Southeastern Diabetes Initiative Clinical Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Extension of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk group<br>Extension of Care | Other: Extension of Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus Type 2, Standard of care, Quality of life, Disease management