Decision MakingDiaanaRCT#2NCT03901495
DD Assessment With Diaana #2
A study testing Diaana in people with Decision Making and Computer-assisted, run by Adrien Schwitzguebel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decision Making, Computer-assisted, General Practitioners
- What is being tested?
- Diaana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study
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.
Read the 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.
- Being tested
- Diaana
- Keywords
- differential diagnosis, hospital outpatient clinics, clinical applications software
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaanaOther
Also called Automated medical history-taking device (AMHTD)
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.
| Study group | Role | What they receive |
|---|---|---|
| Diaana | Experimental | 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, ...) Receives: Other: Diaana |
| Control | No intervention | 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, ...) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential diagnosis established by the resident physician
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.
Measured: At day 0
Secondary outcomes (3)
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.
Measured: At day 0
Patient satisfaction
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
Measured: At day 0
Differential diagnosis estabished by Diaana
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.
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start28 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrien Schwitzguebel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Schwitzguebel, University Hospital, Geneva
- Investigators
- Hervé Spechbach, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901495
- Sponsor's protocol ID
- UNIGE_Diaana
- Acronym
- DiaanaRCT#2
- Status last verified
- Nov 2020
- First submitted
- 2 Mar 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Publications
Healey B, Schwitzguebel A, Spechbach H. Differential Diagnosis Assessment in Ambulatory Care With a Digital Health History Device: Pseudorandomized Study. JMIR Form Res. 2025 Oct 1;9:e56384. doi: 10.2196/56384.
PubMed 40205939
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study
- ClinicalTrials.gov ID
- NCT03901495
- Acronym / sponsor ID
- DiaanaRCT#2 / UNIGE_Diaana
- Keywords
- differential diagnosis, hospital outpatient clinics, clinical applications software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Adrien SchwitzguebelUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaana | Experimental | Other: Diaana1. 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, ...) |
| Control | No intervention | –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, ...) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaanaAlso: Automated medical history-taking device (AMHTD)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 | Diaana |
Primary outcome
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.
3 secondary outcomes
Consultation time
Time frame: At day 0
Patient satisfaction
Time frame: At day 0
Differential diagnosis estabished by Diaana
Time frame: At day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 40205939Healey B, Schwitzguebel A, Spechbach H. Differential Diagnosis Assessment in Ambulatory Care With a Digital Health History Device: Pseudorandomized Study. JMIR Form Res. 2025 Oct 1;9:e56384. doi: 10.2196/56384.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Related trials for Decision Making
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Recruiting
Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
Hernia
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Not yet recruiting
A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns: A Randomized Controlled Trial
Ethical Decision-Making Competence in Nursing Student Interns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Spechbach, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaana in people with Decision Making and Computer-assisted, run by Adrien Schwitzguebel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential diagnosis established by the resident physician (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.