Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors (DUKE PREVENT)

Duke University

Status: Enrolling

Conditions: Hypertension; Hyperlipidemia; ASCVD

Treatments: Other: Referral to the Duke Cardiometabolic Prevention Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT07117695

Pro00109610

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Referral to Cardiometabolic Prevention Clinic

Experimental group

Description:

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.

Treatment:

Other: Referral to the Duke Cardiometabolic Prevention Clinic

Standard of Care Group

No Intervention group

Description:

Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.