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Improving Diabetes Care Collaboratively in the Community

This study has been completed.
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00359996
First received: August 2, 2006
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to determine whether a quality improvement intervention including rapid quality improvement, a chronic care model, and best practices improves diabetes care in community health centers and whether more intensive interventions enhance care further.

Condition Intervention
Diabetes
Behavioral: health disparities collaborative
Other: No additional educational sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Diabetes Care Collaboratively in the Community

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • hemoglobin A1c [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c from baseline


Secondary Outcome Measures:
  • Lipid levels [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Change in Lipid blood levels from baseline

  • Blood pressure [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Change in BP from baseline

  • Urine microalbumin levels [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Change in urine micralbumin levels from baseline


Enrollment: 6993
Study Start Date: June 2000
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health disparities collaborative
The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
Behavioral: health disparities collaborative
The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
Active Comparator: Control
No additional educational sessions added to usual care of patients.
Other: No additional educational sessions

Detailed Description:
In 1998 the Health Resources and Services Administration's Bureau of Primary Health Care began the Health Disparities Collaborative (HDC) to improve chronic disease management in community health centers (HC) nationwide. The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- patients with diabetes age 18-75 years

Exclusion Criteria:

Pregnant women

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359996

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Agency for Healthcare Research and Quality (AHRQ)
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Marshall H Chin, MD, MPH University of Chicago
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00359996     History of Changes
Other Study ID Numbers: 9886 (AHRQ R01 HS10479) 
Study First Received: August 2, 2006
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
diabetes
quality improvement
community health center
health disparities

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 07, 2016