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

Coronary Artery Disease Clinical Trial

— MI FREEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566774
• Other study ID #: 2007-P-000847/1
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2007
• Last updated: January 7, 2016
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: January 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5860
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Full drug coverage
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 coverage
Patients randomized to usual coverage will have no change in their existing benefits

Locations

Country	Name	City	State
United States	Aetna Inc	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Aetna, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure		2.5 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)		3 months	No
Secondary	Total pharmacy and health care costs		2.5 years	No