Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lahey Clinic
- Enrollment
- 285
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.(12 months)