Clinical trial NCT02672137: Knowledge Translation for Patients With Acute Coronary Syndromes
Official title: Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: myocardial infarction
knowledge transfer
acute coronary syndromes
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
First posted: 2016-02-03
Enrollment: 4604
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Cluster randomized open-label experimental study multi-center of 24 hospitals to either knowledge translation vs usual care to improve care of patents hospitalized for acute coronary syndromes.

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.

Eligibility criteria: Inclusion Criteria:Had a final discharge diagnosis of one of the following categories:

1. Myocardial infarction with ST-segment elevation
2. Myocardial infarction without ST-segment elevation
3. Unstable angina
4. Acute coronary syndromes -

Exclusion Criteria:

1. Non-atherosclerotic coronary artery disease (as confirmed by coronary angiograms or other non-invasive tests such as stress test, coronary CT-scan, nuclear scans)
2. Hospital stay of less than 48 hours -

Primary outcomes:
measure: Proportion of patients who received evidence-based medical therapy at hospital discharge (mean of 4 days)
timeFrame: at hospital discharge (average of 4 days)
Secondary outcomes:
measure: Discharge prescription of individual evidence-based medical therapy: aspirin, dual antiplatelets, beta-blockers
timeFrame: at hospital discharge (average of 4 days)
measure: Safety endpoints (mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds))
timeFrame: in-hospital (average of 4 days)
Other outcomes:
Locations:
Study officials:
affiliation: Montreal General Hospital
name: thao huynh, md,msc,phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).