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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Myocardial Infarction
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014