Syncope Decision Aid for Emergency Care

NCT ID: NCT02971163

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-09

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.

Conditions

Syncope

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SynDA

Intervention Type: 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.

Control

Patients in the control arm will receive usual emergency care pertaining to syncope.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Syncope Decision Aid

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne Richardson, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32147870 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23HL132052-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 15-1016

Identifier Type: -

Identifier Source: org_study_id