Randomized Trial of Health Events Costs in Diabetic Blacks
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Nurse Case Manager and Community Health Worker Team |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Prevention |
| Official Title: | Project Sugar 2: Health Events Costs in Diabetic Blacks |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| The Johns Hopkins Medical Institutions | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Frederick L. Brancati, MD, MHS | The Johns Hopkins Medical Institutions |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00022750 History of Changes |
| Other Study ID Numbers: | DK48117 (completed), RO1 DK48117-06, OPD-GCRC R00052 |
| Study First Received: | August 10, 2001 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Type 2 Diabetes Mellitus Nurse Case Manager Community Health Worker |
Behavioral Interventions Cost-effectiveness Randomized trial |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013