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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
#MMPMID41174797
Krüger D
; Legg D
; Jouhoff D
; Eienbröker L
; Köhne N
; Neumann K
; Möckel M
; Slagman A
Trials
2025[Oct]; 26
(1
): 463
PMID41174797
show ga
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.
free
free
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