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 as measured by the 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 Pacific Islands VA Health Care systems.

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) The 1-year coronary event risk as measured by the UKPDS risk engine (primary endpoint), 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 the Providence, RI; West Haven, CT; and Honolulu, HI; VAMC sites and followed for 13 months. This sample will provide us with greater than 90% power to detect a difference between the means of 0.005 in the primary endpoint, with a two-sided alpha of 5%, and assuming an attrition rate of 20%.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Cardiovascular Diseases
  • 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
  • Experimental: Arm 1
    Pharmacist-led group medical visits which consists of medication titration and behavioral modification
    Interventions:
    • Other: Algorithm driven medication titration
    • Behavioral: Monitoring
    • Behavioral: Group support
    • Behavioral: Self efficacy
  • No Intervention: Arm 2
    Patients continued on usual care without pharmacist-led group medical visits
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554671
IAB 06-269
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Wen-Chih Hank Wu, MD VA Medical Center, Providence
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP