Wounds and InjuriesNCT03279575
Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage
A study testing Night Shift, Graveyard Shift and Educational program in people with Wounds and Injuries, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Night Shift, Graveyard Shift and Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2017to 11 Dec 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
- Emergency medicine physicians who work at a non-trauma center.
- Emergency medicine physicians who work at a Level III/IV trauma center.
Who cannot join
- Emergency medicine physicians who work only at a Level I/II trauma center.
- Emergency medicine physicians who do not practice in the US.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage: a Randomized Clinical Trial
The objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics.
Read the detailed description
Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators have developed two separate behavioral interventions to recalibrate physician heuristics in trauma triage, and will compare the effect of these interventions, an educational program, and no intervention on physician performance on a virtual simulation.
- Conditions
- Wounds and Injuries
- Being tested
- Night Shift, Graveyard Shift, Educational program, Control
- 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.
Night ShiftBehavioural
Physicians in this arm of the trial will be asked to play Night Shift, an adventure video game, for two hours.
Graveyard ShiftBehavioural
Physicians in this arm of the trial will be asked to play Graveyard Shift, a puzzle video game, for two hours.
Educational programBehavioural
Physicians in this arm of the trial will be asked to use myATLS, an app designed by the American College of Surgeons to serve as an adjunct to the ATLS course, and Trauma Life Support MCQ Review, an app designed to help students prepare for the ATLS exam. They will be asked to spend at least two hours on the combined tasks.
ControlBehavioural
Physicians in this arm will serve as a no-contact control group.
| Study group | Role | What they receive |
|---|---|---|
| Night Shift | Experimental | Night Shift is an adventure video game with the transformational goal of teaching physicians key characteristics of patients with non-representative severe injuries - injuries classified by the American College of Surgeons as life-threatening or critical but that do not fit the archetype of injuries typically requiring treatment at a trauma center. Players take on the persona of Andy Jordan, a young emergency physician who moves home after the disappearance of his estranged grandfather (Robert Jordan) and takes up a job in the local Emergency Department (ED). In the preamble, players learn they have two explicit objectives. First, they must diagnose and treat patients who present to their ED. Second they must solve the mystery of Robert's disappearance: was he murdered or has he simply chosen to disappear? Receives: Behavioral: Night Shift |
| Graveyard Shift | Experimental | Graveyard Shift is a puzzle video game with the transformational goal of helping physicians derive key triage decision principles for themselves. They complete a three-step game loop to obtain case information, compare cases to determine similarities and differences between cases, and then explicitly state the decision principle that should drive decision making. Receives: Behavioral: Graveyard Shift |
| Educational program | Active comparator | The educational module consists of two separate apps, both commercially available. myATLS includes a review of each chapter of the Advanced Trauma Life Support (ATLS) textbook, a series of videos demonstrating common trauma procedures, and clinical resources including checklists for use at the bedside. Trauma Life Support MCQ Review includes 550 multiple-choice questions with correct answers and explanations. The investigators will ask physicians to review the myATLS app and then com Receives: Behavioral: Educational program |
| Control | Placebo comparator | Physicians in this arm will not be asked to complete any intervention. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of successful triage
Physicians in all arms of the study will be asked to complete a virtual simulation, upon completion of the intervention, ideally within one month of enrollment.
The virtual simulation replicates the environment of the ED. Physicians have to manage 10 patients that appear concurrently, while also responding to a series of audio-visual distractors. Specifically, they must provide information on whether they will admit, transfer, or discharge the patients home. The investigators will categorize severely injured patients as successfully transferred (transferred to a trauma center or died in the ED) or not (admitted). We will use a Poisson regression to estimate the association between successful transfer and exposure to the different interventions (Night Shift v. Graveyard Shift v. educational program v. control).
Measured: One month after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start29 Oct 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
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 Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1:1 allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepika Mohan, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279575
- Sponsor's protocol ID
- PRO17090094
- Status last verified
- Jan 2018
- First submitted
- 7 Sep 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available on application to the investigator team.
Publications
Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
PubMed 30150397
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03279575
- Acronym / sponsor ID
- PRO17090094
- Conditions
- Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 29 Oct 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 12 Sep 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 objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics.
Detailed description
Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators have developed two separate behavioral interventions to recalibrate physician heuristics in trauma triage, and will compare the effect of these interventions, an educational program, and no intervention on physician performance on a virtual simulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 1:1:1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Night Shift | Experimental | Behavioral: Night ShiftNight Shift is an adventure video game with the transformational goal of teaching physicians key characteristics of patients with non-representative severe injuries - injuries classified by the American College of Surgeons as life-threatening or critical but that do not fit the archetype of injuries typically requiring treatment at a trauma center. Players take on the persona of Andy Jordan, a young emergency physician who moves home after the disappearance of his estranged grandfather (Robert Jordan) and takes up a job in the local Emergency Department (ED). In the preamble, players learn they have two explicit objectives. First, they must diagnose and treat patients who present to their ED. Second they must solve the mystery of Robert's disappearance: was he murdered or has he simply chosen to disappear? |
| Graveyard Shift | Experimental | Behavioral: Graveyard ShiftGraveyard Shift is a puzzle video game with the transformational goal of helping physicians derive key triage decision principles for themselves. They complete a three-step game loop to obtain case information, compare cases to determine similarities and differences between cases, and then explicitly state the decision principle that should drive decision making. |
| Educational program | Active comparator | Behavioral: Educational programThe educational module consists of two separate apps, both commercially available. myATLS includes a review of each chapter of the Advanced Trauma Life Support (ATLS) textbook, a series of videos demonstrating common trauma procedures, and clinical resources including checklists for use at the bedside. Trauma Life Support MCQ Review includes 550 multiple-choice questions with correct answers and explanations. The investigators will ask physicians to review the myATLS app and then com |
| Control | Placebo comparator | Behavioral: ControlPhysicians in this arm will not be asked to complete any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency medicine physicians who work at a non-trauma center.
- Emergency medicine physicians who work at a Level III/IV trauma center.
Key exclusion criteria (2 listed)
- Emergency medicine physicians who work only at a Level I/II trauma center.
- Emergency medicine physicians who do not practice in the US.
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 |
|---|---|---|
| Night ShiftPhysicians in this arm of the trial will be asked to play Night Shift, an adventure video game, for two hours. | Behavioural | Night Shift |
| Graveyard ShiftPhysicians in this arm of the trial will be asked to play Graveyard Shift, a puzzle video game, for two hours. | Behavioural | Graveyard Shift |
| Educational programPhysicians in this arm of the trial will be asked to use myATLS, an app designed by the American College of Surgeons to serve as an adjunct to the ATLS course, and Trauma Life Support MCQ Review, an app designed to help students prepare for the ATLS exam. They will be asked to spend at least two hours on the combined tasks. | Behavioural | Educational program |
| ControlPhysicians in this arm will serve as a no-contact control group. | Behavioural | Control |
Primary outcome
Incidence rate of successful triage
Time frame: One month after completion of the intervention
Physicians in all arms of the study will be asked to complete a virtual simulation, upon completion of the intervention, ideally within one month of enrollment. The virtual simulation replicates the environment of the ED. Physicians have to manage 10 patients that appear concurrently, while also responding to a series of audio-visual distractors. Specifically, they must provide information on whether they will admit, transfer, or discharge the patients home. The investigators will categorize severely injured patients as successfully transferred (transferred to a trauma center or died in the ED) or not (admitted). We will use a Poisson regression to estimate the association between successful transfer and exposure to the different interventions (Night Shift v. Graveyard Shift v. educational program v. control).
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 9 Jan 2018.
- Derived from this study: PubMed 30150397Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
- Individual participant dataSharing planned: Yes. De-identified data will be made available on application to the investigator team.
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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?
A study testing Night Shift, Graveyard Shift and Educational program in people with Wounds and Injuries, run by University of Pittsburgh at 1 site in United States.
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 9 Jan 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Incidence rate of successful triage (time frame: One month after completion of the intervention). 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 NCT03279575, 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 9 Jan 2018.