- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01087073
Improving Diabetes Care and Outcomes on the South Side of Chicago
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60615
- Friend Family Health Center
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Chicago, Illinois, United States, 60609
- ACCESS Grand Boulevard Family Health Center
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Chicago, Illinois, United States, 60617
- Chicago Family Health Center
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Chicago, Illinois, United States, 60637
- Kovler Diabetes Center
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Chicago, Illinois, United States, 60637
- University of Chicago, Primary Care Group
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Chicago, Illinois, United States, 60653
- ACCESS Booker Family Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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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:
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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.
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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.
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Experimental: Quality Improvement Evaluation
We measure quality improvement efforts through biannual staff experience surveys and one-on-one provider and clinic staff interviews.
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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.
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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. |
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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HbA1c
Time Frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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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.
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Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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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.
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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.
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Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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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.
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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.
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Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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 |
Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marshall Chin, MD, MPH, University of Chicago
- Principal Investigator: Monica Peek, MD, MPH, University of Chicago
Publications and helpful links
General Publications
- Chin MH, Walters AE, Cook SC, Huang ES. Interventions to reduce racial and ethnic disparities in health care. Med Care Res Rev. 2007 Oct;64(5 Suppl):7S-28S. doi: 10.1177/1077558707305413.
- Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
- Peek ME, Ferguson M, Bergeron N, Maltby D, Chin MH. Integrated community-healthcare diabetes interventions to reduce disparities. Curr Diab Rep. 2014 Mar;14(3):467. doi: 10.1007/s11892-013-0467-8.
- Wilkes AE, Bordenave K, Vinci L, Peek ME. Addressing diabetes racial and ethnic disparities: lessons learned from quality improvement collaboratives. Diabetes Manag (Lond). 2011 Nov;1(6):653-660. doi: 10.2217/dmt.11.48.
- Nundy S, Lu CY, Hogan P, Mishra A, Peek ME. Using Patient-Generated Health Data From Mobile Technologies for Diabetes Self-Management Support: Provider Perspectives From an Academic Medical Center. J Diabetes Sci Technol. 2014 Jan;8(1):74-82. doi: 10.1177/1932296813511727. Epub 2014 Jan 1.
- Nundy S, Dick JJ, Chou CH, Nocon RS, Chin MH, Peek ME. Mobile phone diabetes project led to improved glycemic control and net savings for Chicago plan participants. Health Aff (Millwood). 2014 Feb;33(2):265-72. doi: 10.1377/hlthaff.2013.0589.
- Nundy S, Dick JJ, Solomon MC, Peek ME. Developing a behavioral model for mobile phone-based diabetes interventions. Patient Educ Couns. 2013 Jan;90(1):125-32. doi: 10.1016/j.pec.2012.09.008. Epub 2012 Oct 10.
- Nundy S, Dick JJ, Goddu AP, Hogan P, Lu CY, Solomon MC, Bussie A, Chin MH, Peek ME. Using mobile health to support the chronic care model: developing an institutional initiative. Int J Telemed Appl. 2012;2012:871925. doi: 10.1155/2012/871925. Epub 2012 Dec 5.
- Peek ME, Gorawara-Bhat R, Quinn MT, Odoms-Young A, Wilson SC, Chin MH. Patient trust in physicians and shared decision-making among African-Americans with diabetes. Health Commun. 2013;28(6):616-23. doi: 10.1080/10410236.2012.710873. Epub 2012 Oct 10.
- Peek ME, Tang H, Cargill A, Chin MH. Are there racial differences in patients' shared decision-making preferences and behaviors among patients with diabetes? Med Decis Making. 2011 May-Jun;31(3):422-31. doi: 10.1177/0272989X10384739. Epub 2010 Dec 2.
- Peek ME, Wagner J, Tang H, Baker DC, Chin MH. Self-reported racial discrimination in health care and diabetes outcomes. Med Care. 2011 Jul;49(7):618-25. doi: 10.1097/MLR.0b013e318215d925.
- Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Race and shared decision-making: perspectives of African-Americans with diabetes. Soc Sci Med. 2010 Jul;71(1):1-9. doi: 10.1016/j.socscimed.2010.03.014. Epub 2010 Mar 24.
- Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Racism in healthcare: Its relationship to shared decision-making and health disparities: a response to Bradby. Soc Sci Med. 2010 Jul;71(1):13-7. doi: 10.1016/j.socscimed.2010.03.018. Epub 2010 Mar 24. No abstract available.
- Chin MH. Quality improvement implementation and disparities: the case of the health disparities collaboratives. Med Care. 2010 Aug;48(8):668-75. doi: 10.1097/MLR.0b013e3181e3585c.
- Raffel KE, Goddu AP, Peek ME. "I Kept Coming for the Love": Enhancing the Retention of Urban African Americans in Diabetes Education. Diabetes Educ. 2014 May;40(3):351-360. doi: 10.1177/0145721714522861. Epub 2014 Feb 13.
- Peek ME, Wilkes AE, Roberson TS, Goddu AP, Nocon RS, Tang H, Quinn MT, Bordenave KK, Huang ES, Chin MH. Early lessons from an initiative on Chicago's South Side to reduce disparities in diabetes care and outcomes. Health Aff (Millwood). 2012 Jan;31(1):177-86. doi: 10.1377/hlthaff.2011.1058.
- Peek ME, Harmon SA, Scott SJ, Eder M, Roberson TS, Tang H, Chin MH. Culturally tailoring patient education and communication skills training to empower African-Americans with diabetes. Transl Behav Med. 2012 Sep;2(3):296-308. doi: 10.1007/s13142-012-0125-8.
- Chin MH, Goddu AP, Ferguson MJ, Peek ME. Expanding and sustaining integrated health care-community efforts to reduce diabetes disparities. Health Promot Pract. 2014 Nov;15(2 Suppl):29S-39S. doi: 10.1177/1524839914532649.
- Peek ME, Ferguson MJ, Roberson TP, Chin MH. Putting theory into practice: a case study of diabetes-related behavioral change interventions on Chicago's South Side. Health Promot Pract. 2014 Nov;15(2 Suppl):40S-50S. doi: 10.1177/1524839914532292.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16867B (TRACS ID: 40596)
- P30DK092949 (U.S. NIH Grant/Contract)
- R18DK083946 (U.S. NIH Grant/Contract)
- Alliance to Reduce Disparities (Other Identifier: Merck Company Foundation)
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