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| ID | Type | Description | Link |
|---|---|---|---|
| RC1AG035664-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| Brigham and Women's Hospital | OTHER |
| Corewell Health East | OTHER |
| Duke University |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Department Observation | Experimental | The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria |
|
| Unstructured, inpatient evaluation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Department Observation Protocol | Other | The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Admission Rate | Enrollment date |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day clinical outcomes | 30 days | |
| Quality of life | 30 days | |
| Cost |
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Inclusion Criteria:
Exclusion Criteria:
Risk Stratification Guidelines:
Intermediate Risk
Low Risk
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Sun, MD, MPP | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | United States | |||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24239341 | Result | 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. |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| OTHER |
| National Institute on Aging (NIA) | NIH |
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| Unstructured, inpatient evaluation | Other | This is unstructured management by an inpatient medical team. |
|
| 30 Days |
| Boston |
| Massachusetts |
| United States |
| William Beaumont Hospital | Royal Oaks | Michigan | 48073 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |