Delayed Educational Reminders in Acute Myocardial Infarction (MI) (DERLA-STEMI)

August 28, 2018 updated by: Jon-David Schwalm, Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

852

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences-General Site, Heart Investigation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Usual post-STEMI care
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.
Experimental: Intervention
Recurrent, personalized, educational reminders sent via post on behalf of the interventional cardiologist to the patient and their family physician urging long-term adherence to secondary prevention medications post-STEMI. A copy of the letter will be provided to the patient to take to their pharmacist.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 and 12 months
Statin Dose
Time Frame: 3 and 12 months
Proportion of patients taking high dose statins at three and twelve months
3 and 12 months
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
3 and 12 months
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.
3 and 12 months
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.
3 and 12 months
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.
3 and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Jon-David R Schwalm, BSc, MD, McMaster University/Hamilton Health Sciences/Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC-DS-03-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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