Clinical trial NCT02971163: Syncope Decision Aid for Emergency Care
Official title: SynDA: Syncope Decision Aid for Emergency Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: Syncope
Shared Decision-Making
Emergency Medicine
Decision Aid
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants at End of Study
timeFrame: Two years
Secondary outcomes:
measure: Patient Knowledge
timeFrame: Within 2 hours post ED disposition on Day 1
measure: Decisional Conflict Scale
timeFrame: Within 2 hours post ED disposition on Day 1
measure: Utilization Outcomes
timeFrame: Day 1 and 30 day follow up period
measure: Number of Participants With Repeat Visits to the ED
timeFrame: 30-day follow-up period
measure: Participants With New Significant Clinical Diagnosis
timeFrame: at 30 days
measure: Number of Diagnostic Testing
timeFrame: Day 1
measure: OPTION-5 Scale
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Lynne Richardson, MD
role: STUDY_DIRECTOR
References:
citation: Probst MA, Lin MP, Sze JJ, Hess EP, Breslin M, Frosch DL, Sun BC, Langan MN, Thiruganasambandamoorthy V, Richardson LD. Shared Decision Making for Syncope in the Emergency Department: A Randomized Controlled Feasibility Trial. Acad Emerg Med. 2020 Sep;27(9):853-865. doi: 10.1111/acem.13955. Epub 2020 Apr 2.