NCT00566774已完成4 期
Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,860
- 试验地点
- 1
- 主要终点
- First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
研究概览
简要总结
The objective of this randomized trial is to evaluate the effect of providing full prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins, beta-blockers, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers to patients recently discharged from hospital after acute myocardial infarction.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •discharged alive from hospital after acute MI
- •receive health services and prescription drug benefits through Aetna, Inc.
排除标准
- •enrollment in a Health Savings Account (HSA) plan
- •age ≥ 65 years of age at the time of hospital discharge
- •plan sponsor has opted out of participating in the study
- •receive only medical services or pharmacy coverage but not both through Aetna
研究组 & 干预措施
1
Experimental
干预措施: Full drug coverage (Other)
2
Active Comparator
干预措施: Usual coverage (Other)
结局指标
主要结局
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
时间窗: 2.5 years
次要结局
- First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure(2.5 years)
- First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death(2.5 years)
- Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)(2.5 years)
- Medication adherence (i.e. the mean medication possession ratio and the proportion of patients fully adherent to each and all 3 of the study medications)(3 months)
- Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)(3 months)
- Total pharmacy and health care costs(2.5 years)
研究者
Niteesh K. Choudhry, MD, PhD
Associate Professor and Associate Physician
Brigham and Women's Hospital
研究点 (1)
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