ASCVD, Hyperlipidemia, Hypertension
Conditions
Keywords
ASCVD, Cardiometabolic Clinic, Prevention, Hypertension, Hyperlipidemia
Brief summary
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.
Interventions
OTHERReferral to the Duke Cardiometabolic Prevention Clinic
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.
Sponsors
Duke University
Barnhill Family Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 18 years of age 2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization) 3. Type 2 Diabetes 4. 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 * NOTE: If there are not enough patients with the above inclusion criteria available for enrollment, then we will expand the criteria to include patients with uncontrolled sBP and LDL-C within the last 6 months.
Exclusion criteria
1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey) 2. History of advanced dementia 3. Referred to hospice/on hospice 4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County 5. End Stage Renal Disease (those on dialysis or with EGFR \<20) 6. History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure 7. Pregnant/Planning to become pregnant during study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL-C | Baseline, 12 months after enrollment | Change in low-density-lipoprotein cholesterol from baseline |
| Change in Systolic Blood Pressure | Baseline, 12 months after enrollment | Change in systolic blood pressure from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants meeting Risk Factor Targets | 12 months after enrollment | Those achieving both of the following, and of attaining each component individually: systolic blood pressure (sBP) \< 130 and low-density-lipoprotein (LDL) \< 70mg/dL |
| Change in Number of participants on Evidence-Based Medication Targets | Baseline, 12 months after enrollment | Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA. |
Countries
United States
Contacts
CONTACTSarah Burns, MSCR
PRINCIPAL_INVESTIGATORNeha J Pagidipati, MD, MPH
Duke University
Outcome results
None listed