Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Admission Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Presentation consistent with orthostatic or vasovagal syncope
研究组 & 干预措施
Unstructured, inpatient evaluation
干预措施: Unstructured, inpatient evaluation (Other)
Emergency Department Observation
The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
干预措施: Emergency Department Observation Protocol (Other)
结局指标
主要结局
Admission Rate
时间窗: Enrollment date
次要结局
- 30 day clinical outcomes(30 days)
- Quality of life(30 days)
- Cost(30 Days)