Clinical trial NCT00022750: Randomized Trial of Health Events Costs in Diabetic Blacks
Official title: Project Sugar 2: Health Events Costs in Diabetic Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Nurse Case Manager
Community Health Worker
Behavioral Interventions
Cost-effectiveness
Randomized trial
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2001-08-10
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: The Johns Hopkins Medical Institutions
name: Frederick L. Brancati, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
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