Decision MakingNCT03939650
Diagnosis Assessment With Diaana #3
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, 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Decision Making, Computer-assisted, General Practitioners
- What is being tested?
- Diaana
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jan 2020to 31 Jan 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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 With Accurate Gold-standard Diagnosis
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.
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, 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.
- 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.
DiaanaDevice
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 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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: Likert 1-4 scale
Into 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.
Measured: At day 0
Differential diagnosis established by Diaana
The 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.
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 posted7 May 2019
- Study start31 Jan 2020 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2020 (estimated)
Why it stopped: logistics: not able to get resosurces to beginn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrien Schwitzguebel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Schwitzguebel, Hôpital de la Providence, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939650
- Sponsor's protocol ID
- COLLINE_Diaana
- Status last verified
- Oct 2019
- First submitted
- 3 May 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. 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 With Accurate Gold-standard Diagnosis
- ClinicalTrials.gov ID
- NCT03939650
- Acronym / sponsor ID
- COLLINE_Diaana
- Keywords
- differential diagnosis, hospital outpatient clinics, clinical applications software
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistics: not able to get resosurces to beginn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adrien SchwitzguebelUniversity, hospital or other
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 7 May 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, 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diaana | Experimental | Device: Diaana1. 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. |
| 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
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. | Device | Diaana |
Primary outcome
Accuracy of the diagnosis established by the resident physician
Time frame: At day 0
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.
3 secondary outcomes
Consultation time
Time frame: At day 0
Patient satisfaction: Likert 1-4 scale
Time frame: At day 0
Differential diagnosis established by Diaana
Time frame: At day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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: withdrawn, as of the sponsor's last update on 23 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of the 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?
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 23 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.