A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

Study Overview
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Brief Summary
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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.

Official Title
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Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

Conditions
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Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
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* Other: Full drug coverage
* Other: Usual coverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Full drug coverage<br>* Patients randomized to first-dollar coverage will have their pharmacy benefits changed so that they have no out-of-pocket costs for any beta-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) antagonist, or statin for every subsequent prescription after randomization. All co-pays and co-insurance will be waived at the point of care (i.e. pharmacy) as will any contribution that the cost of these drugs contributes to a patient's deductible<br>|
| Active Comparator: 2<br> | Other: Usual coverage<br>* Patients randomized to usual coverage will have no change in their existing benefits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, secondary prevention, health insurance, cost-sharing