Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon-David Schwalm, McMaster University
ClinicalTrials.gov Identifier:
NCT01325116
First received: March 28, 2011
Last updated: September 17, 2014
Last verified: September 2014

March 28, 2011
September 17, 2014
September 2011
December 2012   (final data collection date for primary outcome measure)
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.
Statin Use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Proportion of patients who reported actively taking a statin at 3 months
Complete list of historical versions of study NCT01325116 on ClinicalTrials.gov Archive Site
  • 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.
  • Other Evidence-based Cardiac Medication Use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of patients who report actively taking aspirin, clopidogrel, beta-blocker, and/or angiotensin blocker
  • Statin Dose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of patients taking high, medium, or low dose statins at 3 months
  • Medication Side-effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Proportion of patients stopping evidence-based cardiac medications due to side effects
  • Discussion with Family physician/specialist [ Time Frame: 3 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.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Acute Myocardial Infarction
  • STEMI
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.
  • Active Comparator: Control
    Usual post-STEMI care
    Intervention: Behavioral: Educational Reminder
  • 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.
    Intervention: Behavioral: Educational Reminder
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
852
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01325116
MAC-DS-03-2011
No
Jon-David Schwalm, McMaster University
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Jon-David R Schwalm, BSc, MD McMaster University/Hamilton Health Sciences/Population Health Research Institute
McMaster University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP