<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03279575</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17090094</org_study_id>
    <nct_id>NCT03279575</nct_id>
  </id_info>
  <brief_title>Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage</brief_title>
  <official_title>Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the efficacy of two behavioral interventions at&#xD;
      recalibrating physician heuristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries.&#xD;
      Accordingly, professional organizations, state authorities, and the federal government have&#xD;
      endorsed the systematic triage and transfer of these patients to trauma centers either&#xD;
      directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30&#xD;
      to 40% of patients with moderate-to-severe injuries still only receive treatment at&#xD;
      non-trauma centers, so-called under-triage. Most of this under-triage occurs because of&#xD;
      physician decisions (rather than first-responder decisions). Existing efforts to change&#xD;
      physician decision making focus primarily on knowledge of clinical practice guidelines and&#xD;
      attitudes towards the guidelines. These strategies ignores the growing consensus that&#xD;
      decision making reflects both knowledge as well as intuitive judgments (heuristics).&#xD;
      Heuristics, mental short cuts based on pattern recognition, drive the majority of decision&#xD;
      making. The investigators have developed two separate behavioral interventions to recalibrate&#xD;
      physician heuristics in trauma triage, and will compare the effect of these interventions, an&#xD;
      educational program, and no intervention on physician performance on a virtual simulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2017</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>1:1:1:1 allocation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>We will mask the intervention status of participants when analyzing the data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of successful triage</measure>
    <time_frame>One month after completion of the intervention</time_frame>
    <description>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.&#xD;
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).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>Night Shift</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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?</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graveyard Shift</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Physicians in this arm will not be asked to complete any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Night Shift</intervention_name>
    <description>Physicians in this arm of the trial will be asked to play Night Shift, an adventure video game, for two hours.</description>
    <arm_group_label>Night Shift</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Graveyard Shift</intervention_name>
    <description>Physicians in this arm of the trial will be asked to play Graveyard Shift, a puzzle video game, for two hours.</description>
    <arm_group_label>Graveyard Shift</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational program</intervention_name>
    <description>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.</description>
    <arm_group_label>Educational program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Physicians in this arm will serve as a no-contact control group.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency medicine physicians who work at a non-trauma center.&#xD;
&#xD;
          -  Emergency medicine physicians who work at a Level III/IV trauma center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency medicine physicians who work only at a Level I/II trauma center.&#xD;
&#xD;
          -  Emergency medicine physicians who do not practice in the US.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Deepika Mohan</investigator_full_name>
    <investigator_title>Assistant professor of critical care medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be made available on application to the investigator team.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03279575
org study id: PRO17090094
nct id: NCT03279575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to compare the efficacy of two behavioral interventions at
      recalibrating physician heuristics.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1:1:1 allocation
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: We will mask the intervention status of participants when analyzing the data.
measure: Incidence rate of successful triage
time frame: One month after completion of the intervention
description: 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).
arm group label: Night Shift
arm group type: Experimental
description: 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?
arm group label: Graveyard Shift
arm group type: Experimental
description: 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.
arm group label: Educational program
arm group type: Active Comparator
description: 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
arm group label: Control
arm group type: Placebo Comparator
description: Physicians in this arm will not be asked to complete any intervention.
intervention type: Behavioral
intervention name: Night Shift
description: Physicians in this arm of the trial will be asked to play Night Shift, an adventure video game, for two hours.
arm group label: Night Shift
intervention type: Behavioral
intervention name: Graveyard Shift
description: Physicians in this arm of the trial will be asked to play Graveyard Shift, a puzzle video game, for two hours.
arm group label: Graveyard Shift
intervention type: Behavioral
intervention name: Educational program
description: 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.
arm group label: Educational program
intervention type: Behavioral
intervention name: Control
description: Physicians in this arm will serve as a no-contact control group.
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Deepika Mohan
investigator title: Assistant professor of critical care medicine
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: De-identified data will be made available on application to the investigator team.
ipd info type: Study Protocol