Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790058
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2020-12-11
Brief Title:
CSRS Implementation - A Pilot Study
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Implementation of Canadian Syncope Risk Score Based Practice Recommendations for Emergency Department Syncope Management - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 ie 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
Identifying which patients will benefit from further cardiac rhythm monitoring andor 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None