Randomized Trial of Health Events Costs in Diabetic Blacks

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Nurse Case Manager and Community Health Worker Team


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Nurse Case Manager and Community Health Worker Team|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Nurse Case Manager, Community Health Worker, Behavioral Interventions, Cost-effectiveness, Randomized trial