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Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00541606
Acronym
PAMPERED
Enrollment
285
Registered
2007-10-10
Start date
2000-09-30
Completion date
2004-07-31
Last updated
2009-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2, Pharmaceutical Care, Collaborative Practice

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.

Interventions

OTHERPharmacist 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.

OTHERUsual 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.

Sponsors

Pfizer
CollaboratorINDUSTRY
Lahey Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026