Clinical trial NCT01325116: Delayed Educational Reminders in Acute Myocardial Infarction (MI)
Official title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
STEMI
Keywords: STEMI
Medication Adherence
Quality Improvement
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Cardiac Medication Use
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Other Evidence-based Cardiac Medication Use
timeFrame: 3 and 12 months
measure: Statin Dose
timeFrame: 3 and 12 months
measure: Medication Side-effects
timeFrame: 3 and 12 months
measure: Discussion with Family physician/specialist
timeFrame: 3 and 12 months
measure: Use of medication combinations
timeFrame: 3 and 12 months
measure: Adherence
timeFrame: 3 and 12 Months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-General Site, Heart Investigation Unit
state: Ontario
Study officials:
affiliation: McMaster University/Hamilton Health Sciences/Population Health Research Institute
name: Jon-David R Schwalm, BSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.