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

NCT00566774 | Completed Phase 4 DMC

• 1 other identifier: 2007-P-000847/1
• Study Type: interventional
• Target: 5,860
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

myocardial infarction; secondary prevention; health insurance; cost-sharing

Outcome Measures

Primary Outcomes (1)

• First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)

  2.5 years

Secondary Outcomes (6)

• First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure

  2.5 years

• First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death

  2.5 years

• Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)

  2.5 years

• 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)

  3 months

• Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)

  3 months

Study Arms (2)

1

EXPERIMENTAL

Other: Full drug coverage

2

ACTIVE COMPARATOR

Other: Usual coverage

Interventions

Full drug coverage 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

1

Usual coverage OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• discharged alive from hospital after acute MI
• receive health services and prescription drug benefits through Aetna, Inc.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Aetna, Inc.: collaborator

Study Sites (1)

Aetna Inc

Hartford, Connecticut, 06156, United States

Location

Related Publications (3)

• 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.

  PMID: 25944633 DERIVED

• 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.

  PMID: 22080794 DERIVED

• 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.

  PMID: 18585494 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Associate Physician

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 4, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)