SyncopeNCT01003262
Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
A study testing Emergency Department Observation Protocol and Unstructured, inpatient evaluation in people with Syncope, run by University of California, Los Angeles at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Emergency Department Observation Protocol and Unstructured, inpatient evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts
Duke University Medical Center
Durham, North Carolina, 27705
University of Southern California
Los Angeles, California
William Beaumont Hospital
Royal Oaks, Michigan, 48073
About this study
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:
Read more
- 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.
- Conditions
- Syncope
- Being tested
- Emergency Department Observation Protocol, Unstructured, inpatient evaluation
- Keywords
- Observation Unit, Emergency Department
- Medical subject headings
- Syncope, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department Observation ProtocolOther
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
Unstructured, inpatient evaluationOther
This is unstructured management by an inpatient medical team.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department Observation | Experimental | The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria Receives: Other: Emergency Department Observation Protocol |
| Unstructured, inpatient evaluation | Active comparator | Not described Receives: Other: Unstructured, inpatient evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission Rate
Measured: Enrollment date
Secondary outcomes (3)
30 day clinical outcomes
Measured: 30 days
Quality of life
Measured: 30 days
Cost
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Brigham and Women's Hospital, Corewell Health East, Duke University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Benjamin Sun, MD, MPP, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003262
- Sponsor's protocol ID
- 3163864
- Other IDs
- RC1AG035664-01
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2009
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24239341
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
- ClinicalTrials.gov ID
- NCT01003262
- Acronym / sponsor ID
- 3163864
- Conditions
- Syncope
- Keywords
- Observation Unit, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, Brigham and Women's Hospital, Corewell Health East, Duke University, National Institute on Aging (NIA)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Observation | Experimental | Other: Emergency Department Observation ProtocolThe EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria |
| Unstructured, inpatient evaluation | Active comparator | Other: Unstructured, inpatient evaluation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Department Observation ProtocolThe EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria | Other | Emergency Department Observation |
| Unstructured, inpatient evaluationThis is unstructured management by an inpatient medical team. | Other | Unstructured, inpatient evaluation |
Primary outcome
Admission Rate
Time frame: Enrollment date
3 secondary outcomes
30 day clinical outcomes
Time frame: 30 days
Quality of life
Time frame: 30 days
Cost
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Results publication: PubMed 24239341Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Sun, MD, MPP principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department Observation Protocol and Unstructured, inpatient evaluation in people with Syncope, run by University of California, Los Angeles at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission Rate (time frame: Enrollment date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.