Clinical trial NCT03939650: Diagnosis Assessment With Diaana #3
Official title: Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study With Accurate Gold-standard Diagnosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Decision Making
Computer-assisted
General Practitioners
Patient Engagement
Keywords: differential diagnosis
hospital outpatient clinics
clinical applications software
Lead sponsor: Hôpital de la Providence, Switzerland
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For each of the six resident physicians of the outpatients clinic, the 6 first eligible patients will be attributed to the control group (with access to "Diaana"), then the 12 next eligible patients will be attributed to the interventional group (with access to "Diaana"). There will therefore be 36 patients in the control group and 72 in the interventional group.
Primary purpose: DIAGNOSTIC

Brief summary: Single-center, unblinded, 2:1 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 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, 2:1 parallel pseudo-randomized efficacy trial will be performed. A consultation follow-up is organized at 4-6 weeks, were the gold-standard diagnosis is established by the senior physician. The study will take place in the emergency outpatient unit of La Colline Hospital (Geneva, Switzerland) and include patients suffering from symptoms covered by Diaana.

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

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the emergency outpatient unit of La Colline hospital (Geneva, Switzerland)
* Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.

Exclusion Criteria:

* Strictly dermatologic concerns
* Toes 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: Accuracy of the diagnosis established by the resident physician
timeFrame: At day 0
Secondary outcomes:
measure: Consultation time
timeFrame: At day 0
measure: Patient satisfaction: Likert 1-4 scale
timeFrame: At day 0
measure: Differential diagnosis established by Diaana
timeFrame: At day 0
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: La Colline Hospital Outpatient Unit
Study officials:
References: