Randomized Trial of Health Events Costs in Diabetic Blacks

National Institutes of Health (NIH)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Nurse Case Manager and Community Health Worker Team

Study type: Interventional

Funder types: NIH

Identifiers

NCT00022750

DK48117 (completed)

OPD-GCRC R00052

R01DK048117-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• African American male or female aged 30 years or older diagnosed with type 2 diabetes mellitus
• Able to provide 2 contact persons outside his/her household with active, verified telephone numbers

Exclusion criteria

• Mentally incompetent to give informed consent
• Refuses to give informed consent
• Comorbid health condition likely to lead to death in next 24 months