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

Primary Purpose

Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Full drug coverage
Usual coverage
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myocardial Infarction focused on measuring myocardial infarction, secondary prevention, health insurance, cost-sharing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aetna Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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)

Secondary Outcome Measures

First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death
Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
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)
Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)
Total pharmacy and health care costs

Full Information

First Posted
November 30, 2007
Last Updated
January 7, 2016
Sponsor
Brigham and Women's Hospital
Collaborators
Aetna, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00566774
Brief Title
A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
Acronym
MI FREEE
Official Title
Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Aetna, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease
Keywords
myocardial infarction, secondary prevention, health insurance, cost-sharing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
5860 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Full drug coverage
Intervention Description
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
Intervention Name(s)
Usual coverage
Intervention Description
Patients randomized to usual coverage will have no change in their existing benefits
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure
Time Frame
2.5 years
Title
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
Title
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
Title
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
Title
Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)
Time Frame
3 months
Title
Total pharmacy and health care costs
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aetna Inc
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06156
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25944633
Citation
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.
Results Reference
derived
PubMed Identifier
22080794
Citation
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.
Results Reference
derived
PubMed Identifier
18585494
Citation
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.
Results Reference
derived

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

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