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Completed

NCT Number: NCT00541606

Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist collaboration in diabetes care

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.

Usual Care

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.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: PAMPERED

Important dates

Study start
2000
Study completion
2004
First posted
Oct 10, 2007
Registry last updated
May 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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