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

Официальное название

Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients

Обзор

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.

Вмешательства

• Другое Referral 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

Первичные конечные точки

• Change in LDL-C [Срок оценки: Baseline, 12 months after enrollment]
• Change in Systolic Blood Pressure [Срок оценки: Baseline, 12 months after enrollment]

Вторичные конечные точки (2)

• Number of participants meeting Risk Factor Targets [Срок оценки: 12 months after enrollment]
• Change in Number of participants on Evidence-Based Medication Targets [Срок оценки: Baseline, 12 months after enrollment]

Критерии участия

Критерии включения

• 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

• 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.

Критерии исключения

• 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
• End Stage Renal Disease (those on dialysis or with EGFR <20)
• History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure
• Pregnant/Planning to become pregnant during study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Duke University Medical Center — Durham

Идентификаторы

NCT: NCT07117695 · Pro00109610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗