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DD Assessment With Diaana #2

Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03901495
Acronym
DiaanaRCT#2
Enrollment
100
Registered
2019-04-03
Start date
2019-02-28
Completion date
2020-03-31
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

differential diagnosis, hospital outpatient clinics, clinical applications software

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.

Interventions

OTHERDiaana

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.

Sponsors

Adrien Schwitzguebel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Differential diagnosis established by the resident physicianAt day 0The 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.

Secondary

MeasureTime frameDescription
Consultation timeAt day 0The resident's consultation (with and without the patient) will be measured by the research coordinator. Consultation time will be compared between groups. A shorter consultation time will be considered as a better outcome.
Patient satisfactionAt day 0Into the experimental group, the patient's satisfaction will be evalued on a Lickert 1-4 scale. 1= fully dissatisfied; 2 = partially dissatisfied; 3 = partially satisfied; 4 = fully satisfied
Differential diagnosis estabished by DiaanaAt day 0The Diaana system will select diagnoses in an exhaustive list. The senior physician will select up to 5 diagnose in an exhaustive list in order to establish the gold-standard differential diagnosis. The accuracy of the differential diagnosis established by the Diaana system will be measured as the percentage of correct diagnose selected compared to the gold standard.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026