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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jon-David Schwalm, McMaster University
ClinicalTrials.gov Identifier:
NCT01325116
First received: March 28, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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 two-page letter sent on behalf of the interventional cardiologists, delivered by mail, 1 month after STEMI, 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.


Condition Intervention
Acute Myocardial Infarction
STEMI
Behavioral: Educational Reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Cardiac Medication Use [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker

  • Statin Dose [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Proportion of patients taking high dose statins at three and twelve months

  • Medication Side-effects [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
    Proportion of patients who report stopping medications due to side effects at three and twelve months

  • Discussion with Family physician/specialist [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 and 12 Months ] [ Designated as safety issue: No ]
    Proportion of patients with a perfect Morisky Medication Adherence Score (MMAS) for cardiac medication compliance at three and twelve months.


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325116

Contacts
Contact: Jon-David R Schwalm, BSc, MD 905-577-1423 schwalj@mcmaster.ca
Contact: Madhu K Natarajan, MD, MSc 905-527-0271 ext 44839 nataraja@mcmaster.ca

Locations
Canada, Ontario
Hamilton Health Sciences-General Site, Heart Investigation Unit Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Jon-David R Schwalm, MD, BSc, FRCPC    905-577-1423    schwalj@mcmaster.ca   
Contact: Madhu K Natarajan, MD, MSc, FRCPC    905-527-0271 ext 44839    nataraja@mcmaster.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Jon-David R Schwalm, BSc, MD McMaster University/Hamilton Health Sciences/Population Health Research Institute
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon-David Schwalm, Interventional Cardiologist, McMaster University
ClinicalTrials.gov Identifier: NCT01325116     History of Changes
Other Study ID Numbers: MAC-DS-03-2011
Study First Received: March 28, 2011
Last Updated: November 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
STEMI
Medication Adherence
Quality Improvement

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014