Improving Diabetes Care for African Americans

March 20, 2009 updated by: Harvard Vanguard Medical Associates

The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care

The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c <7.0), LDL cholesterol (<100 mg/dL), and blood pressure (<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.

Study Type

Interventional

Enrollment (Anticipated)

6000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02466
        • Harvard Vanguard Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
  • At least 18 years old
  • At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years

Exclusion Criteria:

  • Any patient not categorized as either White or Black based on race identifier in the electronic medical record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Intervention clinicians receive monthly performance reports, cultural competency training, and health navigation training
Behavioral: Expanded Chronic Care Model
Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.
No Intervention: 2
Control clinicians function within the context of the generic chronic care model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of LDL cholesterol control (< 100 mg/dL)
Time Frame: 12 months
12 months
Rate of blood pressure control (< 130/80 mmHg)
Time Frame: 12 months
12 months
Rate of HbA1c control (<7%)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of HbA1c control (<8%)
Time Frame: 12 months
12 months
Rate of LDL cholesterol control (< 130 mg/dL)
Time Frame: 12 months
12 months
Rate of blood pressure control (< 140/90 mmHg)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Vanguard Medical Associates

Collaborators

Brigham and Women's Hospital
Harvard University

Investigators

  • Principal Investigator: Thomas D Sequist, MD, MPH, Harvard Vanguard Medical Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2009

Last Update Submitted That Met QC Criteria

March 20, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59751

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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