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NCT01003262 · ClinicalTrials.gov registry record · NA
Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
A NA study of Syncope, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 123
- Enrollment target
- 4
- Study locations
NCT01003262 is a NA study of Syncope that has completed, run by University of California, Los Angeles. The registered enrollment target is 123 participants, below the 840-participant average among 11 other Syncope trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01003262, a NA study of Syncope, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
- 4
- Study locations
Study 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 im
Conditions Studied
Interventions
- OTHER Emergency Department Observation Protocol
- OTHER Unstructured, inpatient evaluation
Study Locations (4)
California
- University of Southern California - Los Angeles
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- William Beaumont Hospital - Royal Oaks
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01003262
The ClinicalTrials.gov registry entry for NCT01003262 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 840-participant average among 11 other Syncope trials with a reported enrollment target (85% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Syncope appearing as the primary indexed condition, and to 2 interventions - of which Emergency Department Observation Protocol is the first listed.
NCT01003262 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT01003262 about?
NCT01003262 is a clinical study titled "Evaluating an Emergency Department Observation Syncope Protocol for Older Adults". 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 ...
What is the current status of trial NCT01003262?
This trial is currently completed. It is a NA study. The enrollment target is 123 participants. The study started on 2010-03. Estimated completion is 2011-12.
What conditions does trial NCT01003262 study?
This clinical trial studies the following conditions: Syncope.
What interventions are being tested in trial NCT01003262?
The interventions under investigation include: Emergency Department Observation Protocol (OTHER), Unstructured, inpatient evaluation (OTHER).
Who is sponsoring clinical trial NCT01003262?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01003262 being conducted?
This trial has 4 study locations across California, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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