Clinical trial NCT04972071: SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations
Official title: Multi-Centre Cluster-Randomized Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Syncope
Keywords: Syncope
Emergency Department
Risk Stratification
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 14400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A Stepped Wedge-Controlled Randomized Trial
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of hospitalization
timeFrame: At time of ED disposition, an average timeframe is 6 hours
Secondary outcomes:
measure: ED disposition time
timeFrame: At time of ED disposition, an average timeframe is 6 hours
measure: All-cause mortality
timeFrame: within 30-days and 1-year of the index ED visit
measure: Number of return ED visits
timeFrame: within 30-days and 1-year
measure: Rate of consultation
timeFrame: 1-year from the index ED visit
measure: Rate of adoption
timeFrame: Before ED disposition, average of 6 hours
measure: Rate of adherence
timeFrame: Before ED disposition, average of 6 hours
measure: Rate of acceptability
timeFrame: Before ED disposition, average of 6 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Hawkesbury
country: Canada
facility: Hawkesbury and District General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: North Bay
country: Canada
facility: North Bay Regional Health Centre
state: Ontario
city: Sudbury
country: Canada
facility: Health Sicence North
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sicences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Welland
country: Canada
facility: Niagara Health
state: Ontario
city: Winchester
country: Canada
facility: Winchester District Memorial Hospital
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Royal Victoria Hospital & Montreal General Hospital
state: Quebec
city: Québec
country: Canada
facility: Hôpital de L'Enfant-Jésus
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier de l'Université Laval
city: Quebec
country: Canada
facility: Hotel Dieu Hospital of Lévis
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc
role: PRINCIPAL_INVESTIGATOR
References: