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Completed

NCT Number: NCT01325116

Delayed Educational Reminders in Acute Myocardial Infarction (MI)

ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.

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Key information

Conditions

Acute Myocardial Infarction Behavior Cardiovascular Diseases Health Behavior Heart Diseases Infarction Ischemia Medication Adherence Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance ST Elevation Myocardial Infarction STEMI Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences-General Site, Heart Investigation Unit

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted with STEMI to a hospital in LHIN IV, coronary angiogram with and without PCI at Hamilton General Hospital during hospital admission

Exclusion criteria

  • Non-english speaking

Treatment and study plan

Educational Reminder

Behavioral

Personalized letters sent via post to the patient and their family physician at one, five, eight, and eleven months after their angiogram, sent on behalf of the interventional cardiologist. The patient letter provides a review of the role of each of the cardiac medications and urges long-term adherence. The language in the patient letter is simplified to a grade 6 level; this letter was tested for understanding and acceptability amongst a series of Cardiology patients.At the same time, close examination of data from Ontario indicated large stepwise declines in adherence at 30 and 60 days post-STEMI. To address this, patients will be provided an additional postcard type reminder two months post-STEMI.

Primary outcomes

  1. Cardiac Medication Use

    Time frame: 3 and 12 months

    Proportion of patients who report taking all cardiac medication classes, measured three and twelve months post-STEMI. Specifically, we will assess whether patients are taking a statin, beta-blocker, angiotensin modifier (ACE or ARB), and aspirin at twelve months, and whether they are taking these plus a secondary antiplatelet (clopidogrel, prasugrel, or ticagrelor) at three months.

Secondary outcomes

  1. Other Evidence-based Cardiac Medication Use

    Time frame: 3 and 12 months

    Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker

  2. Statin Dose

    Time frame: 3 and 12 months

    Proportion of patients taking high dose statins at three and twelve months

  3. Medication Side-effects

    Time frame: 3 and 12 months

    Proportion of patients who report stopping medications due to side effects at three and twelve months

  4. Discussion with Family physician/specialist

    Time frame: 3 and 12 months

    Proportion of patients who state that they had a discussion with their FP regarding the benefits of certain medications to prevent future heart attacks or that focused on medication compliance since their heart attack.

  5. Use of medication combinations

    Time frame: 3 and 12 months

    The proportion of patients using 1 of 5, 2 of 5, 3 of 5, 4 of 5, or 5 of 5 medications at three and twelve months.

  6. Adherence

    Time frame: 3 and 12 Months

    Proportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial

Acronym: DERLA-STEMI

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 29, 2011
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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