Southeastern Diabetes Initiative Clinical Intervention (SEDI)

A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition

The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment existing standard of care in an effort to (1) improve population level diabetes management, health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2 Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs associated with Type 2 Diabetes Mellitus.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Extension of Care

Detailed Description

Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.

The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.

• Study Type: Interventional
• Enrollment (Actual): 648
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Madison, Mississippi, United States
      • Mississippi Public Health Institute
  • North Carolina
    • Durham, North Carolina, United States
      • Durham County Department of Public Health
    • Kannapolis, North Carolina, United States
      • Cabarrus Health Alliance
  • West Virginia
    • Williamson, West Virginia, United States
      • Williamson Health and Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults >=18yrs
• Diagnosis of Type 2 diabetes
• Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
• Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
• Defined as high risk by the risk algorithm or their primary care clinician.
• Referral from the primary care clinician or patient's medical home if one has been designated.

Exclusion Criteria:

• Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
• Have a terminal illness with a life expectancy of 6 months or less
• Diagnosis of Type 1 diabetes or gestational diabetes
• Currently pregnant (confirmed via self-report and/or medical record)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Risk group; Extension of Care	Other: Extension of Care; Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of health services utilization	As measured by inpatient hospital admissions and emergency department visits	up to 24 months
Change in Medication Adherence	As measured by the Morisky Medication Adherence Score	Baseline, 6, 12, 18, and 24 months
Change in HbA1c		Baseline, 6, 12, 18, and 24 months
Change in blood lipids	Measurements include total cholesterol, HDL, LDL, triglycerides	Baseline, 6, 12, 18, and 24 months
Change in blood glucose		Baseline, 6, 12, 18, and 24 months
Change in blood pressure		Baseline, 6, 12, 18, and 24 months
Incidence of micro- and macro-vascular complications	Includes retinopathy, neuropathy, kidney disease, cardiovascular disease	Up to 24 months
Change in patient-reported outcomes	Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys	Baseline, 6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Bristol-Myers Squibb; Centers for Medicare and Medicaid Services
• Investigators: Principal Investigator: Robert Califf, MD, Duke Translational Medicine Institute; Principal Investigator: Bryan Batch, MD, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Quality of life; Disease management; Diabetes Mellitus Type 2; Standard of care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pro00043463; 1C1CMS331018 (Other Grant/Funding Number: Centers for Medicare and Medicaid Services)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No