N/A
N=50
Syncope Decision Aid for Emergency Care
Syncope
Bottom Line
View on ClinicalTrials.gov: NCT02971163 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants at End of Study — 20; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SynDA (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants at End of Study |
20; 24 | — |
| SECONDARY Patient Knowledge |
5.2; 5.3 | — |
| SECONDARY Decisional Conflict Scale |
8.9; 9 | — |
| SECONDARY Utilization Outcomes |
0; 0; 4; 7; 1; 1 | — |
| SECONDARY Number of Participants With Repeat Visits to the ED |
1; 2 | — |
| SECONDARY Participants With New Significant Clinical Diagnosis |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Diagnostic Testing |
1; 1 | — |
| SECONDARY OPTION-5 Scale |
52.0; 26.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02971163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.