<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/NCT03287895</url>
  </required_header>
  <id_info>
    <org_study_id>20170531</org_study_id>
    <nct_id>NCT03287895</nct_id>
  </id_info>
  <brief_title>Improving Decisions About CPR</brief_title>
  <acronym>iCANACP</acronym>
  <official_title>A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Frailty Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital Academic Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital 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>
      Objective&#xD;
&#xD;
      The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision&#xD;
      support intervention aimed at improving the quality of decisions about Cardio Pulmonary&#xD;
      Resuscitation (CPR) for seriously ill, elderly patients in hospital.&#xD;
&#xD;
      The hypothesis is that fewer patients in the intervention group will have a documented order&#xD;
      for CPR and they will have greater satisfaction with decision making about CPR than patients&#xD;
      in the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodological Approach&#xD;
&#xD;
      The study will be a randomized controlled trial comparing a multi-faceted decision support&#xD;
      intervention to usual care for hospitalized patients. The primary objective of this study is&#xD;
      to determine if our multifaceted intervention changes decisions about CPR. The components of&#xD;
      the multifaceted intervention have already been evaluated for feasibility and acceptability&#xD;
      in the hospital setting. The intervention has two parts: the first is a values clarification&#xD;
      exercise, and the second part is a CPR video decision aid that explains the risks and&#xD;
      benefits of CPR as well as the reasons a patient may choose to receive CPR or not. From&#xD;
      previous research it is known that many hospitalized patients have prescribed orders for CPR&#xD;
      despite expressing a preference not to have CPR when asked. Furthermore patients often have&#xD;
      expressed values that are not concordant with their expressed wishes regarding resuscitation.&#xD;
      Therefore it is hypothesized that fewer patients in the intervention group will have a&#xD;
      documented order for CPR and they will have greater satisfaction with decision making about&#xD;
      CPR than patients in the control group.&#xD;
&#xD;
      We will conduct sensitivity analyses to investigate whether the intervention is more&#xD;
      effective among patients who remain in hospital longer after enrollment. We will measure the&#xD;
      intervention effect among patients who remained in hospital for fewer than three days after&#xD;
      enrollment, among patients who were in hospital for 3-7 days after enrollment, and among&#xD;
      patients who remained in hospital for longer than 7 days post-enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 22, 2018</completion_date>
  <primary_completion_date type="Actual">October 22, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CPR Orders</measure>
    <time_frame>14 days post enrollment</time_frame>
    <description>The proportion of patients with an order for CPR in the medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient/Substitute Decision Maker (SDM) satisfaction with decision-making</measure>
    <time_frame>Immediately after intervention, or enrollment for control group</time_frame>
    <description>Decision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict</measure>
    <time_frame>Immediately after intervention, or enrollment for control group</time_frame>
    <description>Measured using a modified version of the Decisional Conflict Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Resource Usage</measure>
    <time_frame>From enrolment to 1 year after enrollment.</time_frame>
    <description>Case costing system at the Ottawa Hospital data warehouse used to measure total cost of hospital care for patients (direct and indirect)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of documented goals of care conversations</measure>
    <time_frame>Between study enrollment and up to 14 days post enrollment</time_frame>
    <description>Count of documented goals of care conversations, defined as &quot;a conversation that addressed at least one of the following domains: patient values and goals; prognosis or illness understanding; end-of-life care planning; or code status (that is, whether or not a patient has requested resuscitation in the event of a Code Blue) or desire for other life-sustaining treatments or procedures.&quot; (Lakin et al. Health Affairs 36, no.7 (2017):1258-1264). We will report the presence or absence of any goals of care conversation, as well as the mean number of conversations in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of documented goals of care conversations</measure>
    <time_frame>Between study enrollment and up to 14 days post enrollment</time_frame>
    <description>Mean quality score for the first instance of a goals of care conversation following study enrollment. Quality assessed using the scale developed for Lakin et al. 2017. This scale has a maximum score of 17 and a minimum score of 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SDM Self-efficacy</measure>
    <time_frame>Immediately after intervention, or enrollment for control group</time_frame>
    <description>For substitute decision-makers who participate, their confidence to make medical decisions on behalf of their loved will be measured using a 5-question questionnaire. The questionnaire asks SDMs to rate their knowledge and confidence about different aspects of decision-making, on a scale from 0 (not confident at all) to 4 (very confident). SDM self-efficacy will be calculated as the mean score among the 5 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency department visits</measure>
    <time_frame>In the year following index admission</time_frame>
    <description>Count of presentations to emergency department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with in-hospital mortality</measure>
    <time_frame>In the year following index admission</time_frame>
    <description>Participants will contribute to this measure if they die while admitted to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Disposition</measure>
    <time_frame>End of index admission</time_frame>
    <description>Patient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>In the year following index admission</time_frame>
    <description>Count of admissions to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital days</measure>
    <time_frame>In the year following index admission</time_frame>
    <description>Count of days admitted to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ICU days</measure>
    <time_frame>In the year following index admission</time_frame>
    <description>Count of days admitted to an intensive care unit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>CPR Decision-Making</condition>
  <arm_group>
    <arm_group_label>Intervention - Decision Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the regular conversation about CPR that a patient's physician may have with them, participants will be given a two-part intervention. First, the participant will receive a values clarification tool which helps them rate and understand which relevant values are most important to them. There are two forms of this tool, a full and simplified version. All participants in this arm will receive both, in randomized order. The second aspect of the intervention is an educational video about the potential risks and benefits of CPR, which all participants in this arm will receive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Support</intervention_name>
    <description>A two-part intervention to help patients make better decisions about CPR</description>
    <arm_group_label>Intervention - Decision Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eligible to receive CPR&#xD;
&#xD;
          2. Satisfying at least one of the following criteria groups&#xD;
&#xD;
               1. 55 years of age or older with one or more of the following diagnoses:&#xD;
&#xD;
                    -  Chronic obstructive lung disease (2 of the 3 of: baseline PaCO2 of &gt; 45&#xD;
                       torr, cor pulmonale; respiratory failure episode within the preceding year;&#xD;
                       forced expiratory volume in 1 sec &lt;0.5 L)&#xD;
&#xD;
                    -  Congestive heart failure (New York Heart Association class IV symptoms and&#xD;
                       left ventricular ejection fraction &lt; 25%)&#xD;
&#xD;
                    -  Cirrhosis (confirmed by imaging studies or documentation of esophageal&#xD;
                       varices and one of three conditions; hepatic coma, child's class C liver&#xD;
                       disease, or child's class B liver disease with gastrointestinal bleeding)&#xD;
&#xD;
                    -  Cancer (metastatic cancer or stage IV lymphoma)&#xD;
&#xD;
                    -  End-stage dementia (inability to perform all ADLs, mutism or minimal verbal&#xD;
                       output secondary to dementia, bed-bound state prior to acute illness).&#xD;
&#xD;
               2. 80 years of age or older and admitted to hospital from the community for an acute&#xD;
                  medical or surgical condition.&#xD;
&#xD;
               3. If none of the above criteria are met, any patient whose death within the next 6&#xD;
                  months would not surprise any member of their care team.&#xD;
&#xD;
               4. At least 55 years old and predicted risk of death in the next 12 months of &gt;=10%&#xD;
                  as calculated with the HOMR Now! Score&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients or SDMs who do not speak English.&#xD;
&#xD;
          -  Patients or SDMs who do not provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Kobewka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Civic Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardio-pulmonary resuscitation</keyword>
  <keyword>CPR</keyword>
  <keyword>Decision-making</keyword>
  <keyword>Advance Care Planning</keyword>
  <keyword>End of life</keyword>
  <keyword>Code Status</keyword>
  <keyword>Goals of Care</keyword>
  <keyword>Communication</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/NCT03287895
org study id: 20170531
nct id: NCT03287895
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective

      The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision
      support intervention aimed at improving the quality of decisions about Cardio Pulmonary
      Resuscitation (CPR) for seriously ill, elderly patients in hospital.

      The hypothesis is that fewer patients in the intervention group will have a documented order
      for CPR and they will have greater satisfaction with decision making about CPR than patients
      in the control group.
Methodological Approach

      The study will be a randomized controlled trial comparing a multi-faceted decision support
      intervention to usual care for hospitalized patients. The primary objective of this study is
      to determine if our multifaceted intervention changes decisions about CPR. The components of
      the multifaceted intervention have already been evaluated for feasibility and acceptability
      in the hospital setting. The intervention has two parts: the first is a values clarification
      exercise, and the second part is a CPR video decision aid that explains the risks and
      benefits of CPR as well as the reasons a patient may choose to receive CPR or not. From
      previous research it is known that many hospitalized patients have prescribed orders for CPR
      despite expressing a preference not to have CPR when asked. Furthermore patients often have
      expressed values that are not concordant with their expressed wishes regarding resuscitation.
      Therefore it is hypothesized that fewer patients in the intervention group will have a
      documented order for CPR and they will have greater satisfaction with decision making about
      CPR than patients in the control group.

      We will conduct sensitivity analyses to investigate whether the intervention is more
      effective among patients who remain in hospital longer after enrollment. We will measure the
      intervention effect among patients who remained in hospital for fewer than three days after
      enrollment, among patients who were in hospital for 3-7 days after enrollment, and among
      patients who remained in hospital for longer than 7 days post-enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: CPR Orders
time frame: 14 days post enrollment
description: The proportion of patients with an order for CPR in the medical record
measure: Patient/Substitute Decision Maker (SDM) satisfaction with decision-making
time frame: Immediately after intervention, or enrollment for control group
description: Decision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire
measure: Decisional Conflict
time frame: Immediately after intervention, or enrollment for control group
description: Measured using a modified version of the Decisional Conflict Scale
measure: Health Resource Usage
time frame: From enrolment to 1 year after enrollment.
description: Case costing system at the Ottawa Hospital data warehouse used to measure total cost of hospital care for patients (direct and indirect)
measure: Number of documented goals of care conversations
time frame: Between study enrollment and up to 14 days post enrollment
description: Count of documented goals of care conversations, defined as "a conversation that addressed at least one of the following domains: patient values and goals; prognosis or illness understanding; end-of-life care planning; or code status (that is, whether or not a patient has requested resuscitation in the event of a Code Blue) or desire for other life-sustaining treatments or procedures." (Lakin et al. Health Affairs 36, no.7 (2017):1258-1264). We will report the presence or absence of any goals of care conversation, as well as the mean number of conversations in each group.
measure: Quality of documented goals of care conversations
time frame: Between study enrollment and up to 14 days post enrollment
description: Mean quality score for the first instance of a goals of care conversation following study enrollment. Quality assessed using the scale developed for Lakin et al. 2017. This scale has a maximum score of 17 and a minimum score of 1.
measure: SDM Self-efficacy
time frame: Immediately after intervention, or enrollment for control group
description: For substitute decision-makers who participate, their confidence to make medical decisions on behalf of their loved will be measured using a 5-question questionnaire. The questionnaire asks SDMs to rate their knowledge and confidence about different aspects of decision-making, on a scale from 0 (not confident at all) to 4 (very confident). SDM self-efficacy will be calculated as the mean score among the 5 questions.
measure: Number of emergency department visits
time frame: In the year following index admission
description: Count of presentations to emergency department
measure: Number of participants with in-hospital mortality
time frame: In the year following index admission
description: Participants will contribute to this measure if they die while admitted to hospital
measure: Discharge Disposition
time frame: End of index admission
description: Patient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).
measure: Number of hospital admissions
time frame: In the year following index admission
description: Count of admissions to hospital
measure: Number of hospital days
time frame: In the year following index admission
description: Count of days admitted to hospital
measure: Number of ICU days
time frame: In the year following index admission
description: Count of days admitted to an intensive care unit
arm group label: Intervention - Decision Support
arm group type: Experimental
description: In addition to the regular conversation about CPR that a patient's physician may have with them, participants will be given a two-part intervention. First, the participant will receive a values clarification tool which helps them rate and understand which relevant values are most important to them. There are two forms of this tool, a full and simplified version. All participants in this arm will receive both, in randomized order. The second aspect of the intervention is an educational video about the potential risks and benefits of CPR, which all participants in this arm will receive.
arm group label: Control
arm group type: No Intervention
description: Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them.
intervention type: Behavioral
intervention name: Decision Support
description: A two-part intervention to help patients make better decisions about CPR
arm group label: Intervention - Decision Support
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Kobewka
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No