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	Behavior: Pharmacist recommendations to primary care providers

Further Study Details: 

Primary Outcomes: 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 Outcomes: Percentage of pharmacist recommendations accepted by primary care providers within 30 days after index visit
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Massachusetts
      Brigham and Women''''s Hospital, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Rebecca J Cunningham, MD,  Principal Investigator,  Brigham and Women''''s Hospital   

Study ID Numbers:  2003-P-000950/2; BWH
Last Updated:  August 1, 2005
Record first received:  July 19, 2005
ClinicalTrials.gov Identifier:  NCT00122421
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23