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Improving the Referral of Patients With Chest Pain (Urgent)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115190
Recruitment Status : Unknown
Verified April 2018 by VieCuri Medical Centre.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
VieCuri Medical Centre

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction Chest Pain Diagnostic Test: General Practitioner diagnosis with Heart score Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Cohort Study to Improve the Accuracy of Referrals of Patients With Chest Pain to the Emergency Department: to Decrease the Delay in Acute Coronary Syndrome Patients and Rule Out Non-cardiac Chest Pain Patients (URGENT)
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : November 1, 2017
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
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.
Diagnostic Test: 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.

No Intervention: 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 Intervention: 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.




Primary Outcome Measures :
  1. Suspected diagnosis [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 30 days, 6 months and 1 year ]
    Combination endpoint of: mortality and any ischemic event (ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, (Unstable)Angina Pectoris, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Resuscitation)



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:

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.

Exclusion Criteria:

  • 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.


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): NCT03115190


Locations
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Netherlands
VieCuri Medical Center
Venlo, Netherlands, 5912BL
Sponsors and Collaborators
VieCuri Medical Centre
Publications:

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Responsible Party: VieCuri Medical Centre
ClinicalTrials.gov Identifier: NCT03115190    
Other Study ID Numbers: Rahel2017Urgent
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to other researchers to secure privacy in study patients.

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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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Myocardial Infarction
Acute Coronary Syndrome
Syndrome
Infarction
Chest Pain
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms