A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients (The INCLUDE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve an LDL-C <70 mg/dL by 1-year.
研究概览
简要总结
Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of <70 mg/dL by increasing statin and/or LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.
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
- •Male or female >18 years of age
- •Receive follow-up care with Intermountain Health
- •Value-based patient (as defined in the EDW)
- •Documentation of an ASCVD diagnosis, by 1 of the following:
- •Coronary artery disease (Primary inpatient CAD diagnosis during index encounter; Primary inpatient MI diagnosis during index encounter; PCI during index encounter; or CABG during index encounter
- •Cerebrovascular accident (Primary inpatient ischemic stroke diagnosis during index encounter; Carotid endarterectomy during index encounter; or Carotid stent during index encounter)
- •Peripheral arterial disease (Bypass or percutaneous intervention during index encounter)
排除标准
- •Patient age <18 years.
- •Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility).
- •Pregnant or lactating women
研究组 & 干预措施
Usual Care
Patients will receive usual care for their LDL-C management.
干预措施: Usual Care (Other)
Clinical Pharmacy Team
Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.
干预措施: Clinical Pharmacy Team (Other)
结局指标
主要结局
Proportion of patients who achieve an LDL-C <70 mg/dL by 1-year.
时间窗: 1 year
次要结局
未报告次要终点