Improving Diabetes Care and Outcomes on the South Side of Chicago

This study is currently recruiting participants.
Verified April 2013 by University of Chicago
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01087073
First received: February 12, 2010
Last updated: September 4, 2013
Last verified: April 2013

February 12, 2010
September 4, 2013
March 2010
July 2015   (final data collection date for primary outcome measure)
  • HbA1c [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected at the end of year 2, year 3, year 4 and year 5 ] [ Designated as safety issue: No ]
    Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older)
  • Blood pressure [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected at the end of year 2, year 3, year 4 and year 5 ] [ Designated as safety issue: No ]
    Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older)
  • Lipids (HDL, LDL, total cholesterol, triglycerides) [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected at the end of year 2, year 3, year 4 and year 5 ] [ Designated as safety issue: No ]
    Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older)
Same as current
Complete list of historical versions of study NCT01087073 on ClinicalTrials.gov Archive Site
comprehensive diabetes care [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected at the end of year 2, year 3, year 4 and year 5 ] [ Designated as safety issue: No ]
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older)
Same as current
Not Provided
Not Provided
 
Improving Diabetes Care and Outcomes on the South Side of Chicago
Improving Diabetes Care and Outcomes on the South Side of Chicago

This project aims to reduce diabetes disparities on the Chicago's South Side by improving the quality of care and outcomes of patients, taking into account the region's marketplace, socioeconomic challenges and history of racial mistrust. We propose to test the effectiveness of a collaborative model program implemented within six clinics. The short-term goal of this project is to improve clinic processes such as appointment scheduling and patient counseling, as well as clinical outcomes including HbA1c, cholesterol and blood pressure in patients with diabetes. Long-term goals are to strengthen the network of community health centers, community-based organizations and academic medical centers, while increasing awareness of local diabetes disparities and empowering communities to combat this problem.

The approach we will use includes:

  1. Culturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior.
  2. Provider cultural competency and communication training to aid in tailoring treatment recommendations to the patient's cultural preferences and readiness.
  3. Team-designed quality improvement projects to improve care for diabetes patients. QI projects will follow the plan-do-study-act methodology, be supported by experts from the field, and be provided additional resources. Collaborative community partnerships with organizations such as Kennedy King College and the Little Black Pearl will support individual QI projects.
  4. Patient advocates and participating health centers will link patients to local resources such as the Washington Park Consortium and Regency Home Health Care to facilitate increased care management.
  5. In addition, we will identify the costs of intervention implementation from the business case perspective of the outpatient clinics and determine the major barriers and solutions to successfully implement this multifaceted intervention.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Behavioral: Patient diabetes education and communication classes
    Culturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior. Participants attend a 10 week interactive class.
  • Behavioral: Provider cultural competency and communication training
    Provider cultural competency and communication training to aid in tailoring treatment recommendations to the patient's cultural preferences and readiness. Providers attend 3 1-hour monthly modules and one booster workshop 3 months following the last class.
  • Behavioral: System redesign

    Team-designed quality improvement projects to improve care for diabetes patients. QI projects will follow the plan-do-study-act methodology, be supported by experts from the field, and be provided additional resources. Collaborative community partnerships with organizations such as Kennedy King College and the Little Black Pearl will support individual QI projects.

    Patient advocates and participating health centers will link patients to local resources such as the Washington Park Consortium and Regency Home Health Care to facilitate increased care management.

  • Experimental: Diabetes education/communication training
    Culturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior.
    Intervention: Behavioral: Patient diabetes education and communication classes
  • Experimental: Provider training
    Provider cultural competency and communication training to aid in tailoring treatment recommendations to the patient's cultural preferences and readiness.
    Intervention: Behavioral: Provider cultural competency and communication training
  • Experimental: System redesign

    Team-designed quality improvement projects to improve care for diabetes patients. QI projects will follow the plan-do-study-act methodology, be supported by experts from the field, and be provided additional resources. Collaborative community partnerships with organizations such as Kennedy King College and the Little Black Pearl will support individual QI projects.

    Patient advocates and participating health centers will link patients to local resources such as the Washington Park Consortium and Regency Home Health Care to facilitate increased care management.

    Intervention: Behavioral: System redesign

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a diabetes diagnosis (ICD-9 codes 250.X) and be age 18 years or older
  • Patients must attend one of the participating health centers

Exclusion Criteria:

  • Gestational diabetes patients
Both
18 Years and older
No
Contact: Molly Ferguson, MPH 773-702-6667 mferguson3@medicine.bsd.uchicago.edu
United States
 
NCT01087073
16867B (TRACS ID: 40596)
No
University of Chicago
University of Chicago
Merck Sharp & Dohme Corp.
Principal Investigator: Marshall Chin, MD, MPH University of Chicago
Principal Investigator: Monica Peek, MD, MPH University of Chicago
University of Chicago
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP