Randomized Trial of Health Events Costs in Diabetic Blacks

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Project Sugar 2: Health Events Costs in Diabetic Blacks

Status Completed

Clinical Trial Summary

Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 deaths and over $130 billion in costs. This burden falls disproportionately upon ethnic minority groups, particularly African Americans, who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications. Suboptimal health care - in terms of access, quality, and adherence -appears to be an important contributing factor. Prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following protocols/clinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy, enhancing continuity of care, promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance culturally sensitive outreach, linkage, and monitoring service; to provide important patient and family education; and to improve access to and continuity of care. Results indicate that this intensive team approach, compared to usual care alone, produces substantial improvements in metabolic control. However, the cost-effectiveness of such interventions is unknown in the ''real-world''.

This has led to our current study, a randomized controlled trial within a managed care organization to determine the effects of a NCM/CHW team on metabolic control, on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. The participants will be African American adults with type 2 diabetes who receive primary care within a managed care organization in inner-city Baltimore.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT00022750
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Completed
• Phase: N/A
• Start date: October 2000
• Completion date: May 2005