SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations

NCT04972071 | Recruiting DMC

• 1 other identifier: 3371
• Study Type: interventional
• Target: 14,400
• Locations: 1 country
• Sites: 15

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

Keywords

Syncope; Emergency Department; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Rate of hospitalization

  to assess the impact on hospital admission

  At time of ED disposition, an average timeframe is 6 hours

Secondary Outcomes (7)

• ED disposition time

  At time of ED disposition, an average timeframe is 6 hours

• All-cause mortality

  within 30-days and 1-year of the index ED visit

• Number of return ED visits

  within 30-days and 1-year

• Rate of consultation

  1-year from the index ED visit

• Rate of adoption

  Before ED disposition, average of 6 hours

Study Arms (1)

CSRS practice recommendation

OTHER

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

Other: Knowledge translation (KT) of the CSRS based practice recommendations

Interventions

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

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.

CSRS practice recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (15)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, Canada

RECRUITING

Health Sicence North

Greater Sudbury, Ontario, Canada

RECRUITING

Hawkesbury and District General Hospital

Hawkesbury, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

North Bay Regional Health Centre

North Bay, Ontario, Canada

RECRUITING

Thunder Bay Regional Health Sicences Centre

Thunder Bay, Ontario, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

RECRUITING

Niagara Health

Welland, Ontario, Canada

RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

Royal Victoria Hospital & Montreal General Hospital

Montreal, Quebec, Canada

RECRUITING

Centre hospitalier de l'Université Laval

Québec, Quebec, Canada

RECRUITING

Hotel Dieu Hospital of Lévis

Québec, Quebec, Canada

RECRUITING

Hôpital de L'Enfant-Jésus

Québec, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Nguyen, BSc

CONTACT

6137985555; pnguyen@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Scientist

Model Details: A Stepped Wedge-Controlled Randomized Trial

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: September 18, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (15)