NCT00359996

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,993

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jun 2000

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

6.2 years

First QC Date

August 2, 2006

Last Update Submit

April 11, 2016

Conditions

Keywords

diabetesquality improvementcommunity health centerhealth disparities

Outcome Measures

Primary Outcomes (1)

  • hemoglobin A1c

    Change in hemoglobin A1c from baseline

    4 years

Secondary Outcomes (3)

  • Lipid levels

    4 years

  • Blood pressure

    4 years

  • Urine microalbumin levels

    4 years

Study Arms (2)

Health disparities collaborative

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

No additional educational sessions added to usual care of patients.

Other: No additional educational sessions

Interventions

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.

Health disparities collaborative

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients with diabetes age 18-75 years

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Chin MH, Drum ML, Guillen M, Rimington A, Levie JR, Kirchhoff AC, Quinn MT, Schaefer CT. Improving and sustaining diabetes care in community health centers with the health disparities collaboratives. Med Care. 2007 Dec;45(12):1135-43. doi: 10.1097/MLR.0b013e31812da80e.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marshall H Chin, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 3, 2006

Study Start

June 1, 2000

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations