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临床试验/NCT02971163
NCT02971163已完成不适用

SynDA: Syncope Decision Aid for Emergency Care

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Number of Participants at End of Study

研究概览

简要总结

Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED) complaint responsible for over 1 million ED visits yearly. Potential causes include benign conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of serious cardiac conditions. In older patients without a clear cause of syncope hospital admission is frequently initiated at very low risk thresholds, though there is little evidence that these admissions improve patient outcomes. These decisions are often made without significant patient input or discussion of reasonable alternatives. In this situation, a patient's values, preferences, and particular circumstances should be taken into account. This mutualistic approach to clinical management is referred to as Shared Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between providers and patients in clinical scenarios where multiple reasonable management options exist. To improve syncope emergency care, the researchers can leverage recent advances in risk stratification to engage patients in SDM and deliver superior, patient-centered care.

This study will provide the groundwork for a larger, randomized controlled trial evaluating the effects of the decision aid for management of low-risk syncope.

详细描述

Setting:

Mount Sinai Hospital (MSH) has a 61-bed adult Emergency Department with a volume of over 100,000 patient visits/year or approximately 300 visits/day. MSH is a large academic tertiary care medical center located in East Harlem and serves a large black and Hispanic community.

Projected Recruitment: There are approximately 60 MSH ED visits for syncope per month of which 35 per month are by patients above age 30. Roughly half of these do not have a clear etiology of their syncope discovered in the ED. The researchers project that of the 17 potentially eligible patients per month, three will be successfully enrolled for a projected 72 patient enrollees at the completion of the 24-month recruitment period. The PI, clinical research coordinators, and SRAs will monitor the real-time electronic tracking system for all ED patients and will identify any patient over age 30 with a chief complaint of syncope or loss of consciousness.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Emergency Department patient
  • •Age 30 years or above
  • •Chief complaint of syncope
  • •Capacity to make medical decisions
  • •Speak and read English
  • •Working phone number and fixed address

排除标准

  • •Altered Mental Status
  • •Cognitive Impairment
  • •Serious acute diagnosis:
  • •(e.g. clinically significant cardiac dysrhythmia, structural heart disease, gastrointestinal hemorrhage, myocardial infarction, pulmonary embolism, pneumonia, arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or stroke.)
  • •Hemodynamic instability
  • •Inability to read or speak English
  • •Major communication barrier
  • •Lack of phone number or fixed address
  • •Too high risk as per physician judgment

研究组 & 干预措施

SynDA

Experimental

The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.

干预措施: SynDA (Behavioral)

Control

No Intervention

Patients in the control arm will receive usual emergency care pertaining to syncope.

结局指标

主要结局

Number of Participants at End of Study

时间窗: Two years

Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.

次要结局

  • Participants With New Significant Clinical Diagnosis(at 30 days)
  • Patient Knowledge(Within 2 hours post ED disposition on Day 1)
  • Utilization Outcomes(Day 1 and 30 day follow up period)
  • Number of Diagnostic Testing(Day 1)
  • Decisional Conflict Scale(Within 2 hours post ED disposition on Day 1)
  • Number of Participants With Repeat Visits to the ED(30-day follow-up period)
  • OPTION-5 Scale(up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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