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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00541606
First received: October 9, 2007
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Other: Pharmacist collaboration in diabetes care
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months ]

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

Enrollment: 285
Study Start Date: September 2000
Study Completion Date: July 2004
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541606

Locations
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Pfizer
Investigators
Principal Investigator: Gary Cushing, MD Lahey Clinic, Burlington, MA
Study Director: Michelle Jacobs, PharmD Currently: Northeastern University, Boston, MA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00541606     History of Changes
Other Study ID Numbers: PAMPERED
Study First Received: October 9, 2007
Last Updated: May 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Diabetes Mellitus, Type 2
Pharmaceutical Care
Collaborative Practice

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013