DD Assessment With Diaana #2 (DiaanaRCT#2)

Adrien Schwitzguebel

Status: Completed

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

Treatments: Other: Diaana

Study type: Interventional

Funder types: Other

Identifiers

NCT03901495

UNIGE_Diaana

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Diaana

Experimental group

Description:

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, ...)

Treatment:

Other: Diaana

Control

No Intervention group

Description:

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, ...)