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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Pharmacist collaboration in diabetes care; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 285
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Received collaborative care including a clinical pharmacist practitioner.	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.
Active Comparator: Control; Patients received usual care directed by their physician.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Lahey Clinic
• Collaborators: Pfizer
• Investigators: Principal Investigator: Gary Cushing, MD, Lahey Clinic, Burlington, MA; Study Director: Michelle Jacobs, PharmD, Currently: Northeastern University, Boston, MA

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Study Completion (Actual): July 1, 2004

Study Registration Dates

• First Submitted: October 9, 2007
• First Submitted That Met QC Criteria: October 9, 2007
• First Posted (Estimate): October 10, 2007

Study Record Updates

• Last Update Posted (Estimate): May 19, 2009
• Last Update Submitted That Met QC Criteria: May 15, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2; Pharmaceutical Care; Collaborative Practice
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PAMPERED