Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04790058 |
| Other study ID # |
CRF 2589 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2021 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
