Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Syncope Clinical Trial

Official title:

Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05538143
• Other study ID #: 1721270
• Status: Enrolling by invitation
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age =16y
• Member of Kaiser Permanente Northern California (KPNC) health plan
• Presentation to the ED with an ED diagnosis of recent syncope or presyncope (<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope.
• Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record.

Exclusion Criteria:

• Age <16 years old
• Non-members of KPNC
• Patients with obvious witnessed seizure, prolonged loss of consciousness (>5 minutes), post-traumatic loss of consciousness, and new mental status changes
• Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope
• Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.

Related Conditions & MeSH terms

• Emergencies
• Syncope

Intervention

Other:
• Comprehensive ED syncope/presyncope management tool
This is a data-only, prospective observational cohort study to validate the performance metrics of the Canadian Syncope Risk Score in a diverse population of patients evaluated in community EDs of a U.S. integrated health care system.

Locations

Country	Name	City	State
United States	Kaiser Permanente Oakland Emergency Department	Oakland	California
United States	Kaiser Permanente Richmond Emergency Department	Richmond	California
United States	Kaiser Permanente Roseville Emergency Department	Roseville	California
United States	Kaiser Permanente Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente South Sacramento Emergency Department	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with arrhythmic and nonarrhythmic serious outcomes	Serious outcomes include those which are arrhythmic (arrhythmias, interventions for arrhythmia, or unknown cause of death) and nonarrhythmic (e.g., myocardial infarction, structural heart disease, pulmonary embolism, or hemorrhage)	30 days