Digitalized Differential Diagnosis Broadening in Emergency Rooms

NCT05346523 | Completed

• 1 other identifier: 407740_187284/1
• Study Type: interventional
• Target: 1,218
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Emergencies; Diagnoses Disease

Keywords

Emergency; Diagnostic Error; Diagnostic Safety; Misdiagnosis; CDDS; Computerized Decision Support System; Diagnostic Quality

Outcome Measures

Primary Outcomes (1)

• Diagnostic quality risk score

  Primary endpoint is a binary score indicating a diagnostic quality risk, composed of: * Death within 14 days after emergency room discharge (yes/no) * Unscheduled medical care (emergency room revisits, General Practitioner visits or hospitalization) within 14 days after emergency room discharge (yes/no) * Unexpected intensive care unit admission from ward within 24 hours when hospitalized (yes/no) * Diagnostic discrepancy between the emergency room discharge diagnosis and the current diagnosis 14 days after emergency room discharge (yes/no)

  From emergency room discharge to 14 days after emergency room discharge

Secondary Outcomes (15)

• Death within 14 days after Emergency Room discharge (yes/no)

  From emergency room discharge to 14 days after emergency room discharge

• Unexpected intensive care unit admission

  Within 24 hours from emergency room transfer to hospital ward

• Diagnostic discrepancy

  From emergency room discharge to 14 days after emergency room discharge

• Unscheduled medical care 72 hours, 7 days and 14 days

  From emergency room discharge to 72 hours, 7 days and 14 days after emergency room discharge

• Length of emergency room stay

  Time from emergency room admission to emergency room discharge, up to 24 hours

Study Arms (2)

Usual Care + CDDS usage

EXPERIMENTAL

Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual but with support of the CDDS.

Device: Isabel Pro - The DDx generator (CDDS)

Usual Care

NO INTERVENTION

Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual without support of the CDDS.

Interventions

Isabel Pro - The DDx generator (CDDS) DEVICE

Isabel Pro - the DDx generator is a software developped for health professionals with the intention to support them in broadening their differential diagnoses. After the first patient examination, the resident is asked to enter patient symptoms into Isabel Pro, which returns a list of possible diagnoses from its underlying database that matches the entered data. The diagnosing resident physicians will be asked to consult Isabel Pro at least once within the first hour after the first patient assessement. After entering patient symptoms into the software, Isabel Pro will itself return a list with possible diagnoses derived from their underlying database. It is then free to the physician to decide whether one or more of the suggested DDx should be considered for further diagnostic or treatment procedure based on clinical judgement.

Usual Care + CDDS usage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• Presentation to the ER with fever, abdominal pain, syncope or Non-specific complaint (NSC) as chief complaint
• Triaged as "not vitally threatened"
• The study subject is 18 years old or older.

You may not qualify if:

• Trauma as chief complaint
• Pregnancy
• Worsening of a known pre-existing condition or medical referral with a definite diagnosis
• Inability to follow the informed consent and investigation procedures
• Previous enrolment into the current investigation

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator

Study Sites (4)

Dept. of internal and emergency medicine, Spital Münsigen

Münsingen, Canton of Bern, 3110, Switzerland

Location

Dept. of Internal and Emergency Medicine, Spital Tiefenau

Bern, 3004, Switzerland

Location

Dept. of Emergency Medicine, Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

Dept. of Internal and Emergency Medicine, Buergerspital Solothurn

Solothurn, 3004, Switzerland

Location

Related Publications (2)

• Hautz WE, Marcin T, Hautz SC, Schauber SK, Krummrey G, Muller M, Sauter TC, Lambrigger C, Schwappach D, Nendaz M, Lindner G, Bosbach S, Griesshammer I, Schonberg P, Pluss E, Romann V, Ravioli S, Werthmuller N, Kolbener F, Exadaktylos AK, Singh H, Zwaan L. 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. Lancet Digit Health. 2025 Feb;7(2):e136-e144. doi: 10.1016/S2589-7500(24)00250-4.

  PMID: 39890244 DERIVED

• Marcin T, Hautz SC, Singh H, Zwaan L, Schwappach D, Krummrey G, Schauber SK, Nendaz M, Exadaktylos AK, Muller M, Lambrigger C, Sauter TC, Lindner G, Bosbach S, Griesshammer I, Hautz WE. 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. BMJ Open. 2023 Mar 29;13(3):e072649. doi: 10.1136/bmjopen-2023-072649.

  PMID: 36990482 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolf Hautz, Prof. MD

  Prof. MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-Randomized Cross-Over Trial

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 26, 2022
• Study Start: June 9, 2022
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

CH (4)