Delayed Educational Reminders in Acute Myocardial Infarction (MI)

Acute Myocardial Infarction Clinical Trial

— DERLA-STEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325116
• Other study ID #: MAC-DS-03-2011
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: August 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Behavioral:
• Educational 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences-General Site, Heart Investigation Unit	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Medication Use	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.	3 and 12 months
Secondary	Other Evidence-based Cardiac Medication Use	Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker	3 and 12 months
Secondary	Statin Dose	Proportion of patients taking high dose statins at three and twelve months	3 and 12 months
Secondary	Medication Side-effects	Proportion of patients who report stopping medications due to side effects at three and twelve months	3 and 12 months
Secondary	Discussion with Family physician/specialist	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.	3 and 12 months
Secondary	Use of medication combinations	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.	3 and 12 months
Secondary	Adherence	Proportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.	3 and 12 Months