Improving the Referral of Patients With Chest Pain

NCT03115190 | Terminated DMC

• 1 other identifier: Rahel2017Urgent
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly, though referring all patients with chest pain is not feasible, as up to 80% of the patients with chest pain in the primary care do not have ACS. 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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Chest Pain

Outcome Measures

Primary Outcomes (1)

• Suspected diagnosis

  The primary outcome measure is a more accurate referral of patients with suspected acute coronary syndrome (ACS) to the cardiac emergency department and thus the concordance of suspected ACS and the actual diagnosis. The endpoint will be compared to the baseline registry that has been executed from 1st of September 2015 until 1st of March 2016.

  30 days

Secondary Outcomes (1)

• Major adverse cardiovascular events

  30 days, 6 months and 1 year

Study Arms (3)

General practitioner diagnosis with Heart score

OTHER

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.

Diagnostic Test: General Practitioner diagnosis with Heart score

Triage Nurse education

NO INTERVENTION

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.

Baseline registry as comparison

NO INTERVENTION

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.

Interventions

General Practitioner diagnosis with Heart score DIAGNOSTIC_TEST

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.

General practitioner diagnosis with Heart score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with chest pain or other complaints suspect of acute coronary syndrome (ACS) can be included in which the general practitioner is in need of further diagnostics to come to a decision of referral.
• All patients referred to the emergency department (ED) with suspected ACS will be included to evaluate the appropriateness of referral.

You may not qualify if:

• Patients younger than 18 years
• 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.

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

VieCuri Medical Center

Venlo, 5912BL, Netherlands

Location

Related Publications (13)

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  PMID: 18561039 BACKGROUND

• 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.

  PMID: 22922416 BACKGROUND

• 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.

  PMID: 19883149 BACKGROUND

• 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.

  PMID: 22691301 BACKGROUND

• 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.

  PMID: 22034535 BACKGROUND

• 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.

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• 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.

  PMID: 11989492 BACKGROUND

• 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.

  PMID: 22008589 BACKGROUND

• 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.

  PMID: 18720273 BACKGROUND

• 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.

  PMID: 26465699 BACKGROUND

• 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.

  PMID: 20802272 BACKGROUND

• 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.

  PMID: 26062607 BACKGROUND

• 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.

  PMID: 28084079 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: April 18, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)