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

NCT ID: NCT00122421

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-02-28

Brief Summary

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pharmacist recommendation

recommendations based on chart review by pharmacist, given to pcp at time of visit

Group Type: ACTIVE_COMPARATOR

Pharmacist recommendations to primary care providers

Intervention Type: BEHAVIORAL

recommendations based on chart review by pharmacist, given to pcp at time of visit

pharmacist recommendations

Intervention Type: OTHER

recommendations based on chart review by pharmacist, given to pcp at time of visit

usual care

usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist recommendations to primary care providers

recommendations based on chart review by pharmacist, given to pcp at time of visit

Intervention Type: BEHAVIORAL

pharmacist recommendations

recommendations based on chart review by pharmacist, given to pcp at time of visit

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rebecca J. Cunningham

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca J Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2003-P-000950/2; BWH

Identifier Type: -

Identifier Source: org_study_id