Improving Diabetes Care and Outcomes on the South Side of Chicago

NCT ID: NCT01087073

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2016-11-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Patient Activation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Provider Training

Intervention Type 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 Evaluation

We measure quality improvement efforts through biannual staff experience surveys and one-on-one provider and clinic staff interviews.

Group Type EXPERIMENTAL

Quality Improvement

Intervention Type 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 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.

Group Type EXPERIMENTAL

Community Outreach

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patient Education Community Partnerships

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marshall Chin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Monica Peek, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ACCESS Grand Boulevard Family Health Center

Chicago, Illinois, United States

Site Status

Friend Family Health Center

Chicago, Illinois, United States

Site Status

Chicago Family Health Center

Chicago, Illinois, United States

Site Status

Kovler Diabetes Center

Chicago, Illinois, United States

Site Status

University of Chicago, Primary Care Group

Chicago, Illinois, United States

Site Status

ACCESS Booker Family Health Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24464339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22563350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24876541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24493770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23063349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23304135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23050731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21127318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21478770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20409625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20403654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17881624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17881626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20613665 (View on PubMed)

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.

Reference Type RESULT
PMID: 24525568 (View on PubMed)

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.

Reference Type RESULT
PMID: 22232108 (View on PubMed)

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.

Reference Type RESULT
PMID: 24073128 (View on PubMed)

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.

Reference Type RESULT
PMID: 25359247 (View on PubMed)

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.

Reference Type RESULT
PMID: 25359248 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://southsidediabetes.com/

Improving Diabetes Care and Outcomes Project Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18DK083946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30DK092949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Alliance to Reduce Disparities

Identifier Type: OTHER

Identifier Source: secondary_id

16867B (TRACS ID: 40596)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes Prevention for Black Men
NCT03708380 TERMINATED NA
Diabetes Prevention Program
NCT00004992 COMPLETED PHASE3
Preventing Diabetes
NCT05395377 COMPLETED NA