DD Assessment With Diaana #2

NCT ID: NCT03901495

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-03-31

Brief Summary

Single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial.

In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.

In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard differential diagnosis of the senior physician.

Detailed Description

Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.

A single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial will be performed. No follow-up is necessary, because patients are seen once and all data are collected on this time. The study will take place in the emergency outpatient unit of Geneva University Hospital and include patients suffering from symptoms covered by Diaana.

Patients in the intervention group will fullfil Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fullfil case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard differential diagnosis. In the control group, the residents will directely establish a differential diagnosis, without the help of Diaana.

Conditions

Decision Making; Computer-assisted; General Practitioners; Patient Engagement

Keywords

differential diagnosis; hospital outpatient clinics; clinical applications software

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diaana

1. The patient fullfill Diaana

2. The resident physician takes connaissance of the Diaana summary

3. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)

4. The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)

Group Type: EXPERIMENTAL

Diaana

Intervention Type: OTHER

Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of "Diaana" mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals.

Control

1. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)

2. The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diaana

Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of "Diaana" mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals.

Intervention Type: OTHER

Other Intervention Names

Automated medical history-taking device (AMHTD)

Eligibility Criteria

Inclusion Criteria

• Patients presenting to the emergency outpatient unit of Geneva University Hospital
• Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.

Exclusion Criteria

• Strictly dermatologic concerns
• Toes and inversion ankle trauma (because the diagnosis of those conditions is generally obvious)
• Medical condition considered as urgent
• Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adrien Schwitzguebel

OTHER

Sponsor Role: lead

Responsible Party

Adrien Schwitzguebel

Principal investigator, Independant physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hervé Spechbach, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Geneva University Hospital

Geneva, , Switzerland

Countries

Switzerland

References

Healey B, Schwitzguebel A, Spechbach H. Differential Diagnosis Assessment in Ambulatory Care With a Digital Health History Device: Pseudorandomized Study. JMIR Form Res. 2025 Oct 1;9:e56384. doi: 10.2196/56384.

Reference Type: DERIVED

PMID: 40205939 (View on PubMed)

Other Identifiers

UNIGE_Diaana

Identifier Type: -

Identifier Source: org_study_id