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

NCT03874546 | Completed

• 2 other identifiers: APHP1804772018-A03135-50
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Severe and moderate traumatic brain injury; Prognosis; IMPACT score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Differences in prognosis between clinicians based on their experience and specialty.

  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.

  At 6 months

• Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.

  At 6 months

Study Arms (1)

Prognostic evaluation

EXPERIMENTAL

Questionnaire at Day1, Day7 and 6 months.

Other: Questionnaire

Interventions

Questionnaire OTHER

* 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

Prognostic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rémy BERNARD, MD

  Assistance Publique Hoptiaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: April 4, 2019
• Primary Completion: February 22, 2021
• Study Completion: September 22, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)