Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

NCT01003262 | Completed DMC

• 2 other identifiers: 3163864RC1AG035664-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 4

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. 1.To compare admission rates and length-of-stay associated with EDOSP to standard care.
2. 2.To compare serious outcomes rates associated with EDOSP to standard care.
3. 3.To compare quality-of-life associated with EDOSP to standard care.
4. 4.To compare the incremental costs and cost-effectiveness of EDOSP to standard care.

Conditions

Syncope

Keywords

Observation Unit; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Admission Rate

  Enrollment date

Secondary Outcomes (3)

• 30 day clinical outcomes

  30 days

• Quality of life

  30 days

• Cost

  30 Days

Study Arms (2)

Emergency Department Observation

EXPERIMENTAL

The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Other: Emergency Department Observation Protocol

Unstructured, inpatient evaluation

ACTIVE COMPARATOR

Other: Unstructured, inpatient evaluation

Interventions

Emergency Department Observation Protocol OTHER

The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Emergency Department Observation

Unstructured, inpatient evaluation OTHER

This is unstructured management by an inpatient medical team.

Unstructured, inpatient evaluation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Southern California: collaborator
• Brigham and Women's Hospital: collaborator
• Corewell Health East: collaborator
• Duke University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

University of Southern California

Los Angeles, California, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

William Beaumont Hospital

Royal Oaks, Michigan, 48073, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related 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. 2014 Aug;64(2):167-75. doi: 10.1016/j.annemergmed.2013.10.029. Epub 2013 Nov 13.

  PMID: 24239341 RESULT

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin Sun, MD, MPP

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

US (4)