- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672137
Knowledge Translation for Patients With Acute Coronary Syndromes (AMI-OPTIMA)
Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The AMI-OPTIMA study was a cluster randomized controlled trial of 24 hospitals to one-year knowledge translation (KT) vs usual care. Prior to randomization, we reviewed charts of 100 consecutive acute coronary syndromes (ACS) patients at each participating hospital in 2009. During one year, hospitals randomized to KT completed: 1) revision of the most recent American Heart Association Guidelines of ACS management, 2) focus groups to identify and solve local care gaps, and 3)local champion team to promote evidence-based medical therapy (EBMT). At the end of 12-month of KT/usual care, we reviewed discharge prescriptions of 100 consecutive ACS patients at each participating hospital (year 2012).
EBMT was pre-defined as in-hospital anticoagulation and discharge prescription of dual anti-platelets, beta-blockers, statins, and angiotensin pathway modulating agents (for patients with impaired left ventricular systolic function). Refusal, impaired cognitive function, allergy or intolerance of patients to any of EBMT were considered valid reasons for withholding EBMT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Had a final discharge diagnosis of one of the following categories:
- Myocardial infarction with ST-segment elevation
- Myocardial infarction without ST-segment elevation
- Unstable angina
- Acute coronary syndromes -
Exclusion Criteria:
- Non-atherosclerotic coronary artery disease (as confirmed by coronary angiograms or other non-invasive tests such as stress test, coronary CT-scan, nuclear scans)
- Hospital stay of less than 48 hours -
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
no intervention
|
|
Experimental: knowledge translation
knowledge translation 12-month multi-facet intensive knowledge translation measures that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.
|
knowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who received evidence-based medical therapy at hospital discharge (mean of 4 days)
Time Frame: at hospital discharge (average of 4 days)
|
Evidence-based medical therapy is defined as aspirin,dual-antiplaquelets, beta-blockers, statins.
|
at hospital discharge (average of 4 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discharge prescription of individual evidence-based medical therapy: aspirin, dual antiplatelets, beta-blockers
Time Frame: at hospital discharge (average of 4 days)
|
For each of the following medication: aspirin, dual anti-platelet, beta-blocker and statin, we calculated the proportion of patients who were prescribed the specific medication at discharge (as recorded on the discharge prescription).
|
at hospital discharge (average of 4 days)
|
Safety endpoints (mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds))
Time Frame: in-hospital (average of 4 days)
|
mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds)
|
in-hospital (average of 4 days)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: thao huynh, md,msc,phd, Montreal General Hospital
Publications and helpful links
General Publications
- Huynh T, Kouz S, Afilalo M, Rinfret S, Schampaert E, Mansour S, Montigny M, Eisenberg MJ, Lauzon C, Dery JP, Nguyen M, L'Allier P, Harvey R, Boudreault C, Tardif JC. Knowledge Translation to improve prescription of evidence-based medical therapy for patients admitted with acute coronary syndromes: insights from the AMI-OPTIMA study. Journal of the American College of Cardiology.J Am Coll Cardiol. 2015;65(10_S).
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIREG_L_04201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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