xml: <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/NCT06002113</url>
    </required_header>
    <id_info>
      <org_study_id>R22-003</org_study_id>
      <nct_id>NCT06002113</nct_id>
    </id_info>
    <brief_title>Eliciting Informed Goals of Care in Elderly Patients</brief_title>
    <acronym>ASKMEGOC</acronym>
    <official_title>Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal Victoria Hospital, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal Victoria Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Alectra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Royal Victoria Hospital, Canada</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Patient-centered medical care considers a patient's values and goals for their health and&#xD;
        well-being. Healthcare providers use this information to formulate a medical care plan that&#xD;
        is aligned with these expectations. This shared-decision making process should occur with&#xD;
        every medical decision, but it is especially important whenever decisions about end-of-life&#xD;
        care are being considered. Eliciting patient preferences about resuscitation and life-support&#xD;
        treatments in the event of life-threatening illnesses are considered to be a standard of&#xD;
        excellent and appropriate medical care. Unfortunately, these discussions don't happen&#xD;
        consistently and even when they do occur, are rarely ideal. The consequences can be&#xD;
        devastating, often resulting in the delivery of unwanted medical care that can be associated&#xD;
        with significant physical and mental suffering among patients and their families. In response&#xD;
        to this problem, the investigators developed a novel tool to help guide these difficult&#xD;
        conversations between healthcare providers and patients. The investigators previously tested&#xD;
        this tool in a small group of hospitalized patients who found it acceptable and helpful. In&#xD;
        this larger study, the investigators will compare how effective this tool is compared to&#xD;
        usual care in ensuring hospitalized patients have their treatment preferences identified,&#xD;
        documented and result in end-of-life care that is consistent with their preferences.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives:&#xD;
  &#xD;
          1. To determine the impact of facilitated Goals of Care Discussions (GOCDs) on the number&#xD;
             of ICU, ventilator, and dialysis days during the index hospitalization (or until death)&#xD;
  &#xD;
          2. To determine the impact of facilitated GOCDs on the number of hospital, ICU, ventilator,&#xD;
             and dialysis days after the index hospitalization until 12 months post-discharge (or&#xD;
             until death).&#xD;
  &#xD;
          3. To determine the impact of facilitated GOCDs on the concordance between documented&#xD;
             patient preferences for Life-Sustaining Therapies (LSTs) (during the index&#xD;
             hospitalization) and whether these LSTs were received after the index hospitalization&#xD;
             until 12 months post-discharge (or until death).&#xD;
  &#xD;
          4. To determine the impact of facilitated GOCDs on other outcomes including decisional&#xD;
             conflict and quality of communication, patient satisfaction with the encounter, and&#xD;
             place of death.&#xD;
  &#xD;
          5. To determine the barriers and facilitators to the implementation of GOCDs.&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        A prospective, single-centre, stratified, parallel group, allocation concealed,&#xD;
        statistician-masked, randomized, pragmatic, mixed-method, comparative effectiveness trial in&#xD;
        hospitalized elderly patients 80 years and older.&#xD;
  &#xD;
        Participants:&#xD;
  &#xD;
        This study will include all elderly patients admitted to the Royal Victoria Regional Health&#xD;
        Centre in Barrie, Ontario, Canada, with an acute medical or surgical diagnosis who fulfill&#xD;
        all the inclusion criteria and for whom none of the exclusion criteria exist.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</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>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ICU-related health care utilization</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>total number of ventilator, ICU, and dialysis days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ICU-related health care utilization</measure>
      <time_frame>12 months after discharge from index hospital admission</time_frame>
      <description>total number of ventilator, ICU, and dialysis days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Goal-concordant care for ICU-related health care utilization</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>proportion of patients who received goal-concordant care according to resuscitation preferences</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Goal-concordant care for ICU-related health care utilization</measure>
      <time_frame>12 months after discharge from index hospital admission</time_frame>
      <description>proportion of patients who received goal-concordant care according to resuscitation preferences</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Resuscitation level designation</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>proportion of patients with completed resuscitation preferences identified</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distribution of ICU-related days of health care utilization</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>compare empirical distributions of total days of health care utilization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time required to complete GOCD-facilitated discussion</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>Total time required to complete intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of communication</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>assessment of patient perceptions of quality of goals of care discussion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction with GOCD discussion</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>patient satisfaction with goals of care discussions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of GOCD tool</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>patient's perceptions of quality of web-based tool</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-provider agreement on resuscitation preferences</measure>
      <time_frame>From date of randomization until hospital discharge or death in hospital, assessed up to 12 months</time_frame>
      <description>decision concordance between patients and providers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death</measure>
      <time_frame>From date of randomization until death in hospital or after discharge, assessed up to 12 months</time_frame>
      <description>date and time and place of death during study period</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Goals of Care</condition>
    <condition>Patient Preference</condition>
    <condition>End of Life</condition>
    <arm_group>
      <arm_group_label>GOCD Tool</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool</description>
    </arm_group>
    <arm_group>
      <arm_group_label>usual care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Usual discussions conducted by attending physician with patient</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>GOCD Tool</intervention_name>
      <description>Web-based tool with 4 components; pre-admission health status; current illness prognosis for hospital survival; in-hospital cardiorespiratory arrest prognosis; values and goals of care</description>
      <arm_group_label>GOCD Tool</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>Attending physicians responsible for GOCD during hospitalization using their usual approaches</description>
      <arm_group_label>usual care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalized patients ≥ 80 years old with an acute medical or surgical condition&#xD;
               admitted to any hospital ward&#xD;
  &#xD;
            -  Duration of admission ≥ 24 hours&#xD;
  &#xD;
            -  English speaking, or translator present&#xD;
  &#xD;
            -  Competent patient or substitute decision maker&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Treating physician, patient, or substitute decision maker declines&#xD;
  &#xD;
            -  Documented resuscitation preferences for comfort or supportive care&#xD;
  &#xD;
            -  New diagnosis of life-limiting illness on this hospital admission, for example, new&#xD;
               diagnosis of metastatic cancer&#xD;
  &#xD;
            -  Clinically unstable, admitted to an intensive care unit, or currently receiving acute&#xD;
               life support treatment (mechanical ventilation, acute dialysis, or&#xD;
               inotropic/vasopressor support)&#xD;
  &#xD;
            -  Readmission after index hospitalization&#xD;
  &#xD;
            -  Pre-existing need for chronic mechanical ventilation (invasive mechanical ventilation&#xD;
               via tracheostomy &gt; 90 days) or maintenance dialysis (peritoneal or hemodialysis &gt; 90&#xD;
               days)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>80 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Giulio DiDiodato, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal Victoria Regional Health Centre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chris Martin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal Victoria Regional Health Centre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Doug Austgarden, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal Victoria Regional Health Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Giulio DiDiodato, MD PhD</last_name>
      <phone>7057289090</phone>
      <phone_ext>45641</phone_ext>
      <email>didiodatog@rvh.on.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kelly Cruise, BHSc</last_name>
      <phone>7057289090</phone>
      <phone_ext>45639</phone_ext>
      <email>cruisek@rvh.on.ca</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Royal Victoria Hospital, Canada</investigator_affiliation>
      <investigator_full_name>Giulio DiDiodato</investigator_full_name>
      <investigator_title>Chief Research Scientist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Death</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only upon request, de-identified data may be shared</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002113
  org study id: R22-003
  nct id: NCT06002113
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patient-centered medical care considers a patient's values and goals for their health and
        well-being. Healthcare providers use this information to formulate a medical care plan that
        is aligned with these expectations. This shared-decision making process should occur with
        every medical decision, but it is especially important whenever decisions about end-of-life
        care are being considered. Eliciting patient preferences about resuscitation and life-support
        treatments in the event of life-threatening illnesses are considered to be a standard of
        excellent and appropriate medical care. Unfortunately, these discussions don't happen
        consistently and even when they do occur, are rarely ideal. The consequences can be
        devastating, often resulting in the delivery of unwanted medical care that can be associated
        with significant physical and mental suffering among patients and their families. In response
        to this problem, the investigators developed a novel tool to help guide these difficult
        conversations between healthcare providers and patients. The investigators previously tested
        this tool in a small group of hospitalized patients who found it acceptable and helpful. In
        this larger study, the investigators will compare how effective this tool is compared to
        usual care in ensuring hospitalized patients have their treatment preferences identified,
        documented and result in end-of-life care that is consistent with their preferences.
  Objectives:
  
          1. To determine the impact of facilitated Goals of Care Discussions (GOCDs) on the number
             of ICU, ventilator, and dialysis days during the index hospitalization (or until death)
  
          2. To determine the impact of facilitated GOCDs on the number of hospital, ICU, ventilator,
             and dialysis days after the index hospitalization until 12 months post-discharge (or
             until death).
  
          3. To determine the impact of facilitated GOCDs on the concordance between documented
             patient preferences for Life-Sustaining Therapies (LSTs) (during the index
             hospitalization) and whether these LSTs were received after the index hospitalization
             until 12 months post-discharge (or until death).
  
          4. To determine the impact of facilitated GOCDs on other outcomes including decisional
             conflict and quality of communication, patient satisfaction with the encounter, and
             place of death.
  
          5. To determine the barriers and facilitators to the implementation of GOCDs.
  
        Design:
  
        A prospective, single-centre, stratified, parallel group, allocation concealed,
        statistician-masked, randomized, pragmatic, mixed-method, comparative effectiveness trial in
        hospitalized elderly patients 80 years and older.
  
        Participants:
  
        This study will include all elderly patients admitted to the Royal Victoria Regional Health
        Centre in Barrie, Ontario, Canada, with an acute medical or surgical diagnosis who fulfill
        all the inclusion criteria and for whom none of the exclusion criteria exist.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: ICU-related health care utilization
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: total number of ventilator, ICU, and dialysis days
  measure: ICU-related health care utilization
  time frame: 12 months after discharge from index hospital admission
  description: total number of ventilator, ICU, and dialysis days
  measure: Goal-concordant care for ICU-related health care utilization
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: proportion of patients who received goal-concordant care according to resuscitation preferences
  measure: Goal-concordant care for ICU-related health care utilization
  time frame: 12 months after discharge from index hospital admission
  description: proportion of patients who received goal-concordant care according to resuscitation preferences
  measure: Resuscitation level designation
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: proportion of patients with completed resuscitation preferences identified
  measure: Distribution of ICU-related days of health care utilization
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: compare empirical distributions of total days of health care utilization
  measure: Time required to complete GOCD-facilitated discussion
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: Total time required to complete intervention
  measure: Quality of communication
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: assessment of patient perceptions of quality of goals of care discussion
  measure: patient satisfaction with GOCD discussion
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: patient satisfaction with goals of care discussions
  measure: Evaluation of GOCD tool
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: patient's perceptions of quality of web-based tool
  measure: Patient-provider agreement on resuscitation preferences
  time frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
  description: decision concordance between patients and providers
  measure: Death
  time frame: From date of randomization until death in hospital or after discharge, assessed up to 12 months
  description: date and time and place of death during study period
  arm group label: GOCD Tool
  arm group type: Experimental
  description: Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool
  arm group label: usual care
  arm group type: Active Comparator
  description: Usual discussions conducted by attending physician with patient
  intervention type: Other
  intervention name: GOCD Tool
  description: Web-based tool with 4 components; pre-admission health status; current illness prognosis for hospital survival; in-hospital cardiorespiratory arrest prognosis; values and goals of care
  arm group label: GOCD Tool
  intervention type: Other
  intervention name: Usual care
  description: Attending physicians responsible for GOCD during hospitalization using their usual approaches
  arm group label: usual care
  criteria: 
  gender: All
  minimum age: 80 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Giulio DiDiodato, MD PhD
  role: Principal Investigator
  affiliation: Royal Victoria Regional Health Centre
  last name: Chris Martin, MD
  role: Principal Investigator
  affiliation: Royal Victoria Regional Health Centre
  last name: Doug Austgarden, MD
  role: Principal Investigator
  affiliation: Royal Victoria Regional Health Centre
  last name: Giulio DiDiodato, MD PhD
  phone: 7057289090
  phone ext: 45641
  email: didiodatog@rvh.on.ca
  last name: Kelly Cruise, BHSc
  phone: 7057289090
  phone ext: 45639
  email: cruisek@rvh.on.ca
  responsible party type: Principal Investigator
  investigator affiliation: Royal Victoria Hospital, Canada
  investigator full name: Giulio DiDiodato
  investigator title: Chief Research Scientist
  mesh term: Death
  sharing ipd: No
  ipd description: Only upon request, de-identified data may be shared