The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca J. Cunningham, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00122421
First received: July 19, 2005
Last updated: February 17, 2012
Last verified: February 2012
  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
Other: pharmacist recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Compliance with process measures at 30 days after the index primary care visit [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    aspirin use, ace inhibitor use, a1c measurement


Secondary Outcome Measures:
  • Percentage of pharmacist recommendations accepted by primary care providers within 30 days after index visit [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    %adherence to recommendations


Enrollment: 300
Study Start Date: June 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pharmacist recommendation
recommendations based on chart review by pharmacist, given to pcp at time of visit
Behavioral: Pharmacist recommendations to primary care providers
recommendations based on chart review by pharmacist, given to pcp at time of visit
Other: pharmacist recommendations
recommendations based on chart review by pharmacist, given to pcp at time of visit
No Intervention: usual care
usual care

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Rebecca J. Cunningham, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00122421     History of Changes
Other Study ID Numbers: 2003-P-000950/2; BWH
Study First Received: July 19, 2005
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014