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Completed

NCT Number: NCT01087073

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACCESS Booker Family Health Center, Chicago, Illinois, United States

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About this study

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:

  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient activation

Behavioral

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 names: Patient Education

Provider training

Behavioral

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.

Quality improvement

Behavioral

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.

Community Outreach

Behavioral

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 names: Community Partnerships

Primary outcomes

  1. HbA1c

    Time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.

    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.

  2. 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.

    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.

  3. 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.

    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.

Secondary outcomes

  1. 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.

    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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2010
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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