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The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients
This study is ongoing, but not recruiting participants.
Sponsored by: Brigham and Women's Hospital
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00122421
  Purpose

The goal of this study is to investigate a comprehensive provider-focused intervention to improve the quality of care for diabetic patients in a large primary care practice at Brigham and Women’s Hospital. This will be accomplished through pharmacist recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.


Condition Intervention
Diabetes Mellitus
Behavioral: Pharmacist recommendations to primary care providers

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Compliance with the following process measures at 30 days after the index primary care visit: semi-annual HbA1c testing
  • annual lipid screening
  • annual urine protein screening
  • semi-annual BP measurement
  • annual creatinine in patients taking metformin
  • pneumococcal vaccination
  • annual influenza vaccination
  • annual foot and ophthalmologic examinations
  • appropriate use of lipid-lowering medications
  • appropriate use of ACE inhibitors when indicated
  • Compliance with the following process measures at 30 days after the index primary care visit: HbA1c value < 8.0
  • LDL value < 100
  • BP measurement < 130/85

Secondary Outcome Measures:
  • Percentage of pharmacist recommendations accepted by primary care providers within 30 days after index visit

Estimated Enrollment: 300
Study Start Date: June 2003
Estimated Study Completion Date: July 2004
Detailed Description:

Type II diabetes mellitus is an increasingly common condition among adults in the United States and is associated with substantial morbidity and mortality. The microvascular and macrovascular complications of diabetes lead to significant disability and early mortality, in addition to tremendous costs to the healthcare system. It has been clearly demonstrated, that both microvascular and macrovascular complications can be reduced through specific interventions that can be carried out by office-based primary care physicians. Despite the accumulation of evidence regarding specific interventions that can reduce diabetes-related morbidity and mortality, multiple studies have shown that the care provided for diabetic patients frequently falls short of recommended standards.

The researcher's goal is to investigate a comprehensive, provider-focused intervention to improve the quality of care for diabetic patients in a large, primary care practice at Brigham and Women’s Hospital. This will be accomplished through pharmacist-delivered recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

Adult diabetic patients age 18 years and older receiving primary care in the Brigham Internal Medicine Associates (BIMA) practice will be randomized to intervention and control groups, based on the practice subset (Suite) within BIMA in which they receive their ongoing care. Patients who receive care from providers in Suites A, B, E, and F will be assigned to the intervention group, while patients who receive care from providers in Suites C, D, G, and H will be assigned to the control group. Patients will not be contacted regarding the study; providers who practice in the intervention Suites will receive specific written recommendations regarding optimal diabetes care parameters from our study pharmacist prior to each patient's visit. Providers who practice in the control Suites will not be contacted. Pre- and post-intervention compliance with multiple diabetes quality-of-care measures (eg, Hemoglobin A1c measurement, LDL cholesterol measurement, pneumococcal vaccination, etc.) will be assessed in the intervention and control groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of diabetes
  • Age 18 years or older
  • Identifiable primary care physician (PCP)
  • Attendance at index appointment with PCP

Exclusion Criteria:

  • No assigned PCP
  • Non-attendance at PCP appointment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122421

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Rebecca J Cunningham, MD Brigham and Women's Hospital
  More Information

Study ID Numbers: 2003-P-000950/2; BWH
Study First Received: July 19, 2005
Last Updated: July 26, 2005
ClinicalTrials.gov Identifier: NCT00122421  
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
diabetes
quality of care
pharmacist recommendations

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009