NCT00566774CompletedPhase 4
Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
Brigham and Women's Hospital1 site in 1 country5,860 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 5,860
- Locations
- 1
- Primary Endpoint
- First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •discharged alive from hospital after acute MI
- •receive health services and prescription drug benefits through Aetna, Inc.
Exclusion Criteria
- •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
Arms & Interventions
1
Experimental
Intervention: Full drug coverage (Other)
2
Active Comparator
Intervention: Usual coverage (Other)
Outcomes
Primary Outcomes
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
Time Frame: 2.5 years
Secondary Outcomes
- 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)
Investigators
Niteesh K. Choudhry, MD, PhD
Associate Professor and Associate Physician
Brigham and Women's Hospital
Study Sites (1)
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