Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

Syncope Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003262
• Other study ID #: 3163864
• Secondary ID: RC1AG035664-01
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syncope

Intervention

Other:
• Emergency Department Observation Protocol
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
• Unstructured, inpatient evaluation
This is unstructured management by an inpatient medical team.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Southern California	Los Angeles	California
United States	William Beaumont Hospital	Royal Oaks	Michigan

Sponsors (6)

Lead Sponsor	Collaborator
University of California, Los Angeles	Brigham and Women's Hospital, Duke University, National Institute on Aging (NIA), University of Southern California, William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sun BC, McCreath H, Liang LJ, Bohan S, Baugh C, Ragsdale L, Henderson SO, Clark C, Bastani A, Keeler E, An R, Mangione CM. Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission. Ann Emerg Med. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission Rate		Enrollment date
Secondary	30 day clinical outcomes		30 days
Secondary	Quality of life		30 days
Secondary	Cost		30 Days