TraumaNCT03485573
Improvement of Trauma Care Quality by Implement Trauma Register in a Middle Income Country
An observational study of Trauma, run by University Hospital, Linkoeping at 1 site in Kenya.
Trial summary
Every year more people die from traumatic injuries than from infections such as malaria, tuberculosis, and HIV/AIDS. About 3000 people are killed annually on Kenyan roads. Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Trauma
- How many people
- 2,000 participants
- Where
- 1 siteKenya
- Study dates
- 8 May 2018to 31 May 2019
- How long will I take part?
- 12 Months
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.
Who may be able to join
- Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.
- -
Who cannot join
- Those brought in dead, revisits, or referred patients will excluded.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Every year more people die from traumatic injuries than from infections such as malaria, tuberculosis, and HIV/AIDS. About 3000 people are killed annually on Kenyan roads. Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Trauma registers offer a unique opportunity to document patient characteristics and audit outcomes, thereby creating a platform for clinical research. One of these systems is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. The establishment of the register enables us to compare the trauma care quality with other existing or upcoming trauma registers, in different settings.
Read the detailed description
The mortality caused by traumatic injuries in Africa is 116 per 100,000 population, compared to Europe with 49/100,000 population . In Kenya, which is a middle-income country in East Africa, the mortality caused by injuries is 101/100,000 population . Injuries, particularly those sustained through road traffic accidents, are a major cause of death in the African region. Statistics from the WHO reveal that, in 2015, 26.6/100,000 died in road traffic accidents in Africa. The corresponding numbers for Europe were 9.3/100,000 population . About 3000 people are killed annually on Kenyan roads, with an estimated road fatality rate of 29.1/100,000 population the affected predominantly from a productive young adult population.
MOI University/Moi Teaching and Referral Hospital (MTRH) Eldoret, Kenya, is the second national referral hospital in Kenya with a catchment of over 22 million people. A previous study, focuses on evaluating the possible benefit of in-hospital triage for trauma patients admitted to the ED at the MTRH. The study illustrated a significant need for improvement in trauma care management and also resulted in the creation of a trauma database containing ICD codes and specific patient parameters.
Although receiving increased attention, implementing strategies to improve trauma care in developing countries to address the health burden on the emergency care service is still warranted. Improved road safety legislation, reducing drunk driving, development of pre-hospital care systems , and strengthened hospital trauma care have been suggested as interventions to mitigate this problem in the health care system .
Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Trauma registers offer a unique opportunity to document patient characteristics and audit outcomes, thereby creating a platform for clinical research. Several scoring systems to assess injury severity with the aim of improving trauma care quality have been developed. One of these systems is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. This powerful tool uses survival risk ratios (SRRs) to calculate the probability of survival for patients and allows accurate estimates of injury severity. To calculate ICISS, each ICD-code is assigned a SRR. Each SRR is equal to the proportion of patients who survived with a specific ICD-code in a reference population. In literature searches, there is lack of published SRRs from low income countries' trauma population.
The Institutional Research and Ethics Committee (IREC) at MOI University and MOI Teaching and Referral Hospital reviewed and approved the research proposal and has been granted a Formal Approval Number (FAN: IREC 3008).
- 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.
Score injury severity with the aim of improving trauma care by using the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death.
To calculate ICISS, each ICD-code is assigned a survival risk ratios (SRR), which represents a true continuous variable that takes on values between 0 and 1. SRR is based on the assumption that a patient's probability of survival can be predicted based on the survival rates of prior patients with similar injuries as classified by the ICD-10.
The ICISS value is the product of SRRs from each injury sustained. A multiplicative prediction model with an assumption that all injuries contribute to the overall severity. The SRR for each code is empirically derived from the upcoming patient data. To obtain ICISS, SRRs of all injuries are multiplied.
ICISS = SRRinj1 × SRRinj2 × SRRinj3 × SRRinj4. Create a ICISS trauma registry is valuable to document epidemiology, process and outcome, thus enabling the measurement of the impact of trauma care following injury.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start8 May 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- 2,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Univeristy
- Responsible party
- Principal investigator, Maria Lampi, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485573
- Sponsor's protocol ID
- KMC-002
- Status last verified
- Oct 2019
- First submitted
- 19 Mar 2018
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Trauma Care Quality by Implement Trauma Register in a Middle Income Country
- ClinicalTrials.gov ID
- NCT03485573
- Acronym / sponsor ID
- KMC-002
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Moi Univeristy
- Study start
- 8 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Apr 2018 (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.
Every year more people die from traumatic injuries than from infections such as malaria, tuberculosis, and HIV/AIDS. About 3000 people are killed annually on Kenyan roads. Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Trauma registers offer a unique opportunity to document patient characteristics and audit outcomes, thereby creating a platform for clinical research. One of these systems is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. The establishment of the register enables us to compare the trauma care quality with other existing or upcoming trauma registers, in different settings.
Detailed description
The mortality caused by traumatic injuries in Africa is 116 per 100,000 population, compared to Europe with 49/100,000 population . In Kenya, which is a middle-income country in East Africa, the mortality caused by injuries is 101/100,000 population . Injuries, particularly those sustained through road traffic accidents, are a major cause of death in the African region. Statistics from the WHO reveal that, in 2015, 26.6/100,000 died in road traffic accidents in Africa. The corresponding numbers for Europe were 9.3/100,000 population . About 3000 people are killed annually on Kenyan roads, with an estimated road fatality rate of 29.1/100,000 population the affected predominantly from a productive young adult population.
MOI University/Moi Teaching and Referral Hospital (MTRH) Eldoret, Kenya, is the second national referral hospital in Kenya with a catchment of over 22 million people. A previous study, focuses on evaluating the possible benefit of in-hospital triage for trauma patients admitted to the ED at the MTRH. The study illustrated a significant need for improvement in trauma care management and also resulted in the creation of a trauma database containing ICD codes and specific patient parameters.
Although receiving increased attention, implementing strategies to improve trauma care in developing countries to address the health burden on the emergency care service is still warranted. Improved road safety legislation, reducing drunk driving, development of pre-hospital care systems , and strengthened hospital trauma care have been suggested as interventions to mitigate this problem in the health care system .
Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Trauma registers offer a unique opportunity to document patient characteristics and audit outcomes, thereby creating a platform for clinical research. Several scoring systems to assess injury severity with the aim of improving trauma care quality have been developed. One of these systems is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. This powerful tool uses survival risk ratios (SRRs) to calculate the probability of survival for patients and allows accurate estimates of injury severity. To calculate ICISS, each ICD-code is assigned a SRR. Each SRR is equal to the proportion of patients who survived with a specific ICD-code in a reference population. In literature searches, there is lack of published SRRs from low income countries' trauma population.
The Institutional Research and Ethics Committee (IREC) at MOI University and MOI Teaching and Referral Hospital reviewed and approved the research proposal and has been granted a Formal Approval Number (FAN: IREC 3008).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.
Key inclusion criteria (2 listed)
- Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.
- -
Key exclusion criteria (2 listed)
- Those brought in dead, revisits, or referred patients will excluded.
- -
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
Score injury severity with the aim of improving trauma care by using the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death.
Time frame: two years
To calculate ICISS, each ICD-code is assigned a survival risk ratios (SRR), which represents a true continuous variable that takes on values between 0 and 1. SRR is based on the assumption that a patient's probability of survival can be predicted based on the survival rates of prior patients with similar injuries as classified by the ICD-10. The ICISS value is the product of SRRs from each injury sustained. A multiplicative prediction model with an assumption that all injuries contribute to the overall severity. The SRR for each code is empirically derived from the upcoming patient data. To obtain ICISS, SRRs of all injuries are multiplied. ICISS = SRRinj1 × SRRinj2 × SRRinj3 × SRRinj4. Create a ICISS trauma registry is valuable to document epidemiology, process and outcome, thus enabling the measurement of the impact of trauma care following injury.
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 8 Oct 2019.
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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 University Hospital, Linkoeping at 1 site in Kenya.
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 2 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 8 Oct 2019. 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 Kenya. 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?
Score injury severity with the aim of improving trauma care by using the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. (time frame: two years). 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 8 Oct 2019.