<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/NCT03833622</url>
  </required_header>
  <id_info>
    <org_study_id>17-000128</org_study_id>
    <nct_id>NCT03833622</nct_id>
  </id_info>
  <brief_title>Shared Decision Making to Improve Goals of Care in the ED</brief_title>
  <official_title>Shared Decision Making to Improve Goals of Care Discussions in the Emergency Department</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>
      This project will develop and refine a shared decision making (SDM) intervention (decision&#xD;
      aid tool) to improve and normalize high quality end of life discussions in the Emergency&#xD;
      Department (ED) setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Develop a shared decision making (SDM) intervention informed by insights elicited from&#xD;
      patients and clinicians to improve goals of care discussions.&#xD;
&#xD;
      The process of decision aid design involves: (1) review and synthesis of the evidence; (2) an&#xD;
      analysis of usual practice through observation of clinical encounters; (3) development of an&#xD;
      initial decision aid prototype; (4) field testing in the context of clinical care to gain&#xD;
      insights on both intended and unintended effects of its use in practice to facilitate patient&#xD;
      centered goals of care discussions; and (5) successive iterations of the decision aid until&#xD;
      thematic saturation is reached and it is ready for testing in a clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient and physician feedback survey for tool development and iterative refinement</measure>
    <time_frame>1 year</time_frame>
    <description>A debrief survey/open-ended questionnaire is filled out by the patient and his/her provider to collect feedback. This is used to refine this shared decision making (SDM) intervention in the Emergency Department (ED) setting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and physician satisfaction questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>A satisfaction questionnaire is filled out by the patient and his/her provider following conversation on goals of care either with or without the SDM intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Goals</condition>
  <arm_group>
    <arm_group_label>Shared decision aid assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be selected to have a goals of care discussion with an emergency physician utilizing a pilot decision aid and will be asked for feedback to assist with refinement of the decision aid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shared Decision Aid Assessment</intervention_name>
    <description>Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department</description>
    <arm_group_label>Shared decision aid assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department,&#xD;
&#xD;
          2. Patients at high risk for critical illness as determined by an Elderly Risk Assessment&#xD;
             (ERA) score ≥ 16 or as determined by provider discretion,&#xD;
&#xD;
          3. ≥ 60 years of age,&#xD;
&#xD;
          4. Ability to provide informed consent,&#xD;
&#xD;
          5. Medically stable at the time of enrollment,&#xD;
&#xD;
          6. Able to participate without causing a delay in care.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. GCS scores &lt; 15,&#xD;
&#xD;
          2. Signs of altered mental status,&#xD;
&#xD;
          3. Known to be pregnant,&#xD;
&#xD;
          4. Incarcerated or in Police Custody,&#xD;
&#xD;
          5. Communication barriers such as visual or hearing impairment that may preclude use of&#xD;
             the decision aid.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura E Walker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Berning</last_name>
      <phone>507-255-5056</phone>
      <email>Berning.Michelle1@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Derek VanMeter</last_name>
      <phone>5072554016</phone>
      <email>vanmeter.derek@mayo.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 3, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Laura E. Walker</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03833622
org study id: 17-000128
nct id: NCT03833622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project will develop and refine a shared decision making (SDM) intervention (decision
      aid tool) to improve and normalize high quality end of life discussions in the Emergency
      Department (ED) setting.
Develop a shared decision making (SDM) intervention informed by insights elicited from
      patients and clinicians to improve goals of care discussions.

      The process of decision aid design involves: (1) review and synthesis of the evidence; (2) an
      analysis of usual practice through observation of clinical encounters; (3) development of an
      initial decision aid prototype; (4) field testing in the context of clinical care to gain
      insights on both intended and unintended effects of its use in practice to facilitate patient
      centered goals of care discussions; and (5) successive iterations of the decision aid until
      thematic saturation is reached and it is ready for testing in a clinical trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient and physician feedback survey for tool development and iterative refinement
time frame: 1 year
description: A debrief survey/open-ended questionnaire is filled out by the patient and his/her provider to collect feedback. This is used to refine this shared decision making (SDM) intervention in the Emergency Department (ED) setting.
measure: Patient and physician satisfaction questionnaire
time frame: 1 year
description: A satisfaction questionnaire is filled out by the patient and his/her provider following conversation on goals of care either with or without the SDM intervention.
arm group label: Shared decision aid assessment
arm group type: Experimental
description: Patients will be selected to have a goals of care discussion with an emergency physician utilizing a pilot decision aid and will be asked for feedback to assist with refinement of the decision aid.
intervention type: Other
intervention name: Shared Decision Aid Assessment
description: Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department
arm group label: Shared decision aid assessment
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Laura E Walker
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
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: Laura E. Walker
investigator title: Principal Investigator