Implementation of Vascular Care Team to Improve Medical Management of Peripheral Arterial Disease (PAD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Month 12 LDL-C
研究概览
简要总结
This study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System.
详细描述
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood. In order to investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all subjects. There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented lower extremity atherosclerotic PAD with recommended goal LDL-C <70 mg/dL by the ACC/AHA Management of Blood Cholesterol Guidelines
- •Receiving care at CU Anschutz
- •Screening/baseline LDL-C ≥70 mg/dL without change in lipid lowering therapy within the last 30 days prior to LDL-C draw.
- •Able to provide informed consent and willing to participate
排除标准
- •Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12 months after randomization)
- •Life expectancy < 12 months
- •Fasting triglycerides >400 mg/ml at screening
- •End-stage renal disease (eGRF<15 mL/min/1.73m2 and/or renal replacement therapy)
- •History of nephrotic syndrome
- •Clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated
- •Current enrollment in another investigational device or drug study with unapproved devices or therapies or with therapies that would impact lipid levels or lipid therapy
- •Any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol
结局指标
主要结局
Month 12 LDL-C
时间窗: 12 months
Percent change from baseline to month 12 in LDL-C
次要结局
- Month 6 LDL-C(6 months)