DD Assessment With Diaana #2

NCT03901495 | Completed

• 1 other identifier: UNIGE_Diaana
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

differential diagnosis; hospital outpatient clinics; clinical applications software

Outcome Measures

Primary Outcomes (1)

• Differential diagnosis established by the resident physician

  The resident physician will select up to 5 diagnose in an exhaustive list. The senior physician will do the same in order to establish the gold-standard differential diagnosis. The accuracy of the resident's differential diagnosis will be measured as the percentage of correct diagnose selected by the resident compared to the gold standard.

  At day 0

Secondary Outcomes (3)

• Consultation time

  At day 0

• Patient satisfaction

  At day 0

• Differential diagnosis estabished by Diaana

  At day 0

Study Arms (2)

Diaana

EXPERIMENTAL

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, ...)

Other: Diaana

Control

NO INTERVENTION

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, ...)

Interventions

Diaana 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.

Also known as: Automated medical history-taking device (AMHTD)

Diaana

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Adrien Schwitzguebel: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40205939 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hervé Spechbach, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The first 50 eligible patients of the emergency outpatient unit in Geneva University Hospital are recruited into the control group (without access to "Diaana"). The next 50 eligible patients are recruited into the intervention group (with access to "Diaana").
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Independant physician

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: April 3, 2019
• Study Start: February 28, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be avaliable within 3 months of the study completion
• Access Criteria: Under request to the sponsor.

Locations

CH (1)