SyncopeNCT04790058
CSRS Implementation - A Pilot Study
An observational study of Syncope, run by Ottawa Hospital Research Institute at 1 site 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 of the CSRS practice recommendations
- How many people
- 900 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2021to 1 May 2027
- Phase
- Observational
- 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
Study population: The investigator will study the effect of Knowledge Translation on physicians involved in ED syncope care and the effect of the practice recommendations on patients, ED management and safety in 30-days and in 1-year. As the unit of randomization is the ED, all patients presenting to the ED with syncope among whom no serious condition was identified during the index ED evaluation and who did not require consultation/ hospitalization for a non-syncope related reason will be included in the study for analysis. The investigator will use the Canadian Emergency Department Information System presenting complaints suggestive of syncope/pre-syncope or an ED discharge diagnosis of syncope using discharge diagnoses fields or ICD-10 code R.55 for syncope to identify patients.
Who may be able to join
None listed.
Who cannot join
- non-syncope (prolonged LOC >5 minutes, change in the mental status from baseline, patients with witnessed obvious seizure, or head trauma preceding the LOC),
- those unable to provide proper details - e.g., intoxication, and those with significant trauma requiring admission as per international consensus.
- patients who had a serious underlying condition identified during the index ED evaluation
- hospitalization for a reason other than syncope work-up (i.e. unable to cope at home).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management - A Pilot Study
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 the high costs. Our group 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. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.
Read the detailed description
ED crowding limits the ability of the emergency providers to provide quality care, is a growing crisis in North America and Europe, and leads to unsafe and rushed disposition decisions which compromise patient care. On the other hand, hospital admission is expensive, and an increasing awareness of nosocomial morbidity and the harms of unnecessary testing and hospitalization exert countervailing pressure on low-yield admissions from the ED. Therefore, improved accuracy in ED disposition decision-making is more important than ever, and syncope typifies a common, high stakes condition in which improvements in efficiency are badly needed.
Identifying which patients will benefit from further cardiac rhythm monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. A comprehensive literature review of risk-tools and international guidelines concede that previously published tools lack or have failed external validation, are excessively complex, include as outcomes obvious conditions readily identified during the index ED evaluation, or lacked power and specificity. These tools also do not offer specific clinical actions and are not supported by the guidelines. The CSRS addresses each of the above weaknesses and coupled with outpatient live cardiac monitoring is an innovative and standardized approach to ED syncope management to expedite ED care, improve patient safety and reduce healthcare costs. The investigators have identified the barriers and facilitators to effectively adapt knowledge into local contexts as per the Knowledge to Action cycle, and have selected implementation strategies accordingly. The proposed pilot study is a right step before widescale implementation.
The primary objective of this pilot study is to assess the feasibility of implementing the practice recommendations. The secondary objectives are to assess the effectiveness and safety of the intervention, implementation of the CSRS-based practice recommendations. Specific objectives include:
Feasibility objectives:
Primary: to assess the reach of the intervention Secondary: to assess the adoption, adherence, and sustainability of the intervention; to assess the acceptability, the feasibility of use and the complexity of the intervention; and to assess the satisfaction to the dose (i.e., exposure) of the intervention received including support and resources.
Effectiveness objectives:
Primary: to assess the impact on ED disposition time, defined as the time interval between ED physician initial assessment and ED disposition.
Secondary: to assess the impact on hospitalizations, investigations and consultations performed in the ED.
Safety objective: To assess mortality, return ED visits and hospitalization within 30-days and 1-year of the index ED visit (generic patient safety outcome) and to monitor the safety of the CSRS application by assessing the 30-day serious outcomes after ED disposition (syncope specific short-term serious outcome).
We will conduct the study over a 9-month period, with the TOH and QCH EDs receiving the intervention at the 3rd and 4th month respectively. The first month of the intervention period will be designated as a transition period during which we will undertake intense educational efforts. The total intervention period for the QCH and TOH EDs will be 5 and 6 months respectively.
- Conditions
- Syncope
- Being tested
- Knowledge translation of the CSRS 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 of the CSRS practice recommendationsOther
The intervention is knowledge translation of the CSRS practice recommendations; the application of the practice recommendations will occur during the patient's ED visit and patients who are eligible for 15-day cardiac rhythm monitoring will have Holter monitor applied at the time of ED discharge. For the secondary objective to validate the accuracy of the ultra-low risk criteria of CSRS and assess for potential improvements in the practice recommendations and the prediction models we will request verbal consent during the index ED visit for addition of cardiac biomarker measurements [troponin and NT-proBNP] for patients who did not have such measurements performed as part of routine clinical care, and a 30-day telephone follow-up for serious outcome assessment. Patients who do not consent will be excluded from these portions of the study but included in the health resource utilization and generic patient safety outcome assessment objectives.
| Study group | Role | What they receive |
|---|---|---|
| Physicians using CSRS practice recommendation to treat syncope patients in ED. | During the control period, there will be no interventions. The intervention is the knowledge translation of the CSRS practice recommendations. 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; 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. The ED physician or non-ED physician performing consultation on the patient can apply all the components of the practice recommendation and decide disposition of the patients who are eligible to be studied. Receives: Other: Knowledge translation of the CSRS practice recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing the practice recommendations.
To assess the reach of the intervention. We will adopt a pragmatic application of the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework to evaluate the pilot study outcomes. The primary feasibility outcome is the Reach or penetration, the proportion of eligible patients who had the intervention applied.
Measured: The intervention period of 6 months
Rate of hospitalization
To assess the impact on hospitalizations.
Measured: At time of ED disposition, an average timeframe is 6 hours
Secondary outcomes (8)
Rate of consultation
To assess the effectiveness of intervention on consultation performed in the ED
Measured: at 6 hours from time of ED disposition
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
Rate of adoption
To assess the adoption of CSRS practice recommendation
Measured: The intervention period of 6 months
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 adherence
To assess the adherence of the CSRS practice recommendation in the ED
Measured: The intervention period of 6 months
Rate of acceptability
To assess the acceptability of the CSRS practice recommendation in the ED
Measured: The intervention period of 6 months
ED disposition time
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 patients for whom a decision to discharge has been made).
Measured: At time of ED disposition, an average timeframe is 6 hours
Degree of satisfaction of the use of CSRS practice recommendation
To assess the satisfaction for the intervention received including support and resources
Measured: The intervention period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start20 Aug 2021
- Primary completion16 Aug 2022
- Study completion1 May 2027 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Queensway Carleton Hospital
- 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
- NCT04790058
- Sponsor's protocol ID
- CRF 2589
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2020
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Thiruganasambandamoorthy V, Keller M, Nguyen PAI, Gupta P, Ghaedi B, Cao GZQ, Cheung WJ, Khatiwada B, Nemnom MJ, Yadav K, Eagles D, Brehaut J, Tarhuni W, Rouleau G, Desveaux L, Taljaard M. Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial. CJEM. 2023 Oct;25(10):808-817. doi: 10.1007/s43678-023-00570-7. Epub 2023 Aug 31.
PubMed 37651075
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management - A Pilot Study
- ClinicalTrials.gov ID
- NCT04790058
- Acronym / sponsor ID
- CRF 2589
- Conditions
- Syncope
- Keywords
- Syncope, Emergency Department, Risk Stratification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Queensway Carleton Hospital
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Mar 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 the high costs. Our group 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. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.
Detailed description
ED crowding limits the ability of the emergency providers to provide quality care, is a growing crisis in North America and Europe, and leads to unsafe and rushed disposition decisions which compromise patient care. On the other hand, hospital admission is expensive, and an increasing awareness of nosocomial morbidity and the harms of unnecessary testing and hospitalization exert countervailing pressure on low-yield admissions from the ED. Therefore, improved accuracy in ED disposition decision-making is more important than ever, and syncope typifies a common, high stakes condition in which improvements in efficiency are badly needed.
Identifying which patients will benefit from further cardiac rhythm monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. A comprehensive literature review of risk-tools and international guidelines concede that previously published tools lack or have failed external validation, are excessively complex, include as outcomes obvious conditions readily identified during the index ED evaluation, or lacked power and specificity. These tools also do not offer specific clinical actions and are not supported by the guidelines. The CSRS addresses each of the above weaknesses and coupled with outpatient live cardiac monitoring is an innovative and standardized approach to ED syncope management to expedite ED care, improve patient safety and reduce healthcare costs. The investigators have identified the barriers and facilitators to effectively adapt knowledge into local contexts as per the Knowledge to Action cycle, and have selected implementation strategies accordingly. The proposed pilot study is a right step before widescale implementation.
The primary objective of this pilot study is to assess the feasibility of implementing the practice recommendations. The secondary objectives are to assess the effectiveness and safety of the intervention, implementation of the CSRS-based practice recommendations. Specific objectives include:
Feasibility objectives:
Primary: to assess the reach of the intervention Secondary: to assess the adoption, adherence, and sustainability of the intervention; to assess the acceptability, the feasibility of use and the complexity of the intervention; and to assess the satisfaction to the dose (i.e., exposure) of the intervention received including support and resources.
Effectiveness objectives:
Primary: to assess the impact on ED disposition time, defined as the time interval between ED physician initial assessment and ED disposition.
Secondary: to assess the impact on hospitalizations, investigations and consultations performed in the ED.
Safety objective: To assess mortality, return ED visits and hospitalization within 30-days and 1-year of the index ED visit (generic patient safety outcome) and to monitor the safety of the CSRS application by assessing the 30-day serious outcomes after ED disposition (syncope specific short-term serious outcome).
We will conduct the study over a 9-month period, with the TOH and QCH EDs receiving the intervention at the 3rd and 4th month respectively. The first month of the intervention period will be designated as a transition period during which we will undertake intense educational efforts. The total intervention period for the QCH and TOH EDs will be 5 and 6 months respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians using CSRS practice recommendation to treat syncope patients in ED. | – | Other: Knowledge translation of the CSRS practice recommendationsDuring the control period, there will be no interventions. The intervention is the knowledge translation of the CSRS practice recommendations. 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; 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. The ED physician or non-ED physician performing consultation on the patient can apply all the components of the practice recommendation and decide disposition of the patients who are eligible to be studied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigator will study the effect of Knowledge Translation on physicians involved in ED syncope care and the effect of the practice recommendations on patients, ED management and safety in 30-days and in 1-year. As the unit of randomization is the ED, all patients presenting to the ED with syncope among whom no serious condition was identified during the index ED evaluation and who did not require consultation/ hospitalization for a non-syncope related reason will be included in the study for analysis. The investigator will use the Canadian Emergency Department Information System presenting complaints suggestive of syncope/pre-syncope or an ED discharge diagnosis of syncope using discharge diagnoses fields or ICD-10 code R.55 for syncope to identify patients.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
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 of the CSRS practice recommendationsThe intervention is knowledge translation of the CSRS practice recommendations; the application of the practice recommendations will occur during the patient's ED visit and patients who are eligible for 15-day cardiac rhythm monitoring will have Holter monitor applied at the time of ED discharge. For the secondary objective to validate the accuracy of the ultra-low risk criteria of CSRS and assess for potential improvements in the practice recommendations and the prediction models we will request verbal consent during the index ED visit for addition of cardiac biomarker measurements [troponin and NT-proBNP] for patients who did not have such measurements performed as part of routine clinical care, and a 30-day telephone follow-up for serious outcome assessment. Patients who do not consent will be excluded from these portions of the study but included in the health resource utilization and generic patient safety outcome assessment objectives. | Other | Physicians using CSRS practice recommendation to treat syncope patients in ED. |
Primary outcome
Feasibility of implementing the practice recommendations.
Time frame: The intervention period of 6 months
To assess the reach of the intervention. We will adopt a pragmatic application of the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework to evaluate the pilot study outcomes. The primary feasibility outcome is the Reach or penetration, the proportion of eligible patients who had the intervention applied.
Rate of hospitalization
Time frame: At time of ED disposition, an average timeframe is 6 hours
To assess the impact on hospitalizations.
8 secondary outcomes
Rate of consultation
Time frame: at 6 hours from time of ED disposition
Mortality
Time frame: within 30-days and 1-year of the index ED visit
Rate of adoption
Time frame: The intervention period of 6 months
Number of return ED visits
Time frame: within 30-days and 1-year
Rate of adherence
Time frame: The intervention period of 6 months
Rate of acceptability
Time frame: The intervention period of 6 months
ED disposition time
Time frame: At time of ED disposition, an average timeframe is 6 hours
Degree of satisfaction of the use of CSRS practice recommendation
Time frame: The intervention period of 6 months
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 24 Mar 2025.
- Derived from this study: PubMed 37651075Thiruganasambandamoorthy V, Keller M, Nguyen PAI, Gupta P, Ghaedi B, Cao GZQ, Cheung WJ, Khatiwada B, Nemnom MJ, Yadav K, Eagles D, Brehaut J, Tarhuni W, Rouleau G, Desveaux L, Taljaard M. Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial. CJEM. 2023 Oct;25(10):808-817. doi: 10.1007/s43678-023-00570-7. Epub 2023 Aug 31.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Syncope
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
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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. This study is not recruiting at the moment.
Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, run by Ottawa Hospital Research Institute at 1 site 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 0 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 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 1 site 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?
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?
Feasibility of implementing the practice recommendations. (time frame: The intervention period of 6 months). The study lists 2 primary outcomes in all. 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 NCT04790058, 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 24 Mar 2025.