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

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?

Study Overview

• Status: Enrolling by invitation
• Conditions: Syncope
• Intervention / Treatment: Other: Comprehensive ED syncope/presyncope management tool

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Emergency Department
    • Richmond, California, United States, 94801
      • Kaiser Permanente Richmond Emergency Department
    • Roseville, California, United States, 95661
      • Kaiser Permanente Roseville Emergency Department
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento Emergency Department
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to KPNC emergency departments with eligibility criteria

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Unconsciousness; Consciousness Disorders; Emergencies; Syncope
• Other Study ID Numbers: 1721270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No