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

Brigham and Women's Hospital5,860 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

5,860

Conditions

Myocardial Infarction Coronary Artery Disease

Interventions

Full drug coverageOTHER

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

Usual coverageOTHER

Patients randomized to usual coverage will have no change in their existing benefits

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Aetna Inc

Hartford, Connecticut, United States

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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 3 months

Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)

Time frame: 3 months

Total pharmacy and health care costs

Time frame: 2.5 years

Data from ClinicalTrials.gov

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