Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

NCT00541606 | Completed DMC

• 1 other identifier: PAMPERED
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Pharmaceutical Care; Collaborative Practice

Outcome Measures

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.

  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.

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Received collaborative care including a clinical pharmacist practitioner.

Other: Pharmacist collaboration in diabetes care

Control

ACTIVE COMPARATOR

Patients received usual care directed by their physician.

Other: Usual care

Interventions

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead
• Pfizer: collaborator

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gary Cushing, MD

  Lahey Clinic, Burlington, MA

  PRINCIPAL INVESTIGATOR

• Michelle Jacobs, PharmD

  Currently: Northeastern University, Boston, MA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2000
• Study Completion: July 1, 2004
• Last Updated: May 19, 2009

Record last verified: 2009-05

Locations

US (1)