TraumaNCT03234049
The Use of a Pediatric Trauma Checklist to Improve Clinical Performance in a Simulated Trauma Resuscitation
A study testing Checklist in people with Trauma, run by KidSIM Simulation Program at 1 site in Canada.
Trial summary
The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH Resuscitation Council with input from the ACH Trauma Program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Jan 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trauma team leader inclusion criteria:
- Pediatric emergency medicine physician
- Second physician inclusion criteria:
- Pediatric emergency medicine physician
- Nurse inclusion criteria:
- Pediatric emergency registered nurse
Who cannot join
- Previous participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Pediatric Trauma Checklist to Improve Clinical Performance in a Simulated Trauma Resuscitation: a Randomized Trial
The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH Resuscitation Council with input from the ACH Trauma Program. The purpose of this study is to determine if the introduction of the ACH Trauma Checklist as a cognitive aid, coupled with an educational session, will improve clinical performance in a simulated environment. The investigators plan to conduct a pilot, randomized control trial assessing the impact of the ACH trauma checklist on time to critical interventions on a simulated pediatric patient by multidisciplinary teams. The investigators hypothesize that teams who use a trauma checklist as a cognitive aid will have faster initiation of key clinical interventions within a simulated pediatric trauma resuscitation. Improvements in performance in a simulated environment with this tool may translate to similar results in the clinical setting.
Read the detailed description
Research Aims:
Aim 1: To evaluate the effectiveness of a pre-arrival, pre-departure trauma checklist on improving time to initiation of key clinical interventions in a simulated pediatric trauma scenario
Aim 2: To evaluate the impact of a pre-arrival, pre-departure trauma checklist on completion of primary and secondary survey tasks as demonstrated by an Advanced Trauma Life Support (ATLS) performance tool.
Aim 3: To evaluate the cognitive task load of a trauma checklist on emergency department physicians during a simulated trauma resuscitation scenario.
Aim 4: To describe patterns of eye movement of a trauma team leader in a simulated scenario in relation to critical patient interventions and team communication.
METHODS:
POPULATION:
Simulation scenarios will be run with multidisciplinary trauma teams recruited from the Alberta Children's Hospital. Each team will be comprised of a trauma team leader, second physician, three registered nurses and a respiratory therapist. Confederate actors will play the role of the medication nurse and respiratory therapist.
STUDY DESIGN:
This study utilizes a prospective, randomized controlled study design. The investigators propose a randomized control trial methodology with a control group representing standard practice to justify the change to adopt the method amongst clinical trauma teams.
Participants recruited to partake in the study will be asked to perform as members of a pediatric trauma resuscitation team. Each team of healthcare providers will be randomized into one of two study arms. In the intervention arm, the participants will watch a 10-minute recorded educational video demonstrating the use of the trauma checklist prior to their simulation scenario. These teams will subsequently receive a copy of the checklist for use during their simulation scenario. In the control arm, teams will not receive a copy of the checklist for use. All simulated trauma resuscitations will be video recorded and reviewed.
All teams will be asked to participate in a standardized 20-minute trauma resuscitation simulation scenario. This scenario will be followed by a 10-minute debriefing session facilitated by a simulation consultant. Following the trauma resuscitation scenario, and debriefing, the trauma team leader and bedside physician will be asked to complete the NASA Task Load Index (NASA-TLX) survey on cognitive workload. The data collected from this survey, will allow further insight into the impact on mental workload on participants with the use of a cognitive aid.
In addition, the trauma team leader will be asked to wear an eye-tracking device during the simulation scenario. Eye movements are recorded using an eye tracking system. The system captures a scene view calibrated to the participant's perspective of the environment, and an eye view capturing the surface anatomy of the eye (i.e. pupil, iris, sclera, eyelids). The software processes eye and scene data to compute point of gaze data in the environment. Eye-tracking data will be collected and analyzed for development of future studies. In particular, the study investigators aim to describe patterns of eye tracking of a trauma team leader during periods of critical interventions and key team member communication within a simulated scenario.
SAMPLE SIZE \& STATISTICAL ANALYSIS:
This study is a pilot study and the investigators will use team performance as unit of measure. In order to achieve a significant level of 0.05 and a power of 0.8, 12 teams per group allows us to detect a large effect size (d = 1.2). A 2-sample t-test is planned to detect the difference in time to initiation of key interventions between 2 groups. If the data does not fall with a normal distribution, the team will use the Wilcoxon rank sum test.
POSSIBLE PROBLEMS \& ANTICIPATED SOLUTIONS:
- Participants may have prior exposure to the trauma checklist: The Alberta Children's Hospital Trauma checklist has been available for use since July 2016. Physical copies are available in the trauma bay; however, the checklist was not formally introduced to the department staff with specific educational initiatives, demonstrations or rounds presentations. Less than 5 completed checklists have been submitted to the Trauma Committee for review. The success of checklist use is influenced by implementation and team culture. The investigators anticipate that participants will have minimal experience with checklist use.
- Imprecision of outcome measurements: Defining the exact timing of initiation and completion of clinical tasks by video review can be difficult and variable. The research team will determine standardized definitions for video reviewers. All video reviewers will undergo an hour long training session and assessment of their inter-rater reliability.
- Variability within the simulation scenario: A standardized simulation lab will be prepared. All simulations will be run by a study co-investigator and study coordinator. Confederate actors will undergo specific training and have tightly scripted roles.
Confidentiality and Privacy Protection
Informed and written consent to participate in this research study will be obtained from each team member before the start of each simulation scenario. All data will be stored on a password protected computer within a secured server that can only be accessed by research team members. Data will be destroyed after completion of the study.
- Conditions
- Trauma
- Being tested
- Checklist
- Keywords
- pediatric, checklist, cognitive aid
- 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.
ChecklistOther
The Alberta Children's Hospital Trauma Checklist was developed by the ACH Resuscitation Council Trauma Committee in response to a quality assurance review of high-acuity trauma activations. It is a cognitive aid and focuses in particular on pre-arrival preparation and a pre-departure review prior to patient transfer to diagnostic imaging or the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | In the control arm, teams will not receive a copy of the checklist for use. |
| Checklist Arm | Experimental | In the intervention arm, the participants will watch a 10 minute recorded educational video demonstrating the use of the trauma checklist prior to their simulation scenario. These teams will subsequently receive a copy of the checklist for use during their simulation scenario. Receives: Other: Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time measurement interval to initiation of endotracheal tube placement
Interval from start of scenario to endotracheal tube placement
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of induction medication
Interval from start of scenario to delivery of intubation induction medication
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of paralytic medication
Interval from start of scenario to delivery of intubation paralytic medication
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of bag mask ventilation
Interval from start of scenario to first assisted bag mask breath
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of fluid bolus administration
Interval from start of scenario to initiation of first crystalloid fluid bolus
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of blood product administration
Interval from start of scenario to initiation of first blood product administration
Measured: within the 20 minute simulation scenario
Time measurement interval to application of pelvic binder
Interval from start of scenario to application of pelvic binder
Measured: within the 20 minute simulation scenario
Time measurement interval to Glasgow Coma Score calculation
Interval from start of scenario to first verbalized and calculated Glasgow Coma Score
Measured: within the 20 minute simulation scenario
Time measurement interval to initiation of hyperosmolar therapy
Interval from start of scenario to initiation of hyperosmolar therapy, either mannitol or 3% saline
Measured: within the 20 minute simulation scenario
Time measurement interval to completion of log roll
Interval from start of scenario to completion of patient log roll
Measured: within the 20 minute simulation scenario
Secondary outcomes (3)
Advanced Trauma Life Support Task Performance
ATLS performance will be scored based on rates of completion of primary and secondary survey tasks, using a previously derived Trauma Resuscitation Checklist
Measured: within the 20 minute simulation scenario
Checklist completion
In the intervention arm, the investigators will determine the completion rate of the ACH trauma checklist by video review.
Measured: within the 20 minute simulation scenario
Eye movements of the trauma team leader
Data will be recorded off an eye tracking device worn by the trauma team leader. In particular, the investigators aim to describe patterns of eye tracking of a trauma team leader during periods critical patient interventions and key team member communication within a simulated scenario. There are 3 specific areas of interest: the patient, the monitor, and the external environment. The frequency of which eye movements rest on those areas will be tracked. This will be reported as a total duration of time (in minutes) spent looking at each of the 3 areas of interest.
Measured: within the 20 minute simulation scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startNov 2016
- Primary completionJan 2017
- Study completionJan 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- KidSIM Simulation Program
- Sponsor type
- Research network
- Collaborators
- KidSIM-ASPIRE
- Responsible party
- Sponsor
- Investigators
- Adam Cheng, MD FRCPC, Principal investigator, Alberta Children's Hospital, University of Calgary, KidSIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234049
- Sponsor's protocol ID
- REB16-1479
- Status last verified
- Jul 2017
- First submitted
- 3 Jan 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Pediatric Trauma Checklist to Improve Clinical Performance in a Simulated Trauma Resuscitation: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03234049
- Acronym / sponsor ID
- REB16-1479
- Conditions
- Trauma
- Keywords
- pediatric, checklist, cognitive aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- KidSIM Simulation ProgramResearch network
- Collaborators
- KidSIM-ASPIRE
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Jul 2017 (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.
The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH Resuscitation Council with input from the ACH Trauma Program. The purpose of this study is to determine if the introduction of the ACH Trauma Checklist as a cognitive aid, coupled with an educational session, will improve clinical performance in a simulated environment. The investigators plan to conduct a pilot, randomized control trial assessing the impact of the ACH trauma checklist on time to critical interventions on a simulated pediatric patient by multidisciplinary teams. The investigators hypothesize that teams who use a trauma checklist as a cognitive aid will have faster initiation of key clinical interventions within a simulated pediatric trauma resuscitation. Improvements in performance in a simulated environment with this tool may translate to similar results in the clinical setting.
Detailed description
Research Aims:
Aim 1: To evaluate the effectiveness of a pre-arrival, pre-departure trauma checklist on improving time to initiation of key clinical interventions in a simulated pediatric trauma scenario
Aim 2: To evaluate the impact of a pre-arrival, pre-departure trauma checklist on completion of primary and secondary survey tasks as demonstrated by an Advanced Trauma Life Support (ATLS) performance tool.
Aim 3: To evaluate the cognitive task load of a trauma checklist on emergency department physicians during a simulated trauma resuscitation scenario.
Aim 4: To describe patterns of eye movement of a trauma team leader in a simulated scenario in relation to critical patient interventions and team communication.
METHODS:
POPULATION:
Simulation scenarios will be run with multidisciplinary trauma teams recruited from the Alberta Children's Hospital. Each team will be comprised of a trauma team leader, second physician, three registered nurses and a respiratory therapist. Confederate actors will play the role of the medication nurse and respiratory therapist.
STUDY DESIGN:
This study utilizes a prospective, randomized controlled study design. The investigators propose a randomized control trial methodology with a control group representing standard practice to justify the change to adopt the method amongst clinical trauma teams.
Participants recruited to partake in the study will be asked to perform as members of a pediatric trauma resuscitation team. Each team of healthcare providers will be randomized into one of two study arms. In the intervention arm, the participants will watch a 10-minute recorded educational video demonstrating the use of the trauma checklist prior to their simulation scenario. These teams will subsequently receive a copy of the checklist for use during their simulation scenario. In the control arm, teams will not receive a copy of the checklist for use. All simulated trauma resuscitations will be video recorded and reviewed.
All teams will be asked to participate in a standardized 20-minute trauma resuscitation simulation scenario. This scenario will be followed by a 10-minute debriefing session facilitated by a simulation consultant. Following the trauma resuscitation scenario, and debriefing, the trauma team leader and bedside physician will be asked to complete the NASA Task Load Index (NASA-TLX) survey on cognitive workload. The data collected from this survey, will allow further insight into the impact on mental workload on participants with the use of a cognitive aid.
In addition, the trauma team leader will be asked to wear an eye-tracking device during the simulation scenario. Eye movements are recorded using an eye tracking system. The system captures a scene view calibrated to the participant's perspective of the environment, and an eye view capturing the surface anatomy of the eye (i.e. pupil, iris, sclera, eyelids). The software processes eye and scene data to compute point of gaze data in the environment. Eye-tracking data will be collected and analyzed for development of future studies. In particular, the study investigators aim to describe patterns of eye tracking of a trauma team leader during periods of critical interventions and key team member communication within a simulated scenario.
SAMPLE SIZE \& STATISTICAL ANALYSIS:
This study is a pilot study and the investigators will use team performance as unit of measure. In order to achieve a significant level of 0.05 and a power of 0.8, 12 teams per group allows us to detect a large effect size (d = 1.2). A 2-sample t-test is planned to detect the difference in time to initiation of key interventions between 2 groups. If the data does not fall with a normal distribution, the team will use the Wilcoxon rank sum test.
POSSIBLE PROBLEMS \& ANTICIPATED SOLUTIONS:
- Participants may have prior exposure to the trauma checklist: The Alberta Children's Hospital Trauma checklist has been available for use since July 2016. Physical copies are available in the trauma bay; however, the checklist was not formally introduced to the department staff with specific educational initiatives, demonstrations or rounds presentations. Less than 5 completed checklists have been submitted to the Trauma Committee for review. The success of checklist use is influenced by implementation and team culture. The investigators anticipate that participants will have minimal experience with checklist use.
- Imprecision of outcome measurements: Defining the exact timing of initiation and completion of clinical tasks by video review can be difficult and variable. The research team will determine standardized definitions for video reviewers. All video reviewers will undergo an hour long training session and assessment of their inter-rater reliability.
- Variability within the simulation scenario: A standardized simulation lab will be prepared. All simulations will be run by a study co-investigator and study coordinator. Confederate actors will undergo specific training and have tightly scripted roles.
Confidentiality and Privacy Protection
Informed and written consent to participate in this research study will be obtained from each team member before the start of each simulation scenario. All data will be stored on a password protected computer within a secured server that can only be accessed by research team members. Data will be destroyed after completion of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –In the control arm, teams will not receive a copy of the checklist for use. |
| Checklist Arm | Experimental | Other: ChecklistIn the intervention arm, the participants will watch a 10 minute recorded educational video demonstrating the use of the trauma checklist prior to their simulation scenario. These teams will subsequently receive a copy of the checklist for use during their simulation scenario. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Trauma team leader inclusion criteria:
- Second physician inclusion criteria:
- Nurse inclusion criteria:
Key exclusion criteria (1 listed)
- Previous participation in the study
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 |
|---|---|---|
| ChecklistThe Alberta Children's Hospital Trauma Checklist was developed by the ACH Resuscitation Council Trauma Committee in response to a quality assurance review of high-acuity trauma activations. It is a cognitive aid and focuses in particular on pre-arrival preparation and a pre-departure review prior to patient transfer to diagnostic imaging or the operating room. | Other | Checklist Arm |
Primary outcome
Time measurement interval to initiation of endotracheal tube placement
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to endotracheal tube placement
Time measurement interval to initiation of induction medication
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to delivery of intubation induction medication
Time measurement interval to initiation of paralytic medication
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to delivery of intubation paralytic medication
Time measurement interval to initiation of bag mask ventilation
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to first assisted bag mask breath
Time measurement interval to initiation of fluid bolus administration
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to initiation of first crystalloid fluid bolus
Time measurement interval to initiation of blood product administration
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to initiation of first blood product administration
Time measurement interval to application of pelvic binder
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to application of pelvic binder
Time measurement interval to Glasgow Coma Score calculation
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to first verbalized and calculated Glasgow Coma Score
Time measurement interval to initiation of hyperosmolar therapy
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to initiation of hyperosmolar therapy, either mannitol or 3% saline
Time measurement interval to completion of log roll
Time frame: within the 20 minute simulation scenario
Interval from start of scenario to completion of patient log roll
3 secondary outcomes
Advanced Trauma Life Support Task Performance
Time frame: within the 20 minute simulation scenario
Checklist completion
Time frame: within the 20 minute simulation scenario
Eye movements of the trauma team leader
Time frame: within the 20 minute simulation scenario
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 31 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Adam Cheng, MD FRCPC principal investigator
Alberta Children's Hospital, University of Calgary, KidSIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist in people with Trauma, run by KidSIM Simulation Program at 1 site in Canada.
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 6 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 31 Jul 2017. 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 Canada. 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?
Time measurement interval to initiation of endotracheal tube placement (time frame: within the 20 minute simulation scenario). The study lists 10 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 31 Jul 2017.