Improving Diabetes Care for African Americans
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes |
Behavioral: Expanded Chronic Care Model |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care |
- Rate of LDL cholesterol control (< 100 mg/dL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of blood pressure control (< 130/80 mmHg) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of HbA1c control (<7%) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of HbA1c control (<8%) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of LDL cholesterol control (< 130 mg/dL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of blood pressure control (< 140/90 mmHg) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6000 |
| Study Start Date: | June 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Massachusetts | |
| Harvard Vanguard Medical Associates | |
| Newton, Massachusetts, United States, 02466 | |
| Principal Investigator: | Thomas D Sequist, MD, MPH | Harvard Vanguard Medical Associates |
More Information
Additional Information:
Publications:
Additional 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 |
| Study First Received: | February 14, 2007 |
| Last Updated: | March 20, 2009 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 21, 2013