Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Syncope
• Intervention / Treatment: Other: Emergency Department Observation Protocol; Other: Unstructured, inpatient evaluation

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • University of Southern California
  • Massachusetts
    • Boston, Massachusetts, United States
      • Brigham and Women's Hospital
  • Michigan
    • Royal Oaks, Michigan, United States, 48073
      • William Beaumont Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emergency Department Observation; 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; The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
ACTIVE_COMPARATOR: Unstructured, inpatient evaluation	Other: Unstructured, inpatient evaluation; This is unstructured management by an inpatient medical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Admission Rate	Enrollment date

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	30 days
30 day clinical outcomes	30 days
Cost	30 Days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Duke University; National Institute on Aging (NIA); University of Southern California; Brigham and Women's Hospital; William Beaumont Hospitals
• Investigators: Principal Investigator: Benjamin Sun, MD, MPP, University of California, Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 27, 2009
• First Posted (ESTIMATE): October 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Observation Unit
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: 3163864; RC1AG035664-01 (NIH)