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

Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Behavioral: knowledge translation

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: Interventional
• Enrollment (Actual): 4604
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	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.

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)	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	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))	mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds)	in-hospital (average of 4 days)

Collaborators and Investigators

• Sponsor: Montreal General Hospital
• Collaborators: Sanofi; Canadian Institutes of Health Research (CIHR); Fonds de la Recherche en Santé du Québec
• 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: January 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 10, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: myocardial infarction; knowledge transfer; acute coronary syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: DIREG_L_04201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO