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OpenTrials
Completed

NCT Number: NCT01003262

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Unstructured, inpatient evaluation

Other

This is unstructured management by an inpatient medical team.

Primary outcomes

  1. Admission Rate

    Time frame: Enrollment date

Secondary outcomes

  1. 30 day clinical outcomes

    Time frame: 30 days

  2. Quality of life

    Time frame: 30 days

  3. Cost

    Time frame: 30 Days

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Brigham and Women's Hospital
  • Corewell Health East
  • Duke University
  • National Institute on Aging (NIA)
  • University of Southern California

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2009
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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