Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Pharmacist collaboration in diabetes care; Other: Usual care

• Registration Number: NCT00541606
• Lead Sponsor: Lahey Clinic

Brief Summary

The purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.

Detailed Description

It is evident that a multi-disciplinary approach is key to the success in controlling the disease of diabetes and its complications. The value of pharmacists' involvement in disease state management in producing positive outcomes for patients has been well documented in the literature. There have been several studies that have shown that pharmacists' involvement in diabetes care improves glycemic control. There are also studies that look at pharmacists' management of glycemic control and adherence to the ADA guidelines. Many of these studies are retrospective, lack a randomized control group, had a small study sample, or were short term. We undertook a prospective, randomized study to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.

Study Timeline

• Study Start: 2000-09
• Study Completion: 2004-07
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• Patients over the age of 18
• A1c > 8% within the 6 months prior to the data acquisition date
• Primary Care physician at Lahey Clinic Burlington site
• Diagnosis of T2 DM for minimum of 6 months

Exclusion Criteria

• Concurrently enrolled in any other pharmacist-run or diabetes study
• Receiving diabetes management by an outside provider
• A medical condition that may adversely affect compliance with the treatment protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pharmacist collaboration in diabetes care	Received collaborative care including a clinical pharmacist practitioner.
Control	Usual care	Patients received usual care directed by their physician.

Primary Outcome Measures

Name	Time	Method
Primary outcomes included the achievement of targets for A1c (< or = 7%), LDL cholesterol (< or = 100 mg/dL) and blood pressure (< or = 130/80), changes in quality of life as measured by the SF-36 Health Survey, and patient satisfaction.	12 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.	12 months

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States