Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age
Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)
Type 2 Diabetes
SBP > 150mmHg on at least 1 occasion in last 3 months, AND
Disqualifiers
Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)
History of advanced dementia
Referred to hospice/on hospice
Lives outside of Durham County, Orange County, Wake County, Person County or Granville County
Trial design
Design model
Parallel
Treatments tested in this trial
Referral to the Duke Cardiometabolic Prevention Clinic
Other interventionPatients 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Referral to Cardiometabolic Prevention ClinicExperimental treatment 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in LDL-C
Change in low-density-lipoprotein cholesterol from baseline
Time frame
Baseline, 12 months after enrollment2
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline
Time frame
Baseline, 12 months after enrollmentSecondary outcomes
1
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
Time frame
12 months after enrollment2
Change in Number of participants on Evidence-Based Medication Targets
Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA.
Time frame
Baseline, 12 months after enrollmentOther outcomes
1
Time to first composite event of all-cause mortality, myocardial infarction, stroke, or coronary revascularization
Time frame
12 months after enrollment2
Healthcare Utilization: Outpatient Encounters
Number of outpatient encounters
Time frame
12 months after enrollment3
Healthcare Utilization: All-cause hospitalizations
Number of all-cause hospitalizations
Time frame
12 months after enrollment4
Healthcare Utilization: Number of cardiovascular (CV) hospitalizations
CV hospitalizations include those for MI (myocardial infarction), HF (heart failure), stroke, coronary or peripheral revascularization/amputation.
Time frame
12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Barnhill Family Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: