Syncope Decision Aid for Emergency Care

NCT02971163 | Completed Results DMC

• 2 other identifiers: GCO 15-10161K23HL132052-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope

Keywords

Syncope; Shared Decision-Making; Emergency Medicine; Decision Aid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Patient Knowledge

  Within 2 hours post ED disposition on Day 1

• Decisional Conflict Scale

  Within 2 hours post ED disposition on Day 1

• Utilization Outcomes

  Day 1 and 30 day follow up period

• Number of Participants With Repeat Visits to the ED

  30-day follow-up period

• Participants With New Significant Clinical Diagnosis

  at 30 days

Study Arms (2)

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.

Behavioral: SynDA

Control

NO INTERVENTION

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

Interventions

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.

Also known as: Syncope Decision Aid

SynDA

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 32147870 DERIVED

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size of only English-speaking patients from a single, busy, urban, academic center.

Results Point of Contact

• Title: Dr. Marc A. Probst
• Organization: Mount Sinai Medical Center

marc.probst@mssm.edu

212-824-8094

Study Officials

• Lynne Richardson, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 22, 2016
• Study Start: January 1, 2017
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: May 26, 2020
• Results First Posted: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)