MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 36
- 主要终点
- The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
研究概览
简要总结
The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics
详细描述
This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS for medical offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. Twenty primary care offices were randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186 represented racial minorities.
Subjects in the intervention arm clinic had regular contact by phone, email or text with a CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with the subject, with the site clinical pharmacist and, as needed, with the site provider to optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS intervention lasted for 12 months.
A complex algorithm was used to calculate the degree to which the subject's care and medical regimen follows national guidelines for reducing the risk of developing cardiovascular risk.
Post-intervention telephone interviews are being conducted with 20 intervention subjects in order to assess their experience with the intervention and barriers and facilitators to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speakers age 55 or greater
- •Must have a medical history of at least one of the following:
- •Coronary artery disease
- •Myocardial infarction
- •Transient Ischemic Attack
- •Atrial Fibrillation
- •Systolic heart failure
- •Peripheral vascular disease/claudication
- •Carotid artery disease
- •Diabetes with either: Low density lipoprotein (LDL) 100 or greater AND/OR systolic blood pressure 140 or higher or diastolic blood pressure 90 or higher
排除标准
- •Signs of acute angina, stroke, heart failure or renal failure
- •Systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater
- •Significant hepatic disease, including: Cirrhosis, Hepatitis B or C infection, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) 3 times control or higher, or total bilirubin 2.0 mg/dl or higher
结局指标
主要结局
The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
时间窗: 12 months
Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point
次要结局
- The percent of intervention group patients who rate the intervention as helpful (versus not helpful)(24 months)
- The average cost per subject, measured in dollars and cents, of implementing the intervention(12 months)
研究者
Korey Kennelty
Assistant Professor
University of Iowa