Clinical trial NCT00541606: Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
Official title: Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Pharmaceutical Care
Collaborative Practice
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-10-10
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Burlington, MA
name: Gary Cushing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Currently: Northeastern University, Boston, MA
name: Michelle Jacobs, PharmD
role: STUDY_DIRECTOR
References: