F-MRI Brain Imaging DataNCT02994004
Exploring Medical Decisions Using Functional MRI
An observational study of F-MRI Brain Imaging Data, run by University Hospital, Montpellier.
Trial summary
Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- F-MRI Brain Imaging Data
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2015
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital physicians
Who may be able to join
- Hospital physicians
- working in the CHU of Montpellier
Who cannot join
- Contra indication to f-MRI
About this study
Official title: Medical Decision-making Under Budgetary Constraint: an fMRI Study
Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.
- Conditions
- F-MRI Brain Imaging Data
- Being tested
- no intervention
- Keywords
- Hospital, medical decision-making, role conflict, f-MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation patterns measured by Functional magnetic resonance imaging
Measured: up to study completion, usually 2 weeks
Secondary outcomes (1)
Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)
Measured: up tu study completion, usually 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for F-MRI Brain Imaging DataStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregoire MERCIER, MD, PhD, Principal investigator, University Montpellier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994004
- Sponsor's protocol ID
- 8989
- Status last verified
- Jul 2014
- First submitted
- 5 Sep 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Decision-making Under Budgetary Constraint: an fMRI Study
- ClinicalTrials.gov ID
- NCT02994004
- Acronym / sponsor ID
- 8989
- Conditions
- F-MRI Brain Imaging Data
- Keywords
- Hospital, medical decision-making, role conflict, f-MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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.
Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital physicians
Key inclusion criteria (2 listed)
- Hospital physicians
- working in the CHU of Montpellier
Key exclusion criteria (1 listed)
- Contra indication to f-MRI
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 |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Brain activation patterns measured by Functional magnetic resonance imaging
Time frame: up to study completion, usually 2 weeks
1 secondary outcome
Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)
Time frame: up tu study completion, usually 2 weeks
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 15 Dec 2016.
- Individual participant dataSharing planned: No
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.
Gregoire MERCIER, MD, PhD principal investigator
University Montpellier Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of F-MRI Brain Imaging Data, run by University Hospital, Montpellier.
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 1 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 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Brain activation patterns measured by Functional magnetic resonance imaging (time frame: up to study completion, usually 2 weeks). 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 15 Dec 2016.