Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
|ClinicalTrials.gov Identifier: NCT00541606|
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : May 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Pharmacist collaboration in diabetes care Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)|
|Study Start Date :||September 2000|
|Actual Study Completion Date :||July 2004|
Received collaborative care including a clinical pharmacist practitioner.
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.
Active Comparator: Control
Patients received usual care directed by their physician.
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.
- 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 included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541606
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||Gary Cushing, MD||Lahey Clinic, Burlington, MA|
|Study Director:||Michelle Jacobs, PharmD||Currently: Northeastern University, Boston, MA|