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

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VA Office of Research and Development

Status

Completed

Conditions

Diabetes Mellitus
Cardiovascular Diseases

Treatments

Behavioral: Group support
Other: Algorithm driven medication titration
Behavioral: Self efficacy
Behavioral: Monitoring

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00554671
IAB 06-269

Details and patient eligibility

About

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

Full 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.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Pharmacist-led Group Visits
Experimental group
Description:
Algorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacy
Treatment:
Behavioral: Monitoring
Behavioral: Self efficacy
Other: Algorithm driven medication titration
Behavioral: Group support
Usual Care
No Intervention group
Description:
Patient continues on usual care for diabetes

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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