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Improving Diabetes Care and Outcomes on the South Side of Chicago

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Chicago
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marshall Chin, M.D., University of Chicago
ClinicalTrials.gov Identifier:
NCT01087073
First received: February 12, 2010
Last updated: October 31, 2014
Last verified: October 2014

February 12, 2010
October 31, 2014
January 2009
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 from years 2-7. ] [ 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). Will also be collected from patients in the patient activation component.
  • Blood pressure [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7. ] [ 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). Will also be collected from patients in the patient activation component.
  • 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 from years 2-7. ] [ 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). Will also be collected from patients in the patient activation component.
  • 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)
Complete list of historical versions of study NCT01087073 on ClinicalTrials.gov Archive Site
Processes of care [ Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7. ] [ 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).

Annual Processes of Care:

At least 1 HbA1c, Lipid assessment, Microalbumin assessment, ACE inhibitor or ARB prescribed, Aspirin prescribed, Dental referral, Eye exam or referral, Foot exam or referral, Influenza vaccination, Home glucose monitoring, Dietary counseling or referral, Exercise counseling, Diabetes education

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)
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

The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and engages patients, providers, clinics, and community collaborators to improve the health care and outcomes of African-Americans on the South Side of Chicago. Initiated in 2009, this project is a collaborative, community-based intervention that employs a multifaceted, integrated approach to address many of the root causes of health disparities. The short-term goal of this project is to improve clinic processes such as appointment scheduling and patient counseling through quality improvement efforts, as well as clinical outcomes including HbA1c, cholesterol and blood pressure in patients with diabetes through patient education. 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.

This multifactorial intervention contains four overlapping core components reflecting key elements of the Chronic Care Model.This model identifies patients, practice teams, the community, and health systems as four necessary elements in the successful management of chronic diseases such as diabetes. Six health centers (two academic center clinics affiliated with the University of Chicago and four FQHCs) are part of the intervention. Researchers at the University of Chicago received grant funding from the Merck Company Foundation's Alliance to Reduce Disparities in Diabetes and the National Institutes of Health to implement and evaluate the intervention.

The research and implementation team includes faculty and staff members with expertise in quality improvement, behavioral change, community outreach, patient education, and research methods.

The intervention has four main components:

  1. Patient Activation: We hold culturally tailored, 10-week patient education classes that combine culturally tailored patient education with training in shared decision-making skills to empower patients to be proactive in their diabetes self-management.
  2. Provider Training: We provide educational workshops for provider, clinical, and non-clinical staff at our six intervention clinics on patient-centered communication, cultural competency, behavior change counseling, and shared decision making.
  3. Quality Improvement: Our team facilitates quality improvement (QI) programs redesigning clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits through EMR, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. We also perform a cost/benefits analysis of intervention implementation from the business case perspective of the outpatient clinics and determine the major barriers and solutions to successfully implement and sustain the project at each location.
  4. Community Outreach: We collaborate with existing community resources to create sustainable collaborations that support diabetes patients outside of the health care system and promote nutrition and a healthy lifestyle. We collaborate with grocery stores, food pantries, the Chicago Park District, farmers markets, media outlets, grocery stores and other community-based organizations.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Behavioral: Patient Activation
    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. Diabetes support groups after the completion of these classes help patient maintain self-management and adherence to healthy behaviors.
    Other Name: Patient Education
  • Behavioral: Provider Training
    Provider patient-centered communication training focuses on cultural competency and communication skills training to aid in shared decision-making and tailoring treatment recommendations to the patient's cultural preferences and readiness. Providers attend 4 1-hour monthly modules and one booster workshop 3 months post-class.
  • Behavioral: Quality Improvement
    Participating clinics participate in quality improvement (QI) programs which aim to redesign clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. Provider and clinical staff members from all six project clinics attend collaborative quarterly QI sessions with project staff to discuss improvements in QI efforts, share QI methods among clinic teams, and provide brief training sessions.
  • Behavioral: Community Outreach
    The project collaborates with many community based organizations and resources to reach out to communities at high risk for diabetes on the South Side of Chicago and facilitate diabetes education, particularly in the area of nutrition and physical activity. We provide monthly health education events, nutrition tours, and frequently participate in community-based health fairs and health promotion events. We also work to promote nutrition through the Food Rx program, which utilizes a prescription to link patients at our clinics with nutrition resources on the South Side of Chicago through a coupon that gives discounts towards healthy purchases at participating stores, and have initiated a 10-week fitness program to promote physical activity among minority patients with diabetes.
    Other Name: Community Partnerships
  • Experimental: Patient Activation
    Patient knowledge in diabetes self-management behaviors and clinical measures (HbA1c, LDL, HDL, BMI, BP) are tracked at baseline, 10-weeks (post-program), 3 months (post-program) and 6 months (post-program).
    Intervention: Behavioral: Patient Activation
  • Experimental: Provider Training Evaluation
    Pre-post surveys are conducted at each training session to assess overall satisfaction with the curriculum, knowledge of SDM, and understanding of techniques to promote its use in the healthcare setting.
    Intervention: Behavioral: Provider Training
  • Experimental: Quality Improvement Evaluation
    We measure quality improvement efforts through biannual staff experience surveys and one-on-one provider and clinic staff interviews.
    Intervention: Behavioral: Quality Improvement
  • Experimental: Community Outreach Evaluation

    Pre-post surveys will be disseminated at nutrition tours (Save-A-Lot, Walgreens, 61st Street Farmers Market) to assess change in knowledge of healthy eating behaviors and proper nutrition. Surveys will also assess participant satisfaction of the tours.

    Interviews will also be performed with community stakeholders to assess the costs/benefits of the collaboration and overall feedback on involvement.

    Intervention: Behavioral: Community Outreach
  • No Intervention: Global Evaluation of the Intervention
    A chart review will be performed in order to evaluate our intervention to improve diabetes processes of care and clinical outcomes among our target population. Chart abstractions will be performed on medical records obtained from our six intervention clinics. In addition, chart abstractions from two University of Illinois at Chicago clinics and three FQHCs located on the West Side of Chicago will serve as control data.100 charts will be randomly selected from each clinic per year of the intervention. The chart review will contain charts from adult diabetes patients over a seven year period that matches the duration of the Improving Diabetes project.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
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: Nyahne Bergeron, MPH 773-702-8847 nbergeron@medicine.bsd.uchicago.edu
United States
 
NCT01087073
16867B (TRACS ID: 40596), R18DK083946, P30DK092949, Alliance to Reduce Disparities
No
Marshall Chin, M.D., University of Chicago
University of Chicago
  • Merck Sharp & Dohme Corp.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Marshall Chin, MD, MPH University of Chicago
Principal Investigator: Monica Peek, MD, MPH University of Chicago
University of Chicago
October 2014

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