<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/NCT04441632</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000786</org_study_id>
    <nct_id>NCT04441632</nct_id>
  </id_info>
  <brief_title>Effect of Positive Attitudes on Behavior and Wellness</brief_title>
  <acronym>TEAM-ICU</acronym>
  <official_title>The Impact of Positive Reinforcement on Teamwork Climate, Resiliency, and Burnout During the COVID-19 Pandemic: the TEAM-ICU Study (Transforming Employee Attitudes Via Messaging Strengthens Interconnection, Communication, and Unity)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe,&#xD;
      but none more than to the providers on the front-line. The purpose of the study is to first,&#xD;
      assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare&#xD;
      providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators&#xD;
      hope to then assess the effects of simple positive feedback on transforming culture and&#xD;
      attitudes during times of major stress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 26, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 * 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resiliency, as measured by the validated Brief Resilience Scale (BRS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Burnout, as validated by the single-item burnout scale inventory</measure>
    <time_frame>4 weeks</time_frame>
    <description>This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Burnout</condition>
  <condition>Stress, Emotional</condition>
  <arm_group>
    <arm_group_label>Positive feedback</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the study will provide consistent positive feedback to the colleagues they work with in the medical ICU (MICU) over a 4 week duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive feedback</intervention_name>
    <description>Participants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period).</description>
    <arm_group_label>Positive feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Front-line healthcare providers in the Medical Intensive Care Unit (MICU): nurses,&#xD;
             respiratory therapists, resident physicians, fellow physicians, and attending&#xD;
             physicians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthcare providers providing only consultatory care in the MICU&#xD;
&#xD;
          -  Front-line healthcare providers not working in the MICU during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack Green, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Jack Green</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>wellness</keyword>
  <keyword>healthcare</keyword>
  <keyword>burnout</keyword>
  <keyword>COVID</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04441632
org study id: STUDY00000786
nct id: NCT04441632
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe,
      but none more than to the providers on the front-line. The purpose of the study is to first,
      assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare
      providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators
      hope to then assess the effects of simple positive feedback on transforming culture and
      attitudes during times of major stress.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)
time frame: 4 weeks
description: The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 * 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points).
measure: Resiliency, as measured by the validated Brief Resilience Scale (BRS)
time frame: 4 weeks
description: The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.
measure: Burnout, as validated by the single-item burnout scale inventory
time frame: 4 weeks
description: This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment
arm group label: Positive feedback
arm group type: Other
description: Participants in the study will provide consistent positive feedback to the colleagues they work with in the medical ICU (MICU) over a 4 week duration.
intervention type: Behavioral
intervention name: Positive feedback
description: Participants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period).
arm group label: Positive feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jack Green, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Jack Green
investigator title: Assistant Professor of Pediatrics
mesh term: Burnout, Psychological
sharing ipd: No