Diagnosis Assessment With Diaana #3

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Patient Engagement; Decision Making; General Practitioners; Computer-assisted
• Intervention / Treatment: Device: 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, 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • La Colline Hospital Outpatient Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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 fulfill Diaana; The resident physician reads the Diaana summary; The resident physician see the patient in consultation. He establishes his DD without having access to the complementray exams (blood tests, x-ray, ...); The senior physician see the patient at the follow-up consultation. He establishes the gold-standard diagnosis highlighted by complementary exams and imagery.	Device: 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 complementray exams (blood tests, x-ray, ...); The senior physician see the patient at the follow-up consultation. He establishes the gold-standard diagnosis highlighted by complementary exams and imagery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the diagnosis established by the resident physician	The resident physician will select up to 5 diagnose in an exhaustive list, from the most to the least relevant. The accuracy of the diagnosis established will be measured as following: 100% if the gold-standard diagnosis is in position#1 into the resident diagnosis list; 80% if the gond-standard diagnosis is in position#2; 60% in position #3; 40% in position #4; 20% in position #5; 0% if the gold-standard diagnosis absent of the resident diagnosis list A higher percentage is considered as a better outcome.	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: Likert 1-4 scale	Into the experimental group, the patient's satisfaction will be evalatued on a Likert 1-4 scale. 1= fully dissatisfied; 2 = partially dissatisfied; 3 = partially satisfied; 4 = fully satisfied A higher score is considered as a better outcome.	At day 0
Differential diagnosis established by Diaana	The Diaana system will select diagnoses in an exhaustive list. The percentage of cases were the gold-standard diagnosis is present into the differential diagnosis list will be measured. A higher percentage is a better outcome.	At day 0

Collaborators and Investigators

• Sponsor: Adrien Schwitzguebel

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2020
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: differential diagnosis; hospital outpatient clinics; clinical applications software
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: COLLINE_Diaana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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