Study Results
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Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2017-04-18
2018-11-01
Brief Summary
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Objective: The primary objective is to refer patients who contact the out-of-hours GP cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10% in unnecessary referrals.
Study design: This study is a prospective, observational, prevalence-based cohort study within the standard care of ACS patients.
Study population: All patients with chest pain, or other complaints suspect of ACS, will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral. The follow-up will be a registry of all patients with suspected ACS referred to the emergency department (ED). Patients with typical complaints of ACS, and thus a high suspicion, will be excluded and referred promptly.
Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the study. The GP evaluates patients using the Heart score, this includes electrocardiogram recording and point of care (POC) troponin testing. With the Heart score the GP can make an informed decision to refer the patient to the ED.
To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first measurement.
The burden and risks associated with participation, benefit and group relatedness: Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement. We may follow-up by telephone if we can not obtain the required information from medical records. We expect no adverse events and there are no expected risks associated with this protocol. We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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General practitioner diagnosis with Heart score
Patients with chest pain who are reviewed by the general practitioner (GP) at the GP cooperation will be evaluated with the Heart score to support the GP with the diagnosis.
General Practitioner diagnosis with Heart score
All patients seen by the general practitioner (GP) at the GP cooperation and agreeing to participation will be evaluated with the Heart score. This is a score including history, electrocardiogram, age, risk factors and troponin to assess whether a patient is at high risk for acute coronary syndrome. The troponins asked for in the Heart score are at arrival of the patient, not regarding the time of onset of chest pain. We shall use point of care (POC) troponin, thereby modifying the Heart score. The GP must realize that the POC troponin is not reliable on its own with one test. If the Heart score is low, it is acceptable and safe to not refer the patient, it is however not safe to refer the patient solely on negative troponin result.
Triage Nurse education
The general practitioner cooperation employs nurses for (telephone) triage. They are aided by a computer based triage system, the Netherlands triage system (NTS), a 6-level urgency triage system. With this study we aim to educate the nurses in the signs and symptoms of chest pain patients. The training program will aim to educate the triage nurses in acute coronary syndrome, including pathophysiology, symptoms and risk factors. The NTS will be incorporated within the training. The triage nurses will receive a training session by Cardiologists with information about acute coronary syndrome, the symptoms and the risks.
No interventions assigned to this group
Baseline registry as comparison
All patients referred to the emergency department (ED) with suspected acute coronary syndrome (ACS) will be evaluated. They will receive a questionnaire to evaluate the accuracy of referral and the delays of ACS patients. This will be compared to the registry at baseline. Some patients will either have not contacted the general practitioner cooperation (GPC) at all, or will have been referred to the ED directly through the GPC nurse triage.
The 30 day, 6 months and one year follow-up of all patients will be via medical records, or in case of no or not enough information, by telephone.
No interventions assigned to this group
Interventions
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General Practitioner diagnosis with Heart score
All patients seen by the general practitioner (GP) at the GP cooperation and agreeing to participation will be evaluated with the Heart score. This is a score including history, electrocardiogram, age, risk factors and troponin to assess whether a patient is at high risk for acute coronary syndrome. The troponins asked for in the Heart score are at arrival of the patient, not regarding the time of onset of chest pain. We shall use point of care (POC) troponin, thereby modifying the Heart score. The GP must realize that the POC troponin is not reliable on its own with one test. If the Heart score is low, it is acceptable and safe to not refer the patient, it is however not safe to refer the patient solely on negative troponin result.
Eligibility Criteria
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Inclusion Criteria
All patients referred to the emergency department (ED) with suspected ACS will be included to evaluate the appropriateness of referral.
Exclusion Criteria
* Patients in which a typical history and/or physical examination requires immediate referral; high suspicion of ACS
* Patients in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
The baseline of patients seen at the ED will not exclude any patients referred with suspected ACS.
18 Years
ALL
No
Sponsors
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VieCuri Medical Centre
OTHER
Responsible Party
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Locations
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VieCuri Medical Center
Venlo, , Netherlands
Countries
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References
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Verdon F, Herzig L, Burnand B, Bischoff T, Pecoud A, Junod M, Muhlemann N, Favrat B; GMIRG. Chest pain in daily practice: occurrence, causes and management. Swiss Med Wkly. 2008 Jun 14;138(23-24):340-7. doi: 10.4414/smw.2008.12123.
Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
Bosner S, Becker A, Haasenritter J, Abu Hani M, Keller H, Sonnichsen AC, Karatolios K, Schaefer JR, Seitz G, Baum E, Donner-Banzhoff N. Chest pain in primary care: epidemiology and pre-work-up probabilities. Eur J Gen Pract. 2009;15(3):141-6. doi: 10.3109/13814780903329528.
Ruddox V, Mathisen M, Otterstad JE. Prevalence and prognosis of non-specific chest pain among patients hospitalized for suspected acute coronary syndrome - a systematic literature search. BMC Med. 2012 Jun 12;10:58. doi: 10.1186/1741-7015-10-58.
Webster R, Norman P, Goodacre S, Thompson A. The prevalence and correlates of psychological outcomes in patients with acute non-cardiac chest pain: a systematic review. Emerg Med J. 2012 Apr;29(4):267-73. doi: 10.1136/emermed-2011-200526. Epub 2011 Oct 27.
Weinstock MB, Weingart S, Orth F, VanFossen D, Kaide C, Anderson J, Newman DH. Risk for Clinically Relevant Adverse Cardiac Events in Patients With Chest Pain at Hospital Admission. JAMA Intern Med. 2015 Jul;175(7):1207-12. doi: 10.1001/jamainternmed.2015.1674.
Knockaert DC, Buntinx F, Stoens N, Bruyninckx R, Delooz H. Chest pain in the emergency department: the broad spectrum of causes. Eur J Emerg Med. 2002 Mar;9(1):25-30. doi: 10.1097/00063110-200203000-00007.
Huibers L, Giesen P, Smits M, Mokkink H, Grol R, Wensing M. Nurse telephone triage in Dutch out-of-hours primary care: the relation between history taking and urgency estimation. Eur J Emerg Med. 2012 Oct;19(5):309-15. doi: 10.1097/MEJ.0b013e32834d3e67.
Nilsson S, Ortoft K, Molstad S. The accuracy of general practitioners' clinical assessment of chest pain patients. Eur J Gen Pract. 2008;14(2):50-5. doi: 10.1080/13814780802342622.
Wilcox HM, Vickery AW, Emery JD. Cardiac troponin testing for diagnosis of acute coronary syndromes in primary care. Med J Aust. 2015 Oct 19;203(8):336. doi: 10.5694/mja14.01154.
Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.
Leite L, Baptista R, Leitao J, Cochicho J, Breda F, Elvas L, Fonseca I, Carvalho A, Costa JN. Chest pain in the emergency department: risk stratification with Manchester triage system and HEART score. BMC Cardiovasc Disord. 2015 Jun 11;15:48. doi: 10.1186/s12872-015-0049-6.
Ishak M, Ali D, Fokkert MJ, Slingerland RJ, Tolsma RT, Badings E, van der Sluis A, van Eenennaam F, Mosterd A, Ten Berg JM, van 't Hof AW. Fast assessment and management of chest pain patients without ST-elevation in the pre-hospital gateway (FamouS Triage): ruling out a myocardial infarction at home with the modified HEART score. Eur Heart J Acute Cardiovasc Care. 2018 Mar;7(2):102-110. doi: 10.1177/2048872616687116. Epub 2017 Jan 13.
Other Identifiers
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Rahel2017Urgent
Identifier Type: -
Identifier Source: org_study_id
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