Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus Type 2, Standard of care, Quality of life, Disease management
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.
Interventions
OTHERExtension 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.
Sponsors
Centers for Medicare and Medicaid Services
Bristol-Myers Squibb
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | Up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 blood lipids | Baseline, 6, 12, 18, and 24 months | Measurements include total cholesterol, HDL, LDL, triglycerides |
| Rate of health services utilization | up to 24 months | As measured by inpatient hospital admissions and emergency department visits |
| 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 |
| 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 |
| Change in blood glucose | Baseline, 6, 12, 18, and 24 months | — |
Countries
United States
Outcome results
None listed