NCT05346523: DDX-BRO

Digitalized Differential Diagnosis Broadening in Emergency Rooms

Completed NA Last updated 21 July 2023

What this trial tests

NA trial testing Isabel Pro - The DDx generator (CDDS) in Emergencies in 1,218 participants. Completed in 13 July 2023.

Timeline

9 June 2022

Primary endpoint
13 July 2023

13 July 2023

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	diagnostic
Enrollment	1,218
Start date	9 June 2022
Primary completion	13 July 2023
Estimated completion	13 July 2023
Sites	4 locations across Switzerland

Drugs / interventions tested

• Isabel Pro - The DDx generator (CDDS)

Conditions studied

• Emergencies — all drugs for Emergencies →
• Diagnoses Disease — all drugs for Diagnoses Disease →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Emergencies or Diagnoses Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

10 to 35% of patients admitted to an emergency department receive an incorrect diagnosis. Not surprisingly, given the wide variety of health conditions encountered in emergency medicine, physicians often do not consider, remember, or know all possible diagnoses that fit the patient's symptoms. Nowadays, computer software (CDDS) is able to support physicians with a list of possible diagnoses by matching entered patient data to a large database with diagnoses. However, it is still unclear how the use of such a CDDS actually affects the diagnostic quality and workflow in 'real world' ER routine care. Therefore, the aim of this cluster-randomized cross-over trial is to evaluate the consequences of CDDS usage on diagnostic quality, patient outcomes and diagnostic workflow within the ER. Four ER's will provide a CDDS to the diagnosing physicians for specific periods (randomly and alternatingly allocated) in which physicians will be asked to use it for all included study patients. Outcomes between periods with and without the CDDS will be compared. Primary outcome is a diagnostic quality risk score composed of unscheduled ER revisits, unexpected hospitalization (both within 14 days), unexpected intensive medical care unit admission if hospitalized and diagnostic discrepancy between the ER discharge diagnosis and the current diagnosis after 14 days. In total, 1'184 patients will be included.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnoses supported by a computerised diagnostic decision support system versus conventional diagnoses in emergency patients (DDX-BRO): a multicentre, multiple-period, double-blind, cluster-randomised, crossover superiority trial.
   Hautz WE, Marcin T, Hautz SC, Schauber SK, et al · · 2025 · cited 7× · PMID 39890244 · DOI 10.1016/s2589-7500(24)00250-4
2. Effects of a computerised diagnostic decision support tool on diagnostic quality in emergency departments: study protocol of the DDx-BRO multicentre cluster randomised cross-over trial.
   Marcin T, Hautz SC, Singh H, Zwaan L, et al · · 2023 · cited 4× · PMID 36990482 · DOI 10.1136/bmjopen-2023-072649
3. Identification of diagnostic discrepancies as a quality assurance measure in emergency medicine - a validation study.
   Marcin T, Werthmüller N, Kölbener F, Müller M, et al · · 2026 · PMID 41673906 · DOI 10.1186/s13049-026-01572-x