Clinical trial NCT01003262: Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: Observation Unit
Emergency Department
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Brigham and Women's Hospital
name: William Beaumont Hospitals
name: Duke University
name: National Institute on Aging (NIA)
First posted: 2009-10-28
Enrollment: 123
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.


Eligibility 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

Primary outcomes:
measure: Admission Rate
timeFrame: Enrollment date
Secondary outcomes:
measure: 30 day clinical outcomes
timeFrame: 30 days
measure: Quality of life
timeFrame: 30 days
measure: Cost
timeFrame: 30 Days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Royal Oaks
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of California, Los Angeles
name: Benjamin Sun, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.