A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Primary Purpose
Telemetry Usage, Chest Pain, Unstable Angina
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemetry
Unmonitored
Sponsored by
About this trial
This is an interventional health services research trial for Telemetry Usage
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)
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unmonitored floor admission
Floor admission with telemetry
Arm Description
Participants in this arm will be admitted to an unmonitored floor bed.
Participants in this arm will be admitted to a telemetry bed.
Outcomes
Primary Outcome Measures
Total hospital resource utilization (costs)
Total cost of the acute hospitalization and use of diagnostic testing and therapies
Secondary Outcome Measures
Inhospital mortality
Death in hospital - binary measurement
Total number of serious dysrhythmias by type
Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
Provider reasons for telemetry exclusion
Association of reasons for telemetry exclusion, including provider discretion, with subsequent adverse events (e.g. death or serious dysrhythmias resulting in defibrillation, cardioversion or acute IV antiarrhythmic therapy)
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Measurement of whether or not a participant was transferred to the ICU
Total hospital and ED length of stay
Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
Rapid response team (RRT) call
Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
Cardiology consult
Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not
Full Information
NCT ID
NCT03906812
First Posted
April 5, 2019
Last Updated
November 7, 2019
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03906812
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of feasibility.
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemetry Usage, Chest Pain, Unstable Angina, Resource Utilization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative effectiveness - on admission, eligible, low-risk patients will be individually assigned to either unmonitored floor admission or floor admission with telemetry.
Masking
Outcomes Assessor
Masking Description
The study statistician will be blinded to study arm assignment.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unmonitored floor admission
Arm Type
Active Comparator
Arm Description
Participants in this arm will be admitted to an unmonitored floor bed.
Arm Title
Floor admission with telemetry
Arm Type
Active Comparator
Arm Description
Participants in this arm will be admitted to a telemetry bed.
Intervention Type
Other
Intervention Name(s)
Telemetry
Intervention Description
Bed type assignment
Intervention Type
Other
Intervention Name(s)
Unmonitored
Intervention Description
Bed type assignment
Primary Outcome Measure Information:
Title
Total hospital resource utilization (costs)
Description
Total cost of the acute hospitalization and use of diagnostic testing and therapies
Time Frame
ED to discharge (approximately 1 to 5 days)
Secondary Outcome Measure Information:
Title
Inhospital mortality
Description
Death in hospital - binary measurement
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Total number of serious dysrhythmias by type
Description
Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Provider reasons for telemetry exclusion
Description
Association of reasons for telemetry exclusion, including provider discretion, with subsequent adverse events (e.g. death or serious dysrhythmias resulting in defibrillation, cardioversion or acute IV antiarrhythmic therapy)
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Description
Measurement of whether or not a participant was transferred to the ICU
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Total hospital and ED length of stay
Description
Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Rapid response team (RRT) call
Description
Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
Time Frame
ED to discharge (approximately 1 to 5 days)
Title
Cardiology consult
Description
Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not
Time Frame
ED to discharge (approximately 1 to 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean P Collins, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
IPD Sharing Time Frame
The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
IPD Sharing Access Criteria
Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.
Citations:
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A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
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