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| Name | Class |
|---|---|
| Barnhill Family Foundation | UNKNOWN |
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This project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors.
The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use.
Participants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referral to Cardiometabolic Prevention Clinic | Experimental | Participants referred to the Duke Cardiometabolic Prevention Clinic will be evaluated by a cardiology provider and receive coordinated care based on their risk factors. This may include referrals to specialists in endocrinology, nephrology, or hepatology. A multidisciplinary team will manage their care to help improve heart and metabolic health. |
|
| Standard of Care Group | No Intervention | Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Referral to the Duke Cardiometabolic Prevention Clinic | Other | Patients who are referred to the cardiometabolic prevention clinic within the intervention arm will be evaluated first by a cardiology provider (as each patient has a history of ASCVD). On this initial visit, the cardiology provider will assess the patient's risk factor profile - to identify the presence of co-morbid conditions or uncontrolled risk factors. The need for additional referrals to other clinicians within the cardiometabolic clinic will specifically outlined criteria. These referrals will be offered to the patient and facilitated after the first visit. Preventive care will follow routine, evidence-based care. Clinicians within the cardiometabolic prevention clinic will meet bi-weekly to discuss enrolled patients, thus every individual in the intervention arm will receive coordinated, multi-specialty care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C | Change in low-density-lipoprotein cholesterol from baseline | Baseline, 12 months after enrollment |
| Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline | Baseline, 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants meeting Risk Factor Targets | Those achieving both of the following, and of attaining each component individually: systolic blood pressure (sBP) < 130 and low-density-lipoprotein (LDL) < 70mg/dL | 12 months after enrollment |
| Change in Number of participants on Evidence-Based Medication Targets |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first composite event of all-cause mortality, myocardial infarction, stroke, or coronary revascularization | 12 months after enrollment | |
| Healthcare Utilization: Outpatient Encounters | Number of outpatient encounters |
Inclusion Criteria:
Adults ≥ 18 years of age
Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)
Type 2 Diabetes
Uncontrolled sBP AND LDL-C within the preceding 3 months:
SBP > 150mmHg on at least 1 occasion in last 3 months, AND
LDL > 130mg/dL in last 3 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Burns, MSCR | Contact | 910-272-7239 | sarah.durden@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neha J Pagidipati, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA. |
| Baseline, 12 months after enrollment |
| 12 months after enrollment |
| Healthcare Utilization: All-cause hospitalizations | Number of all-cause hospitalizations | 12 months after enrollment |
| Healthcare Utilization: Number of cardiovascular (CV) hospitalizations | CV hospitalizations include those for MI (myocardial infarction), HF (heart failure), stroke, coronary or peripheral revascularization/amputation. | 12 months after enrollment |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |