Evaluating an Emergency Department Observation Syncope Protocol for Older Adults

NCT ID: NCT01003262

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-12-31

Brief Summary

Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S. emergency department visits and may herald a life-threatening condition in older adults (age≥60 years). Existing risk prediction instruments cannot reliably identify who among such older patients can safely be discharged home from an emergency department. As a result, the majority of older patients without a clear cause for syncope are hospitalized for diagnostic evaluation. However, current admission practices are characterized by low diagnostic yield, do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs. Most admitted patients are discharged within 48 hours, and approximately 50% of patients do not have an identified cause of syncope after their hospitalization.

The implementation of an expedited and standardized Emergency Department Observation Syncope Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The investigators propose a pilot randomized trial to implement and evaluate EDOSP at two emergency departments. This study has the following exploratory Specific Aims:

1. To compare admission rates and length-of-stay associated with EDOSP to standard care.

2. To compare serious outcomes rates associated with EDOSP to standard care.

3. To compare quality-of-life associated with EDOSP to standard care.

4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care.

Over a one-year period, 120 intermediate-risk older adults who present with syncope at the two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the emergency department.

If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators will plan a larger study powered to evaluate clinical, quality-of-life, and economic outcomes. A successful EDOSP intervention would have important clinical policy implications and improve the emergency department care of older adults with syncope.

Conditions

Syncope

Study Design

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

Study Groups

Emergency Department Observation

The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Group Type: EXPERIMENTAL

Emergency Department Observation Protocol

Intervention Type: OTHER

The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Unstructured, inpatient evaluation

Group Type: ACTIVE_COMPARATOR

Unstructured, inpatient evaluation

Intervention Type: OTHER

This is unstructured management by an inpatient medical team.

Interventions

Emergency Department Observation Protocol

The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria

Intervention Type: OTHER

Unstructured, inpatient evaluation

This is unstructured management by an inpatient medical team.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age≥60 years
• A complaint of syncope or near-syncope (Syncope is defined as a sudden, transient loss of consciousness. Near-syncope is defined as a sensation of imminent loss of consciousness, without actual syncope.)
• Intermediate risk of adverse outcome (see Table)
• Patient speaks either English or Spanish as a primary language.

Exclusion Criteria

• Syncope mimics (intoxication, weakness or dizziness with syncope/ near-syncope, hypoglycemia, and cardiac arrest)
• New or baseline cognitive impairment or dementia)
• Inability to provide follow-up information (e.g. homeless or resides outside of U.S.)
• Inability to speak Spanish or English
• Low- and high-risk patients (see Table).

Risk Stratification Guidelines:

• High Risk
• Serious condition identified in ED
• History of ventricular arrhythmia
• Cardiac Device with dysfunction
• Presentation consistent with acute coronary ischemia

Intermediate Risk

• No High Risk features
• Presentation not consistent with orthostatic or vasovagal syncope

Low Risk

• Presentation consistent with orthostatic or vasovagal syncope

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

William Beaumont Hospitals

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Sun, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of Southern California

Los Angeles, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

William Beaumont Hospital

Royal Oaks, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Sun BC, McCreath H, Liang LJ, Bohan S, Baugh C, Ragsdale L, Henderson SO, Clark C, Bastani A, Keeler E, An R, Mangione CM. Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission. Ann Emerg Med. 2014 Aug;64(2):167-75. doi: 10.1016/j.annemergmed.2013.10.029. Epub 2013 Nov 13.

Reference Type: RESULT

PMID: 24239341 (View on PubMed)

Other Identifiers

RC1AG035664-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3163864

Identifier Type: -

Identifier Source: org_study_id