Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury (PREDICT-TBI)

Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prognostic evaluation; 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).; Other Names: French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Rémy BERNARD, MD, Assistance Publique Hoptiaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Prognosis; Severe and moderate traumatic brain injury; IMPACT score
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: APHP180477; 2018-A03135-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No