Clinical trial NCT00566774: A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: myocardial infarction
secondary prevention
health insurance
cost-sharing
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Aetna, Inc.
First posted: 2007-12-04
Enrollment: 5860
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
timeFrame: 2.5 years
Secondary outcomes:
measure: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure
timeFrame: 2.5 years
measure: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death
timeFrame: 2.5 years
measure: Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)
timeFrame: 2.5 years
measure: 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)
timeFrame: 3 months
measure: Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)
timeFrame: 3 months
measure: Total pharmacy and health care costs
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Aetna Inc
state: Connecticut
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.