Clinical trial NCT03906812: A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Official title: A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Telemetry Usage
Chest Pain
Unstable Angina
Resource Utilization
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness - on admission, eligible, low-risk patients will be individually assigned to either unmonitored floor admission or floor admission with telemetry.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in emergency department (ED) patients admitted with chest pain and low-risk features.

Detailed description: Many patients admitted to the hospital with concern for cardiopulmonary and other acute illnesses are routinely placed on electrocardiographic monitoring (telemetry). Telemetry surveillance theoretically allows the clinical staff to monitor admitted patients for the development of both brady- and tachydysrhythmias. The goal is to identify dysrhythmias immediately via active cardiac monitoring in the very few patients who develop them, rather than identifying the dysrhythmia after the patient becomes symptomatic. However, the overwhelming majority (greater than 99 percent) of monitored patients do not experience any significant arrhythmia. The liberal use of monitoring in unnecessary situations may give the hospital staff a false sense of security and/or desensitize them to alarms. Studies also suggest the liberal use of telemetry inflates costs and clogs telemetry beds with little potential for benefit. These findings have contributed to the American Heart Association's statement that telemetry is of no benefit in patients with chest pain who are clinically low-risk or who are awake and alert and can describe their angina. Importantly, previous findings provide a foundation for identifying patients that do not need to undergo monitoring, but no study to date has rigorously prospectively applied these criteria in a randomized trial to determine the impact of selective telemetry utilization on clinical care and resources.

This study is a pragmatic, randomized, controlled trial of telemetry compared with unmonitored floor admissions in ED patients with low-risk chest pain. The primary aim is to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in ED patients admitted with chest pain and low-risk features. In addition, the study will evaluate the effects of the same intervention in the same population on secondary outcomes including defibrillation, cardioversion or acute IV antiarrhythmic/vasoactive therapy. Finally, the study will associate reasons for telemetry exclusion, including provider discretion, with subsequent adverse events.

Eligibility criteria: Inclusion Criteria:

* Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.

Exclusion Criteria:

* Age less than 18 years
* Chest pain patients admitted to the ICU
* Patients with sickle cell disease
* Chest pain patients with high-risk electrocardiogram (ECG) criteria:
* abnormal but non-diagnostic of myocardial ischemia (prolonged PR, QRS, QTc intervals, new bundle branch blocks, left ventricular hypertrophy with strain)
* ischemia or prior infarction
* suggestive of acute myocardial infarction
* A positive troponin at any time during the current evaluation (above the 99 percent reference limit, greater than 0.03 nanograms per milliliter)
* Patients whom the admitting team feels has another non-low-risk indication for telemetry (e.g. acute heart failure, syncope with features concerning for a cardiac etiology, other arrhythmia)

Primary outcomes:
measure: Total hospital resource utilization (costs)
timeFrame: ED to discharge (approximately 1 to 5 days)
Secondary outcomes:
measure: Inhospital mortality
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Total number of serious dysrhythmias by type
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Provider reasons for telemetry exclusion
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Number of participants requiring transfer to the Intensive Care Unit (ICU)
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Total hospital and ED length of stay
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Rapid response team (RRT) call
timeFrame: ED to discharge (approximately 1 to 5 days)
measure: Cardiology consult
timeFrame: ED to discharge (approximately 1 to 5 days)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sean P Collins, MD
role: PRINCIPAL_INVESTIGATOR
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