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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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ClinicalTrials.gov Identifier: NCT03906812
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Telemetry Usage Chest Pain Unstable Angina Resource Utilization Other: Telemetry Other: Unmonitored Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The study statistician will be blinded to study arm assignment.
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
Active Comparator: Unmonitored floor admission
Participants in this arm will be admitted to an unmonitored floor bed.
Other: Unmonitored
Bed type assignment

Active Comparator: Floor admission with telemetry
Participants in this arm will be admitted to a telemetry bed.
Other: Telemetry
Bed type assignment




Primary Outcome Measures :
  1. Total hospital resource utilization (costs) [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Total cost of the acute hospitalization and use of diagnostic testing and therapies


Secondary Outcome Measures :
  1. Inhospital mortality [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Death in hospital - binary measurement

  2. Total number of serious dysrhythmias by type [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy

  3. Provider reasons for telemetry exclusion [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    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)

  4. Number of participants requiring transfer to the Intensive Care Unit (ICU) [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Measurement of whether or not a participant was transferred to the ICU

  5. Total hospital and ED length of stay [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days

  6. Rapid response team (RRT) call [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not

  7. Cardiology consult [ Time Frame: ED to discharge (approximately 1 to 5 days) ]
    Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906812


Contacts
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Contact: Sean P Collins, MD 615-936-0087 sean.collins@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Sean P Collins, MD Vanderbilt University Medical Center

Publications:

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Responsible Party: Sean Collins, Sean Collins, M.D., MSc, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03906812     History of Changes
Other Study ID Numbers: TeleVunmonitored
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angina, Unstable
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases