Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04810039 |
| Other study ID # |
APHP210394 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
June 6, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
