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

This study has been completed.
Sponsor:
Collaborator:
Aetna, Inc.
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00566774
First received: November 30, 2007
Last updated: July 3, 2012
Last verified: July 2012

November 30, 2007
July 3, 2012
November 2007
September 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00566774 on ClinicalTrials.gov Archive Site
  • First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Total pharmacy and health care costs [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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: 1 year ] [ Designated as safety issue: No ]
  • Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Total pharmacy and health care costs [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
Post-myocardial Infarction Free Rx Event and Economic Evaluation (Post-MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
  • Myocardial Infarction
  • Coronary Artery Disease
  • 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
  • Other: Usual coverage
    Patients randomized to usual coverage will have no change in their existing benefits
  • Experimental: 1
    Intervention: Other: Full drug coverage
  • Active Comparator: 2
    Intervention: Other: Usual coverage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5860
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566774
2007-P-000847/1
Yes
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
Aetna, Inc.
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
Brigham and Women's Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP