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Completed

NCT Number: NCT00436176

Improving Diabetes Care for African Americans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expanded Chronic Care Model

Behavioral

Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Harvard Vanguard Medical Associates

Other

Collaborators

  • Brigham and Women's Hospital
  • Harvard University

Registry information

Official study title

The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 16, 2007
Registry last updated
Mar 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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