An interventional study of Questionnaire in Traumatic Brain Injury, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.
The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.
Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included.
Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected.
Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit.
At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (\<7 days), by a committee of adjudication composed of 2 examiners.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 83 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Questionnaire at Day1, Day7 and 6 months.
Other: Questionnaire
* Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7. * At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7).
Also known as: French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis
Compare the quality of the prognostic assessment of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.
Comparison of the area under the ROC curve of the IMPACT model score for the prediction of the 6-month Glasgow Outcome Scale (GOS) ≤ 3 to the area under the ROC curve of the first day clinician's prediction.
Time frame: At 6 month
Differences in prognosis between clinicians based on their experience and specialty.
Evaluation of the effect of the clinician's experience (number of years of neuro-ICU exercise) and specialty on the clinician's prognosis ROC curve.
Time frame: At 6 months
To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic.
Comparison between the clinician's ROC curves at D1 (between the 6th and the 24th hour) and at D7 of the trauma for the prognosis of the patient.
Time frame: At 6 months
Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.
Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve.
Time frame: At 6 months
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris