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Delayed Educational Reminders in Acute Myocardial Infarction (MI)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01325116
Acronym
DERLA-STEMI
Enrollment
852
Registered
2011-03-29
Start date
2011-09-30
Completion date
2013-03-31
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, STEMI

Keywords

STEMI, Medication Adherence, Quality Improvement

Brief summary

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.

Interventions

BEHAVIORALEducational Reminder

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.

Sponsors

Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Medication Use3 and 12 monthsProportion 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

MeasureTime frameDescription
Statin Dose3 and 12 monthsProportion of patients taking high dose statins at three and twelve months
Medication Side-effects3 and 12 monthsProportion of patients who report stopping medications due to side effects at three and twelve months
Other Evidence-based Cardiac Medication Use3 and 12 monthsProportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker
Use of medication combinations3 and 12 monthsThe 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.
Adherence3 and 12 MonthsProportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.
Discussion with Family physician/specialist3 and 12 monthsProportion 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026