Improving Diabetes Care and Outcomes on the South Side of Chicago

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Patient diabetes education and communication classes
Behavioral: Provider cultural competency and communication training
Behavioral: System redesign

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Diabetes Care and Outcomes on the South Side of Chicago

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 4000
Study Start Date: March 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: Provider training
Provider cultural competency and communication training to aid in tailoring treatment recommendations to the patient's cultural preferences and readiness.
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.
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.

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.


Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01087073

Contacts
Contact: Molly Ferguson, MPH 773-702-6667 mferguson3@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago, Primary Care Group Recruiting
Chicago, Illinois, United States, 60637
ACCESS Booker Family Health Center Recruiting
Chicago, Illinois, United States, 60653
ACCESS Grand Boulevard Family Health Center Recruiting
Chicago, Illinois, United States, 60609
Chicago Family Health Center Active, not recruiting
Chicago, Illinois, United States, 60617
Kovler Diabetes Center Recruiting
Chicago, Illinois, United States, 60637
Friend Family Health Center Not yet recruiting
Chicago, Illinois, United States, 60615
Sponsors and Collaborators
University of Chicago
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Marshall Chin, MD, MPH University of Chicago
Principal Investigator: Monica Peek, MD, MPH University of Chicago
  More Information

Additional Information:
Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01087073     History of Changes
Other Study ID Numbers: 16867B (TRACS ID: 40596)
Study First Received: February 12, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Healthcare Disparities
Health Care Quality, Access, and Evaluation

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

ClinicalTrials.gov processed this record on September 14, 2014