Telemetry UsageNCT03906812
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
A study testing Telemetry and Unmonitored in people with Telemetry Usage and Chest Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemetry Usage, Chest Pain, Unstable Angina
- What is being tested?
- Telemetry and Unmonitored
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Telemetry Usage, Chest Pain, Unstable Angina, Resource Utilization
- Being tested
- Telemetry, Unmonitored
- Medical subject headings
- Chest Pain, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemetryOther
Bed type assignment
UnmonitoredOther
Bed type assignment
| Study group | Role | What they receive |
|---|---|---|
| Unmonitored floor admission | Active comparator | Participants in this arm will be admitted to an unmonitored floor bed. Receives: Other: Unmonitored |
| Floor admission with telemetry | Active comparator | Participants in this arm will be admitted to a telemetry bed. Receives: Other: Telemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospital resource utilization (costs)
Total cost of the acute hospitalization and use of diagnostic testing and therapies
Measured: ED to discharge (approximately 1 to 5 days)
Secondary outcomes (7)
Inhospital mortality
Death in hospital - binary measurement
Measured: ED to discharge (approximately 1 to 5 days)
Total number of serious dysrhythmias by type
Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
Measured: ED to discharge (approximately 1 to 5 days)
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)
Measured: ED to discharge (approximately 1 to 5 days)
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Measurement of whether or not a participant was transferred to the ICU
Measured: ED to discharge (approximately 1 to 5 days)
Total hospital and ED length of stay
Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
Measured: ED to discharge (approximately 1 to 5 days)
Rapid response team (RRT) call
Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
Measured: ED to discharge (approximately 1 to 5 days)
Cardiology consult
Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not
Measured: ED to discharge (approximately 1 to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study startSep 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Lack of feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Telemetry UsageStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Collins, Vanderbilt University Medical Center
- Investigators
- Sean P Collins, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906812
- Sponsor's protocol ID
- TeleVunmonitored
- Status last verified
- Nov 2019
- First submitted
- 5 Apr 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
Publications
Selker HP, Griffith JL, Dorey FJ, D'Agostino RB. How do physicians adapt when the coronary care unit is full? A prospective multicenter study. JAMA. 1987 Mar 6;257(9):1181-5.
PubMed 3806915Ward MJ, Eckman MH, Schauer DP, Raja AS, Collins S. Cost-effectiveness of telemetry for hospitalized patients with low-risk chest pain. Acad Emerg Med. 2011 Mar;18(3):279-86. doi: 10.1111/j.1553-2712.2011.01008.x.
PubMed 21401791Sandau KE, Funk M, Auerbach A, Barsness GW, Blum K, Cvach M, Lampert R, May JL, McDaniel GM, Perez MV, Sendelbach S, Sommargren CE, Wang PJ; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 7;136(19):e273-e344. doi: 10.1161/CIR.0000000000000527. Epub 2017 Oct 3.
PubMed 28974521Goldman L, Weinberg M, Weisberg M, Olshen R, Cook EF, Sargent RK, Lamas GA, Dennis C, Wilson C, Deckelbaum L, Fineberg H, Stiratelli R. A computer-derived protocol to aid in the diagnosis of emergency room patients with acute chest pain. N Engl J Med. 1982 Sep 2;307(10):588-96. doi: 10.1056/NEJM198209023071004.
PubMed 7110205Hollander JE, Valentine SM, McCuskey CF, Brogan GX Jr. Are monitored telemetry beds necessary for patients with nontraumatic chest pain and normal or nonspecific electrocardiograms? Am J Cardiol. 1997 Apr 15;79(8):1110-1. doi: 10.1016/s0002-9149(97)00057-x.
PubMed 9114775Snider A, Papaleo M, Beldner S, Park C, Katechis D, Galinkin D, Fein A. Is telemetry monitoring necessary in low-risk suspected acute chest pain syndromes? Chest. 2002 Aug;122(2):517-23. doi: 10.1378/chest.122.2.517.
PubMed 12171825Schull MJ, Redelmeier DA. Continuous electrocardiographic monitoring and cardiac arrest outcomes in 8,932 telemetry ward patients. Acad Emerg Med. 2000 Jun;7(6):647-52. doi: 10.1111/j.1553-2712.2000.tb02038.x.
PubMed 10905643Reaney PDW, Elliott HI, Noman A, Cooper JG. Risk stratifying chest pain patients in the emergency department using HEART, GRACE and TIMI scores, with a single contemporary troponin result, to predict major adverse cardiac events. Emerg Med J. 2018 Jul;35(7):420-427. doi: 10.1136/emermed-2017-207172. Epub 2018 Apr 5.
PubMed 29622596Estrada CA, Prasad NK, Rosman HS, Young MJ. Outcomes of patients hospitalized to a telemetry unit. Am J Cardiol. 1994 Aug 15;74(4):357-62. doi: 10.1016/0002-9149(94)90403-0.
PubMed 8059698Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
PubMed 7484840Hollander JE, Sites FD, Pollack CV Jr, Shofer FS. Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain. Ann Emerg Med. 2004 Jan;43(1):71-6. doi: 10.1016/s0196-0644(03)00719-4.
PubMed 14707944Lee TH, Juarez G, Cook EF, Weisberg MC, Rouan GW, Brand DA, Goldman L. Ruling out acute myocardial infarction. A prospective multicenter validation of a 12-hour strategy for patients at low risk. N Engl J Med. 1991 May 2;324(18):1239-46. doi: 10.1056/NEJM199105023241803.
PubMed 2014037
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
- ClinicalTrials.gov ID
- NCT03906812
- Acronym / sponsor ID
- TeleVunmonitored
- Conditions
- Telemetry Usage, Chest Pain, Unstable Angina, Resource Utilization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative effectiveness - on admission, eligible, low-risk patients will be individually assigned to either unmonitored floor admission or floor admission with telemetry.
| Arm | Type | Receives |
|---|---|---|
| Unmonitored floor admission | Active comparator | Other: UnmonitoredParticipants in this arm will be admitted to an unmonitored floor bed. |
| Floor admission with telemetry | Active comparator | Other: TelemetryParticipants in this arm will be admitted to a telemetry bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemetryBed type assignment | Other | Floor admission with telemetry |
| UnmonitoredBed type assignment | Other | Unmonitored floor admission |
Primary outcome
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
7 secondary outcomes
Inhospital mortality
Time frame: ED to discharge (approximately 1 to 5 days)
Total number of serious dysrhythmias by type
Time frame: ED to discharge (approximately 1 to 5 days)
Provider reasons for telemetry exclusion
Time frame: ED to discharge (approximately 1 to 5 days)
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Time frame: ED to discharge (approximately 1 to 5 days)
Total hospital and ED length of stay
Time frame: ED to discharge (approximately 1 to 5 days)
Rapid response team (RRT) call
Time frame: ED to discharge (approximately 1 to 5 days)
Cardiology consult
Time frame: ED to discharge (approximately 1 to 5 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 3806915Selker HP, Griffith JL, Dorey FJ, D'Agostino RB. How do physicians adapt when the coronary care unit is full? A prospective multicenter study. JAMA. 1987 Mar 6;257(9):1181-5.
- Background: PubMed 21401791Ward MJ, Eckman MH, Schauer DP, Raja AS, Collins S. Cost-effectiveness of telemetry for hospitalized patients with low-risk chest pain. Acad Emerg Med. 2011 Mar;18(3):279-86. doi: 10.1111/j.1553-2712.2011.01008.x.
- Background: PubMed 28974521Sandau KE, Funk M, Auerbach A, Barsness GW, Blum K, Cvach M, Lampert R, May JL, McDaniel GM, Perez MV, Sendelbach S, Sommargren CE, Wang PJ; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 7;136(19):e273-e344. doi: 10.1161/CIR.0000000000000527. Epub 2017 Oct 3.
- Background: PubMed 7110205Goldman L, Weinberg M, Weisberg M, Olshen R, Cook EF, Sargent RK, Lamas GA, Dennis C, Wilson C, Deckelbaum L, Fineberg H, Stiratelli R. A computer-derived protocol to aid in the diagnosis of emergency room patients with acute chest pain. N Engl J Med. 1982 Sep 2;307(10):588-96. doi: 10.1056/NEJM198209023071004.
- Background: PubMed 9114775Hollander JE, Valentine SM, McCuskey CF, Brogan GX Jr. Are monitored telemetry beds necessary for patients with nontraumatic chest pain and normal or nonspecific electrocardiograms? Am J Cardiol. 1997 Apr 15;79(8):1110-1. doi: 10.1016/s0002-9149(97)00057-x.
- Background: PubMed 12171825Snider A, Papaleo M, Beldner S, Park C, Katechis D, Galinkin D, Fein A. Is telemetry monitoring necessary in low-risk suspected acute chest pain syndromes? Chest. 2002 Aug;122(2):517-23. doi: 10.1378/chest.122.2.517.
- Background: PubMed 10905643Schull MJ, Redelmeier DA. Continuous electrocardiographic monitoring and cardiac arrest outcomes in 8,932 telemetry ward patients. Acad Emerg Med. 2000 Jun;7(6):647-52. doi: 10.1111/j.1553-2712.2000.tb02038.x.
- Background: PubMed 29622596Reaney PDW, Elliott HI, Noman A, Cooper JG. Risk stratifying chest pain patients in the emergency department using HEART, GRACE and TIMI scores, with a single contemporary troponin result, to predict major adverse cardiac events. Emerg Med J. 2018 Jul;35(7):420-427. doi: 10.1136/emermed-2017-207172. Epub 2018 Apr 5.
- Background: PubMed 8059698Estrada CA, Prasad NK, Rosman HS, Young MJ. Outcomes of patients hospitalized to a telemetry unit. Am J Cardiol. 1994 Aug 15;74(4):357-62. doi: 10.1016/0002-9149(94)90403-0.
- Background: PubMed 7484840Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
- Background: PubMed 14707944Hollander JE, Sites FD, Pollack CV Jr, Shofer FS. Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain. Ann Emerg Med. 2004 Jan;43(1):71-6. doi: 10.1016/s0196-0644(03)00719-4.
- Background: PubMed 2014037Lee TH, Juarez G, Cook EF, Weisberg MC, Rouan GW, Brand DA, Goldman L. Ruling out acute myocardial infarction. A prospective multicenter validation of a 12-hour strategy for patients at low risk. N Engl J Med. 1991 May 2;324(18):1239-46. doi: 10.1056/NEJM199105023241803.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Collins, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemetry and Unmonitored in people with Telemetry Usage and Chest Pain, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hospital resource utilization (costs) (time frame: ED to discharge (approximately 1 to 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906812, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.