Acute Coronary SyndromesAMI-OPTIMANCT02672137
Knowledge Translation for Patients With Acute Coronary Syndromes
A study testing knowledge translation in people with Acute Coronary Syndromes, run by Montreal General Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- knowledge translation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,604 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 -
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- knowledge translation
- Keywords
- myocardial infarction, knowledge transfer, acute coronary syndromes
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knowledge translationBehavioural
knowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.
| Study group | Role | What they receive |
|---|---|---|
| knowledge translation | Experimental | 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. Receives: Behavioral: knowledge translation |
| Usual care | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at hospital discharge (average of 4 days)
Secondary outcomes (2)
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).
Measured: 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)
Measured: in-hospital (average of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Thao Huynh, Montreal General Hospital
- Investigators
- thao huynh, md,msc,phd, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672137
- Sponsor's protocol ID
- DIREG_L_04201
- Acronym
- AMI-OPTIMA
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2016
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT02672137
- Acronym / sponsor ID
- AMI-OPTIMA / DIREG_L_04201
- Conditions
- Acute Coronary Syndromes
- Keywords
- myocardial infarction, knowledge transfer, acute coronary syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,604 participants (actual)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Collaborators
- Sanofi, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knowledge translation | Experimental | Behavioral: knowledge translationknowledge 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. |
| Usual care | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knowledge translationknowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams. | Behavioural | knowledge translation |
Primary outcome
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.
2 secondary outcomes
Discharge prescription of individual evidence-based medical therapy: aspirin, dual antiplatelets, beta-blockers
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Results publicationHuynh 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).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
thao huynh, md,msc,phd principal investigator
Montreal General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing knowledge translation in people with Acute Coronary Syndromes, run by Montreal General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.