Knowledge Translation for Patients With Acute Coronary Syndromes

Acute Coronary Syndromes Clinical Trial

— AMI-OPTIMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672137
• Other study ID #: DIREG_L_04201
• Status: Completed
• Phase: N/A
• First received: January 10, 2016
• Last updated: February 2, 2016
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Montreal General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4604
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Montreal General Hospital	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Sanofi

References & Publications (1)

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 patie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	Yes

External Links

•   abstract presented at ACC 2015