Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

This study has been completed.
Sponsor:
Collaborators:
University of Southern California
Brigham and Women's Hospital
William Beaumont Hospitals
Duke University
Information provided by (Responsible Party):
Benjamin Sun, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01003262
First received: October 27, 2009
Last updated: December 23, 2011
Last verified: December 2011

October 27, 2009
December 23, 2011
March 2010
December 2011   (final data collection date for primary outcome measure)
Admission Rate [ Time Frame: Enrollment date ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01003262 on ClinicalTrials.gov Archive Site
  • 30 day clinical outcomes [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cost [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Syncope
  • 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
  • Other: Unstructured, inpatient evaluation
    This is unstructured management by an inpatient medical team.
  • Experimental: Emergency Department Observation
    The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
    Intervention: Other: Emergency Department Observation Protocol
  • Active Comparator: Unstructured, inpatient evaluation
    Intervention: Other: Unstructured, inpatient evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01003262
3163864, RC1AG035664-01
Yes
Benjamin Sun, University of California, Los Angeles
University of California, Los Angeles
  • University of Southern California
  • Brigham and Women's Hospital
  • William Beaumont Hospitals
  • Duke University
Principal Investigator: Benjamin Sun, MD, MPP University of California, Los Angeles
University of California, Los Angeles
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP