Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist collaboration in diabetes care
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Pharmaceutical Care, Collaborative Practice
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
Sites / Locations
- Lahey Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Received collaborative care including a clinical pharmacist practitioner.
Patients received usual care directed by their physician.
Outcomes
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.
Secondary Outcome Measures
Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.
Full Information
NCT ID
NCT00541606
First Posted
October 9, 2007
Last Updated
May 15, 2009
Sponsor
Lahey Clinic
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00541606
Brief Title
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
Acronym
PAMPERED
Official Title
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lahey Clinic
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Pharmaceutical Care, Collaborative Practice
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Received collaborative care including a clinical pharmacist practitioner.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients received usual care directed by their physician.
Intervention Type
Other
Intervention Name(s)
Pharmacist collaboration in diabetes care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Cushing, MD
Organizational Affiliation
Lahey Clinic, Burlington, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Jacobs, PharmD
Organizational Affiliation
Currently: Northeastern University, Boston, MA
Official's Role
Study Director
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
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