Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain InjuryPREDICT IINCT04810039
Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors
An observational study of Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury
- What is being tested?
- Predict the outcome of the Glasgow Outcome Scale
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 6 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.
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.
Read the 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.
- Conditions
- Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury
- Being tested
- Predict the outcome of the Glasgow Outcome Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predict the outcome of the Glasgow Outcome ScaleOther
Predict the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Predict the outcome of the Glasgow Outcome Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (At inclusion of physicians) or minimum 6 month after patient inclusion
variability between physicians
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.
Measured: Baseline (At inclusion)
confidence in their prognosis
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.
Measured: Baseline (At inclusion)
the information offered to relatives
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".
Measured: Baseline (At inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Mar 2021
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810039
- Sponsor's protocol ID
- APHP210394
- Acronym
- PREDICT II
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.
- ClinicalTrials.gov ID
- NCT04810039
- Acronym / sponsor ID
- PREDICT II / APHP210394
- Conditions
- Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doctor working in neuro-intensive unite care | – | Other: Predict the outcome of the Glasgow Outcome Scaledoctor predicting the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predict the outcome of the Glasgow Outcome ScalePredict the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records. | Other | doctor working in neuro-intensive unite care |
Primary outcome
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prognosis of Neurological Outcome at 6 Months in Patients Undergoing Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.