Development of a guideline-based clinical decision support system for emergency department assessment of suspected non-ST-elevation acute coronary syndromes

BACKGROUND: Chest pain is the leading cause of presentations to the emergency department (ED), and the number of patients presenting with this symptom may cause overcrowding. To accelerate triage in the ED, clinical decision pathways using fast diagnostic protocols and high sensitivity cTn (hs-cTn) assays are being recommended by guidelines. However, their implementation is challenging. OBJECTIVE: To develop an electronic health records (EHR)-embedded clinical decision support system (CDSS) that helps to follow protocol recommendations, improve safety and effectiveness of triage and improve guideline-adherence regarding appropriate use of fast troponin-based protocols in patients presenting with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS). METHODS: The CDSS was designed as a knowledge-based decision support tool based on the latest version of the 2023 ESC guideline recommended clinical decision pathways, i.e. ESC 0/1 h and ESC 0/2 h algorithm, and can be programmed to consider sex-specific upper limit of normal and different commercially available hs-cTn assays. Data can be entered manually or automatically. Input variables include time since symptom onset, baseline and follow-up hs-cTn levels and time intervals between blood samples. The system's output ultimately provides an unequivocal classification into a triage category, adjusted for the exact time elapsed between measurements. The tool further provides information on the need and timing of a second, or even a third hs-cTn, if two measurements are inconclusive. PERSPECTIVE: A prospective, single-centre validation study using a sequential roll-out design with alternating 2-week blocks of standard-of-care and CDSS-supported care is planned over a 24-week enrolment period. The primary endpoint is the proportion of protocol adherence. Key secondary endpoints include rates of correct triage, length of ED stay, proportion of direct discharge after rule-out in patients at low risk and the proportion of inappropriate blood draws (excessive or deferred) as an estimate for cost-effectiveness. CONCLUSIONS: A novel CDSS that represents a Class IIa medical software device and has already received CE mark for use in clinical routine. It is expected to improve guideline adherence, effectiveness and safety of patients admitted to an ED with suspected NSTE-ACS. A prospective pilot study for validation is planned.