CSRS Implementation - A Pilot Study

NCT04790058 | Active Not Recruiting

• 1 other identifier: CRF 2589
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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 the high costs. Our group 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. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.

Conditions

Syncope

Keywords

Syncope; Emergency Department; Risk Stratification

Outcome Measures

Primary Outcomes (2)

• Feasibility of implementing the practice recommendations.

  To assess the reach of the intervention. We will adopt a pragmatic application of the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework to evaluate the pilot study outcomes. The primary feasibility outcome is the Reach or penetration, the proportion of eligible patients who had the intervention applied.

  The intervention period of 6 months

• Rate of hospitalization

  To assess the impact on hospitalizations.

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

Secondary Outcomes (8)

• Rate of consultation

  at 6 hours from time of ED disposition

• Mortality

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

• Rate of adoption

  The intervention period of 6 months

• Number of return ED visits

  within 30-days and 1-year

• Rate of adherence

  The intervention period of 6 months

Study Arms (1)

Physicians using CSRS practice recommendation to treat syncope patients in ED.

During the control period, there will be no interventions. The intervention is the knowledge translation of the CSRS 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; 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. The ED physician or non-ED physician performing consultation on the patient can apply all the components of the practice recommendation and decide disposition of the patients who are eligible to be studied.

Other: Knowledge translation of the CSRS practice recommendations

Interventions

Knowledge translation of the CSRS practice recommendations OTHER

The intervention is knowledge translation of the CSRS practice recommendations; the application of the practice recommendations will occur during the patient's ED visit and patients who are eligible for 15-day cardiac rhythm monitoring will have Holter monitor applied at the time of ED discharge. For the secondary objective to validate the accuracy of the ultra-low risk criteria of CSRS and assess for potential improvements in the practice recommendations and the prediction models we will request verbal consent during the index ED visit for addition of cardiac biomarker measurements \[troponin and NT-proBNP\] for patients who did not have such measurements performed as part of routine clinical care, and a 30-day telephone follow-up for serious outcome assessment. Patients who do not consent will be excluded from these portions of the study but included in the health resource utilization and generic patient safety outcome assessment objectives.

Physicians using CSRS practice recommendation to treat syncope patients in ED.

Eligibility Criteria

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

Study Population

The investigator will study the effect of Knowledge Translation on physicians involved in ED syncope care and the effect of the practice recommendations on patients, ED management and safety in 30-days and in 1-year. As the unit of randomization is the ED, all patients presenting to the ED with syncope among whom no serious condition was identified during the index ED evaluation and who did not require consultation/ hospitalization for a non-syncope related reason will be included in the study for analysis. The investigator will use the Canadian Emergency Department Information System presenting complaints suggestive of syncope/pre-syncope or an ED discharge diagnosis of syncope using discharge diagnoses fields or ICD-10 code R.55 for syncope to identify patients.

You may not qualify if:

• non-syncope (prolonged LOC \>5 minutes, change in the mental status from baseline, patients with witnessed obvious seizure, or head trauma preceding the LOC),
• those unable to provide proper details - e.g., intoxication, and those with significant trauma requiring admission as per international consensus.
• patients who had a serious underlying condition identified during the index ED evaluation
• hospitalization for a reason other than syncope work-up (i.e. unable to cope at home).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Queensway Carleton Hospital: collaborator

Study Sites (1)

Queensway-Carleton hospital

Ottawa, Ontario, K2H 8P4, Canada

Location

Related Publications (1)

• Thiruganasambandamoorthy V, Keller M, Nguyen PAI, Gupta P, Ghaedi B, Cao GZQ, Cheung WJ, Khatiwada B, Nemnom MJ, Yadav K, Eagles D, Brehaut J, Tarhuni W, Rouleau G, Desveaux L, Taljaard M. Implementation of the Canadian syncope pathway: a pilot non-randomized stepped wedge trial. CJEM. 2023 Oct;25(10):808-817. doi: 10.1007/s43678-023-00570-7. Epub 2023 Aug 31.

  PMID: 37651075 DERIVED

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: March 10, 2021
• Study Start: August 20, 2021
• Primary Completion: August 16, 2022
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)