Syncope Decision Aid for Emergency Care
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 1/20/2019 |
| Start Date: | January 2017 |
| End Date: | January 9, 2019 |
SynDA: Syncope Decision Aid for Emergency Care
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.
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.
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.
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.
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
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Marc Probst, MD, MS
Phone: 212-824-8080
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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