Clinical trial NCT04790058: CSRS Implementation - A Pilot Study
Official title: Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management - A Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Syncope
Keywords: Syncope
Emergency Department
Risk Stratification
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Queensway Carleton Hospital
First posted: 2021-03-10
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 1. Physician: physicians involved in ED syncope care
2. Patients:

   * Inclusion Criteria: adult (aged \> 18 years) patients who present within 24 hours of syncope
   * 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).

Primary outcomes:
measure: Feasibility of implementing the practice recommendations.
timeFrame: The intervention period of 6 months
measure: Rate of hospitalization
timeFrame: At time of ED disposition, an average timeframe is 6 hours
Secondary outcomes:
measure: Rate of consultation
timeFrame: at 6 hours from time of ED disposition
measure: Mortality
timeFrame: within 30-days and 1-year of the index ED visit
measure: Rate of adoption
timeFrame: The intervention period of 6 months
measure: Number of return ED visits
timeFrame: within 30-days and 1-year
measure: Rate of adherence
timeFrame: The intervention period of 6 months
measure: Rate of acceptability
timeFrame: The intervention period of 6 months
measure: ED disposition time
timeFrame: At time of ED disposition, an average timeframe is 6 hours
measure: Degree of satisfaction of the use of CSRS practice recommendation
timeFrame: The intervention period of 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Queensway-Carleton hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc
role: PRINCIPAL_INVESTIGATOR
References: