DD Assessment With Diaana #2 (DiaanaRCT#2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03901495|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 11, 2019
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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").|
|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|
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
- 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.
- 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.
- 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
- 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.
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
|Contact: Adrien Schwitzguebel, MDfirstname.lastname@example.org|
|Contact: Hervé Spechbach, MDemail@example.com|
|Geneva University Hospital||Recruiting|
|Geneva, Switzerland, 1205|
|Contact: Hervé Spechbach, MD firstname.lastname@example.org|
|Principal Investigator:||Hervé Spechbach, MD||University Hospital, Geneva|