Improving the Referral of Patients With Chest Pain (Urgent)

January 5, 2021 updated by: VieCuri Medical Centre

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Venlo, Netherlands, 5912BL
        • VieCuri Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VieCuri Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rahel2017Urgent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be made available to other researchers to secure privacy in study patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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