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Improving Diabetes Care for African Americans

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ClinicalTrials.gov Identifier: NCT00436176
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : March 23, 2009
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Expanded Chronic Care Model Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
Study Start Date : June 2007
Primary Completion Date : June 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Rate of LDL cholesterol control (< 100 mg/dL) [ Time Frame: 12 months ]
  2. Rate of blood pressure control (< 130/80 mmHg) [ Time Frame: 12 months ]
  3. Rate of HbA1c control (<7%) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Rate of HbA1c control (<8%) [ Time Frame: 12 months ]
  2. Rate of LDL cholesterol control (< 130 mg/dL) [ Time Frame: 12 months ]
  3. Rate of blood pressure control (< 140/90 mmHg) [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436176

United States, Massachusetts
Harvard Vanguard Medical Associates
Newton, Massachusetts, United States, 02466
Sponsors and Collaborators
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Harvard University
Principal Investigator: Thomas D Sequist, MD, MPH Harvard Vanguard Medical Associates
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Sequist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00436176     History of Changes
Other Study ID Numbers: 59751
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: March 23, 2009
Last Verified: March 2009

Keywords provided by Harvard Vanguard Medical Associates:
Diabetes mellitus
Quality of Health Care
Cultural Competency
Performance Feedback
Health navigator
Health disparities
Racial disparities

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