Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
Primary Purpose
Syncope
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency Department Observation Protocol
Unstructured, inpatient evaluation
Sponsored by
About this trial
This is an interventional health services research trial for Syncope focused on measuring Observation Unit, Emergency Department
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
Sites / Locations
- University of Southern California
- Brigham and Women's Hospital
- William Beaumont Hospital
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Emergency Department Observation
Unstructured, inpatient evaluation
Arm Description
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
Outcomes
Primary Outcome Measures
Admission Rate
Secondary Outcome Measures
30 day clinical outcomes
Quality of life
Cost
Full Information
NCT ID
NCT01003262
First Posted
October 27, 2009
Last Updated
February 9, 2023
Sponsor
University of California, Los Angeles
Collaborators
University of Southern California, Brigham and Women's Hospital, William Beaumont Hospitals, Duke University, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01003262
Brief Title
Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Southern California, Brigham and Women's Hospital, William Beaumont Hospitals, Duke University, National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
To compare admission rates and length-of-stay associated with EDOSP to standard care.
To compare serious outcomes rates associated with EDOSP to standard care.
To compare quality-of-life associated with EDOSP to standard care.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
Observation Unit, Emergency Department
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency Department Observation
Arm Type
Experimental
Arm Description
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
Arm Title
Unstructured, inpatient evaluation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Emergency Department Observation Protocol
Intervention Description
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
Intervention Type
Other
Intervention Name(s)
Unstructured, inpatient evaluation
Intervention Description
This is unstructured management by an inpatient medical team.
Primary Outcome Measure Information:
Title
Admission Rate
Time Frame
Enrollment date
Secondary Outcome Measure Information:
Title
30 day clinical outcomes
Time Frame
30 days
Title
Quality of life
Time Frame
30 days
Title
Cost
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Sun, MD, MPP
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oaks
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24239341
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.
Results Reference
result
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