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

Primary Purpose

Acute Myocardial Infarction, STEMI

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational Reminder
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction focused on measuring STEMI, Medication Adherence, Quality Improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences-General Site, Heart Investigation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Usual post-STEMI care

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Other Evidence-based Cardiac Medication Use
Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker
Statin Dose
Proportion of patients taking high dose statins at three and twelve months
Medication Side-effects
Proportion of patients who report stopping medications due to side effects at three and twelve months
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.
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.
Adherence
Proportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.

Full Information

First Posted
March 28, 2011
Last Updated
August 28, 2018
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01325116
Brief Title
Delayed Educational Reminders in Acute Myocardial Infarction (MI)
Acronym
DERLA-STEMI
Official Title
Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, STEMI
Keywords
STEMI, Medication Adherence, Quality Improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
852 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual post-STEMI care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Reminder
Intervention Description
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 Outcome Measure Information:
Title
Cardiac Medication Use
Description
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.
Time Frame
3 and 12 months
Secondary Outcome Measure Information:
Title
Other Evidence-based Cardiac Medication Use
Description
Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker
Time Frame
3 and 12 months
Title
Statin Dose
Description
Proportion of patients taking high dose statins at three and twelve months
Time Frame
3 and 12 months
Title
Medication Side-effects
Description
Proportion of patients who report stopping medications due to side effects at three and twelve months
Time Frame
3 and 12 months
Title
Discussion with Family physician/specialist
Description
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.
Time Frame
3 and 12 months
Title
Use of medication combinations
Description
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.
Time Frame
3 and 12 months
Title
Adherence
Description
Proportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.
Time Frame
3 and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon-David R Schwalm, BSc, MD
Organizational Affiliation
McMaster University/Hamilton Health Sciences/Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences-General Site, Heart Investigation Unit
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26542498
Citation
Schwalm JD, Ivers NM, Natarajan MK, Taljaard M, Rao-Melacini P, Witteman HO, Zwarenstein M, Grimshaw JM. Cluster randomized controlled trial of Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI). Am Heart J. 2015 Nov;170(5):903-13. doi: 10.1016/j.ahj.2015.08.014. Epub 2015 Aug 20.
Results Reference
derived
PubMed Identifier
22682691
Citation
Ivers NM, Schwalm JD, Grimshaw JM, Witteman H, Taljaard M, Zwarenstein M, Natarajan MK. Delayed educational reminders for long-term medication adherence in ST-elevation myocardial infarction (DERLA-STEMI): protocol for a pragmatic, cluster-randomized controlled trial. Implement Sci. 2012 Jun 9;7:54. doi: 10.1186/1748-5908-7-54.
Results Reference
derived

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Delayed Educational Reminders in Acute Myocardial Infarction (MI)

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