<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/NCT03757884</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00145793</org_study_id>
    <nct_id>NCT03757884</nct_id>
  </id_info>
  <brief_title>Medical Decisions in the Hospital Setting- M-Safety</brief_title>
  <acronym>M-Safety</acronym>
  <official_title>Improving Medical-Decision Through Cognition, Technology and Communication, Phase 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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>
      This project will introduce and evaluate an intervention designed to improve diagnostic&#xD;
      decision making. The intervention will attempt to increase clinician mindfulness and reduce&#xD;
      environmental distractions to promote focused thinking. A meta-cognitive intervention using a&#xD;
      structured checklist will be evaluated to identify improvement in diagnostic and therapeutic&#xD;
      decision-making and examine the role of mindfulness and architectural design in enhancing&#xD;
      patient safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will introduce and evaluate an intervention designed to improve diagnostic&#xD;
      decision making. The intervention will attempt to increase clinician mindfulness and reduce&#xD;
      environmental distractions to promote system 2 thinking. A meta-cognitive intervention using&#xD;
      a structured checklist will be evaluated to identify improvement in diagnostic and&#xD;
      therapeutic decision-making and examine the role of mindfulness and architectural design in&#xD;
      enhancing patient safety.&#xD;
&#xD;
      This a pretest-posttest design study that will be conducted with hospitalist physicians&#xD;
      working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed&#xD;
      intervention will provide the participants with tools to help promote mindfulness and focus&#xD;
      to assist with the diagnostic process. To reduce distraction, headphones to block out&#xD;
      surrounding noise and table screens to limit distractions will be offered. To assist with&#xD;
      diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application&#xD;
      will be provided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Actual">September 17, 2019</completion_date>
  <primary_completion_date type="Actual">September 17, 2019</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>
    <intervention_model_description>Pre-posttest study design</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Number of Patient Differential Diagnosis</measure>
    <time_frame>8 months</time_frame>
    <description>Differential Diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Use of Diagnostic Checklist</measure>
    <time_frame>8 months</time_frame>
    <description>Diagnostic Checklist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mindfulness Behaviors Score</measure>
    <time_frame>8 months</time_frame>
    <description>This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Patient Diagnostic Testing</measure>
    <time_frame>8 months</time_frame>
    <description>Diagnostic Testing includes Laboratory and Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time Participants are Measured as Calm</measure>
    <time_frame>8 months</time_frame>
    <description>Time Measured in Minutes, Using the Spire Monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time Participants are Measured as Focused</measure>
    <time_frame>8 months</time_frame>
    <description>Time Measured in Minutes, Using the Spire Monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time Participants are Measured as Tense</measure>
    <time_frame>8 months</time_frame>
    <description>Time Measured in Minutes, Using the Spire Monitor</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Diagnostic Errors</condition>
  <arm_group>
    <arm_group_label>Virtual Pod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness breathing exercise</intervention_name>
    <description>Spire monitor instructed mindfulness breathing</description>
    <arm_group_label>Virtual Pod</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diagnostic Checklist</intervention_name>
    <description>Checklist reminder for diagnosis</description>
    <arm_group_label>Virtual Pod</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Noise cancelling headphones</intervention_name>
    <description>Noise cancelling headphones</description>
    <arm_group_label>Virtual Pod</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Privacy tablescreen</intervention_name>
    <description>Privacy Tablescreen</description>
    <arm_group_label>Virtual Pod</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diagnostic assistance application</intervention_name>
    <description>Diagnostic assistance application</description>
    <arm_group_label>Virtual Pod</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital Medicine Physicians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physicians other than Hopitalists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vineet I Chopra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann Arbor VA Healthcare System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://psep.med.umich.edu/</url>
    <description>Patient Safety &amp; Enhancement Program at the University of Michigan and the Ann Arbor VA Heathcare System</description>
  </link>
  <reference>
    <citation>Chopra V, Harrod M, Winter S, Forman J, Quinn M, Krein S, Fowler KE, Singh H, Saint S. Focused Ethnography of Diagnosis in Academic Medical Centers. J Hosp Med. 2018 Oct 1;13(10):668-672. doi: 10.12788/jhm.2966. Epub 2018 Apr 25.</citation>
    <PMID>29694450</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Vineet Chopra</investigator_full_name>
    <investigator_title>Chief, Division of Hospital Medicine</investigator_title>
  </responsible_party>
  <keyword>Diagnostic Errors</keyword>
  <keyword>Hospital Medicine</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data security rules and regulations of the participating facilities (such as the University of Michigan and the Department of Veterans Affairs) will be followed. If data can be shared, all identifiers will be removed from the data. Data will be made available for research to those who request it once analyses has been conducted and findings have been published. Persons interested in using the data will need to submit a request in writing, stating their intended use.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Following completion of data analysis and manuscript publication</ipd_time_frame>
    <ipd_access_criteria>Persons interested in using the data will need to submit a request in writing, stating their intended use. Requirements for sharing will include proof of IRB approval, acknowledgement in all publications of the funding source and of the study authors.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03757884/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03757884
org study id: HUM00145793
nct id: NCT03757884
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This project will introduce and evaluate an intervention designed to improve diagnostic
      decision making. The intervention will attempt to increase clinician mindfulness and reduce
      environmental distractions to promote focused thinking. A meta-cognitive intervention using a
      structured checklist will be evaluated to identify improvement in diagnostic and therapeutic
      decision-making and examine the role of mindfulness and architectural design in enhancing
      patient safety.
This project will introduce and evaluate an intervention designed to improve diagnostic
      decision making. The intervention will attempt to increase clinician mindfulness and reduce
      environmental distractions to promote system 2 thinking. A meta-cognitive intervention using
      a structured checklist will be evaluated to identify improvement in diagnostic and
      therapeutic decision-making and examine the role of mindfulness and architectural design in
      enhancing patient safety.

      This a pretest-posttest design study that will be conducted with hospitalist physicians
      working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed
      intervention will provide the participants with tools to help promote mindfulness and focus
      to assist with the diagnostic process. To reduce distraction, headphones to block out
      surrounding noise and table screens to limit distractions will be offered. To assist with
      diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application
      will be provided.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-posttest study design
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Number of Patient Differential Diagnosis
time frame: 8 months
description: Differential Diagnosis
measure: Change in the Use of Diagnostic Checklist
time frame: 8 months
description: Diagnostic Checklist
measure: Change in Mindfulness Behaviors Score
time frame: 8 months
description: This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never
measure: Change in Number of Patient Diagnostic Testing
time frame: 8 months
description: Diagnostic Testing includes Laboratory and Imaging
measure: Change in Time Participants are Measured as Calm
time frame: 8 months
description: Time Measured in Minutes, Using the Spire Monitor
measure: Change in Time Participants are Measured as Focused
time frame: 8 months
description: Time Measured in Minutes, Using the Spire Monitor
measure: Change in Time Participants are Measured as Tense
time frame: 8 months
description: Time Measured in Minutes, Using the Spire Monitor
arm group label: Virtual Pod
arm group type: Experimental
description: Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application
intervention type: Behavioral
intervention name: Mindfulness breathing exercise
description: Spire monitor instructed mindfulness breathing
arm group label: Virtual Pod
intervention type: Behavioral
intervention name: Diagnostic Checklist
description: Checklist reminder for diagnosis
arm group label: Virtual Pod
intervention type: Behavioral
intervention name: Noise cancelling headphones
description: Noise cancelling headphones
arm group label: Virtual Pod
intervention type: Behavioral
intervention name: Privacy tablescreen
description: Privacy Tablescreen
arm group label: Virtual Pod
intervention type: Behavioral
intervention name: Diagnostic assistance application
description: Diagnostic assistance application
arm group label: Virtual Pod
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vineet I Chopra, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
country: United States
url: http://psep.med.umich.edu/
description: Patient Safety & Enhancement Program at the University of Michigan and the Ann Arbor VA Heathcare System
citation: Chopra V, Harrod M, Winter S, Forman J, Quinn M, Krein S, Fowler KE, Singh H, Saint S. Focused Ethnography of Diagnosis in Academic Medical Centers. J Hosp Med. 2018 Oct 1;13(10):668-672. doi: 10.12788/jhm.2966. Epub 2018 Apr 25.
PMID: 29694450
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Vineet Chopra
investigator title: Chief, Division of Hospital Medicine
sharing ipd: Yes
ipd description: Data security rules and regulations of the participating facilities (such as the University of Michigan and the Department of Veterans Affairs) will be followed. If data can be shared, all identifiers will be removed from the data. Data will be made available for research to those who request it once analyses has been conducted and findings have been published. Persons interested in using the data will need to submit a request in writing, stating their intended use.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Following completion of data analysis and manuscript publication
ipd access criteria: Persons interested in using the data will need to submit a request in writing, stating their intended use. Requirements for sharing will include proof of IRB approval, acknowledgement in all publications of the funding source and of the study authors.
provided document: 