Southeastern Diabetes Initiative Clinical Intervention

Not Applicable

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
High Risk group	Extension of Care	Extension of Care

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 24 months

Secondary Outcome Measures

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

Locations (4): Cabarrus Health Alliance
🇺🇸
Kannapolis, North Carolina, United States
Durham County Department of Public Health
🇺🇸
Durham, North Carolina, United States
Williamson Health and Wellness Center
🇺🇸
Williamson, West Virginia, United States
Mississippi Public Health Institute
🇺🇸
Madison, Mississippi, United States