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

NCT ID: NCT04972071

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2026-03-01

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.

Detailed Description

The investigators will conduct a SW-CRT involving 16 participating ED clusters across Canada. The design will be a batched SW-CRT with two batches of 8 cluster EDs with the first 8 cluster EDs that are ready for the trial included in the first batch. Some EDs will be grouped to avoid contamination between multiple sites operating within the same hospital organization. The total study duration is 16 months for each batch. All clusters in the two batches will start the trial in a control period (usual care) for three months with no intervention being delivered at any site, then sequentially cross over from the control period to the intervention period in random sequence, with 2 clusters crossing over every third month, until all sites have adopted the intervention. Clusters will be randomly allocated to one of four steps (two clusters per step) with step lengths of three months. The first month after crossing over will be designated as a transition period to allow the intervention to be fully implemented. During the first three months of the study, all clusters will be in the control period and during the last three months all clusters will be in the intervention period. Hence, the total study period will be 16 months for each batch.

The following principal research questions will be addressed 1) What is the effect of the knowledge translation and implementation of the CSRS-based practice recommendations on health resource utilization? The health resource utilization measures include the proportion hospitalized, the proportion investigated in the ED, and ED disposition time 2) How and why did the implementation achieve the observed effect? The embedded process evaluation measures align with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework and include: a) adoption - the proportion of physicians who attended the educational sessions and the proportion who adopted the CSRS in practice; b) reach- the proportion of eligible patients for whom the CSRS was utilized during their ED visit; c) intervention fidelity - the proportion of patients for whom the resulting CSRS recommendations were followed d) maintenance- whether observed adoption rates remain stable or increase over time. 3) What is the effect of the knowledge translation strategy on patient safety, as measured by 30-day serious outcome identification, 30-day and 1-year return ED visits, hospitalizations, and mortality? and 4) validate the ultra-low-risk criteria in a new cohort of patients and assess if the CSRS can be improved in its ability to predict 30-day serious outcomes.

Conditions

Syncope

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CSRS practice recommendation

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

Group Type: OTHER

Knowledge translation (KT) of the CSRS based practice recommendations

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

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:

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Venkatesh Thiruganasambandamoorthy

Professor and Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Health Sicence North

Greater Sudbury, Ontario, Canada

Site Status: RECRUITING

Hawkesbury and District General Hospital

Hawkesbury, Ontario, Canada

Site Status: RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

North Bay Regional Health Centre

North Bay, Ontario, Canada

Site Status: RECRUITING

Thunder Bay Regional Health Sicences Centre

Thunder Bay, Ontario, Canada

Site Status: RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Niagara Health

Welland, Ontario, Canada

Site Status: RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, Canada

Site Status: RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Royal Victoria Hospital & Montreal General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre hospitalier de l'Université Laval

Québec, Quebec, Canada

Site Status: RECRUITING

Hotel Dieu Hospital of Lévis

Québec, Quebec, Canada

Site Status: RECRUITING

Hôpital de L'Enfant-Jésus

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Iris Nguyen, BSc

Role: CONTACT

pnguyen@ohri.ca

6137985555 ext. 17766

Facility Contacts

Andrew McRae, MD

Role: primary

(403) 944-1110

Mona Hegdekar

Role: primary

Danielle Waltenbury

Role: primary

dwaltenbury@hsnri.ca

Jean-Francois Borduas, MD

Role: primary

(613) 632-1111

Justin Yan, MD

Role: primary

(519) 685-8500

Taylor Lougheed, MD

Role: primary

(705) 474-8600

Rabail Siddiqui

Role: primary

Amanda Bakke

Role: backup

Konika Nirmalanathan

Role: primary

Stephenson Strobel, MD

Role: primary

(905) 378-4647

Mohamed Gazarin

Role: primary

Xiaoqing Xue

Role: primary

David Iannuzz

Role: primary

Simon Berthelot, MD

Role: primary

(418) 525-4444

Patrick Archambault, MD

Role: primary

(418) 835-7121

Alexandra Nadeau

Role: primary

Other Identifiers

3371

Identifier Type: -

Identifier Source: org_study_id