Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury (PREDICT-TBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Traumatic Brain Injury focused on measuring Severe and moderate traumatic brain injury, Prognosis, IMPACT score
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 years or older,
- Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma,
- Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma,
- Relatives informed of the research and not having objected to the patient's participation in the study.
Exclusion Criteria:
- Opposition of the patient,
- Patient under the protection of justice,
- Pregnant woman,
- Modified scale of Rankin> 1 before the traumatic brain injury.
- Patient unable to speak French.
Sites / Locations
- Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prognostic evaluation
Arm Description
Questionnaire at Day1, Day7 and 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03874546
First Posted
March 12, 2019
Last Updated
October 11, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03874546
Brief Title
Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury
Acronym
PREDICT-TBI
Official Title
Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Severe and moderate traumatic brain injury, Prognosis, IMPACT score
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prognostic evaluation
Arm Type
Experimental
Arm Description
Questionnaire at Day1, Day7 and 6 months.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Differences in prognosis between clinicians based on their experience and specialty.
Description
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
Title
To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic.
Description
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
Title
Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.
Description
Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve.
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 years or older,
Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma,
Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma,
Relatives informed of the research and not having objected to the patient's participation in the study.
Exclusion Criteria:
Opposition of the patient,
Patient under the protection of justice,
Pregnant woman,
Modified scale of Rankin> 1 before the traumatic brain injury.
Patient unable to speak French.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémy BERNARD, MD
Organizational Affiliation
Assistance Publique Hoptiaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury
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