<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/NCT03297320</url>
  </required_header>
  <id_info>
    <org_study_id>R-16-299</org_study_id>
    <nct_id>NCT03297320</nct_id>
  </id_info>
  <brief_title>Advance Care Planning at London Health Sciences Centre</brief_title>
  <acronym>ACP@LHSC</acronym>
  <official_title>Advance Care Planning at London Health Sciences Centre</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their&#xD;
      preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that&#xD;
      necessitate an Intensive Care Unit (ICU) admission.&#xD;
&#xD;
      Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their&#xD;
      end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader&#xD;
      dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but&#xD;
      rarely is this the case.&#xD;
&#xD;
      The innovation will involve the use of trained nurse facilitators to have meaningful&#xD;
      conversations with patients and their families in an effective way that bridges the gap&#xD;
      between resuscitation status, GOC discussions and ACP across the continuum of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. On admission, the usual LHSC process will be followed whereby the patient's wishes for&#xD;
           resuscitation are documented on the resuscitation record in the patient's chart. This&#xD;
           constitutes the &quot;original&quot; resuscitation status.&#xD;
&#xD;
        2. After referral or screening and written consent, the RA will conduct semi-structured,&#xD;
           face-to-face interviews with the patient and or SDM as appropriate. If the RA has&#xD;
           concern about a discordance, he/she will then provide verbal feedback to the health-care&#xD;
           team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request&#xD;
           them to communicate with the patient/SDM again. A case of discordance shall be recorded&#xD;
           ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms&#xD;
           that a change in resuscitation status is needed. The output of this intervention will be&#xD;
           the &quot;revised&quot; resuscitation status. This &quot;standardized&quot; process for determining this&#xD;
           outcome has worked well in our pilot study. Any disagreements between RA and SMR on&#xD;
           patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up&#xD;
           to the team to reconcile the &quot;revised&quot; resuscitation preferences on official records&#xD;
           (Resuscitation status can only be filled in only by an MD as per hospital policy).&#xD;
&#xD;
      4. Advanced Clinical Notes: These will be typed by the RA and a note be made of the &quot;revised&quot;&#xD;
      resuscitation preferences along with GOC and ACP discussions.&#xD;
&#xD;
      5. A pilot study related to this work started in August 2016 and has allowed the research&#xD;
      team to evaluate barriers and facilitators of conducting this intervention on Internal&#xD;
      Medicine patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Healthcare teams in Internal Medicine at London Health Sciences Centre will be asked if they have any patients that need further goals of care discussions or ACP.&#xD;
A random selection of Internal Medicine patients will also be selected for further indepth conversations related to goals of care discussions or ACP</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Discordance</measure>
    <time_frame>2 years</time_frame>
    <description>Discordance between patients' prior expressed preferences and those documented in their healthcare record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors associated with discordance</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate predisposing factors for the discordance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Team Referrals</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In-depth conversations about Goals of Care and ACP (the intervention) will be held for the patients referred to the research team by the three healthcare teams in Internal Medicine at London Health Sciences Centre (University Campus)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Random selection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A random selection of patients (not referred to the research team by the healthcare team) in Internal Medicine at London Health Sciences Centre (University Campus) will be selected to have in-depth conversations about Goals of Care and ACP (the intervention)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-depth conversation about Goals of Care and ACP</intervention_name>
    <description>In-depth conversation regarding Goals of Care and ACP by an experienced practitioner</description>
    <arm_group_label>Random selection</arm_group_label>
    <arm_group_label>Team Referrals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients admitted to internal medicine teams at or after hospitalization day 2 with:&#xD;
&#xD;
          1. Age ≥55 years with ≥1 diagnoses: Chronic lung disease, Coronary artery disease,&#xD;
             Congestive heart failure, Cirrhosis, Renal failure, Diabetes, Peripheral vascular&#xD;
             disease, Cancer, Dementia (inability with ADLs) or&#xD;
&#xD;
          2. If none of these criteria were met, any patient whose death within the next 1 year&#xD;
             would not surprise health-care team members.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of written consent&#xD;
&#xD;
          2. Patients who do not speak English; hard of hearing&#xD;
&#xD;
          3. Expected to die or be discharged ≤ 24 hours&#xD;
&#xD;
          4. Referral to or having an established palliative care plan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Taneja, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Launa Elliott, BSc</last_name>
    <phone>519 685-8500</phone>
    <phone_ext>32846</phone_ext>
    <email>Ravi.Taneja@lhsc.on.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ravi Taneja, FRCPC</last_name>
    <phone>519 685-8500</phone>
    <phone_ext>32846</phone_ext>
    <email>Ravi.Taneja@lhsc.on.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ravi Taneja, FRCPC</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advance Care Planning, End of life, CPR</keyword>
  <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/NCT03297320
org study id: R-16-299
nct id: NCT03297320
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their
      preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that
      necessitate an Intensive Care Unit (ICU) admission.

      Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their
      end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader
      dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but
      rarely is this the case.

      The innovation will involve the use of trained nurse facilitators to have meaningful
      conversations with patients and their families in an effective way that bridges the gap
      between resuscitation status, GOC discussions and ACP across the continuum of care.
1. On admission, the usual LHSC process will be followed whereby the patient's wishes for
           resuscitation are documented on the resuscitation record in the patient's chart. This
           constitutes the "original" resuscitation status.

        2. After referral or screening and written consent, the RA will conduct semi-structured,
           face-to-face interviews with the patient and or SDM as appropriate. If the RA has
           concern about a discordance, he/she will then provide verbal feedback to the health-care
           team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request
           them to communicate with the patient/SDM again. A case of discordance shall be recorded
           ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms
           that a change in resuscitation status is needed. The output of this intervention will be
           the "revised" resuscitation status. This "standardized" process for determining this
           outcome has worked well in our pilot study. Any disagreements between RA and SMR on
           patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up
           to the team to reconcile the "revised" resuscitation preferences on official records
           (Resuscitation status can only be filled in only by an MD as per hospital policy).

      4. Advanced Clinical Notes: These will be typed by the RA and a note be made of the "revised"
      resuscitation preferences along with GOC and ACP discussions.

      5. A pilot study related to this work started in August 2016 and has allowed the research
      team to evaluate barriers and facilitators of conducting this intervention on Internal
      Medicine patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Healthcare teams in Internal Medicine at London Health Sciences Centre will be asked if they have any patients that need further goals of care discussions or ACP.
A random selection of Internal Medicine patients will also be selected for further indepth conversations related to goals of care discussions or ACP
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Discordance
time frame: 2 years
description: Discordance between patients' prior expressed preferences and those documented in their healthcare record
measure: Risk factors associated with discordance
time frame: 2 years
description: Evaluate predisposing factors for the discordance
arm group label: Team Referrals
arm group type: Active Comparator
description: In-depth conversations about Goals of Care and ACP (the intervention) will be held for the patients referred to the research team by the three healthcare teams in Internal Medicine at London Health Sciences Centre (University Campus)
arm group label: Random selection
arm group type: Active Comparator
description: A random selection of patients (not referred to the research team by the healthcare team) in Internal Medicine at London Health Sciences Centre (University Campus) will be selected to have in-depth conversations about Goals of Care and ACP (the intervention)
intervention type: Other
intervention name: In-depth conversation about Goals of Care and ACP
description: In-depth conversation regarding Goals of Care and ACP by an experienced practitioner
arm group label: Random selection
arm group label: Team Referrals
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ravi Taneja, FRCPC
role: Principal Investigator
affiliation: Western University, Canada
last name: Launa Elliott, BSc
phone: 519 685-8500
phone ext: 32846
email: Ravi.Taneja@lhsc.on.ca
last name: Ravi Taneja, FRCPC
phone: 519 685-8500
phone ext: 32846
email: Ravi.Taneja@lhsc.on.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
sharing ipd: No