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

NCT ID: NCT00566774

Last Updated: 2016-01-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Full drug coverage

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Usual coverage

Intervention Type OTHER

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

Intervention Type OTHER

Usual coverage

Patients randomized to usual coverage will have no change in their existing benefits

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aetna, Inc.

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niteesh K. Choudhry, MD, PhD

Associate Professor and Associate Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 25944633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22080794 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18585494 (View on PubMed)

Other Identifiers

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2007-P-000847/1

Identifier Type: -

Identifier Source: org_study_id

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