Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-15 @ 9:36 AM
Study NCT ID:
NCT03906812
Status:
WITHDRAWN
Last Update Posted:
2019-11-13
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013686', 'term': 'Telemetry'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study statistician will be blinded to study arm assignment.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative effectiveness - on admission, eligible, low-risk patients will be individually assigned to either unmonitored floor admission or floor admission with telemetry.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of feasibility.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-07', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total hospital resource utilization (costs)', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Total cost of the acute hospitalization and use of diagnostic testing and therapies'}], 'secondaryOutcomes': [{'measure': 'Inhospital mortality', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Death in hospital - binary measurement'}, {'measure': 'Total number of serious dysrhythmias by type', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy'}, {'measure': 'Provider reasons for telemetry exclusion', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', '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)'}, {'measure': 'Number of participants requiring transfer to the Intensive Care Unit (ICU)', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Measurement of whether or not a participant was transferred to the ICU'}, {'measure': 'Total hospital and ED length of stay', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days'}, {'measure': 'Rapid response team (RRT) call', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not'}, {'measure': 'Cardiology consult', 'timeFrame': 'ED to discharge (approximately 1 to 5 days)', 'description': 'Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telemetry Usage', 'Chest Pain', 'Unstable Angina', 'Resource Utilization']}, 'referencesModule': {'references': [{'pmid': '3806915', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '21401791', 'type': 'BACKGROUND', 'citation': 'Ward 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.'}, {'pmid': '28974521', 'type': 'BACKGROUND', 'citation': 'Sandau 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.'}, {'pmid': '7110205', 'type': 'BACKGROUND', 'citation': 'Goldman 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.'}, {'pmid': '9114775', 'type': 'BACKGROUND', 'citation': 'Hollander 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.'}, {'pmid': '12171825', 'type': 'BACKGROUND', 'citation': 'Snider 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.'}, {'pmid': '10905643', 'type': 'BACKGROUND', 'citation': 'Schull 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.'}, {'pmid': '29622596', 'type': 'BACKGROUND', 'citation': 'Reaney 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.'}, {'pmid': '8059698', 'type': 'BACKGROUND', 'citation': 'Estrada 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.'}, {'pmid': '7484840', 'type': 'BACKGROUND', 'citation': 'Estrada 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.'}, {'pmid': '14707944', 'type': 'BACKGROUND', 'citation': 'Hollander 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.'}, {'pmid': '2014037', 'type': 'BACKGROUND', 'citation': 'Lee 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Chest pain patients admitted to the ICU\n* Patients with sickle cell disease\n* Chest pain patients with high-risk electrocardiogram (ECG) criteria:\n* abnormal but non-diagnostic of myocardial ischemia (prolonged PR, QRS, QTc intervals, new bundle branch blocks, left ventricular hypertrophy with strain)\n* ischemia or prior infarction\n* suggestive of acute myocardial infarction\n* A positive troponin at any time during the current evaluation (above the 99 percent reference limit, greater than 0.03 nanograms per milliliter)\n* 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)'}, 'identificationModule': {'nctId': 'NCT03906812', 'briefTitle': 'A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain', 'orgStudyIdInfo': {'id': 'TeleVunmonitored'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unmonitored floor admission', 'description': 'Participants in this arm will be admitted to an unmonitored floor bed.', 'interventionNames': ['Other: Unmonitored']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Floor admission with telemetry', 'description': 'Participants in this arm will be admitted to a telemetry bed.', 'interventionNames': ['Other: Telemetry']}], 'interventions': [{'name': 'Telemetry', 'type': 'OTHER', 'description': 'Bed type assignment', 'armGroupLabels': ['Floor admission with telemetry']}, {'name': 'Unmonitored', 'type': 'OTHER', 'description': 'Bed type assignment', 'armGroupLabels': ['Unmonitored floor admission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Sean P Collins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sean Collins, M.D., MSc, Professor', 'investigatorFullName': 'Sean Collins', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}