Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin. In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria. In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires. This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,500
Already described
Lyngen Emergency Primary Care Centre
Lyngseidet, Lyngen, Norway
RECRUITINGAlta Emergency Primary Care Centre
Alta, Norway
RECRUITINGDrammen Emergency Primary Care Centre
Drammen, Norway
RECRUITINGFredrikstad and Hvaler Emergency Primary Care Centre
Fredrikstad, Norway
RECRUITINGOslo Accident and Emergency Outpatient Clinic
Oslo, Norway
RECRUITINGTrondheim Intermunicipal Emergency Primary Care Centre
Trondheim, Norway
RECRUITINGTotal number of acute myocardial infarctions at the index episode
Proportion of acute myocardial infarction at baseline, to assess the predictive performance of the TriageTrue 0/1-hour algorithm (incl. safety and accuracy) at index
Time frame: From baseline to 30 days
PROM: Health-related quality of life
Differences in health-related quality of life among chest pain participants will be assessed through self-reported EQ-5D questionnaire with five levels (EQ-5D-5L) incl. the EQ-5D visual analogue scale (EQ VAS).
Time frame: At baseline and repeated after 90 days
Efficiency
The proportion of patients finished triaged as rule-out or rule-in by the protocol at index
Time frame: Baseline
Total number of hospital referrals at index
Proportion of patients being directly hospitalised at index
Time frame: Baseline
Total length of stay
Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)
Time frame: Baseline to 24 hours
Composite of acute MI and all-cause death
To assess the prognostic performance of the algorithm after 30, 90, and 365 days
Time frame: From baseline to 1 year
PROM: Cardiac Anxiety
Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ)
Time frame: At baseline and repeated after 90 days
PROM: Depression
Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4)
Time frame: At baseline and repeated after 90 days
PROM: Insomnia
Changes in sleep disturbances, measured by the Sleep Condition Indicator-02
Time frame: At baseline and repeated after 90 days
PROM: Burden of chest pain
Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire
Time frame: At baseline and repeated after 90 days
Incremental cost-effectiveness ratio
Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control)
Time frame: From baseline to 1 year
Societal costs
Proportion of production loss/sick leave due to chest pain-related diagnoses
Time frame: From baseline to 1 year
Healthcare utilization
Total number and type of treatment and follow-up in primary and secondary care due to chest pain-related diagnoses
Time frame: From baseline to 1 year
Healthcare costs
Total costs of assessing patients with chest pain in emergency primary care by using the protocol compared to usual care (control), including unit costs per treatment, visit, stay.
Time frame: From baseline to 1 year
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