Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— PAMPERED  

Official title:

Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541606
• Other study ID #: PAMPERED
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: May 15, 2009
• Start date: September 2000
• Est. completion date: July 2004

Study information

• Verified date: May 2009
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: July 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.		12 months