TraumaNCT02838459
Can Prediction Models Triage Trauma Patients More Accurately Than Clinicians?
An observational study of Trauma, run by Karolinska Institutet at 1 site in India.
Trial summary
Using a prospective cohort design, the aim of this study is to compare the performance of clinicians with prediction models in triaging trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- How many people
- 5,155 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2016to 5 May 2018
- 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: Individuals presenting to the emergency department (ED) because of trauma at any of the participating hospitals.
Who may be able to join
- Having any of the external causes of mortality and morbidity listed in block V01-Y36, chapter XX of International Classification of Disease Version 10 (ICD-10) codebook as primary complaint
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Post Graduate Medical Education & Research
Kolkata, 700 020
About this study
Using a prospective cohort design, the aim of this study is to compare the performance of clinicians with prediction models in triaging trauma patients.
Read the detailed description
Title Can prediction models triage trauma patients more accurately than clinicians?
Background Nearly 5 million people die because of trauma each year. Hence trauma, defined as external injury combined with the body's associated response, is a major contributor to health issues globally. Trauma's time sensitive nature differentiates it from other health conditions. Therefore, prioritisation is crucial to treat the most urgent trauma cases first. This prioritisation is generally referred to as triage. Henceforth, formalized and non-formalized triage systems are distinguished between, where the former is defined as explicit triage consciously performed according to a priori determined criteria, and the latter as decisions on prioritisation by clinicians subconsciously taken in the absence of formalized triage.
There are two conceptually different methods currently used to triage trauma patients. Triage may be done by clinicians. Triage performed by clinicians may be affected by human factors such as tiredness and experience, yet may be viewed as the most morally appropriate method to triage trauma patients. Algorithms, such as statistical algorithms, may also be constructed for triage purpose. To predict the possibility of a certain outcome using statistical methods is called prediction modelling. Algorithms exclude human factors when triaging patients. However, algorithmic triaging may seem morally inappropriate due to the absence of human connection between the clinician and the patient.
Formalised triage systems are frequently used in trauma care in high income countries. Such systems are believed to have improved trauma care and hence trauma patient outcome. However, more than 90 per cent of all deaths due to trauma occur in low- and middle income countries, where formalised triage systems are uncommon to non-existing. Formalized triage systems may help strengthen trauma care in low - and middle income countries. However, research is lacking on whether algorithms or clinicians perform the most accurate in triaging patients.
Aim To compare the performance of prediction models with clinicians in trauma patient triage.
Method Study design Prospective cohort study
Setting A prospective cohort study will be conducted in India, a lower middle income country. India accounts for 20 per cent of global trauma deaths per year, hence efforts to strengthen trauma care in India are urgently needed. Data will be collected from four urban hospitals: one in Mumbai, one in Kolkata, one in Delhi, and one in Nellore. The collection of data began on the 11th of July, however only from the hospital situated in Kolkata. Once ethical permission has been formally provided data will be collected from the remaining hospitals and will continue until the desired study size is reached (see study size). Data is collected by full-time project officers at the mentioned hospitals.
Participants Individuals presenting to the emergency department (ED) because of trauma at any of the participating hospitals. The individuals are included in the study once they arrive to the ED. The project officers are the ones including individuals. The participating individuals are visited by the project officers if they are still hospitalized after 30 days. Otherwise, the follow up is done per phone.
Variables
Models:
RTS (Systolic blood pressure (SBP), Glasgow coma scale (GCS), and respiratory rate (RR)) The Gerdin et al. model (SBP, heart rate (HR), and GCS) GAP (age, SBP, and GCS) KTS (SBP, GCS, RR, and number of serious injuries) Clinical judgement (Clinicians assign a triage category to trauma patients by categorising them into four color coded groups. The groups are green, yellow, orange, and red. The colors are intended to represent trauma severity and how soon patients needs to be treated, with green corresponding to the least severe patient and red to the most severe patient.)
Other descriptive variables:
Sex, mechanism of injury
Outcome variables:
Mortality within 30 days
Study size 200 trauma patients with mortality as outcome and all patients that survived during the same time period. Mortality within 30 days is assumed to be 15 %, based on past studies. Thus, 1350 patients is the desired study size. The estimated time needed to collect the desired data is two months (four project officers, one per hospital. A project officer collect data from the first ten patients per shift, 5 days per week. Thus, a data collector collect data from 50 patients per week and from 200 patients per month. The total collected data per month will then be from 800 patients. Two months of collected data will be from 1600 patients. Consequently, it will take about two months to reach the desired study size.)
Quantitative variables Quantitative variables will be treated as in the original studies. In other words, the quantitative variables will be categorised or non linear methods will be used as they were in the original studies.
Statistical methods The performance of prediction models and clinicians will be evaluated and compared in terms of discrimination, calibration and reclassification. First, the scores obtained from the prediction models will be used to assign patients to green, yellow, orange or red categories. Discrimination will then be assessed by calculating the area under the receiver operating characteristics curve for both the original scores and the color groupings based on the scores. Calibration will be assessed by calculating the mortality in each color group, assuming a linear association between increased severity and higher mortality. Finally, reclassification will be assessed by comparing what patients end up in which group, depending on whether the grouping is based on prediction models or clinicians. Only patients with complete data will be analysed. All analyses will be conducted using the R statistical environment, using standard 95% confidence intervals and a 5% significance level.
- Conditions
- Trauma
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Defined as mortality within 30 days of arrival to hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gerdin, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838459
- Sponsor's protocol ID
- ludvig-gerdin-16072016
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
Publications
Warnberg Gerdin L, Khajanchi M, Kumar V, Roy N, Saha ML, Soni KD, Mishra A, Kamble J, Borle N, Verma CP, Gerdin Warnberg M. Comparison of emergency department trauma triage performance of clinicians and clinical prediction models: a cohort study in India. BMJ Open. 2020 Feb 18;10(2):e032900. doi: 10.1136/bmjopen-2019-032900.
PubMed 32075827
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Prediction Models Triage Trauma Patients More Accurately Than Clinicians?
- ClinicalTrials.gov ID
- NCT02838459
- Acronym / sponsor ID
- ludvig-gerdin-16072016
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,155 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
Using a prospective cohort design, the aim of this study is to compare the performance of clinicians with prediction models in triaging trauma patients.
Detailed description
Title Can prediction models triage trauma patients more accurately than clinicians?
Background Nearly 5 million people die because of trauma each year. Hence trauma, defined as external injury combined with the body's associated response, is a major contributor to health issues globally. Trauma's time sensitive nature differentiates it from other health conditions. Therefore, prioritisation is crucial to treat the most urgent trauma cases first. This prioritisation is generally referred to as triage. Henceforth, formalized and non-formalized triage systems are distinguished between, where the former is defined as explicit triage consciously performed according to a priori determined criteria, and the latter as decisions on prioritisation by clinicians subconsciously taken in the absence of formalized triage.
There are two conceptually different methods currently used to triage trauma patients. Triage may be done by clinicians. Triage performed by clinicians may be affected by human factors such as tiredness and experience, yet may be viewed as the most morally appropriate method to triage trauma patients. Algorithms, such as statistical algorithms, may also be constructed for triage purpose. To predict the possibility of a certain outcome using statistical methods is called prediction modelling. Algorithms exclude human factors when triaging patients. However, algorithmic triaging may seem morally inappropriate due to the absence of human connection between the clinician and the patient.
Formalised triage systems are frequently used in trauma care in high income countries. Such systems are believed to have improved trauma care and hence trauma patient outcome. However, more than 90 per cent of all deaths due to trauma occur in low- and middle income countries, where formalised triage systems are uncommon to non-existing. Formalized triage systems may help strengthen trauma care in low - and middle income countries. However, research is lacking on whether algorithms or clinicians perform the most accurate in triaging patients.
Aim To compare the performance of prediction models with clinicians in trauma patient triage.
Method Study design Prospective cohort study
Setting A prospective cohort study will be conducted in India, a lower middle income country. India accounts for 20 per cent of global trauma deaths per year, hence efforts to strengthen trauma care in India are urgently needed. Data will be collected from four urban hospitals: one in Mumbai, one in Kolkata, one in Delhi, and one in Nellore. The collection of data began on the 11th of July, however only from the hospital situated in Kolkata. Once ethical permission has been formally provided data will be collected from the remaining hospitals and will continue until the desired study size is reached (see study size). Data is collected by full-time project officers at the mentioned hospitals.
Participants Individuals presenting to the emergency department (ED) because of trauma at any of the participating hospitals. The individuals are included in the study once they arrive to the ED. The project officers are the ones including individuals. The participating individuals are visited by the project officers if they are still hospitalized after 30 days. Otherwise, the follow up is done per phone.
Variables
Models:
RTS (Systolic blood pressure (SBP), Glasgow coma scale (GCS), and respiratory rate (RR)) The Gerdin et al. model (SBP, heart rate (HR), and GCS) GAP (age, SBP, and GCS) KTS (SBP, GCS, RR, and number of serious injuries) Clinical judgement (Clinicians assign a triage category to trauma patients by categorising them into four color coded groups. The groups are green, yellow, orange, and red. The colors are intended to represent trauma severity and how soon patients needs to be treated, with green corresponding to the least severe patient and red to the most severe patient.)
Other descriptive variables:
Sex, mechanism of injury
Outcome variables:
Mortality within 30 days
Study size 200 trauma patients with mortality as outcome and all patients that survived during the same time period. Mortality within 30 days is assumed to be 15 %, based on past studies. Thus, 1350 patients is the desired study size. The estimated time needed to collect the desired data is two months (four project officers, one per hospital. A project officer collect data from the first ten patients per shift, 5 days per week. Thus, a data collector collect data from 50 patients per week and from 200 patients per month. The total collected data per month will then be from 800 patients. Two months of collected data will be from 1600 patients. Consequently, it will take about two months to reach the desired study size.)
Quantitative variables Quantitative variables will be treated as in the original studies. In other words, the quantitative variables will be categorised or non linear methods will be used as they were in the original studies.
Statistical methods The performance of prediction models and clinicians will be evaluated and compared in terms of discrimination, calibration and reclassification. First, the scores obtained from the prediction models will be used to assign patients to green, yellow, orange or red categories. Discrimination will then be assessed by calculating the area under the receiver operating characteristics curve for both the original scores and the color groupings based on the scores. Calibration will be assessed by calculating the mortality in each color group, assuming a linear association between increased severity and higher mortality. Finally, reclassification will be assessed by comparing what patients end up in which group, depending on whether the grouping is based on prediction models or clinicians. Only patients with complete data will be analysed. All analyses will be conducted using the R statistical environment, using standard 95% confidence intervals and a 5% significance level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the emergency department (ED) because of trauma at any of the participating hospitals.
Key inclusion criteria (1 listed)
- Having any of the external causes of mortality and morbidity listed in block V01-Y36, chapter XX of International Classification of Disease Version 10 (ICD-10) codebook as primary complaint
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day mortality
Time frame: 30 days
Defined as mortality within 30 days of arrival to hospital
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 20 Feb 2020.
- Derived from this study: PubMed 32075827Warnberg Gerdin L, Khajanchi M, Kumar V, Roy N, Saha ML, Soni KD, Mishra A, Kamble J, Borle N, Verma CP, Gerdin Warnberg M. Comparison of emergency department trauma triage performance of clinicians and clinical prediction models: a cohort study in India. BMJ Open. 2020 Feb 18;10(2):e032900. doi: 10.1136/bmjopen-2019-032900.
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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 Trauma, run by Karolinska Institutet at 1 site in India.
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 1 inclusion and 1 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 20 Feb 2020. 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 India. 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?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838459, which also lists 1 linked publication.
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 20 Feb 2020.