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
  Purpose

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 Intervention Phase
Diabetes Mellitus
Cardiovascular Diseases
Other: Algorithm driven medication titration
Behavioral: Monitoring
Behavioral: Group support
Behavioral: Self efficacy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Group Intervention for DM Guideline Implementation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 1 year coronary event risk as measured by the UK Prospective Diabetes Study risk engine [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: May 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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: Arm 2
Patients continued on usual care without pharmacist-led group medical visits

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 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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554671

Locations
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
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908-4799
Sponsors and Collaborators
Investigators
Principal Investigator: Wen-Chih Hank Wu, MD VA Medical Center, Providence
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00554671     History of Changes
Other Study ID Numbers: IAB 06-269
Study First Received: November 5, 2007
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
Clinical pharmacists
guideline adherence
group medical visits
behavioral modification
pharmacotherapy

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

ClinicalTrials.gov processed this record on September 18, 2014