Improving Diabetes Care for African Americans

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Harvard University
Information provided by:
Harvard Vanguard Medical Associates
ClinicalTrials.gov Identifier:
NCT00436176
First received: February 14, 2007
Last updated: March 20, 2009
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by Harvard Vanguard Medical Associates:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436176

Locations
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
Investigators
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014