Risk Score Tool for Fainting

Recruiting at 19 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: Unknown

14400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Canadian Syncope Risk Score (CSRS), to assist doctors in determining the best care for patients who faint. While fainting is often harmless, it can sometimes indicate serious health issues. The trial evaluates whether this tool can help doctors make quicker and safer decisions about hospital admission. Adults who faint and arrive at the emergency room within 24 hours may qualify for this study, unless their fainting resulted from a head injury or seizure.

As an unphased trial, this study allows patients to contribute to research that could enhance emergency care for fainting.

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 prior data suggests that this risk score tool is safe for use in emergency departments?

Research has shown that the Canadian Syncope Risk Score (CSRS) is safe and effective in emergency rooms. This tool assists doctors in determining which patients who faint require further tests or hospitalization. Studies have found that CSRS accurately predicts the risk of serious health issues within 30 days after an emergency room visit.

Following CSRS guidelines enables doctors to make better decisions without causing harm. As it is not a drug or medical device, it lacks the side effects associated with new medications. Instead, it helps identify patients who truly need more care, potentially reducing unnecessary hospital stays. Overall, using CSRS is considered safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk Score Tool for Fainting because it aims to improve the way doctors predict the risk of fainting using the Canadian Syncope Risk Score (CSRS). Unlike other methods that may rely on more general clinical assessments, this tool uses a detailed, standardized approach to assess fainting risks. This means it could help healthcare providers make more accurate decisions more quickly, potentially leading to better patient outcomes and more efficient use of medical resources.

What evidence suggests that the CSRS-based practice recommendations are effective for syncope?

This trial will evaluate the knowledge translation of the Canadian Syncope Risk Score (CSRS) based practice recommendations. Studies have shown that the CSRS helps predict the risk of serious health issues within 30 days after a patient visits the emergency room for fainting. The CSRS uses specific guidelines to identify high-risk patients who may need more detailed tests or a hospital stay. Research indicates that these guidelines can reduce unnecessary hospital stays and shorten emergency room visits for low-risk patients. The tool aims to standardize decisions, allowing medium-risk patients to be safely sent home after discussing their condition. This approach could improve patient safety and reduce healthcare costs by focusing resources on those who truly need them. ^{1 2 3 6 7}

Who Is on the Research Team?

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04972071

SW-RCT Implementation of Canadian Syncope Risk Score ... The overall objective of this study is to evaluate the effectiveness of the knowledge translation (KT) of the CSRS-based practice recommendations in multiple ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37058217/

Development of practice recommendations based on the ... The Canadian Syncope Risk Score (CSRS) was developed to predict the probability of 30-day serious outcomes after ED disposition.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04790058

NCT04790058 | CSRS Implementation - A Pilot Study Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management - A Pilot Study ... knowledge translation ...

4. studies.bethecure.ca studies.bethecure.ca/find/bcc78179739377958963a0c51023f059bd6265f7-multi-centre-cluster-randomized-implementation-

SW-RCT Implementation of Canadian Syncope Risk Score ... The overall objective of this study is to evaluate the effectiveness of the knowledge translation (KT) of the CSRS-based practice recommendations in multiple ...

5. humanfactors.jmir.org humanfactors.jmir.org/2023/1/e44089

Developing Implementation Strategies to Support the Uptake ... Background: The Canadian Syncope Risk Score (CSRS) was developed to improve syncope management in emergency department settings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337431/

Developing Implementation Strategies to Support the Uptake ... The Canadian Syncope Risk Score (CSRS) is a validated risk stratification tool to optimize the accuracy of ED decisions and inform evidence-based clinical ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2763181

Multicenter Emergency Department Validation of the ... This cohort study evaluates the Canadian Syncope Risk Score to validate its ability to predict 30-day serious outcomes during emergency ...