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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Canada1 site
  • KidSIM, Alberta Children's Hospital

    Calgary, Alberta, T3B6A8

Other trials in Canada

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:

  1. 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.
  2. 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.
  3. 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 groups in NCT03234049
Study groupRoleWhat they receive
Control ArmNo interventionIn the control arm, teams will not receive a copy of the checklist for use.
Checklist ArmExperimentalIn 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted31 Jul 2017
  2. Study startNov 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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)
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

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.

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