Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in LDL-C
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard of Care Group
Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.
Referral to Cardiometabolic Prevention Clinic
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.
干预措施: Referral to the Duke Cardiometabolic Prevention Clinic (Other)
结局指标
主要结局
Change in LDL-C
时间窗: Baseline, 12 months after enrollment
Change in low-density-lipoprotein cholesterol from baseline
Change in Systolic Blood Pressure
时间窗: Baseline, 12 months after enrollment
Change in systolic blood pressure from baseline
次要结局
- Change in Number of participants on Evidence-Based Medication Targets(Baseline, 12 months after enrollment)
- Number of participants meeting Risk Factor Targets(12 months after enrollment)