A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
NCT ID: NCT00566774
Last Updated: 2016-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
5860 participants
INTERVENTIONAL
2007-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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1
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
2
Usual coverage
Patients randomized to usual coverage will have no change in their existing benefits
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* receive health services and prescription drug benefits through Aetna, Inc.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Aetna, Inc.
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Niteesh K. Choudhry, MD, PhD
Associate Professor and Associate Physician
Principal Investigators
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Niteesh K Choudhry, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital/Harvard Medical School
Locations
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Aetna Inc
Hartford, Connecticut, United States
Countries
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References
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Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK. Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):252-9. doi: 10.1161/CIRCOUTCOMES.114.001330. Epub 2015 May 5.
Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, Reisman L, Fernandes J, Spettell C, Lee JL, Levin R, Brennan T, Shrank WH; Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 2011 Dec 1;365(22):2088-97. doi: 10.1056/NEJMsa1107913. Epub 2011 Nov 14.
Choudhry NK, Brennan T, Toscano M, Spettell C, Glynn RJ, Rubino M, Schneeweiss S, Brookhart AM, Fernandes J, Mathew S, Christiansen B, Antman EM, Avorn J, Shrank WH. Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies. Am Heart J. 2008 Jul;156(1):31-6. doi: 10.1016/j.ahj.2008.03.021. Epub 2008 Jun 6.
Other Identifiers
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2007-P-000847/1
Identifier Type: -
Identifier Source: org_study_id
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