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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL132052-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynDA | Experimental | 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. |
|
| Control | No Intervention | Patients in the control arm will receive usual emergency care pertaining to syncope. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynDA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 2 hours post ED disposition on Day 1 |
| Decisional Conflict Scale |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lynne Richardson, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32147870 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Patients in the control arm will receive usual emergency care pertaining to syncope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Two years |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Small sample size of only English-speaking patients from a single, busy, urban, academic center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc A. Probst | Mount Sinai Medical Center | 212-824-8094 | marc.probst@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2018 | Apr 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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). |
| Within 2 hours post ED disposition on Day 1 |
| 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 | Day 1 and 30 day follow up period |
| Number of Participants With Repeat Visits to the ED | Number of participants with repeat visits to the ED during 30-day follow-up period | 30-day follow-up period |
| Participants With New Significant Clinical Diagnosis | Number of participants with clinical diagnosis at 30 days after index visit to the ED | at 30 days |
| Number of Diagnostic Testing | Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed | Day 1 |
| 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. | up to 2 years |
| BG001 | Control | Patients in the control arm will receive usual emergency care pertaining to syncope. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Control Preferences Scale | A validated single question measure of patient's desire for involvement in medical decisions that ranges from 1 (active) to 3 (collaborative) to 5 (passive). | Count of Participants | Participants |
|
| Subjective Numeracy Score (SNS) | The SNS consists of three questions summed to give a min and max score of 3-18 with higher scores indicating higher subjective numeracy skills. | Mean | Standard Deviation | units on a scale |
|
| Short Literacy Survey (SLS) | The SLS consists of three questions summed to give a score of 3-15 with higher scores indicating greater subjective health literacy. | Mean | Standard Deviation | units on a scale |
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| Education | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Canadian Syncope Risk Score | Count of Participants | Participants |
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Patients in the control arm will receive usual emergency care pertaining to syncope. |
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Within 2 hours post ED disposition on Day 1 |
|
|
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| 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). | Posted | Mean | Standard Deviation | score on a scale | Within 2 hours post ED disposition on Day 1 |
|
|
|
| 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 | Posted | Count of Participants | Participants | Day 1 and 30 day follow up period |
|
|
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| 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 | Posted | Count of Participants | Participants | 30-day follow-up period |
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| Secondary | Participants With New Significant Clinical Diagnosis | Number of participants with clinical diagnosis at 30 days after index visit to the ED | Posted | Count of Participants | Participants | at 30 days |
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|
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| Secondary | Number of Diagnostic Testing | Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | up to 2 years |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Control | Patients in the control arm will receive usual emergency care pertaining to syncope. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Admitted to hospital 30 day follow up period |
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| Office visit 30 day follow up period |
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| Cardiac Arrhythmia |
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| Large Pericardial Effusion |
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