CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
SynDAbehavioral
Likely dose
Not stated in record
Key inclusion· 4
  • Emergency Department patient presenting with syncope as chief complaint
  • Age 30 years or above
  • Capacity to make medical decisions
  • Speak and read English fluently
Key exclusion· 6
  • Altered mental status or cognitive impairment
  • Serious acute diagnoses including cardiac dysrhythmia, structural heart disease, GI hemorrhage, myocardial infarction, pulmonary embolism, pneumonia, arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or stroke
  • Hemodynamic instability
  • Major communication barrier or inability to read/speak English

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02971163
NCT02971163N/ACompleted

SynDA: Syncope Decision Aid for Emergency Care

Icahn School of Medicine at Mount Sinai·interventional·Posted Nov 22, 2016·Updated May 26, 2020

In Brief

A clinical study evaluating SynDA for Syncope. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSyncope
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 22, 2016
Enrollment StartJan 1, 2017
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.6 years ago

Interventions

SynDAbehavioral

SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.