Acute Coronary Syndromes (ACS), Acute Myocardial Infarction (AMI), Chest Pain, Non-cardiac Chest Pain, Out-of-hours Medical Care, Point of Care Testing, Primary Care, Troponin
Conditions
Keywords
TriageTrue, POC, hs-cTnI, 0/1-hour algorithm, troponin, chest pain, primary care, OOH, out-of-hours, acute myocardial infarction, point-of-care, OUT-POC, QuidelOrtho
Brief summary
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.
Interventions
DIAGNOSTIC_TESTQuidelOrthos TriageTrue hs-cTnI whole-blood assay
Already described
Sponsors
University of Oslo
Norwegian Health Association
Oslo University Hospital
QuidelOrtho
Vestre Viken Hospital Trust
The Dam Foundation
Amsterdam UMC
Sorlandet Hospital HF
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, investigator-initiated pre-post intervention study aiming to evaluate implementation of the QuidelOrthos TriageTrue hs-cTnI whole-blood assay at six Norwegian (non-randomised) emergency primary care clinics. A control group will be identified to estimate the effect of the OUT-POC protocol. We will benefit from registry data to 1) estimate hospital referrals before the intervention in the same regions and 2) establish an external control group consisting of municipalities that are not using POC hs-cTn testing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care * Troponin testing requested by the treating physician
Exclusion criteria
* Acute STEMI (direct hospital referral required) * Haemodynamically unstable (direct hospital referral required) * Not able to provide written, informed consent (i.e., due to time restraints, language barriers, impaired cognitive function, or other reasons)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of acute myocardial infarctions at the index episode | From baseline to 30 days | 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 |
| PROM: Health-related quality of life | At baseline and repeated after 90 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency | Baseline | The proportion of patients finished triaged as rule-out or rule-in by the protocol at index |
| Total number of hospital referrals at index | Baseline | Proportion of patients being directly hospitalised at index |
| Total length of stay | Baseline to 24 hours | Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge) |
| Composite of acute MI and all-cause death | From baseline to 1 year | To assess the prognostic performance of the algorithm after 30, 90, and 365 days |
| PROM: Cardiac Anxiety | At baseline and repeated after 90 days | Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ) |
| PROM: Depression | At baseline and repeated after 90 days | Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4) |
| PROM: Insomnia | At baseline and repeated after 90 days | Changes in sleep disturbances, measured by the Sleep Condition Indicator-02 |
| PROM: Burden of chest pain | At baseline and repeated after 90 days | Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire |
| Incremental cost-effectiveness ratio | From baseline to 1 year | Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control) |
| Societal costs | From baseline to 1 year | Proportion of production loss/sick leave due to chest pain-related diagnoses |
| Healthcare utilization | From baseline to 1 year | Total number and type of treatment and follow-up in primary and secondary care due to chest pain-related diagnoses |
| Healthcare costs | From baseline to 1 year | 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. |
Countries
Norway
Outcome results
None listed