Risk Score Tool for Fainting

Recruiting at 14 trial locations

Overseen By Iris Nguyen, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Prolonged unconsciousness, Seizure, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 0

14400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Knowledge translation (KT) of the CSRS based practice recommendations?

The Canadian Syncope Risk Score (CSRS) has been validated for accuracy and safety in assessing patients with fainting episodes, and its implementation in emergency departments has shown promise in improving management practices. Additionally, a multifaceted strategy involving education and process improvements has demonstrated initial success in enhancing adherence to syncope care guidelines. ^{1 2 3 4 5}

Is the Canadian Syncope Risk Score (CSRS) safe for use in humans?

The Canadian Syncope Risk Score (CSRS) has been validated for safety in predicting serious outcomes in patients with fainting episodes, showing it is generally safe for use in humans. ^{1 6 7 8 9}

How is the Canadian Syncope Risk Score (CSRS) based practice recommendations treatment different from other syncope treatments?

The Canadian Syncope Risk Score (CSRS) based practice recommendations are unique because they provide a structured way to assess the risk of serious events in patients who faint, helping doctors make better decisions in the emergency department. Unlike other treatments that might focus on symptoms, this approach uses a risk score to guide management and improve patient outcomes. ^{1 2 7 10 11}

Research Team

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for emergency department (ED) physicians and their delegates involved in the care of patients who faint, known as syncope. It aims to improve decision-making on whether these patients need further tests, monitoring, or hospital admission.

Inclusion Criteria

Physicians: Physician's delegates involved in ED syncope care

Physicians: ED physicians involved in ED syncope care

Physicians: Non-ED physicians involved in ED syncope care

Exclusion Criteria

Physicians: ED physicians not involved in ED syncope care

Physicians: Non-ED physicians not involved in ED syncope care

Physicians: Physician's delegates not involved in ED syncope care

Timeline

Control Period

All clusters start the trial in a control period with usual care and no intervention

3 months

Intervention Period

Clusters sequentially cross over to the intervention period, implementing CSRS-based practice recommendations

15 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including 30-day and 1-year outcomes

1 year

Treatment Details

Interventions

• Knowledge translation (KT) of the CSRS based practice recommendations

Trial Overview The study is testing the effectiveness of implementing Canadian Syncope Risk Score (CSRS)-based practice recommendations across multiple EDs. The goal is to see if using CSRS can reduce unnecessary hospitalizations and standardize patient discharge decisions.

Participant Groups

Group I: CSRS practice recommendation Experimental Treatment 1 Intervention

Knowledge translation of the Canadian Syncope Risk Score (CSRS) based practice recommendations

Knowledge translation (KT) of the CSRS based practice recommendations is already approved in Canada for the following indications:

Approved in Canada as Canadian Syncope Risk Score (CSRS) based practice recommendations for:

• Risk stratification for syncope patients in emergency departments

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

The Canadian Syncope Risk Score (CSRS) was validated in a study of 283 patients presenting with syncope, showing a low rate of serious adverse events (2.5%) within 30 days, indicating its potential safety for assessing risk in these patients.

The CSRS demonstrated moderate sensitivity (71.4%) and specificity (72.8%) for predicting serious outcomes, suggesting it can help identify low-risk patients effectively, although further research is needed to confirm its accuracy in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of the Canadian Syncope Risk Score for patients presenting with undifferentiated syncope to the emergency department. Chan, J., Ballard, E., Brain, D., et al.[2023]

The Canadian Syncope Pathway (CSP) was successfully implemented in a pilot study involving 1002 patients, achieving key benchmarks for adoption (84.4%) and fidelity (83.3%), indicating effective integration into emergency department practices.

Although the CSP met most targets for multicenter implementation, the reach (55.0%) was below the desired threshold, suggesting that further strategies will be needed to ensure the pathway is applied to all eligible patients during full-scale implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial. Thiruganasambandamoorthy, V., Keller, M., Nguyen, PAI., et al.[2023]

A study involving 114 clinicians and 32 stakeholders identified significant barriers to implementing clinical practice guidelines (CPGs) for syncope, including low awareness of guidelines and communication challenges with patients.

The developed MISSION implementation strategy, which includes educational materials and a mobile app, showed feasibility and initial success in improving adherence to syncope CPGs and appropriate testing in emergency departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning Implementation Success of Syncope Clinical Practice Guidelines in the Emergency Department Using CFIR Framework. Li, J., Smyth, SS., Clouser, JM., et al.[2022]

In a study of 402 unselected patients, a protocol based on European guidelines for diagnosing syncope achieved a high diagnosis rate of 83.3%, demonstrating its effectiveness in a real-world setting.

The tilt test was particularly effective, with a performance rate of 62.4%, indicating it is a valuable tool in the diagnostic process for syncope, while other tests showed lower performance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of a protocol for the diagnosis and management of syncope in an unselected population]. Planas Comes, F., San Vicente, L., Planas Ayma, F., et al.[2019]

The implementation of a new protocol for diagnosing and managing syncope significantly improved diagnostic classification from 71% in 1998 to 78% in 2000, ensuring every patient had an appropriate diagnostic hypothesis.

While the protocol enhanced the use of effective diagnostic tests, it also led to increased costs of investigation and hospital stays, highlighting the need for continued improvement in test selection to avoid unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of a syncope diagnostic protocol improve the investigation and management of syncope? Farwell, DJ., Sulke, AN.[2019]

The study developed implementation strategies for the Canadian Syncope Risk Score (CSRS) to enhance its use in emergency departments, involving 14 emergency medicine physicians in workshops to identify barriers and effective delivery methods.

Key strategies included educational initiatives like meetings and videos, creating a web-based calculator for the CSRS, appointing local champions to foster team support, and using email communications to share evidence summaries, all aimed at improving physician engagement and patient safety in syncope management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Implementation Strategies to Support the Uptake of a Risk Tool to Aid Physicians in the Clinical Management of Patients With Syncope: Systematic Theoretical and User-Centered Design Approach. Rouleau, G., Thiruganasambandamoorthy, V., Wu, K., et al.[2023]

The Canadian Syncope Risk Score is a predictive tool designed to assess the risk of serious adverse events within 30 days for patients who experience syncope, which is a temporary loss of consciousness.

This review evaluates the evidence supporting the effectiveness of the Syncope Risk Score, highlighting its potential to improve patient management and outcomes in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calculated decisions: Canadian Syncope Risk Score. Yang, T., Steinberg, E.[2023]

A new scoring system was developed to predict severe adverse events in patients who experienced syncope, based on a study of 393 patients followed for 12 months.

The score, which includes factors like previous syncope and abnormal ECG results, effectively identified patients at higher risk of death or hospital admission, achieving a c-statistic of 0.76, comparable to existing scores, while being simple and cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple risk stratification score for prognosis of syncope. Gomes, DG., Kus, T., Sant'anna, RT., et al.[2021]

The Canadian Syncope Risk Score has been validated as an effective tool for predicting serious outcomes within 30 days for patients who experience syncope and visit the emergency department within 24 hours.

This validation enhances the ability of healthcare providers to assess risk and make informed decisions regarding patient management after a syncopal event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validated scoring system identifies low-risk syncope patients. Lewton, AK., Morris, LE.[2022]

The Canadian Syncope Risk Score (CSRS) was validated in a study of 345 patients presenting with syncope in the emergency department, showing a predictive accuracy similar to that of clinical judgement for assessing risk of adverse events.

While the CSRS identified a 6.7% risk of adverse events in low-risk patients, clinical judgement indicated a lower risk of 2%, suggesting that further research is needed to determine if using the CSRS can improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre external validation of the Canadian Syncope Risk Score to predict adverse events and comparison with clinical judgement. Solbiati, M., Talerico, G., Villa, P., et al.[2022]

The Canadian Cardiovascular Society (CCS) has released its first clinical practice update on syncope, providing structured guidelines for assessment and management based on a thorough review of medical literature and expert consensus.

This update emphasizes the importance of risk stratification and initial evaluation in emergency settings, aiming to improve diagnosis and treatment of syncope, which can have a wide range of causes from benign to life-threatening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian Cardiovascular Society Clinical Practice Update on the Assessment and Management of Syncope. Sandhu, RK., Raj, SR., Thiruganasambandamoorthy, V., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

External validation of the Canadian Syncope Risk Score for patients presenting with undifferentiated syncope to the emergency department. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Planning Implementation Success of Syncope Clinical Practice Guidelines in the Emergency Department Using CFIR Framework. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

[Efficacy of a protocol for the diagnosis and management of syncope in an unselected population]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Does the use of a syncope diagnostic protocol improve the investigation and management of syncope? [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Developing Implementation Strategies to Support the Uptake of a Risk Tool to Aid Physicians in the Clinical Management of Patients With Syncope: Systematic Theoretical and User-Centered Design Approach. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Calculated decisions: Canadian Syncope Risk Score. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Simple risk stratification score for prognosis of syncope. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Validated scoring system identifies low-risk syncope patients. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Multicentre external validation of the Canadian Syncope Risk Score to predict adverse events and comparison with clinical judgement. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Canadian Cardiovascular Society Clinical Practice Update on the Assessment and Management of Syncope. [2021]