Diagnosis Assessment With Diaana #3

NCT03939650 | Withdrawn

• 1 other identifier: COLLINE_Diaana
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

differential diagnosis; hospital outpatient clinics; clinical applications software

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Consultation time

  At day 0

• Patient satisfaction: Likert 1-4 scale

  At day 0

• Differential diagnosis established by Diaana

  At day 0

Study Arms (2)

Diaana

EXPERIMENTAL

1. The patient fulfill Diaana 2. The resident physician reads the Diaana summary 3. The resident physician see the patient in consultation. He establishes his DD without having access to the complementray exams (blood tests, x-ray, ...) 4. 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

Control

NO INTERVENTION

1. The resident physician see the patient in consultation. He establishes his DD without having access to the complementray exams (blood tests, x-ray, ...) 2. The senior physician see the patient at the follow-up consultation. He establishes the gold-standard diagnosis highlighted by complementary exams and imagery.

Interventions

Diaana DEVICE

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.

Also known as: Automated medical history-taking device (AMHTD)

Diaana

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Adrien Schwitzguebel: lead

Study Sites (1)

La Colline Hospital Outpatient Unit

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor & principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: January 31, 2020
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: September 23, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)