Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

NCT ID: NCT00541606

Last Updated: 2009-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-07-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

Intervention

Received collaborative care including a clinical pharmacist practitioner.

Group Type: EXPERIMENTAL

Pharmacist collaboration in diabetes care

Intervention Type: OTHER

Patients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12.

Control

Patients received usual care directed by their physician.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Control patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period.

Interventions

Pharmacist collaboration in diabetes care

Patients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12.

Intervention Type: OTHER

Usual care

Control patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period.

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Lahey Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Gary Cushing, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic, Burlington, MA

Michelle Jacobs, PharmD

Role: STUDY_DIRECTOR

Currently: Northeastern University, Boston, MA

Locations

Lahey Clinic

Burlington, Massachusetts, United States

Countries

United States

Other Identifiers

PAMPERED

Identifier Type: -

Identifier Source: org_study_id