Improving the Referral of Patients With Chest Pain

NCT03115190 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • VieCuri Medical Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-11-01
Completion
2018-11-01

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03115190 on ClinicalTrials.gov