SynDA: Syncope Decision Aid for Emergency Care
Phase: NA
Conditions: Syncope
Sponsor: Icahn School of Medicine at Mount Sinai

SynDA: Syncope Decision Aid for Emergency Care 
PI: Marc A. Probst, MD 
NCT02971163 
Document Date: 05-01-2018

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
1 
Revised  8/14/2017 
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Brief Summary of Research (250-400 words): 
Syncope, or transient loss of consciousness, is a common emergency 
department (ED) complaint responsible for over 1 million ED visits and $2.4 
billion in hospital costs yearly(Sun, Emond et al. 2004, Sun, Emond et al. 2005).  
Presyncope is defined as the sudden onset of a sense of impending loss of 
consciousness, but without actual loss of consciousness. Potential causes of 
syncope/presyncope include benign conditions such as dehydration or vaso-vagal 
syncope. Rarely, syncope/presyncope is the result of serious cardiac conditions 
such as dysrhythmia or structural heart disease, but often no cause is 
found(Serrano, Hess et al. 2010). In older patients without a clear cause of 
syncope hospital admission is frequently initiated at very low risk 
thresholds(Manheimer, Pacio et al. 2014), though there is little evidence that these 
diagnostic admissions improve patient outcomes(Canzoniero, Afshar et al. 2015). 
These decisions are often made without significant patient input or discussion of 
reasonable alternatives. This clinical equipoise surrounding the disposition 
decision creates a situation in which 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 (Probst, 
Kanzaria et al. 2015). To improve syncope/presyncope emergency care, we can 
leverage recent advances in risk stratification to engage patients in SDM and 
deliver superior, patient-centered care. 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
2 
Revised  8/14/2017 
In this research project, we will conduct a randomized controlled feasibility 
trial of a patient Syncope Decision Aid (SynDA) use vs. usual care in patients 30 
years or older who present to the Emergency Department with syncope or 
presyncope. SynDA is a paper-based, personalized decision aid which gives 
information to patients about their medical condition and options for care. It is 
written in lay language and aims to create an informed conversation between a 
patient and their ED provider. Only stable, asymptomatic patients with a normal 
evaluation, i.e. no serious diagnosis found in the ED, will be included. We plan to 
enroll 50 patients, 25 in each arm, over 24 months from the Mount Sinai 
Emergency Department and the Mount Sinai Beth Israel Emergency Department. 
Primary (feasibility) outcomes will include recruitment and follow-up rates. 
Secondary outcomes will include patient knowledge and satisfaction measured via 
survey immediately post-visit, as well as provider satisfaction. Data on clinical 
outcomes will also be collected including serious adverse events, admission rates, 
and downstream testing at 30 days. 
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/presyncope. 
1) Objectives: 
Research Question: Is a randomized controlled trial (RCT) of our syncope decision 
aid (SynDA) feasible in stable, adult syncope and presyncope patients age 30 and 
over with a normal ED work-up? 
Hypothesis 1: We will be able to recruit and enroll a sufficient number of patients as 
needed to calculate feasibility and follow-up rates of the use of SynDA. We 
hypothesize that we will be able to enroll at least 50 patients over a 24-month period.  
Hypothesis 2: We predict that using this structured approach to SDM with the 
SynDA tool will be superior to usual care with regard to patient satisfaction and 
knowledge. 
Objective: To determine whether a randomized, controlled trial of SynDA use vs. 
usual care after a normal ED evaluation in adult syncope/presyncope patients (age 
>30) is feasible at the Mount Sinai Emergency Department. 
2) Background 
Syncope is defined as a “transient loss of consciousness, associated with 
inability to maintain the postural tone and spontaneous recovery” (Sun, 
Costantino et al. 2014). Presyncope is defined as the sudden onset of a sense of 
impending loss of consciousness, but without actual loss of consciousness. They 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
3 
Revised  8/14/2017 
are common and potentially serious complaints responsible for over 1 million 
Emergency Department (ED) visits per year in the United States (US) with 
roughly one third resulting in admission to the hospital (Probst, Kanzaria et al. 
2015). National data from 2001 to 2010 demonstrate that the absolute number of 
ED visits for syncope is on the rise (Probst, Kanzaria et al. 2015). These 
admissions account for over $2.4 billion in health facility costs per year1. While 
syncope/presyncope is most often benign and self-limited, its etiology can be 
difficult to discern. Potential causes include benign conditions such as 
dehydration or vaso-vagal syncope (i.e. triggered by emotional distress) as well as 
rare but potentially serious cardiac conditions such dysrhythmias or structural 
heart disease. The ED diagnostic evaluation typically consists of careful history-
taking, physical exam, EKG, laboratory tests, and imaging if indicated. There are 
then three possible outcomes: 1) a clear, benign etiology is found (e.g. vasovagal 
syncope), 2) a dangerous diagnosis is revealed (e.g. third-degree heart block), or 
3) no diagnosis is made [see above figure]. The initial evaluation of syncope only 
reveals a clear diagnosis 20-50% of the time (Blanc, L'Her et al. 2002). In this 
common third scenario where no diagnosis is made, a disposition decision must 
be made under conditions of uncertainty: was the syncope/presyncope a result of a 
serious but occult cardiac condition (e.g. dysrhythmia) or was it truly benign? 
Current clinical practice guidelines and existing risk-stratification tools offer 
differing recommendations on admission criteria and in-patient admissions to 
exclude possible cardiac causes are often initiated at very low-risk thresholds 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
4 
Revised  8/14/2017 
(Linzer, Yang et al. 1997, Linzer, Yang et al. 1997, Sun, Emond et al. 2004, 
Strickberger, Benson et al. 2006, Huff, Decker et al. 2007, Task Force for the, 
Management of et al. 2009). Clinicians are fearful of inappropriately discharging 
these patients lest they suffer a rare preventable adverse event. Admission rates 
ranged from 27% to 35% and showed an upward trend. The diagnostic yield of in-
patient admission also remained steady; the most common International 
Classification of Diseases, 9th Revision (ICD-9) hospital discharge diagnosis 
remained “syncope and collapse” at 36% of all admitted patients.  
Despite substantial efforts by researchers and professional societies, 
considerable inefficiencies remain in the acute care of syncope/presyncope 
patients. It is still unclear if syncope patients with a negative ED work-up benefit 
from subsequent in-patient admission (Crane 2002, Mendu, McAvay et al. 2009, 
Sun, Costantino et al. 2014, Canzoniero, Afshar et al. 2015). Diagnostic in-patient 
hospitalization can lead to iatrogenic harms, such as medication errors, delirium 
and nosocomial infections. A recent study of patients admitted for low-risk 
syncope found that in-patient admission may actually be harmful; 13% of patients 
experienced adverse events such as medication errors, delirium, and nosocomial 
infections. 
Adults who present to the ED with syncope/presyncope often have no etiology 
uncovered during their visit and risk developing an adverse event through 
diagnostic in-patient admission. For this subgroup of patients, often both out-
patient and in-patient management can be medically reasonable. Both pathways 
are associated with small and difficult to precisely quantify risk and benefits.  
The clinical equipoise surrounding the disposition decision of patients who 
present to the ED with syncope/presyncope creates a situation in which the 
patient’s values, preferences, and circumstances could be taken into account for 
their disposition decision (admit vs. discharge). Patient engagement can be 
broadly defined in the ED context as active patient involvement in their own 
healthcare to strengthen their influence on medical decisions and behaviors 
(Coulter 2011). This mutualistic approach to clinical management is referred to as 
Shared Decision-Making (SDM). 
We believe that structured approach to SDM for syncope/presyncope patients 
using a paper-based, patient decision-aid containing personalized risk-
stratification and information on medical options is safe and superior to usual care 
with regard to patient satisfaction and knowledge. Decision aids are evidenced-
based tools designed to increase patient understanding of medical options and 
possible outcomes. They have been shown to increase patient knowledge and 
engagement in decision-making (O'Connor, Bennett et al. 2009). Our preliminary 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
5 
Revised  8/14/2017 
work demonstrated that a majority of emergency physicians perceive that Shared 
Decision-Making is appropriate for the disposition of low-risk ED syncope 
patients (Kanzaria, Hoffman et al. 2015). Previous studies have shown that 
emergency physicians are, in general, amenable to the use of shared decision-
making (Kanzaria, Brook et al. 2015). 
Structured shared decision-making using a decision-aid has been successfully 
applied to the management of ED patients with low-risk chest pain (Hess, 
Knoedler et al. 2012). We propose a similar methodology but for syncope and 
presyncope patients. During the last year, we conducted semi-structured 
interviews with ED providers investigating the rationale behind their clinical 
management of low-risk ED syncope patients and their opinions on the use of 
SDM for this scenario.  
Similarly, we conducted interviews with patients who had presented to the ED 
with syncope and had been discharged or sent to the observation unit. We asked 
them to what extent they wanted to be involved in the decision to be admitted and 
what information they felt was necessary to engage meaningfully in this process. 
Patients wanted to be more informed and involved, and preferred information be 
presented to them verbally from their physician or via short, simple text. Based on 
our findings, we developed SynDA, an ED-based decision aid to be used to 
facilitate SDM between patients and providers after a non-diagnostic ED visit for 
syncope (Appendix 1). This 11x14 inch, paper-based tool provides an easy-to-
understand, 4-step process to engage patients in their disposition decision: 1) 
describe syncope and its potential causes, 2) explain the concept of downstream 
risk, 3) provide an individualized risk evaluation presented as a 100-man, color-
coded pictogram, and 4) present options for further management. SynDA is now 
ready for pilot testing in this proposed trial. 
We believe SynDA will be an appropriate tool to engage syncope/presyncope 
patients in SDM in the Mount Sinai Hospital Emergency Department/ Mount 
Sinai Beth Israel Emergency Department and it will increase patient satisfaction 
and knowledge. To test this hypothesis, we must perform an experimental trial. 
Using the final, refined version of SynDA, we will conduct a small scale, single-
center RCT to assess the feasibility and necessary logistics of performing such a 
trial. Results of future trials of SynDA could positively impact the over 1 million 
patients who present to US EDs with syncope/presyncope every year.  
 
3) Setting of the Human Research 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
6 
Revised  8/14/2017 
Mount Sinai Hospital (MSH) is 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. 
4) Resources Available to Conduct the Human Research 
Projected Recruitment: Based on internal data from 2014, there are 60 
MSH ED visits for syncope per month of which 35 per month are by 
patients above age 40. Roughly half of these do not have a clear etiology 
of their syncope discovered in the ED. We 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 our 24-month 
recruitment period. Assuming an attrition rate of 20%, the target sample 
size (50) will be reached within 24 months. 
There are an estimated 30-40 ED visits for syncope per month at Mount 
Sinai Beth Israel Emergency Department. Similarly, about half of these do 
not have a clear etiology of their syncope discovered in the ED. We 
project that of the 8-9 potentially eligible patients per month, 1-2 will be 
successfully enrolled. This will augment our total enrollment to ensure 
that we reach our target sample size of 50 patients within 24 months.  
Available Staff: The research staff for this study includes Dr. Marc Probst 
(Principal Investigator), Lauren Gordon (Project Manager). This research 
team has extensive experience conducting and completing both 
observational and interventional prospective research.  SRAs staff the ED 
from 8 a.m. to 8 p.m. seven days per week at Mount Sinai Hospital 
Emergency Department. Clinical Research Coordinators are now working 
at Mount Sinai Beth Israel (MSBI) Emergency Department 5 days a week 
for 8 hours per day. 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/presyncope or loss of consciousness. 
Resources: The research material obtained from the participants includes 
clinical data extracted from the electronic health record (EHR), contact 
information to obtain 30-day clinical follow-up, and the audio recording of 
the final discussion between the patient and the physician regarding 
admission vs. discharge. The contact information, survey data, and EHR 
data will be safely stored in an electronic database (REDCap) on the 
password-protected computers of the PI and clinical research coordinators. 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
7 
Revised  8/14/2017 
The PI will meet with the clinical research coordinators (CRCs) on a 
weekly basis to ensure that enrollment is progressing as planned, that no 
protocol violations have occurred and to address any potential issues as 
they arise.  
5) Study Design 
a) Recruitment Methods 
Participants will be recruited from the MSH/MSBI ED and will be 
identified by the PI or trained research associates (RA) from the Sinai 
Research Associate program. SRAs staff the MSH ED from 8 a.m. to 8 
p.m. seven days per week and the MSBI ED 8 hours a day from Monday 
to Friday. All potential patients will be identified from the Emergency 
Department of Mount Sinai Hospital and Mount Sinai Beth Israel. Patients 
will NOT be recruited from the Mount Sinai Queens or Elmhurst Hospital 
EDs. The PI, CRCs, and SRAs will monitor the real-time electronic 
tracking system (EPIC) for all ED patients and will identify any patient 
over age 30 with a chief complaint of syncope/presyncope or loss of 
consciousness. A HIPAA Waiver is requested solely for the purpose of 
identifying eligible patients in the ED, i.e. pre-screening. If a SRA has 
identified a syncope/presyncope patient over age 30, he or she will alert a 
clinical research coordinator. The on-call CRC will screen the patient’s 
ED visit chart for evidence of exclusion criteria and confirm if the patient 
had a syncopal episode according to the team’s notes. Patients will be 
recruited solely from the ED and not from any other settings since the 
intervention (i.e. the SynDA tool) is designed and intended for use in the 
ED by ED clinicians to engage patients in ED medical decisions.  
A total of $50 in cash payments will be offered to the patient as incentive. 
A $25 cash payment will be offered in person upon completion of the pre 
and post-encounter survey. An additional $25 cash payment will be mailed 
to the patient after 30-day follow-up information is obtained from them. 
The CRC will verify the patient's e-mail, mailing address and telephone 
number (with a real time call) at the time of enrollment to maximize the 
fidelity of follow-up. 
b) Inclusion and Exclusion Criteria 
Patient participants eligible for inclusion will be adults 30 years or older 
who present to the ED with a chief complaint of either loss of 
consciousness, syncope/presyncope, fall, or dizziness and who have a 
normal ED evaluation (i.e. no serious diagnosis was made in the ED). 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
8 
Revised  8/14/2017 
They must have capacity to make medical decisions, be proficient in 
English and be deemed appropriate for either inpatient or outpatient 
management by the treating attending physician.  
Other exclusion criteria include inability to read in English, major 
communication barrier, or lack of fixed address and telephone number.  
The SynDA tool was developed based on input derived from interviews 
with English-speaking patients and English-speaking clinicians. The tool 
was then shown to English-speaking patients for iterative feedback and 
modification. Thus, even if translated into Spanish, the tool would not 
culturally be adapted for Hispanic/Latino patients. It may not adequately 
communicate information and concepts to Spanish-speakers. For this 
reason, we are currently excluding Spanish-speaking patients. However, if 
the results of this study are promising, our research team intends to 
culturally and linguistically adapt the SynDA tool for use with Spanish-
speaking patients.  
All ED treating clinicians (Attendings, residents, and PAs) will be eligible 
for inclusion for participation. 
c) Number of Subjects 
Based on internal data from 2014, there are 60 MSH ED visits for syncope 
per month, approximately 35 of which are for patients above age 40. 
Roughly half of these do not have a clear etiology of their syncope 
discovered in the ED. We project that of the 17 potentially eligible 
patients per month, three will be successfully enrolled for a projected 72 
possible enrollees at the completion of our 24-month recruitment period. 
Assuming an attrition rate of 20%, the target sample size (50) will be 
reached within 24 months. 
There are an estimated 30-40 ED visits for syncope per month at Mount 
Sinai Beth Israel Emergency Department. Similarly, about half of these do 
not have a clear etiology of their syncope discovered in the ED. We 
project that of the 8-9 potentially eligible patients per month, 1-2 will be 
successfully enrolled. 
All MSH attending physicians, ED residents, and physician assistants 
(PAs) – approximately 140 ED treating clinicians – will be pre-consented 
and trained on the use of SynDA to facilitate SDM during a 1-hour 
training course prior to the start of the trial. 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
9 
Revised  8/14/2017 
The MSBI attending physicians, ED residents not already trained and 
consented will be trained and consented in the same fashion as those at 
MSH. There are currently ED residents from MSH who are working 
clinically at MSBI.  
d) Study Timelines 
Duration of the participant actively engaging in SDM the study in the ED will last 
up to two hours from the time of consent. This includes randomization, pre-
encounter survey, engaging in shared decision-making with the provider (audio 
recorded with prior consent, and post-encounter survey. Participants will be 
followed for 30 days post index visit and a medical record review will be 
conducted. The Clinical Research Coordinator (CRC) will review the Emergency 
Health Records of enrolled patients and hospital billing statements to determine 
the disposition of patient after the index ED encounter (discharge to home, 
admission to observation, admission to hospital) and any subsequent encounters 
that have occurred including repeat ED visits, hospitalizations, new diagnoses or 
procedures, and further diagnostic testing (e.g. cardiac stress testing, coronary CT 
angiography, echocardiography, neuroimaging, pulmonary CT angiography, etc.).  
Approximately 30 days (up to 45 days) after the index ED visit, the CRC will 
contact the patient by phone or e-mail. If this is not successful after three 
attempts, the research coordinator will contact the patient using the secondary 
method of contact specified by the patient at the time of consent to arrange a 
telephone interview. During the follow-up telephone interview, the clinical 
research coordinator will inquire about major adverse cardiac events, hospital 
admissions, ED visits, physician office visits, and further testing since discharge 
within the 30 days of discharge from the ED. Attempts to contact patients will last 
up to 15 days after the 30-day post ED visit day or after ten attempts to contact 
the patient, whichever comes first.  The follow-up interview will last 
approximately 15 minutes. 
 
Data analysis will take approximately six months to complete starting from the 
enrollment of the last patient. Descriptive summaries for all demographic and 
clinical variables will be performed. Pre and post-encounter survey results will be 
tabulated and compared between the two arms of the trial. Outcomes with 
continuous distributions will be evaluated using independent samples t-tests while 
binary outcomes (e.g. admitted or not) will be assessed using logistic regression. 
We will follow an intention to treat protocol. Analyses will be conducted with the 
help of Dr. Winkel using SAS software (version 9.3; SAS Institute, Cary, NC). 
 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
10 
Revised  8/14/2017 
We expect to reach our enrollment goal in 24 months and we plan on completing 
final analysis and submitting a manuscript for publication within one year after 
completing recruitment. 
e) Study Endpoints 
The primary outcome for the study is feasibility. Feasibility will be determined by 
calculating the proportion of eligible syncope/presyncope patients who are 
enrolled in the study. A de-identified record (e.g. a screening log) of the number 
of patients who were eligible but were excluded from the study for any reason 
will be maintained on a secure shared drive accessible by members of the research 
team.  
Other parameters we will measure relevant to feasibility will be follow up rate 
(proportion of enrolled patients who are successfully contacted at 30 days) and 
proportion of patients deemed inappropriate for SDM by the ED team. Secondary 
outcomes will include the OPTION scale and the Informed Decision Making 
scale used to evaluate the quality of the decision making based on the audio 
recordings. The scale enables a viewer to quantify the extent to which clinicians 
involve patients in the decision making process. We will also measure differences 
in patient satisfaction, knowledge, and provider satisfaction with the tool. 
We will compare the two study groups with respect to admission rate 
(hospital/observation unit vs discharge home), post-randomization diagnostic 
testing (e.g. exercise stress testing, echocardiography, computed tomography 
scans), repeat visits to the ED, and clinical outcomes at 30 days. 
Clinical outcomes will include death from any cause, myocardial infarction, 
dysrhythmia, new diagnosis of clinically significant structural heart disease, 
pulmonary embolism, significant hemorrhage/anemia, aortic dissection, acute 
pulmonary edema, stroke, transient ischemic attack, or syncope-related 
surgery/medical procedure within 30-days.  
f) Procedures Involved in the Human Research 
Overall Study Design: A randomized, controlled, unblinded, feasibility 
trial of SynDA use versus usual care for clinically stable, adult ED 
syncope/presyncope patients. The ideal sample size will be 50 patients 
with an age-stratified 1:1 allocation to each arm. Participants will be 
followed for 30 days post index visit. 
Detailed Study Procedure:  

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
11 
Revised  8/14/2017 
The PI, CRCs, and SRAs will monitor the real-time electronic tracking 
system (EPIC) for all ED patients and will identify any patient over age 30 
with a chief complaint of syncope/presyncope, loss of consciousness, fall, 
or dizziness. These additional chief complaints are included because some 
patients with syncope/presyncope are initially triaged by the triage nurse 
as “dizziness” or “fall”. If a SRA has identified a potential patient, he or 
she will alert a clinical research coordinator. The on-call CRC will screen 
the patient’s ED visit chart for signs of any obvious exclusion criteria. 
Exclusion criteria the CRC can preliminarily identify through screening a 
potential patient’s chart include advanced dementia, psychosis, altered 
mental status, present intoxication, hemodynamic instability (e.g. low 
blood pressure, elevated pulse), elevated troponin level, or any 
documented serious diagnosis that was identified in the ED. Examples of 
serious diagnoses include but are not limited to clinically significant 
cardiac dysrhythmia, structural heart disease, gastrointestinal hemorrhage, 
myocardial infarction, pulmonary embolism, arterial dissection, serious 
infection, ectopic pregnancy, subarachnoid hemorrhage, or stroke. After 
ruling out all of the above, the CRC will calculate the Canadian Syncope 
Risk Score (CSR) of the potential patient using results from labs and 
EKGs, and also from speaking with the ED team. The CRC explicitly will 
confirm the interpretation of the lab results and the EKG with the 
physician or PA caring for the patient, as well as confirming the clinical 
variables. To calculate the CSR, he or she will use clinical data from our 
Electronic Health Record (EHR) to extract blood pressure, troponin 
results, and objective EKG parameters (variables 3, 6-9). The clinician 
judgment criteria of the risk score (variables 1, 2, 4 and 5) will be verified 
by the CRC using direct consultation with the attending physician, 
resident, or physician assistant. If the CSR is equal to or greater than 
15.3%, the patient will be excluded from participating in the study. 
If no exclusion criteria are present in the patient’s chart at the time of 
screening and the CSR is calculated to be less than 15.3% (i.e. total risk 
score below 5), the CRC will then inform the ED clinical team that the 
patient is eligible to participate in the study. If the ED team deems that the 
patient is potentially appropriate for SDM and is agreeable to engage in 
SDM with the patient, the PI or CRC will consent the patient into the 
study if he or she expresses interest in participating. All ED providers 
(residents, attending physician, and physician assistants) will have been 
pre-consented. The PI or clinical research coordinator will confirm with 
the treating ED team that the patient experienced a true 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
12 
Revised  8/14/2017 
syncopal/presyncopal episode, no serious diagnosis has been made, and 
ask whether the patient is potentially appropriate for SDM. For patient 
participants, the CRC or PI will consent at beside after ED provider 
approval. 
After consent, the PI or CRC will record the patient’s contact information 
and complete a pre-encounter survey (Appendix 2). This pre-encounter 
survey contains 12 short questions and will assess demographics, 
preferences, numeracy, health literacy, education level, and income.  
After completing the initial necessary documentation, the CRC will 
randomize the patient to the SynDA arm vs. usual care stratified by age 
(less than or greater than 60 years) to ensure a balance of geriatric patients 
in both groups. The age-stratified randomization process will involve 
sealed, opaque envelopes stored in a secure area of in the ED (i.e. the 
Clinical Research Office). Patients will only be randomized after their ED 
diagnostic evaluation is fully complete (not revealing a serious diagnosis) 
and the treating attending physician has deemed the patient is appropriate 
for shared decision making i.e. has medical decision-making capacity.  
 
For those patients in the intervention arm (SynDA), the CRC 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. If the calculated 30-day risk exceeds the comfort 
level of the attending physician, he or she will have the option to override 
the study protocol calling for SDM and unilaterally determine the 
disposition (e.g. admit to hospital).  
If SDM is still deemed to be appropriate, the attending will perform SDM 
with the patient using the SynDA tool. The CRC will give a copy of the 
print out to the clinician to use at the bedside with the patient. All 
attending physicians, ED residents, and physician assistants (PAs) will be 
pre-consented and trained on the use of SynDA to facilitate SDM during a 
1-hour training course prior to the start of the trial. The CRC will also 
review the contents of the decision aid in real time with the clinician 
before the disposition discussion. 
For participants in the usual care arm, the ED clinical team will proceed 
with clinical management as per standard care for ED syncope/presyncope 
patients, without any study intervention. This may or may not include 
some form of shared decision making with the patient, depending on the 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
13 
Revised  8/14/2017 
usual practice of the clinicians involved. However, the ED team will not 
use the SynDA tool in order to make their decision and the patient will not 
be shown the tool.  
All participants will be offered the option of having the final disposition 
discussion audio recorded. If they consent to audio recording, the CRC 
will record these discussions using portable electronic device (e.g. a tablet 
computer) with the patient and provider’s explicit consent. The audio 
recordings will be done in the patient’s designated care area within the 
ED, where s/he has been receiving their care. This is where all disposition 
discussions occur during usual care. As well, if a family member or 
caregiver is present in the ED and would like to participate in the 
discussion with the patient and the physician, the will be given the option 
to consent (caregiver consent attached) to being audio-recorded. The 
recording device and all recordings will be securely managed. The 
purpose of the audio recording is to objectively assess how involved the 
patient was in the decision-making process. The audio recordings will be 
kept for 30 days after completion of the transcription and review by the PI 
and then will be deleted.  
If the patient or the provider does not consent to the recording, patients 
will still be permitted to remain in the trial and participate in SDM with 
SynDA or usual care discussions with the treating team and complete the 
rest of the study. In the event that either participant does not consent to 
being audio recorded, the CRC will silently observe the interaction.  
Recordings will be used to calculate the OPTION scale or the Informed 
Decision Making scale rating by independent observers at a later time. 
These validated scales are used to evaluate the degree of patient 
engagement. 
All enrolled participants will complete a post-encounter survey (Appendix 
3). This will occur after the disposition decision has been made, i.e. the 
decision to discharge home, admit to the observation unit, or admit to 
hospital. This survey will be administered to the patient by the CRC to 
assess the patient's perceptions about the amount, clarity and helpfulness 
of the information shared, their knowledge about syncope, their decisional 
conflict, and their satisfaction with the ED visit. ED providers (the 
resident, attending or PA) will also be asked to complete a survey 
(Appendix 4) assessing their perception of the decision-making process 
and the acceptability of the SynDA tool if in the SynDA arm. For 
encounters without the intervention, a shorter clinician survey will be 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
14 
Revised  8/14/2017 
administered (Appendix 5). The post-visit surveys were adapted from a 
previous randomized trial of decision aid vs. usual care for low risk chest 
pain patients and have demonstrated construct validity (Hess, Knoedler et 
al. 2012). 
All participants in the study will be contacted by phone or email at 30 
days. A chart review of four Mount Sinai System EHRs (MSH, Mount 
Sinai Beth Israel, Mount Sinai Queens, Elmhurst Medical center) will be 
queried to determine downstream diagnostic testing and clinical events.  
Approximately 30 days after the index ED visit, the CRC will contact patient 
participants by phone or e-mail. If this is not successful after three attempts, the 
research coordinator will contact the patient using the secondary method of 
contact specified by the patient at the time of consent to arrange a telephone 
interview. During the follow-up telephone interview, the clinical research 
coordinator will inquire about major adverse cardiac events, hospital admissions, 
ED visits, physician office visits, and further testing since discharge within the 30 
days of discharge from the ED. Opening script and questions in the telephone 
follow-up at 30 days are described in Appendix 6. Attempts to contact patients 
will last up to 15 days after the 30-day post ED visit day or after ten attempts to 
contact the patient, whichever comes first.  The follow-up interview will last 
approximately 15 minutes. Patient participants will be given a $25 cash payment 
after the completion of the surveys and an additional $25 cash payment if they 
provide follow-up information at 30 days. The New York State social security 
death index may be consulted for patients who were not reachable at 40 days. 
 
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
Data will be collected by the CRCs using telephone/email follow-up and 
review of the EHR at four Mount Sinai Medical Centers (MSH, Mount 
Sinai Beth Israel, Mount Sinai Queens, and Elmhurst Medical Center). 
Electronic data collection forms using REDCap will be used to record data 
including patient demographics and clinical variables, pre- and post-
encounter surveys and 30-day clinical outcomes. In the case of unclear 
clinical outcomes, a panel of two emergency physicians, blinded to the 
treatment arm will adjudicate. Identifiable data will be kept on a password 
protected database on a secure server. All data that are shared (i.e. with the 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
15 
Revised  8/14/2017 
statistician, Dr. Winkel) will be de-identified; participants will be assigned 
a unique study ID number. 
Analysis: 
Basic descriptive summaries for baseline demographic and clinical 
variables will be conducted. Secondary outcomes with continuous 
distributions will be evaluated using independent samples t-tests while 
binary outcomes (e.g. admitted or not) will be assessed using Logistic 
Regression. While we anticipate no mean differences in the Canadian 
Syncope Risk Scores between the SynDA and the usual care groups at 
baseline, it is quite possible that these scores may influence the SDM 
outcomes. In an effort to increase the precision of the differences between 
the two groups, each patient’s syncope score will be used a covariate in 
addition to the main effect of treatment group. All analyses will be run 
with two-sided tests and a significance level of 0.05. We will follow an 
intention to treat protocol. Analyses will be conducted with the help of Dr. 
Gary Winkel using SAS software (version 9.3; SAS Institute, Cary, NC).  
Sample size considerations: Since the primary outcome of this trial relates 
to feasibility, the study is not powered to detect differences in clinical 
outcomes. Previous RCTs of ED decision aids (versus usual care) for chest 
pain have shown a 21% increase in patient satisfaction (61% vs 40%). 
This result is encouraging but we do not know what the effect size for the 
mean (or percentage) differences are for the SynDA and usual care 
arms(Sun, Costantino et al. 2014). An estimate of this would inform the 
sample size needed to achieve power >= 0.80 at alpha equal to 0.05 in a 
future study of ED syncope/presyncope patients. However, we believe that 
a sample of 50 patients divided into two arms equally will be sufficiently 
large to allow us to obtain a reliable estimate of the effect size which can 
be used to guide sample size considerations in a larger study of SynDA 
effectiveness. 
i) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The intervention is a paper-based decision aid (SynDA) designed 
to improve patient-provider communication around syncope/presyncope 
risk and clinical management options. Therefore, the proposed research 
involves only activities that present minimal risk of harm to subjects. 
Clinical care will not be altered by this trial since clinicians will always 
provide the care they feel is appropriate for each syncope/presyncope 
patient. Possible risks include risks to privacy of individuals or 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
16 
Revised  8/14/2017 
confidentiality of data, which includes demographic data, though 
accidental disclosure of participants’ responses could not reasonably place 
the participants at risk of liability or damage to their financial standing, 
employability, or reputation. Nevertheless, appropriate protections against 
loss of confidentiality will be taken by study investigators and staff using 
standard data handling procedures. The likely effectiveness of these 
protections to avoid accidental disclosure of participant information is 
very high. 
Part I: List the name(s) of the individual(s) at MSSM who will be 
responsible for data and safety monitoring of this study. For each 
individual, indicate their role, name, title, and department 
MSSM Principal Monitor: Dr. Lynne Richardson 
Indicate whether this person is the PI, a Team Member, or is Independent: 
Supervisor and Team Member 
Last Name: Richardson 
First Name: Lynne 
Academic Title: Full Professor, Vice Chair of Research 
Department: Emergency Medicine  
Mailing Address: 1 Gustave Levy Place Box 1620 
Phone: (212) 824-8066 
Fax: (212) 426-1946 
E-mail: lynne.richardson@mountsinai.org 
 
MSSM Additional Monitor: Dr. Marc Probst 
Indicate whether this person is the PI, a Team Member, or is Independent: PI 
Last Name: Probst 
First Name: Marc 
Academic Title: Assistant Professor 
Department: Emergency Medicine 
Mailing Address: 
 
New York, NY USA 
10029 
Phone: (212)-824-8094 
Fax: (212)-426-1946 
E-mail: marc.probst@mssm.edu 
 
Part II: 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
17 
Revised  8/14/2017 
Due to the minimal risk to participants, a formal Data and Safety 
Monitoring Board (DSMB) will be not convened for the feasibility trial. 
Dr. Probst (PI) will actively monitor the clinical data for any safety 
concerns on a weekly basis. The PI will be responsible for reporting 
adverse events to the IRB with all necessary information. 
Although no serious adverse events are anticipated, all adverse events, 
regardless of relationship to the research, will be reported to the IRB 
within 24 hours, as per IRB policies, and will be listed in the annual IRB 
application for continuation or termination of the research.  
All expected non-serious adverse events that occur at a greater frequency 
or severity than anticipated and all unexpected non-serious adverse events 
will be reported to the IRB within 15 working days and summarized 
annually to the IRB in the continuation or termination applications. Non-
serious adverse events include unscheduled health care visit to the ED, 
urgent care, or out-patient clinic for benign reasons not related to syncope, 
not cardiopulmonary or neurological in possible etiology (e.g. mild rash, 
urinary symptoms, medication refill.) 
Reports of adverse events will also be reviewed by the PI and the primary 
mentor (Dr. Richardson) at their biweekly meetings. 
j) Withdrawal of Subjects 
If at any time, a subject expresses verbal or nonverbal unwillingness to 
participate, the subject will be withdrawn from the study. 
If new clinical information arises that causes the treating ED team to deem 
the patient too high risk for potential discharge home, then the patient will 
be withdrawn from the study for safety reasons. For example, if while the 
patient is on the cardiac monitor in the ED and demonstrates a serious 
cardiac arrhythmia, then the attending physician will tell the patient that 
they should be admitted to the hospital for medical treatment and thus 
cannot participate in shared decision-making with the option to go home.  
The CRC and ED provider will explain the change in clinical course and 
the reason for the withdrawal from the trial to the patient. All medical 
questions will be answered by the ED provider 
The CRC will record the specific clinical reason why the patient was 
withdrawn from the trial. These reasons will be collected alongside other 
exclusion criteria being met by patients. Already collected data will be 
analyzed to measure any differences between enrolled and excluded 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
18 
Revised  8/14/2017 
patients to assess for selection bias. No further data collection will occur 
after a patient has been withdrawn from the trial. 
 
6) Risks to Subjects 
The intervention is a paper-based decision aid (SynDA) designed to 
improve patient-doctor communication around syncope risk and 
management options. Therefore, the proposed research involves only 
activities that present minimal risk of harm to subjects. There may be non-
serious psychological risks to the physicians who may appear to be 
uninformed about syncope or recent research in this area in front of the 
patient who may ask questions, however, there is a low likelihood of this 
occurring. There may be mild psychological risks to the patients who may 
be caused anxiety from learning about potential causes of 
syncope/presyncope and their 30-day risk of serious medical events. This 
anxiety will be mitigated by the provider who will emphasize that these 
risks are population-level estimates. Despite the possible anxiety caused, it 
is ethical to share information with patients about the probability of 
adverse events. Additional risks include risks to privacy of individuals or 
confidentiality of data, which includes demographic data, though 
accidental disclosure of participants’ responses could not reasonably place 
the participants at risk of liability or damage to their financial standing, 
employability, or reputation. There are no physical, legal, or financial risks 
to subjects. Nevertheless, appropriate protections against loss of 
confidentiality will be taken by study investigators and staff using 
standard data handling procedures. The likely effectiveness of these 
protections to avoid accidental disclosure of participant information is 
very high. 
 
7) Provisions for Research Related Injury 
We do not expect any research related injuries since the intervention is a 
piece of paper (SynDA) with information for the patient and provider to 
discuss. This tool is designed to facilitate conversation between the patient 
and the ED provider.   
8) Potential Benefits to Subjects 
Patients and clinicians may benefit psychologically from knowing that 
they have helped advance medical science. Clinicians (residents, attending 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
19 
Revised  8/14/2017 
physicians, PAs) will not be reimbursed. Other future patients presenting 
to the ED with syncope could potentially benefit from the results of this 
research. 
9) Provisions to Protect the Privacy Interests of Subjects 
There is potential risk to privacy of individuals or confidentiality of data, 
which does include demographic data, though accidental disclosure of 
participants’ responses could not reasonably place the participants at risk 
of liability or damage to their financial standing, employability, or 
reputation. Nevertheless, appropriate protections against loss of 
confidentiality will be taken using standard data handling procedures 
(unique study ID, password-protected computers, de-identifying data prior 
to analysis) as has been done with other clinical trials at the MSH ED. The 
likely effectiveness of these protections to avoid accidental disclosure of 
participant information is very high. 
10) 
Economic Impact on Subjects 
None, since the study coincides with the patients’ ED visit. All tests that 
are performed will be as part of the patient’s ED work-up determined by 
the attending and clinical team.  
11) 
Payment to Subjects 
Participants will receive a 
 after successful completion 
of the post-encounter survey. Another 
 will be mailed to 
the participant’s provided address upon completion of the telephone 
interview 30 days after enrollment. 
12) 
Consent Process 
To consent obtain written consent, the PI or CRC will approach eligible 
patients in the bed area of the ED once all diagnostic testing is complete 
and the ED attending physician has deemed the patient clinically 
appropriate for the study. If the patient expresses interest in participating 
in the study, the PI or CRC will provide additional information about the 
study as stated in the consent form and only after that is complete will the 
patient sign the form. It will be made clear to the patient that refusing to 
enroll in the study will in NO WAY alter their clinical care. Patients will 
have the opportunity to ask questions about the study before signing the 
consent form. 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
20 
Revised  8/14/2017 
All ED residents, attending physicians and PAs will be consented prior to 
the start of the trial. For new hires in the department which occur after the 
commencement of the trial, the PI will consent the providers as soon as 
feasible.  
Since children, cognitively impaired adults, and non-English speaking 
subjects meet exclusion criteria for this study, they will not be consented 
nor will be participants of this study. We will also exclude vulnerable 
populations from this study, as stated in section 14 of the protocol. 
13) 
Process to Document Consent in Writing 
Plans for the recruitment of subjects and the process for obtaining 
informed consent for participation are described in the section above. 
Written informed consent will be obtained from each participant as 
approved by the Mount Sinai Hospital IRB. All ED attending physicians, 
residents and PAs will be pre-consented (by written informed consent) 
during the 1-hour training session on shared decision-making and SynDA 
use. All completed written consent forms will be collected by the CRCs 
and kept in a secure location at Mount Sinai. 
 
14) 
Vulnerable Populations 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet 
adults (e.g. infants, children, 
teenagers) 
 
X 
Wards of the State (e.g. foster 
children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 

 
Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
21 
Revised  8/14/2017 
N/A 
16) 
Community-Based Participatory Research 
N/A 
17) 
Sharing of Results with Subjects 
N/A 
18) 
External IRB Review History 
N/A 
 
19) 
Control of Drugs, Biologics, or Devices 
N/A 
 
 
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Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
22 
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Protocol Title: 
SynDA: Syncope Decision Aid for Emergency Care 
Principal 
Investigator 
Name/Contact Info:  
Marc A. Probst, MD 
212-824-8094 
marc.probst@mssm.edu 
Primary Contact 
Name/Contact Info 
Avis A Harper-Brooks   
212-824-8080  
avis.harperbrooks@mountsinai.org 
Date Revised: 
 5/1/2018 
Study Number: 
Study ID: GCO#: 15-1016, IF#:1768978 
 
 
23 
Revised  8/14/2017 
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