Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

NCT00541606

Last updated date
Study Location
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
Official Title  ICMJE Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Received collaborative care including a clinical pharmacist practitioner.
    Intervention: Other: Pharmacist collaboration in diabetes care
  • Active Comparator: Control
    Patients received usual care directed by their physician.
    Intervention: Other: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2007)
285
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541606
Other Study ID Numbers  ICMJE PAMPERED
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Lahey Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Gary Cushing, MDLahey Clinic, Burlington, MA
Study Director:Michelle Jacobs, PharmDCurrently: Northeastern University, Boston, MA
PRS Account Lahey Clinic
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP