Pharmacist-led Group Medical Visits to Help With Diabetes Management

NCT ID: NCT00554671

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-06-30

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

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pharmacist-led Group Visits

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

Group Type: EXPERIMENTAL

Algorithm driven medication titration

Intervention Type: OTHER

Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes

Monitoring

Intervention Type: BEHAVIORAL

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

Group support

Intervention Type: BEHAVIORAL

Peer support are provided in the group setting

Self efficacy

Intervention Type: BEHAVIORAL

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

Usual Care

Patient continues on usual care for diabetes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Algorithm driven medication titration

Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes

Intervention Type: OTHER

Monitoring

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

Intervention Type: BEHAVIORAL

Group support

Peer support are provided in the group setting

Intervention Type: BEHAVIORAL

Self efficacy

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen-Chih H Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

VA Pacific Islands Health Care System, Honolulu

Honolulu, Hawaii, United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19476571 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29672567 (View on PubMed)

Other Identifiers

IAB 06-269

Identifier Type: -

Identifier Source: org_study_id