DD Assessment With Diaana #2 (DiaanaRCT#2)

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Decision Making; General Practitioners; Computer-assisted
• Intervention / Treatment: Other: Diaana

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diaana; The patient fullfill Diaana; The resident physician takes connaissance of the Diaana summary; The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...); 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; 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.; Other Names: Automated medical history-taking device (AMHTD)
No Intervention: Control; The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...); The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consultation time	The 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.	At day 0
Patient satisfaction	Into 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	At day 0
Differential diagnosis estabished by Diaana	The 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.	At day 0

Collaborators and Investigators

• Sponsor: Adrien Schwitzguebel
• Investigators: Principal Investigator: Hervé Spechbach, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: March 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: differential diagnosis; hospital outpatient clinics; clinical applications software
• Other Study ID Numbers: UNIGE_Diaana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcomes measures will be made avaliable
• IPD Sharing Time Frame: Data will be avaliable within 3 months of the study completion
• IPD Sharing Access Criteria: Under request to the sponsor.
• IPD Sharing Supporting Information Type: SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No