NCT01087073

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,209

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2016

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

7.9 years

First QC Date

February 12, 2010

Last Update Submit

April 24, 2023

Conditions

Keywords

Healthcare DisparitiesHealth Care Quality ImprovementShared Decision-MakingPatient EducationPatient ActivationCommunity OutreachProvider Training

Outcome Measures

Primary Outcomes (3)

  • HbA1c

    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.

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

  • Blood pressure

    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.

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

  • Lipids (HDL, LDL, total cholesterol, triglycerides)

    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.

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

Secondary Outcomes (1)

  • Processes of care

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

Study Arms (5)

Patient Activation

EXPERIMENTAL

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).

Behavioral: Patient Activation

Provider Training Evaluation

EXPERIMENTAL

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.

Behavioral: Provider Training

Quality Improvement Evaluation

EXPERIMENTAL

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

Behavioral: Quality Improvement

Community Outreach Evaluation

EXPERIMENTAL

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.

Behavioral: Community Outreach

Global Evaluation of the Intervention

NO 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.

Interventions

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.

Also known as: Patient Education
Patient Activation

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.

Provider Training Evaluation

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.

Quality Improvement Evaluation

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.

Also known as: Community Partnerships
Community Outreach Evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Gestational diabetes patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ACCESS Grand Boulevard Family Health Center

Chicago, Illinois, 60609, United States

Location

Friend Family Health Center

Chicago, Illinois, 60615, United States

Location

Chicago Family Health Center

Chicago, Illinois, 60617, United States

Location

Kovler Diabetes Center

Chicago, Illinois, 60637, United States

Location

University of Chicago, Primary Care Group

Chicago, Illinois, 60637, United States

Location

ACCESS Booker Family Health Center

Chicago, Illinois, 60653, United States

Location

Related Publications (19)

  • 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.

    PMID: 24464339BACKGROUND
  • 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.

    PMID: 22563350BACKGROUND
  • 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.

    PMID: 24876541BACKGROUND
  • 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.

    PMID: 24493770BACKGROUND
  • 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.

    PMID: 23063349BACKGROUND
  • 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.

    PMID: 23304135BACKGROUND
  • 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.

    PMID: 23050731BACKGROUND
  • 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.

    PMID: 21127318BACKGROUND
  • 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.

    PMID: 21478770BACKGROUND
  • 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.

    PMID: 20409625BACKGROUND
  • 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.

    PMID: 20403654BACKGROUND
  • 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.

    PMID: 17881624BACKGROUND
  • 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.

    PMID: 17881626BACKGROUND
  • 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.

    PMID: 20613665BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Diabetes MellitusPatient Participation

Interventions

Patient Education as TopicQuality ImprovementCommunity-Institutional Relations

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesEngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services AdministrationPublic RelationsOrganization and Administration

Study Officials

  • Marshall Chin, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Monica Peek, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

March 15, 2010

Study Start

January 1, 2009

Primary Completion

November 9, 2016

Study Completion

November 9, 2016

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations