Wound and InjuriesHTPSNCT02303613
A Validation of Current Hospital Triage Performance System Versus RETTS
An observational study of Wound and Injuries and Trauma, run by University Hospital, Linkoeping at 1 site in Kenya.
Trial summary
Background: Triage in the emergency department (ED) together with initial assessment is used to identify patient's level of urgency and treatment based on their triage level. Triage in the ED is a complex decision-making process, and several triage scales have been designed as decision support systems to guide the… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Wound and Injuries, Trauma
- What is being tested?
- Mapping
- How many people
- 628 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2014to Jul 2015
- How long will I take part?
- 30 Days
- 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: Close to 600 trauma patients of ages 14 and above seen at the ED will be captured. All patients presenting through the ED will be identified and those who meet the inclusion criteria will be recruited into the study on a daily basis until close to the 600 patient records is achieved. Patients will be followed through the ED to the receiving facilities (wards, ICU, HDU, theatre etc)
Who may be able to join
- Close to 600 trauma patients of ages 14 and above seen at the ED will be captured. All patients presenting through the ED will be identified and those who meet the inclusion criteria will be recruited into the study on a daily basis until close to the 600 patient records is achieved. Patients will be followed through the ED to the receiving facilities (wards, ICU, HDU, theatre etc) -
Who cannot join
- Those brought in dead, those below 14 years, revisits, or referred patients will be excluded The patient records will be traced for the entire period the patient is in the hospital or until key decisions are made on triage category by the ED or receiving units.
- There may be need to follow up patients for longer but since the study has a limited period, records will have to be made up to 30 days admission for those admitted during the last month.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Validation of Current Hospital Triage Performance System Versus RETTS and Identify Trauma Patient Outcome at Moi Teaching and Referral Hospital, Kenya.
Background: Triage in the emergency department (ED) together with initial assessment is used to identify patient's level of urgency and treatment based on their triage level. Triage in the ED is a complex decision-making process, and several triage scales have been designed as decision support systems to guide the triage nurse to a correct decision. Worldwide there are four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden introduced a process-oriented triage scale with physiological parameters called Rapid Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital signs and chief complaints, which describe the incident or symptoms that caused the patient to seek care. These two variables are evaluated and results in a color coded 5-level scale. Each level of priority has a defined time limit within which evaluation by a doctor should begin. Although, all international triage system guidelines seem to function well in western countries, they are difficult to implement and have a high failure rate in developing low-income countries. One of the reasons may be the lack of extensive training. Teaching and assessing abilities in performing mass casualty triage in inherently challenging due to the inability to accurately replicate a given disaster environment in a comprehensive way. Disaster drills and simulation exercises are ways of training triage performance and there are different tools available. One tool that can contribute to this kind of training may be the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems could be used to test and evaluate incident and command systems, surge capacity, hospital preparedness and triage.
Study objective study III: The aim of the study is to validate the currently practiced system for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS. Furthermore map the current patient outcome of trauma patients.
Read the detailed description
A tool has been developed by the research group. It has been developed in which on identification of trauma patient record, details will be entered and later transferred to an Excel format for ease of analysis.
Trauma patient card record for collecting data including respiratory rate, pulse, blood pressure, GCS, SaO2, body temperature, type of injury and mechanism of injury is developed will be used. Time of accident and arrival to ED, sex, age and intervention at ED will also be registered. Time at ED, number of days and where the patient has been treated during the hospital visit are also going to be registered. According to the protocol there is also a discharge evaluation where The International Classification of Disease (ICD) and Injury Severity Score (ISS) will be registered.
- Conditions
- Wound and Injuries, Trauma
- Being tested
- Mapping
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MappingOther
Mapping of current triage situation regarding 30 days mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and mapping of the current 30 days mortality and morbidity.
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 posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
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 Wound and InjuriesStudies 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
- 628 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Lampi, University Hospital, Linkoeping
- Investigators
- Maria Lampi, PhD-cand, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303613
- Sponsor's protocol ID
- KMC-001
- Acronym
- HTPS
- Status last verified
- Sep 2015
- First submitted
- 25 Nov 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lampi M, Junker JPE, Tabu JS, Berggren P, Jonson CO, Wladis A. Potential benefits of triage for the trauma patient in a Kenyan emergency department. BMC Emerg Med. 2018 Nov 29;18(1):49. doi: 10.1186/s12873-018-0200-7.
PubMed 30497397
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of Current Hospital Triage Performance System Versus RETTS and Identify Trauma Patient Outcome at Moi Teaching and Referral Hospital, Kenya.
- ClinicalTrials.gov ID
- NCT02303613
- Acronym / sponsor ID
- HTPS / KMC-001
- Conditions
- Wound and Injuries, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Dec 2014 (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.
Background: Triage in the emergency department (ED) together with initial assessment is used to identify patient's level of urgency and treatment based on their triage level. Triage in the ED is a complex decision-making process, and several triage scales have been designed as decision support systems to guide the triage nurse to a correct decision. Worldwide there are four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden introduced a process-oriented triage scale with physiological parameters called Rapid Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital signs and chief complaints, which describe the incident or symptoms that caused the patient to seek care. These two variables are evaluated and results in a color coded 5-level scale. Each level of priority has a defined time limit within which evaluation by a doctor should begin. Although, all international triage system guidelines seem to function well in western countries, they are difficult to implement and have a high failure rate in developing low-income countries. One of the reasons may be the lack of extensive training. Teaching and assessing abilities in performing mass casualty triage in inherently challenging due to the inability to accurately replicate a given disaster environment in a comprehensive way. Disaster drills and simulation exercises are ways of training triage performance and there are different tools available. One tool that can contribute to this kind of training may be the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems could be used to test and evaluate incident and command systems, surge capacity, hospital preparedness and triage.
Study objective study III: The aim of the study is to validate the currently practiced system for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS. Furthermore map the current patient outcome of trauma patients.
Detailed description
A tool has been developed by the research group. It has been developed in which on identification of trauma patient record, details will be entered and later transferred to an Excel format for ease of analysis.
Trauma patient card record for collecting data including respiratory rate, pulse, blood pressure, GCS, SaO2, body temperature, type of injury and mechanism of injury is developed will be used. Time of accident and arrival to ED, sex, age and intervention at ED will also be registered. Time at ED, number of days and where the patient has been treated during the hospital visit are also going to be registered. According to the protocol there is also a discharge evaluation where The International Classification of Disease (ICD) and Injury Severity Score (ISS) will be registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Close to 600 trauma patients of ages 14 and above seen at the ED will be captured. All patients presenting through the ED will be identified and those who meet the inclusion criteria will be recruited into the study on a daily basis until close to the 600 patient records is achieved. Patients will be followed through the ED to the receiving facilities (wards, ICU, HDU, theatre etc)
Key inclusion criteria (1 listed)
- Close to 600 trauma patients of ages 14 and above seen at the ED will be captured. All patients presenting through the ED will be identified and those who meet the inclusion criteria will be recruited into the study on a daily basis until close to the 600 patient records is achieved. Patients will be followed through the ED to the receiving facilities (wards, ICU, HDU, theatre etc) -
Key exclusion criteria (3 listed)
- Those brought in dead, those below 14 years, revisits, or referred patients will be excluded The patient records will be traced for the entire period the patient is in the hospital or until key decisions are made on triage category by the ED or receiving units.
- There may be need to follow up patients for longer but since the study has a limited period, records will have to be made up to 30 days admission for those admitted during the last month.
- -
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 |
|---|---|---|
| MappingMapping of current triage situation regarding 30 days mortality | Other | – |
Primary outcome
Identify and mapping of the current 30 days mortality and morbidity.
Time frame: 30 days
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 29 Sep 2015.
- Derived from this study: PubMed 30497397Lampi M, Junker JPE, Tabu JS, Berggren P, Jonson CO, Wladis A. Potential benefits of triage for the trauma patient in a Kenyan emergency department. BMC Emerg Med. 2018 Nov 29;18(1):49. doi: 10.1186/s12873-018-0200-7.
Related trials for Wound and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Maria Lampi, PhD-cand principal investigator
Linkoeping University
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 Wound and Injuries and 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 1 inclusion and 3 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 29 Sep 2015. 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?
Identify and mapping of the current 30 days mortality and morbidity. (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 NCT02303613, 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 29 Sep 2015.