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

NCT ID: NCT05538143

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syncope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaiser Permanente Oakland Emergency Department

Oakland, California, United States

Site Status

Kaiser Permanente Richmond Emergency Department

Richmond, California, United States

Site Status

Kaiser Permanente Roseville Emergency Department

Roseville, California, United States

Site Status

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1721270

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.