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
  Purpose

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.


Condition Intervention
Syncope
Other: Emergency Department Observation Protocol
Other: Unstructured, inpatient evaluation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Admission Rate [ Time Frame: Enrollment date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 123
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003262

Locations
United States, California
University of Southern California
Los Angeles, California, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States
United States, Michigan
William Beaumont Hospital
Royal Oaks, Michigan, United States, 48073
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
University of California, Los Angeles
University of Southern California
Brigham and Women's Hospital
William Beaumont Hospitals
Duke University
Investigators
Principal Investigator: Benjamin Sun, MD, MPP University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Benjamin Sun, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01003262     History of Changes
Other Study ID Numbers: 3163864, RC1AG035664-01
Study First Received: October 27, 2009
Last Updated: December 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Observation Unit
Emergency Department

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014