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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03939650
Enrollment
0
Registered
2019-05-07
Start date
2020-01-31
Completion date
2020-01-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

differential diagnosis, hospital outpatient clinics, clinical applications software

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.

Interventions

DEVICEDiaana

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.

Sponsors

Adrien Schwitzguebel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the diagnosis established by the resident physicianAt day 0The 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.

Secondary

MeasureTime frameDescription
Consultation timeAt day 0The 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.
Patient satisfaction: Likert 1-4 scaleAt day 0Into 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.
Differential diagnosis established by DiaanaAt day 0The 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026