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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

October 9, 2007
May 15, 2009
September 2000
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00541606 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
  • 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.
  • 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.
  • Experimental: Intervention
    Received collaborative care including a clinical pharmacist practitioner.
    Intervention: Other: Pharmacist collaboration in diabetes care
  • Active Comparator: Control
    Patients received usual care directed by their physician.
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
285
July 2004
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00541606
PAMPERED
Yes
Not Provided
Lahey Clinic
Pfizer
Principal Investigator: Gary Cushing, MD Lahey Clinic, Burlington, MA
Study Director: Michelle Jacobs, PharmD Currently: Northeastern University, Boston, MA
Lahey Clinic
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP