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

ConditionSyncope
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

ED physicians involved in ED syncope care

Non-ED physicians involved in ED syncope care

Physician's delegates involved in ED syncope care

Disqualifiers

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 who are adults (aged > 18 years)

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

14,400 Participants
are divided into 1 treatment group
Group A: CSRS practice recommendationOther 1 intervention

Trial outcomes

Primary outcomes

1

Rate of hospitalization

to assess the impact on hospital admission

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

Secondary outcomes

1

ED disposition time

The ED disposition time is defined as the time interval between ED physician initial assessment and ED disposition. We chose this time interval rather than ED length of stay which is the time interval between ED arrival/registration and departure from the ED. The ED disposition time more accurately reflects the active phase of ED physician care for collecting clinical information, work-up of patients and resolution of diagnostic uncertainty. The longer interval of ED length of stay includes wait times both before and after, which are often determined by triage acuity as well as extraneous system factors (e.g., ED and hospital crowding, staffing patterns, sudden influx of patients, availability of inpatient beds and overcapacity protocols, and availability of transportation for a subgroup of patients for whom a decision to discharge has been made);

Time frame
At time of ED disposition, an average timeframe is 6 hours
2

All-cause mortality

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

Time frame
within 30-days and 1-year of the index ED visit
3

Number of return ED visits

To assess return ED visits within 30-days and 1-year of the index ED visit

Time frame
within 30-days and 1-year
4

Rate of consultation

To assess the effectiveness of intervention on consultation performed in the ED

Time frame
1-year from the index ED visit

Other outcomes

Sponsors and contacts

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