Recruiting

CSRS Implementation

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04972071

Conditions

Syncope

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Knowledge translation (KT) of the CSRS based practice recommendations

Study Details

Brief 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. 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.

Conditions

Syncope

Study ID

NCT04972071

Start date

Sep 18, 2023

Status verified date

Mar, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Physicians:

Inclusion criteria:

  • ED physicians involved in ED syncope care
  • Non-ED physicians involved in ED syncope care
  • Physician's delegates involved in ED syncope care

Exclusion criteria:

  • 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:

Inclusion criteria:

  • Patients who are adults (aged > 18 years)
  • Patients who present to the ED within 24 hours of syncope.

Exclusion criteria:

  • 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).

Study Design

Enrollment

14400 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: CSRS practice recommendation

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

Interventions

Knowledge translation (KT) of the CSRS based 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; 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.

Primary outcome measure

  • Rate of hospitalization [ Time Frame: At time of ED disposition, an average timeframe is 6 hours ]

Central Contacts and Locations

Central contacts

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Andrew McRae, MD

(403) 944-1110

Principal Investigator:

Andrew McRae

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada

Principal Investigator:

Mona Hegdekar

Hawkesbury and District General Hospital

Recruiting

Hawkesbury, Ontario, Canada

Contacts

Jean-Francois Borduas, MD

(613) 632-1111

Principal Investigator:

Jean-Francois Borduas, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Justin Yan, MD

(519) 685-8500

Principal Investigator:

Justin Yan, MD

North Bay Regional Health Centre

Recruiting

North Bay, Ontario, Canada

Contacts

Taylor Lougheed, MD

(705) 474-8600

Principal Investigator:

Taylor Lougheed, MD

Health Sicence North

Recruiting

Sudbury, Ontario, Canada

Contacts

Danielle Waltenbury

dwaltenbury@hsnri.ca

Principal Investigator:

Robert Ohle

Thunder Bay Regional Health Sicences Centre

Recruiting

Thunder Bay, Ontario, Canada

Principal Investigator:

David Savage

University Health Network

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Anna Nowacki

Niagara Health

Recruiting

Welland, Ontario, Canada

Contacts

Stephenson Strobel, MD

(905) 378-4647

Principal Investigator:

Stephenson Strobel, MD

Winchester District Memorial Hospital

Recruiting

Winchester, Ontario, Canada

Principal Investigator:

Mohamed Gazarin

Jewish General Hospital

Recruiting

Montréal, Quebec, Canada

Principal Investigator:

Lars Grant

Royal Victoria Hospital & Montreal General Hospital

Recruiting

Montréal, Quebec, Canada

Principal Investigator:

Gregory Clark

Hôpital de L'Enfant-Jésus

Recruiting

Québec, Quebec, Canada

Principal Investigator:

Eric Mercier

Centre hospitalier de l'Université Laval

Recruiting

Quebec, Canada

Contacts

Simon Berthelot, MD

(418) 525-4444

Principal Investigator:

Simon Berthelot, MD

Hotel Dieu Hospital of Lévis

Recruiting

Quebec, Canada

Contacts

Patrick Archambault, MD

(418) 835-7121

Principal Investigator:

Patrick Archambault, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

  • Syncope
  • Emergency Department
  • Risk Stratification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-03-27.