SyncopeNCT04972071
SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations
A study testing Knowledge translation (KT) of the CSRS based practice recommendations in people with Syncope, run by Ottawa Hospital Research Institute at 15 sites in Canada.
Trial summary
Syncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Knowledge translation (KT) of the CSRS based practice recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,400 participants
- Where
- 15 sitesCanada
- Study dates
- 18 Sep 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED physicians involved in ED syncope care
- Non-ED physicians involved in ED syncope care
- Physician's delegates involved in ED syncope care
- Patients who are adults (aged > 18 years)
- Patients who present to the ED within 24 hours of syncope.
Who cannot join
- ED physicians not involved in ED syncope care
- Non-ED physicians not involved in ED syncope care
- Physician's delegates not involved in ED syncope care
- Patients:
- Patients who do not fulfill the definition of syncope, namely those with a prolonged loss of consciousness (i.e., > 5 minutes), Glasgow Coma Scale < 15 in patients without dementia (or a change in the mental status from baseline in those with dementia);
- Patients with witnessed obvious seizure, or head trauma preceding the loss of consciousness; and those who are unable to provide proper details (e.g., alcohol intoxication or other substance use).
- Patients who had a serious underlying for the syncope identified during the index ED evaluation and those who were consulted to an inpatient service or hospitalized for reasons other than syncope workup (e.g., social reasons such as inability to cope at home, pain due to the fall, significant trauma).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Canada15 sites, 15 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Andrew McRae, MD, (403) 944-1110
Andrew McRae
- Recruiting
Health Sicence North
Greater Sudbury, Ontario
Danielle Waltenbury, dwaltenbury@hsnri.ca
Robert Ohle
- Recruiting
Hawkesbury and District General Hospital
Hawkesbury, Ontario
Jean-Francois Borduas, MD, (613) 632-1111
Jean-Francois Borduas, MD
- Recruiting
London Health Sciences Centre
London, Ontario
Justin Yan, MD, (519) 685-8500
Justin Yan, MD
- Recruiting
Jewish General Hospital
Montreal, Quebec
Xiaoqing Xue
Lars Grant
- Recruiting
Royal Victoria Hospital & Montreal General Hospital
Montreal, Quebec
David Iannuzz
Gregory Clark
- Recruiting
North Bay Regional Health Centre
North Bay, Ontario
Taylor Lougheed, MD, (705) 474-8600
Taylor Lougheed, MD
- Recruiting
Centre hospitalier de l'Université Laval
Québec, Quebec
Simon Berthelot, MD, (418) 525-4444
Simon Berthelot, MD
- Recruiting
Hotel Dieu Hospital of Lévis
Québec, Quebec
Patrick Archambault, MD, (418) 835-7121
Patrick Archambault, MD
- Recruiting
Hôpital de L'Enfant-Jésus
Québec, Quebec
Alexandra Nadeau
Eric Mercier
- Recruiting
Thunder Bay Regional Health Sicences Centre
Thunder Bay, Ontario
Rabail Siddiqui
Amanda Bakke
- Recruiting
University Health Network
Toronto, Ontario
Konika Nirmalanathan
Anna Nowacki
- Recruiting
Niagara Health
Welland, Ontario
Stephenson Strobel, MD, (905) 378-4647
Stephenson Strobel, MD
- Recruiting
Winchester District Memorial Hospital
Winchester, Ontario
Mohamed Gazarin
Mohamed Gazarin
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba
Mona Hegdekar
Mona Hegdekar
About this study
Official title: Multi-Centre Cluster-Randomized Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management
Syncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. The research team has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS-based practice recommendations to demonstrate its real-world effectiveness. These recommendations, if applied, could lead to reduction in hospitalization with only 6% of high-risk patients requiring hospitalization, shorter ED lengths of stay for the 76% of ED syncope patients who are at low risk for 30-day serious outcomes, and more standardized disposition decisions, specifically discharge of 18% of medium-risk patients after appropriate discussion. Hence, the investigators hypothesize that an important reduction in hospitalization and ED disposition time can be achieved by implementing the CSRS-based recommendations with potential improvements in patient safety. The overall objective of this study is to evaluate the effectiveness of the knowledge translation (KT) of the CSRS-based practice recommendations in multiple Canadian EDs using a stepped wedge cluster randomized trial (SW-CRT) on health care efficiency and patient safety.
Read the detailed description
The investigators will conduct a SW-CRT involving 16 participating ED clusters across Canada. The design will be a batched SW-CRT with two batches of 8 cluster EDs with the first 8 cluster EDs that are ready for the trial included in the first batch. Some EDs will be grouped to avoid contamination between multiple sites operating within the same hospital organization. The total study duration is 16 months for each batch. All clusters in the two batches will start the trial in a control period (usual care) for three months with no intervention being delivered at any site, then sequentially cross over from the control period to the intervention period in random sequence, with 2 clusters crossing over every third month, until all sites have adopted the intervention. Clusters will be randomly allocated to one of four steps (two clusters per step) with step lengths of three months. The first month after crossing over will be designated as a transition period to allow the intervention to be fully implemented. During the first three months of the study, all clusters will be in the control period and during the last three months all clusters will be in the intervention period. Hence, the total study period will be 16 months for each batch.
The following principal research questions will be addressed 1) What is the effect of the knowledge translation and implementation of the CSRS-based practice recommendations on health resource utilization? The health resource utilization measures include the proportion hospitalized, the proportion investigated in the ED, and ED disposition time 2) How and why did the implementation achieve the observed effect? The embedded process evaluation measures align with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework and include: a) adoption - the proportion of physicians who attended the educational sessions and the proportion who adopted the CSRS in practice; b) reach- the proportion of eligible patients for whom the CSRS was utilized during their ED visit; c) intervention fidelity - the proportion of patients for whom the resulting CSRS recommendations were followed d) maintenance- whether observed adoption rates remain stable or increase over time. 3) What is the effect of the knowledge translation strategy on patient safety, as measured by 30-day serious outcome identification, 30-day and 1-year return ED visits, hospitalizations, and mortality? and 4) validate the ultra-low-risk criteria in a new cohort of patients and assess if the CSRS can be improved in its ability to predict 30-day serious outcomes.
- Conditions
- Syncope
- Being tested
- Knowledge translation (KT) of the CSRS based practice recommendations
- Keywords
- Syncope, Emergency Department, Risk Stratification
- Medical subject headings
- Syncope, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge translation (KT) of the CSRS based practice recommendationsOther
The components of the practice recommendations include: 1) evidence-informed systematic clinical evaluation with appropriate history, physical examination and in-ED investigations (e.g., troponin testing, work-up for pulmonary embolism and CT head) for detecting serious underlying conditions and predicting 30-day serious outcomes; 2) application of the CSRS for risk-stratification at the end of ED visit after no serious underlying conditions for the syncope were identified; 3) use of patient information materials to aid in disposition; and 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. All the components of the practice recommendations will be applied by the ED physician treating the patient.
| Study group | Role | What they receive |
|---|---|---|
| CSRS practice recommendation | Other | Knowledge translation of the Canadian Syncope Risk Score (CSRS) based practice recommendations Receives: Other: Knowledge translation (KT) of the CSRS based practice recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospitalization
to assess the impact on hospital admission
Measured: At time of ED disposition, an average timeframe is 6 hours
Secondary outcomes (7)
ED disposition time
The ED disposition time is defined as the time interval between ED physician initial assessment and ED disposition. We chose this time interval rather than ED length of stay which is the time interval between ED arrival/registration and departure from the ED. The ED disposition time more accurately reflects the active phase of ED physician care for collecting clinical information, work-up of patients and resolution of diagnostic uncertainty. The longer interval of ED length of stay includes wait times both before and after, which are often determined by triage acuity as well as extraneous system factors (e.g., ED and hospital crowding, staffing patterns, sudden influx of patients, availability of inpatient beds and overcapacity protocols, and availability of transportation for a subgroup of patients for whom a decision to discharge has been made);
Measured: At time of ED disposition, an average timeframe is 6 hours
All-cause mortality
To assess mortality within 30-days and 1-year of the index ED visit
Measured: within 30-days and 1-year of the index ED visit
Number of return ED visits
To assess return ED visits within 30-days and 1-year of the index ED visit
Measured: within 30-days and 1-year
Rate of consultation
To assess the effectiveness of intervention on consultation performed in the ED
Measured: 1-year from the index ED visit
Rate of adoption
To assess the adoption of CSRS practice recommendation
Measured: Before ED disposition, average of 6 hours
Rate of adherence
To assess the adherence of the CSRS practice recommendation in the ED
Measured: Before ED disposition, average of 6 hours
Rate of acceptability
To assess the acceptability of the CSRS practice recommendation in the ED
Measured: Before ED disposition, average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start18 Sep 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A Stepped Wedge-Controlled Randomized Trial
- Masking
- None (open label)
- Enrolment
- 14,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Venkatesh Thiruganasambandamoorthy, Ottawa Hospital Research Institute
- Investigators
- Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972071
- Sponsor's protocol ID
- 3371
- Status last verified
- Mar 2025
- First submitted
- 12 Jul 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Cluster-Randomized Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management
- ClinicalTrials.gov ID
- NCT04972071
- Acronym / sponsor ID
- 3371
- Conditions
- Syncope
- Keywords
- Syncope, Emergency Department, Risk Stratification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14,400 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Jul 2021 (actual)
- 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.
Syncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. The research team has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS-based practice recommendations to demonstrate its real-world effectiveness. These recommendations, if applied, could lead to reduction in hospitalization with only 6% of high-risk patients requiring hospitalization, shorter ED lengths of stay for the 76% of ED syncope patients who are at low risk for 30-day serious outcomes, and more standardized disposition decisions, specifically discharge of 18% of medium-risk patients after appropriate discussion. Hence, the investigators hypothesize that an important reduction in hospitalization and ED disposition time can be achieved by implementing the CSRS-based recommendations with potential improvements in patient safety. The overall objective of this study is to evaluate the effectiveness of the knowledge translation (KT) of the CSRS-based practice recommendations in multiple Canadian EDs using a stepped wedge cluster randomized trial (SW-CRT) on health care efficiency and patient safety.
Detailed description
The investigators will conduct a SW-CRT involving 16 participating ED clusters across Canada. The design will be a batched SW-CRT with two batches of 8 cluster EDs with the first 8 cluster EDs that are ready for the trial included in the first batch. Some EDs will be grouped to avoid contamination between multiple sites operating within the same hospital organization. The total study duration is 16 months for each batch. All clusters in the two batches will start the trial in a control period (usual care) for three months with no intervention being delivered at any site, then sequentially cross over from the control period to the intervention period in random sequence, with 2 clusters crossing over every third month, until all sites have adopted the intervention. Clusters will be randomly allocated to one of four steps (two clusters per step) with step lengths of three months. The first month after crossing over will be designated as a transition period to allow the intervention to be fully implemented. During the first three months of the study, all clusters will be in the control period and during the last three months all clusters will be in the intervention period. Hence, the total study period will be 16 months for each batch.
The following principal research questions will be addressed 1) What is the effect of the knowledge translation and implementation of the CSRS-based practice recommendations on health resource utilization? The health resource utilization measures include the proportion hospitalized, the proportion investigated in the ED, and ED disposition time 2) How and why did the implementation achieve the observed effect? The embedded process evaluation measures align with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework and include: a) adoption - the proportion of physicians who attended the educational sessions and the proportion who adopted the CSRS in practice; b) reach- the proportion of eligible patients for whom the CSRS was utilized during their ED visit; c) intervention fidelity - the proportion of patients for whom the resulting CSRS recommendations were followed d) maintenance- whether observed adoption rates remain stable or increase over time. 3) What is the effect of the knowledge translation strategy on patient safety, as measured by 30-day serious outcome identification, 30-day and 1-year return ED visits, hospitalizations, and mortality? and 4) validate the ultra-low-risk criteria in a new cohort of patients and assess if the CSRS can be improved in its ability to predict 30-day serious outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Stepped Wedge-Controlled Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| CSRS practice recommendation | Other | Other: Knowledge translation (KT) of the CSRS based practice recommendationsKnowledge translation of the Canadian Syncope Risk Score (CSRS) based practice recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ED physicians involved in ED syncope care
- Non-ED physicians involved in ED syncope care
- Physician's delegates involved in ED syncope care
- Patients who are adults (aged > 18 years)
- Patients who present to the ED within 24 hours of syncope.
Key exclusion criteria (7 listed)
- ED physicians not involved in ED syncope care
- Non-ED physicians not involved in ED syncope care
- Physician's delegates not involved in ED syncope care
- Patients who do not fulfill the definition of syncope, namely those with a prolonged loss of consciousness (i.e., > 5 minutes), Glasgow Coma Scale < 15 in patients without dementia (or a change in the mental status from baseline in those with dementia);
- Patients with witnessed obvious seizure, or head trauma preceding the loss of consciousness; and those who are unable to provide proper details (e.g., alcohol intoxication or other substance use).
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 translation (KT) of the CSRS based practice recommendationsThe components of the practice recommendations include: 1) evidence-informed systematic clinical evaluation with appropriate history, physical examination and in-ED investigations (e.g., troponin testing, work-up for pulmonary embolism and CT head) for detecting serious underlying conditions and predicting 30-day serious outcomes; 2) application of the CSRS for risk-stratification at the end of ED visit after no serious underlying conditions for the syncope were identified; 3) use of patient information materials to aid in disposition; and 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. All the components of the practice recommendations will be applied by the ED physician treating the patient. | Other | CSRS practice recommendation |
Primary outcome
Rate of hospitalization
Time frame: At time of ED disposition, an average timeframe is 6 hours
to assess the impact on hospital admission
7 secondary outcomes
ED disposition time
Time frame: At time of ED disposition, an average timeframe is 6 hours
All-cause mortality
Time frame: within 30-days and 1-year of the index ED visit
Number of return ED visits
Time frame: within 30-days and 1-year
Rate of consultation
Time frame: 1-year from the index ED visit
Rate of adoption
Time frame: Before ED disposition, average of 6 hours
Rate of adherence
Time frame: Before ED disposition, average of 6 hours
Rate of acceptability
Time frame: Before ED disposition, average of 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. No plan to share IPD
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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Cardioneuroablation for Reflex Syncope and Exercise Capacity
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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.
Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc principal investigator
Ottawa Hospital Research Institute
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge translation (KT) of the CSRS based practice recommendations in people with Syncope, run by Ottawa Hospital Research Institute at 15 sites in Canada.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Nguyen, BSc (6137985555 ext. 17766, pnguyen@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hospitalization (time frame: At time of ED disposition, an average timeframe is 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.