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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus
• Intervention / Treatment: Other: Algorithm driven medication titration; Behavioral: Monitoring; Behavioral: Group support; Behavioral: Self efficacy

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
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Health Care System (West Haven)
  • Hawaii
    • Honolulu, Hawaii, United States, 96819-1522
      • VA Pacific Islands Health Care System, Honolulu
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VA Medical Center, Providence, RI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led Group Visits; Algorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacy	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; Patient continues on usual care for diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Hemoglobin A1c levels at 6 months	6 months
Hemoglobin A1c	hemoglobin A1c levels at 13 months	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment	Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.	Baseline and 13 months
Health-care Costs to the VHA	The reported values represent the "Total VHA expenditure per person". Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0.	13 months (during study) and 13 months (after the study) = 26 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Wen-Chih H Wu, MD, Providence VA Medical Center, Providence, RI

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 5, 2007
• First Submitted That Met QC Criteria: November 6, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Clinical pharmacists; guideline adherence; group medical visits; behavioral modification; pharmacotherapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: IAB 06-269

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No