Improving Diabetes Care for African Americans

NCT ID: NCT00436176

Last Updated: 2009-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-11-30

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.

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Expanded Chronic Care Model

Intervention Type: BEHAVIORAL

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

2

Control clinicians function within the context of the generic chronic care model.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Expanded Chronic Care Model

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role: lead

Responsible Party

Brigham and Women's Hospital

Principal Investigators

Thomas D Sequist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Vanguard Medical Associates

Locations

Harvard Vanguard Medical Associates

Newton, Massachusetts, United States

Countries

United States

References

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. doi: 10.1001/archinte.166.6.675.

Reference Type: BACKGROUND

PMID: 16567608 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18214625 (View on PubMed)

Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Marston A, Safran DG, Ayanian JZ. Cultural competency training and performance reports to improve diabetes care for black patients: a cluster randomized, controlled trial. Ann Intern Med. 2010 Jan 5;152(1):40-6. doi: 10.7326/0003-4819-152-1-201001050-00009.

Reference Type: DERIVED

PMID: 20048271 (View on PubMed)

Related Links

http://www.harvardvanguard.org

HVMA website

http://www.solvingdisparities.org/

Robert Wood Johnson Foundation national program office

Other Identifiers

59751

Identifier Type: -

Identifier Source: org_study_id