Syncope
Conditions
Keywords
Syncope, Shared Decision-Making, Emergency Medicine, Decision Aid
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.
Interventions
BEHAVIORALSynDA
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants at End of Study | Two years | Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Within 2 hours post ED disposition on Day 1 | Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict). |
| Utilization Outcomes | Day 1 and 30 day follow up period | Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period |
| Number of Participants With Repeat Visits to the ED | 30-day follow-up period | Number of participants with repeat visits to the ED during 30-day follow-up period |
| Patient Knowledge | Within 2 hours post ED disposition on Day 1 | One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge |
| Number of Diagnostic Testing | Day 1 | Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed |
| OPTION-5 Scale | up to 2 years | The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement. |
| Participants With New Significant Clinical Diagnosis | at 30 days | Number of participants with clinical diagnosis at 30 days after index visit to the ED |
Countries
United States
Participant flow
Recruitment details
After screening 351 patients, 51 randomized, one was excluded because not syncope, resulting in 50 participants enrolled with unexplained syncope from January 2017 to January 2019.
Participants by arm
| Arm | Count |
|---|---|
| SynDA The research coordinator 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.
SynDA: 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. | 24 |
| Control Patients in the control arm will receive usual emergency care pertaining to syncope. | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
Baseline characteristics
| Characteristic | SynDA | Control | Total |
|---|---|---|---|
| Age, Continuous | 54.5 years | 60 years | 58.5 years |
| Canadian Syncope Risk Score Low: 0 (≈2% risk) | 3 Participants | 6 Participants | 9 Participants |
| Canadian Syncope Risk Score Medium: 1 (≈3% risk) | 13 Participants | 15 Participants | 28 Participants |
| Canadian Syncope Risk Score Medium: 2 (≈5% risk) | 8 Participants | 5 Participants | 13 Participants |
| Control Preferences Scale 1 | 3 Participants | 0 Participants | 3 Participants |
| Control Preferences Scale 2 | 8 Participants | 7 Participants | 15 Participants |
| Control Preferences Scale 3 | 10 Participants | 13 Participants | 23 Participants |
| Control Preferences Scale 4 | 2 Participants | 2 Participants | 4 Participants |
| Control Preferences Scale 5 | 0 Participants | 2 Participants | 2 Participants |
| Control Preferences Scale Missing data | 1 Participants | 2 Participants | 3 Participants |
| Education College Graduate | 4 Participants | 6 Participants | 10 Participants |
| Education Graduate School | 8 Participants | 8 Participants | 16 Participants |
| Education High School Graduate/GED | 3 Participants | 4 Participants | 7 Participants |
| Education Some College | 8 Participants | 7 Participants | 15 Participants |
| Education Some High School | 1 Participants | 1 Participants | 2 Participants |
| Income $100,000 or more | 4 Participants | 5 Participants | 9 Participants |
| Income $20,000 to $29,999 | 1 Participants | 4 Participants | 5 Participants |
| Income $30,000 to $39,999 | 2 Participants | 2 Participants | 4 Participants |
| Income $40,000 to $59,999 | 3 Participants | 2 Participants | 5 Participants |
| Income $60,000 to $79,999 | 3 Participants | 0 Participants | 3 Participants |
| Income $80,000 to $99,999 | 2 Participants | 1 Participants | 3 Participants |
| Income Less than $20,000 | 2 Participants | 7 Participants | 9 Participants |
| Income Rather Not Say | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African-American | 7 Participants | 11 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
| Short Literacy Survey (SLS) | 13.2 units on a scale STANDARD_DEVIATION 2.6 | 12.6 units on a scale STANDARD_DEVIATION 2.6 | 12.9 units on a scale STANDARD_DEVIATION 2.6 |
| Subjective Numeracy Score (SNS) | 13.2 units on a scale STANDARD_DEVIATION 2.6 | 12.6 units on a scale STANDARD_DEVIATION 2.6 | 12.9 units on a scale STANDARD_DEVIATION 2.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Number of Participants at End of Study
Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.
Time frame: Two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SynDA | Number of Participants at End of Study | 20 Participants |
| Control | Number of Participants at End of Study | 24 Participants |
Secondary
Decisional Conflict Scale
Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).
Time frame: Within 2 hours post ED disposition on Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SynDA | Decisional Conflict Scale | 8.9 score on a scale | Standard Deviation 1.5 |
| Control | Decisional Conflict Scale | 9 score on a scale | Standard Deviation 1.6 |
Secondary
Number of Diagnostic Testing
Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SynDA | Number of Diagnostic Testing | 1 Participants |
| Control | Number of Diagnostic Testing | 1 Participants |
Secondary
Number of Participants With Repeat Visits to the ED
Number of participants with repeat visits to the ED during 30-day follow-up period
Time frame: 30-day follow-up period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SynDA | Number of Participants With Repeat Visits to the ED | 1 Participants |
| Control | Number of Participants With Repeat Visits to the ED | 2 Participants |
Secondary
OPTION-5 Scale
The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.
Time frame: up to 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SynDA | OPTION-5 Scale | 52.0 score on a scale | Standard Deviation 18 |
| Control | OPTION-5 Scale | 26.6 score on a scale | Standard Deviation 21 |
Secondary
Participants With New Significant Clinical Diagnosis
Number of participants with clinical diagnosis at 30 days after index visit to the ED
Time frame: at 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SynDA | Participants With New Significant Clinical Diagnosis | Acute Stroke | 1 Participants |
| SynDA | Participants With New Significant Clinical Diagnosis | Heart Failure | 1 Participants |
| SynDA | Participants With New Significant Clinical Diagnosis | Large Pericardial Effusion | 0 Participants |
| SynDA | Participants With New Significant Clinical Diagnosis | Cardiac Arrhythmia | 0 Participants |
| Control | Participants With New Significant Clinical Diagnosis | Large Pericardial Effusion | 1 Participants |
| Control | Participants With New Significant Clinical Diagnosis | Acute Stroke | 0 Participants |
| Control | Participants With New Significant Clinical Diagnosis | Heart Failure | 0 Participants |
| Control | Participants With New Significant Clinical Diagnosis | Cardiac Arrhythmia | 1 Participants |
Secondary
Patient Knowledge
One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge
Time frame: Within 2 hours post ED disposition on Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SynDA | Patient Knowledge | 5.2 score on a scale | Standard Deviation 1.8 |
| Control | Patient Knowledge | 5.3 score on a scale | Standard Deviation 1.8 |
Secondary
Utilization Outcomes
Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period
Time frame: Day 1 and 30 day follow up period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SynDA | Utilization Outcomes | Admitted to hospital Day 1 | 0 Participants |
| SynDA | Utilization Outcomes | Sent to observation unit Day 1 | 4 Participants |
| SynDA | Utilization Outcomes | Admitted to hospital 30 day follow up period | 1 Participants |
| SynDA | Utilization Outcomes | Office visit 30 day follow up period | 14 Participants |
| Control | Utilization Outcomes | Office visit 30 day follow up period | 17 Participants |
| Control | Utilization Outcomes | Admitted to hospital Day 1 | 0 Participants |
| Control | Utilization Outcomes | Admitted to hospital 30 day follow up period | 1 Participants |
| Control | Utilization Outcomes | Sent to observation unit Day 1 | 7 Participants |