Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

Not Applicable

Completed

• Conditions: Syncope
• Interventions: Other: Unstructured, inpatient evaluation; Other: Emergency Department Observation Protocol

• Registration Number: NCT01003262
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S. emergency department visits and may herald a life-threatening condition in older adults (age≥60 years). Existing risk prediction instruments cannot reliably identify who among such older patients can safely be discharged home from an emergency department. As a result, the majority of older patients without a clear cause for syncope are hospitalized for diagnostic evaluation. However, current admission practices are characterized by low diagnostic yield, do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs. Most admitted patients are discharged within 48 hours, and approximately 50% of patients do not have an identified cause of syncope after their hospitalization.

The implementation of an expedited and standardized Emergency Department Observation Syncope Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The investigators propose a pilot randomized trial to implement and evaluate EDOSP at two emergency departments. This study has the following exploratory Specific Aims:

1. To compare admission rates and length-of-stay associated with EDOSP to standard care.

2. To compare serious outcomes rates associated with EDOSP to standard care.

3. To compare quality-of-life associated with EDOSP to standard care.

4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care.

Over a one-year period, 120 intermediate-risk older adults who present with syncope at the two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the emergency department.

If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators will plan a larger study powered to evaluate clinical, quality-of-life, and economic outcomes. A successful EDOSP intervention would have important clinical policy implications and improve the emergency department care of older adults with syncope.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Study Start: 2010-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Age≥60 years
• A complaint of syncope or near-syncope (Syncope is defined as a sudden, transient loss of consciousness. Near-syncope is defined as a sensation of imminent loss of consciousness, without actual syncope.)
• Intermediate risk of adverse outcome (see Table)
• Patient speaks either English or Spanish as a primary language.

Exclusion Criteria

• Syncope mimics (intoxication, weakness or dizziness with syncope/ near-syncope, hypoglycemia, and cardiac arrest)
• New or baseline cognitive impairment or dementia)
• Inability to provide follow-up information (e.g. homeless or resides outside of U.S.)
• Inability to speak Spanish or English
• Low- and high-risk patients (see Table).

Risk Stratification Guidelines:

• High Risk
• Serious condition identified in ED
• History of ventricular arrhythmia
• Cardiac Device with dysfunction
• Presentation consistent with acute coronary ischemia

Intermediate Risk

• No High Risk features
• Presentation not consistent with orthostatic or vasovagal syncope

Low Risk

• Presentation consistent with orthostatic or vasovagal syncope

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstructured, inpatient evaluation	Unstructured, inpatient evaluation	-
Emergency Department Observation	Emergency Department Observation Protocol	The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Primary Outcome Measures

Name	Time	Method
Admission Rate	Enrollment date

Secondary Outcome Measures

Name	Time	Method
30 day clinical outcomes	30 days
Quality of life	30 days
Cost	30 Days

Trial Locations

Locations (4)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

William Beaumont Hospital; 🇺🇸 Royal Oaks, Michigan, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States