<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/NCT04466423</url>
  </required_header>
  <id_info>
    <org_study_id>13-004834</org_study_id>
    <nct_id>NCT04466423</nct_id>
  </id_info>
  <brief_title>Intervention Trial to Increase Meaning in Work and Reduce Burnout</brief_title>
  <official_title>Intervention Trial Designed to Promote Collegiality and Mutual Support at Work as a Way to Increase Meaning in Work and Reduce Burnout</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Collegiality is a one of the great virtues of physician-hood. Mutual support from colleagues&#xD;
      to help deal with the challenges of being a physician has long helped physicians manage the&#xD;
      stress related to practicing medicine and helped physicians derive meaning from their work.&#xD;
      Unfortunately, increased productivity expectations and other changes to the practice of&#xD;
      medicine over the last several decades have decreased the time physicians have to interact&#xD;
      with colleagues and eroded the fabric of collegiality. Recent studies suggest burnout affects&#xD;
      nearly half of U.S. physicians at any given point in time and has substantial personal and&#xD;
      professional consequences. The steps organizations can take to promote collegiality are&#xD;
      unknown. The goal of the present study is to evaluate the ability of an organizational&#xD;
      intervention to encourage collegiality, shared experience, connectedness, and mutual support.&#xD;
      This study builds on two prior intervention studies directed by the Mayo Clinic Department of&#xD;
      Medicine Program on Physician Well-Being, the first focusing on a small group facilitated&#xD;
      well-being curriculum and the second focusing on individual electronic tasks to prompt&#xD;
      positive reflection and gratitude.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2013</start_date>
  <completion_date type="Actual">October 1, 2014</completion_date>
  <primary_completion_date type="Actual">October 1, 2014</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>Two-arm randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Groups labeled &quot;1&quot; or &quot;2&quot; with random order assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Burnout</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>Maslach Burnout Inventory results</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>PRIME-MD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>LASA QOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Job satisfaction</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>PJSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meaning at work</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>EWS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>Social Provisions Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social isolation</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>PROMIS Social Isolation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Job turnover</measure>
    <time_frame>12 month outcomes</time_frame>
    <description>Single item asking about 2-year plans to leave current practice</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Burnout, Professional</condition>
  <arm_group>
    <arm_group_label>Small group intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those randomized to the immediate intervention arm will be asked to meet approximately every other week for 6 months, covering 12 sessions. We will ask each group to meet in a relatively private setting (e.g., a restaurant near campus or a reserved meeting room), rather than more public spaces (e.g. river room, cafeteria) where interruptions are more likely.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to Arm 2 (delayed intervention) will be &quot;wait listed&quot; to begin sessions 6 months after the start of the study. This participation will be optional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)</intervention_name>
    <description>The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question. Group leaders will be provided 3-4 discussion questions for each session. The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together. Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies. The remainder of the time can be used for socializing and building relationships with colleagues.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Small group intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Senior Associate Consultants and Consultants in the Mayo Clinic Department of Medicine&#xD;
             will be eligible for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None beyond inclusion criteria.&#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>Colin West, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Colin West</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>well-being</keyword>
  <keyword>burnout</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulfamethazine</mesh_term>
  </intervention_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/NCT04466423
org study id: 13-004834
nct id: NCT04466423
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Collegiality is a one of the great virtues of physician-hood. Mutual support from colleagues
      to help deal with the challenges of being a physician has long helped physicians manage the
      stress related to practicing medicine and helped physicians derive meaning from their work.
      Unfortunately, increased productivity expectations and other changes to the practice of
      medicine over the last several decades have decreased the time physicians have to interact
      with colleagues and eroded the fabric of collegiality. Recent studies suggest burnout affects
      nearly half of U.S. physicians at any given point in time and has substantial personal and
      professional consequences. The steps organizations can take to promote collegiality are
      unknown. The goal of the present study is to evaluate the ability of an organizational
      intervention to encourage collegiality, shared experience, connectedness, and mutual support.
      This study builds on two prior intervention studies directed by the Mayo Clinic Department of
      Medicine Program on Physician Well-Being, the first focusing on a small group facilitated
      well-being curriculum and the second focusing on individual electronic tasks to prompt
      positive reflection and gratitude.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Groups labeled "1" or "2" with random order assignment.
measure: Burnout
time frame: 12 month outcomes
description: Maslach Burnout Inventory results
measure: Depressive symptoms
time frame: 12 month outcomes
description: PRIME-MD
measure: Quality of life
time frame: 12 month outcomes
description: LASA QOL
measure: Job satisfaction
time frame: 12 month outcomes
description: PJSS
measure: Meaning at work
time frame: 12 month outcomes
description: EWS
measure: Social support
time frame: 12 month outcomes
description: Social Provisions Scale
measure: Social isolation
time frame: 12 month outcomes
description: PROMIS Social Isolation
measure: Job turnover
time frame: 12 month outcomes
description: Single item asking about 2-year plans to leave current practice
arm group label: Small group intervention
arm group type: Experimental
description: Those randomized to the immediate intervention arm will be asked to meet approximately every other week for 6 months, covering 12 sessions. We will ask each group to meet in a relatively private setting (e.g., a restaurant near campus or a reserved meeting room), rather than more public spaces (e.g. river room, cafeteria) where interruptions are more likely.
arm group label: Control
arm group type: Placebo Comparator
description: Participants randomized to Arm 2 (delayed intervention) will be "wait listed" to begin sessions 6 months after the start of the study. This participation will be optional.
intervention type: Behavioral
intervention name: Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)
description: The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question. Group leaders will be provided 3-4 discussion questions for each session. The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together. Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies. The remainder of the time can be used for socializing and building relationships with colleagues.
arm group label: Control
arm group label: Small group intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Colin West, MD
role: Principal Investigator
affiliation: Mayo Clinic
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Colin West
investigator title: Principal Investigator
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
mesh term: Sulfamethazine
sharing ipd: No