Evaluation of the accuracy, safety, utility and feasibility of using an urgency self-assessment application in self-referred patients in the emergency department: study protocol for a prospective, multicenter cohort trial

BACKGROUND: Algorithm-based patient navigation is a key feature of the emergency and acute care reform being discussed in Germany. The software Structured Initial Medical Evaluation in Germany (SmED) is designed to assist in determining the appropriate time for medical complaints to be treated, as well as their most appropriate level of care. SmED is available in three different configurations, each of which is currently used in the German acute care sector and can be utilized by either a provider (SmED-Contact, SmED-Contact +) or a self-applicant (SmED-Patient). SmED-Patient is offered as a web-based self-assessment application that provides recommendations on the medical urgency and appropriate level of care for acute symptoms. This is the first study to explore and evaluate the accuracy, safety, utility and feasibility of using the self-assessment application SmED-Patient for self-referring patients and medical staff in the emergency department (ED) setting in Germany. METHODS: The study uses a mixed methods approach, including a prospective, multicenter cohort study combined with retrospective expert review of SmED-Patient recommendations for all cases by an expert panel as well as focus groups and a microsimulation. Expert reviews assess SmED-Patient recommendations on patients' treatment urgency and the appropriate level of care based on routine clinical data. Adult patients (≥ 18 years) who self-refer at two inner-city emergency departments in Berlin (Germany) and able to provide written informed consent will be invited to participate. Target number of patients is n = 150. The primary endpoint is the accuracy of SmED-Patient's recommended level of care, measured as the agreement with the expert review for all cases. Secondary endpoints include safety, utility and feasibility of use. Data sources include primary data, routine clinical data, and qualitative data from focus groups and a microsimulation. DISCUSSION: This study will provide insight into the accuracy, utility, safety and feasibility of using the self-assessment application SmED-Patient in the ED. By facilitating medical self-assessment for self-referring walk-in patients, SmED-Patient could contribute to re-directing patients to ambulatory care providers, improving the efficiency of ED operations and benefit providers' as well as patients' care experiences in the ED. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00036266. 25/02/2025.