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

Sponsor:	Brigham and Women's Hospital
Collaborator:	Aetna, Inc.
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00566774

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Coronary Artery Disease	Other: Full drug coverage Other: Usual coverage	Phase IV

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Post-myocardial Infarction Free Rx Event and Economic Evaluation (Post-MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

Resource links provided by NLM:

MedlinePlus related topics: Angina Angioplasty Coronary Artery Disease Heart Attack Heart Failure

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

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) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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: 1 year ] [ Designated as safety issue: No ]
Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Total pharmacy and health care costs [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	7500
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: 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: Active Comparator	Other: Usual coverage Patients randomized to usual coverage will have no change in their existing benefits

Arms

Assigned Interventions

1: Experimental

Other: 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: Active Comparator

Other: Usual coverage

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566774

Contacts

Contact: Michele Toscano, MS

860-273-5970

ToscanoM@aetna.com

Locations

United States, Connecticut
Aetna Inc	Recruiting
Hartford, Connecticut, United States, 06156
Contact: Michele Toscano, MS 860-273-5970 ToscanoM@aetna.com
Sub-Investigator: Troyen Brennan, MD, MPH, JD

Sponsors and Collaborators

Brigham and Women's Hospital

Aetna, Inc.

Investigators

Principal Investigator:

Niteesh K Choudhry, MD, PhD

Brigham and Women's Hospital/Harvard Medical School

More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Jun 6.

Responsible Party:	Brigham and Women's Hospital/Harvard Medical School ( Niteesh K. Choudhry, Assistant Professor )
Study ID Numbers:	2007-P-000847/1
Study First Received:	November 30, 2007
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00566774 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

myocardial infarction
secondary prevention
health insurance
cost-sharing

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Disease
Neoplasms

Neoplastic Processes
Necrosis
Pathologic Processes
Neoplasm Metastasis
Cardiovascular Diseases
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010