Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors (PREDICT II)

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ClinicalTrials.gov Identifier: NCT04810039

Recruitment Status : Completed

First Posted : March 22, 2021

Last Update Posted : July 13, 2021

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

PREDICT II is an observational, prospective design, single-center study aiming to determine whether the prognosis of neurological outcome at 6 months in patients undergoing traumatic brain injury established by a doctor at his initial management is more accurate in experienced doctors versus junior doctors.

Condition or disease	Intervention/treatment
Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury	Other: Predict the outcome of the Glasgow Outcome Scale

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Detailed Description:

Head injury is a non-rare cause of mortality and morbidity in young adults. It is difficult and often uncertain to assess the long-term neurological prognosis in these patients. However, this element is of major importance because it allows the clinician to determine the intensity of the therapies used and to adapt the information given to the patient and his relatives.

Numerous studies have been carried out to study the prognosis of these patients, of which two are the most important: CRASH-study and IMPACT-study. However, of all these studies, none of them had the objective of comparing whether the experience of the clinician influenced the accuracy of his prognosis. Similarly, the PREDICT-TBI study conducted at our center, which aimed to compare the clinician's assessment with a prognostic score already in use (IMPACT score) for determining the prognosis of the brain injured person, did not study the influence of the clinician's experience on the accuracy of the prognosis.

Assessment of clinicians' judgment of neurological outcome in 20 patient charts.

20 records will be randomly selected from the N patients included in the PREDICT-TBI study.

These 20 pseudonymities records will be presented, including admission scans and pre-hospital clinical data.

For each clinician included, a questionnaire of the assumed neurological outcome of each patient will be completed and compared with the true neurological outcome, the main variable being the GOSE neurological outcome at 6 months (already collected in the PREDICT-TBI study).

Our hypothesis is that clinicians have a reliable judgment of the neurological outcome of the patient by estimating the probability of error of 30% in senior physicians and 40% in junior physicians. The reliability of this judgment will be measured by assessing the number of errors each clinician will make on the 20 medical records.

The main issue of the study is to better understand the prognosis at the initial phase in order to adapt the nature of the information given to the families in terms of prognosis.

The number of subjects needed is calculated by simulating two-sided tests of a generalized binomial model that compares the "senior" group to the "junior" group on 10,000 samples made up of n * 2 binomial variables (n = 20, probability of error in seniors p1 = 0.3 (PREDCIT-TBI) and p2 = 0.4 for juniors). With an alpha risk of 5%, a power of 80%, we calculate the n = 18 physicians per group.

Inclusion and consent: After obtaining their consent we will include 18 doctors per group spread over several establishments.

Methodology: We will randomly select 20 files of moderate or severe traumatic brain injury patients treated in the neuro-ICU department of the Pitié-Salpêtrière hospital between March 2019 and December 2020 and included in the PREDICT-TBI study (CPP no. 19.01.21.68040) after having obtained their non-opposition from themselves or from their trusted person and not having been the subject of a limitation of active therapies during the first 24 hours. The patient was also not the victim of a lack of care during the first 24 hours. The prognostic data recognized in the literature for the first 24 hours of treatment are found in the computerized medical records of METAVISION and Carestream. This data, after being anonymized, will be submitted to the clinician for evaluation during an interview of a predefined duration. The prognosis will be assessed by means of a questionnaire submitted to all physicians detailed in the appendix. Then, it will be compared to the effective neurological status 6 months after the trauma assessed by a phone interview with the patient himself or his relatives.

Study Design

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Study Type :	Observational
Actual Enrollment :	36 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.
Actual Study Start Date :	March 1, 2021
Actual Primary Completion Date :	June 6, 2021
Actual Study Completion Date :	June 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
doctor working in neuro-intensive unite care doctor predicting the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records.	Other: Predict the outcome of the Glasgow Outcome Scale Predict the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records.

Outcome Measures

Primary Outcome Measures :

The primary outcome is the number of errors the doctor makes when predicting the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records [ Time Frame: Baseline (At inclusion of physicians) or minimum 6 month after patient inclusion ]
variability between physicians [ Time Frame: Baseline (At inclusion) ]
We will ask the intensivists for each patients' data the patient's risk of becoming GOS < 4 at 6 months between 0 and 100. This measure will be analyzed as a response variable (16*38 = 576 assessments) in a three-level hierarchical linear mixed model. We will introduce random intercepts for patients within the intensivists and we will add fixed effects as the patient's real becoming and the intensivist's seniority. This model will yield an estimate of a variance between intensivists and another method to test the effect of seniority to determine the patient's becoming. We will carry out analysis with nlme package in R.
confidence in their prognosis [ Time Frame: Baseline (At inclusion) ]
measured with the multiple choice question: "How confident are you in the prognosis you just made?" and possible answers: Certain, Very confident, Confident, Not Confident, Unsure.
the information offered to relatives [ Time Frame: Baseline (At inclusion) ]
measured with the multiple choice question: " The family arrives distressed ond would like more information on the prognosis and disability at 6 months. You are the first point of contact. Do you insist on?" and possible answers: "The good prognosis factors", "prognostic uncertainty", "disability or possible death".

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The senior group will be made up of intensive care anaesthesists with more than 4 years of experience in neuro-intensive care unit, and the junior group, of advanced semester intensive care anaesthesists interns at the end of an internship composed of 5 months specialized in neuro-ICU.

Criteria

Inclusion Criteria:

Senior group: intensive care anaesthesists with more than 4 years of experience in neuro-intensive care unit
Junior group : advanced semester intensive care anaesthesists interns at the end of an internship composed of 5 months specialized in neuro-ICU

Exclusion Criteria: None

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810039

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

More Information

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT04810039
Other Study ID Numbers:	APHP210394
First Posted:	March 22, 2021 Key Record Dates
Last Update Posted:	July 13, 2021
Last Verified:	April 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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

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