Abstract
BackgroundDespite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality.Methods/designThis is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item); stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled.DiscussionThis intervention is designed to be easily generalizable. If effective, it could be implemented broadly. If it does not change medication utilization, the process evaluation will offer insights regarding how such an intervention could be optimized in future.Trial registrationClinicaltrials.gov NCT01325116
Highlights
Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time
50% of myocardial infarctions (MIs) and 70% of cardiovascular disease (CVD) deaths occur in patients who have already documented coronary artery disease (CAD) [2]
While acute treatment is crucial for segment elevation myocardial infarction (STEMI) patients, relevant guidelines emphasize that the initiation and long-term maintenance of evidence-based secondary preventative therapies are essential for reducing the overall burden of CVD [3,8,9]
Summary
Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. The prompt identification of modifiable cardiovascular risk factors and initiation of proven secondary preventative medications post-MI are essential to the prevention of subsequent cardiac events [3]. Population-level observational studies provide evidence that the rate of cardiovascular morbidity and mortality has been decreased through the use evidence-based therapies [4,5]. While acute treatment is crucial for STEMI patients, relevant guidelines emphasize that the initiation and long-term maintenance of evidence-based secondary preventative therapies are essential for reducing the overall burden of CVD [3,8,9]
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