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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Other: Usual coverage; Other: Full drug coverage

• Registration Number: NCT00566774
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-04
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5860

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Usual coverage	-
1	Full drug coverage	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Total pharmacy and health care costs	2.5 years

Trial Locations

Locations (1)

Aetna Inc; 🇺🇸 Hartford, Connecticut, United States