Pharmacist-led Group Medical Visits to Help With Diabetes Management

NCT00554671 | Completed Results DMC

• 1 other identifier: IAB 06-269
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Keywords

Diabetes Mellitus; Clinical pharmacists; guideline adherence; group medical visits; behavioral modification; pharmacotherapy

Outcome Measures

Primary Outcomes (2)

• Hemoglobin A1c

  Hemoglobin A1c levels at 6 months

  6 months

• Hemoglobin A1c

  hemoglobin A1c levels at 13 months

  13 months

Secondary Outcomes (2)

• Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment

  Baseline and 13 months

• Health-care Costs to the VHA

  13 months (during study) and 13 months (after the study) = 26 months

Study Arms (2)

Pharmacist-led Group Visits

EXPERIMENTAL

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

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

Usual Care

NO INTERVENTION

Patient continues on usual care for diabetes

Interventions

Algorithm driven medication titration OTHER

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

Pharmacist-led Group Visits

Monitoring BEHAVIORAL

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

Pharmacist-led Group Visits

Group support BEHAVIORAL

Peer support are provided in the group setting

Pharmacist-led Group Visits

Self efficacy BEHAVIORAL

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

Pharmacist-led Group Visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Pacific Islands Health Care System, Honolulu

Honolulu, Hawaii, 96819-1522, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (2)

• 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.

  PMID: 19476571 BACKGROUND

• 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.

  PMID: 29672567 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Wen-Chih Wu, MD
• Organization: Providence VA Medical Center

wen-chih.wu@va.gov

4012737100

Study Officials

• Wen-Chih H Wu, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 7, 2007
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 11, 2018
• Results First Posted: December 31, 2014

Record last verified: 2018-07

Locations

US (3)