Clinical trial NCT03901495: DD Assessment With Diaana #2
Official title: Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Computer-assisted
General Practitioners
Patient Engagement
Keywords: differential diagnosis
hospital outpatient clinics
clinical applications software
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Differential diagnosis established by the resident physician
timeFrame: At day 0
Secondary outcomes:
measure: Consultation time
timeFrame: At day 0
measure: Patient satisfaction
timeFrame: At day 0
measure: Differential diagnosis estabished by Diaana
timeFrame: At day 0
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Hervé Spechbach, MD
role: PRINCIPAL_INVESTIGATOR
References: