CSRS Implementation - A Pilot Study

NCT ID: NCT04790058

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2027-05-01

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 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.

Detailed Description

ED crowding limits the ability of the emergency providers to provide quality care, is a growing crisis in North America and Europe, and leads to unsafe and rushed disposition decisions which compromise patient care. On the other hand, hospital admission is expensive, and an increasing awareness of nosocomial morbidity and the harms of unnecessary testing and hospitalization exert countervailing pressure on low-yield admissions from the ED. Therefore, improved accuracy in ED disposition decision-making is more important than ever, and syncope typifies a common, high stakes condition in which improvements in efficiency are badly needed.

Identifying which patients will benefit from further cardiac rhythm monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. A comprehensive literature review of risk-tools and international guidelines concede that previously published tools lack or have failed external validation, are excessively complex, include as outcomes obvious conditions readily identified during the index ED evaluation, or lacked power and specificity. These tools also do not offer specific clinical actions and are not supported by the guidelines. The CSRS addresses each of the above weaknesses and coupled with outpatient live cardiac monitoring is an innovative and standardized approach to ED syncope management to expedite ED care, improve patient safety and reduce healthcare costs. The investigators have identified the barriers and facilitators to effectively adapt knowledge into local contexts as per the Knowledge to Action cycle, and have selected implementation strategies accordingly. The proposed pilot study is a right step before widescale implementation.

The primary objective of this pilot study is to assess the feasibility of implementing the practice recommendations. The secondary objectives are to assess the effectiveness and safety of the intervention, implementation of the CSRS-based practice recommendations. Specific objectives include:

Feasibility objectives:

Primary: to assess the reach of the intervention Secondary: to assess the adoption, adherence, and sustainability of the intervention; to assess the acceptability, the feasibility of use and the complexity of the intervention; and to assess the satisfaction to the dose (i.e., exposure) of the intervention received including support and resources.

Effectiveness objectives:

Primary: to assess the impact on ED disposition time, defined as the time interval between ED physician initial assessment and ED disposition.

Secondary: to assess the impact on hospitalizations, investigations and consultations performed in the ED.

Safety objective: To assess mortality, return ED visits and hospitalization within 30-days and 1-year of the index ED visit (generic patient safety outcome) and to monitor the safety of the CSRS application by assessing the 30-day serious outcomes after ED disposition (syncope specific short-term serious outcome).

We will conduct the study over a 9-month period, with the TOH and QCH EDs receiving the intervention at the 3rd and 4th month respectively. The first month of the intervention period will be designated as a transition period during which we will undertake intense educational efforts. The total intervention period for the QCH and TOH EDs will be 5 and 6 months respectively.

Conditions

Syncope

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Knowledge translation of the CSRS practice recommendations

Intervention Type: 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.

Interventions

Knowledge translation of the CSRS practice recommendations

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.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• 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).

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

Sponsors

Queensway Carleton Hospital

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Venkatesh Thiruganasambandamoorthy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Queensway-Carleton hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37651075 (View on PubMed)

Other Identifiers

CRF 2589

Identifier Type: -

Identifier Source: org_study_id