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Knowledge Translation for Patients With Acute Coronary Syndromes (AMI-OPTIMA)

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ClinicalTrials.gov Identifier: NCT02672137
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborators:
Sanofi
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Thao Huynh, Montreal General Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Behavioral: knowledge translation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes
Study Start Date : January 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
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.
Behavioral: knowledge translation
knowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.

No Intervention: Usual care
no intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672137


Sponsors and Collaborators
Montreal General Hospital
Sanofi
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: thao huynh, md,msc,phd Montreal General Hospital
Additional Information:
Publications of Results:
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).

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Responsible Party: Thao Huynh, Cardiologist, associate professor of medicine, Montreal General Hospital
ClinicalTrials.gov Identifier: NCT02672137    
Other Study ID Numbers: DIREG_L_04201
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thao Huynh, Montreal General Hospital:
myocardial infarction
knowledge transfer
acute coronary syndromes
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases