RecruitingNot ApplicableNCT04972071

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

Multi-Centre Cluster-Randomized Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management


Sponsor

Ottawa Hospital Research Institute

Enrollment

14,400 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Physicians:
  • 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 Criteria7

  • 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).

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Interventions

OTHERKnowledge 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.


Locations(15)

Foothills Medical Centre

Calgary, Alberta, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Health Sicence North

Greater Sudbury, Ontario, Canada

Hawkesbury and District General Hospital

Hawkesbury, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

North Bay Regional Health Centre

North Bay, Ontario, Canada

Thunder Bay Regional Health Sicences Centre

Thunder Bay, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Niagara Health

Welland, Ontario, Canada

Winchester District Memorial Hospital

Winchester, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital & Montreal General Hospital

Montreal, Quebec, Canada

Centre hospitalier de l'Université Laval

Québec, Quebec, Canada

Hotel Dieu Hospital of Lévis

Québec, Quebec, Canada

Hôpital de L'Enfant-Jésus

Québec, Quebec, Canada

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NCT04972071


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