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

• Conditions: Syncope

• Registration Number: NCT05538143
• Lead Sponsor: Kaiser Permanente

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with arrhythmic and nonarrhythmic serious outcomes	30 days	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)

Trial Locations

Locations (5)

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 South Sacramento Emergency Department; 🇺🇸 Sacramento, California, United States

Kaiser Permanente Sacramento Emergency Department; 🇺🇸 Sacramento, California, United States