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

NCT05538143 | Enrolling By Invitation

• 1 other identifier: 1721270
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

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?

Conditions

Syncope

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Comprehensive ED syncope/presyncope management tool OTHER

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to KPNC emergency departments with eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (5)

Kaiser Permanente Oakland Emergency Department

Oakland, California, 94611, United States

Location

Kaiser Permanente Richmond Emergency Department

Richmond, California, 94801, United States

Location

Kaiser Permanente Roseville Emergency Department

Roseville, California, 95661, United States

Location

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, 95825, United States

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)