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DD Assessment With Diaana #2 (DiaanaRCT#2)

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ClinicalTrials.gov Identifier: NCT03901495
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Adrien Schwitzguebel, University Hospital, Geneva

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Decision Making Computer-assisted General Practitioners Patient Engagement Other: Diaana Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: The first 50 eligible patients of the emergency outpatient unit in Geneva University Hospital are recruited into the control group (without access to "Diaana"). The next 50 eligible patients are recruited into the intervention group (with access to "Diaana").
Primary Purpose: Diagnostic
Official Title: Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: Diaana
  1. The patient fullfill Diaana
  2. The resident physician takes connaissance of the Diaana summary
  3. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)
  4. 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 Name: Automated medical history-taking device (AMHTD)

No Intervention: Control
  1. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)
  2. The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)



Primary Outcome Measures :
  1. Differential diagnosis established by the resident physician [ Time Frame: At day 0 ]

    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.



Secondary Outcome Measures :
  1. Consultation time [ Time Frame: At day 0 ]
    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.

  2. Patient satisfaction [ Time Frame: At day 0 ]
    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

  3. Differential diagnosis estabished by Diaana [ Time Frame: At day 0 ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901495


Contacts
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Contact: Adrien Schwitzguebel, MD +41797620562 adrien.schwitzguebel@gmail.com
Contact: Hervé Spechbach, MD herve.spechback@hcuge.ch

Locations
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Switzerland
Geneva University Hospital Recruiting
Geneva, Switzerland, 1205
Contact: Hervé Spechbach, MD       herve.spechbach@hcuge.ch   
Sponsors and Collaborators
Adrien Schwitzguebel
Investigators
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Principal Investigator: Hervé Spechbach, MD University Hospital, Geneva

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Responsible Party: Adrien Schwitzguebel, Principal investigator, Independant physician, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03901495     History of Changes
Other Study ID Numbers: UNIGE_Diaana
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be avaliable within 3 months of the study completion
Access Criteria: Under request to the sponsor.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrien Schwitzguebel, University Hospital, Geneva:
differential diagnosis
hospital outpatient clinics
clinical applications software