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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Coronary Artery Disease
 Other: Full drug coverage
Other: Usual coverage
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5860
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Other: Usual coverage
Patients randomized to usual coverage will have no change in their existing benefits

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566774

Locations
United States, Connecticut
Aetna Inc
Hartford, Connecticut, United States, 06156
Sponsors and Collaborators
Brigham and Women's Hospital
Aetna, Inc.
Investigators
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Niteesh K. Choudhry, MD, PhD, Associate Professor and Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00566774     History of Changes
Other Study ID Numbers: 2007-P-000847/1
Study First Received: November 30, 2007
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
myocardial infarction
secondary prevention
health insurance
cost-sharing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013