Improving Diabetes Care for African Americans

Diabetes Clinical Trial

Official title:

The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436176
• Other study ID #: 59751
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2007
• Last updated: March 20, 2009
• Start date: June 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2009
• Source: Harvard Vanguard Medical Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Expanded Chronic Care Model
Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Newton	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard Vanguard Medical Associates	Brigham and Women's Hospital, Harvard University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sequist TD, Adams A, Zhang F, Ross-Degnan D, Ayanian JZ. Effect of quality improvement on racial disparities in diabetes care. Arch Intern Med. 2006 Mar 27;166(6):675-81. — View Citation

Sequist TD, Ayanian JZ, Marshall R, Fitzmaurice GM, Safran DG. Primary-care clinician perceptions of racial disparities in diabetes care. J Gen Intern Med. 2008 May;23(5):678-84. doi: 10.1007/s11606-008-0510-7. Epub 2008 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of LDL cholesterol control (< 100 mg/dL)		12 months	No
Primary	Rate of blood pressure control (< 130/80 mmHg)		12 months	No
Primary	Rate of HbA1c control (<7%)		12 months	No
Secondary	Rate of HbA1c control (<8%)		12 months	No
Secondary	Rate of LDL cholesterol control (< 130 mg/dL)		12 months	No
Secondary	Rate of blood pressure control (< 140/90 mmHg)		12 months	No

External Links

•   HVMA website
•   Robert Wood Johnson Foundation national program office