<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/NCT02984124</url>
  </required_header>
  <id_info>
    <org_study_id>CHRMS 16-227</org_study_id>
    <nct_id>NCT02984124</nct_id>
  </id_info>
  <brief_title>Communication During Hospitalization About Resuscitation Trial</brief_title>
  <acronym>CHART</acronym>
  <official_title>Communication During Hospitalization About Resuscitation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter RCT of 200 hospitalized patients and their family members evaluates an&#xD;
      &quot;informed assent&quot; approach to discussing cardiopulmonary resuscitation, compared to usual&#xD;
      care, in older seriously ill hospitalized patients with severe life-limiting illness or&#xD;
      severe functional impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing evidence suggests that high quality palliative care in older patients improves&#xD;
      quality of care, patient and family satisfaction, and costs of care. However, while some&#xD;
      specific palliative care interventions have been investigated, exactly how we should provide&#xD;
      this care remains unclear. One important component of high quality provider-patient&#xD;
      communication is discussing cardiopulmonary resuscitation (CPR) within the context of the&#xD;
      patient's values and goals of care. Unfortunately, these conversations are often rushed,&#xD;
      focused only on the procedure rather than the patient's goals and values, and CPR is often&#xD;
      offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made&#xD;
      decisions about CPR prior to hospitalization, and these discussions often leave patients and&#xD;
      families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in&#xD;
      chronically ill older patients continue to be very poor, despite decades of efforts toward&#xD;
      improvement.&#xD;
&#xD;
      The investigators aim to change the paradigm of CPR discussions with older adults unlikely to&#xD;
      benefit from CPR. This study is a randomized controlled trial comparing an innovative&#xD;
      &quot;informed assent&quot; approach to discussing CPR versus usual care with attention control for&#xD;
      older hospitalized adults with life-limiting illness or severe functional impairment,&#xD;
      enrolling patients and family members at three different study sites. Informed assent&#xD;
      includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3)&#xD;
      a caring statement that the patient should not receive CPR if values include avoiding&#xD;
      burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values,&#xD;
      convey information, and state an assessment, while allowing the patient or family to&#xD;
      disagree. The investigators hypothesize that informed assent will improve quality of and&#xD;
      satisfaction with communication about CPR; reduce the burden of potentially harmful CPR&#xD;
      discussions, including reduced patient and family symptoms of depression and anxiety; and&#xD;
      reduce intensity of care and health care utilization. The intervention builds on prior work&#xD;
      investigating CPR outcomes in older adults and performing pilot studies of the informed&#xD;
      assent intervention in both inpatients and outpatients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">February 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge, whichever is earlier</time_frame>
    <description>Patient-Assessed Quality of Communication about CPR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge, whichever is earlier</time_frame>
    <description>Family-Assessed Quality of Communication about CPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge, whichever is earlier</time_frame>
    <description>Patient-Assessed Satisfaction with Communication about CPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge, whichever is earlier</time_frame>
    <description>Family-Assessed Satisfaction with Communication about CPR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Survey (HADS)</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months</time_frame>
    <description>Patient Depressive and Anxiety Symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Survey (HADS)</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months</time_frame>
    <description>Family Depressive and Anxiety Symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do-Not-Resuscitate Orders (yes/no)</measure>
    <time_frame>Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Do-Not-Resuscitate Orders</measure>
    <time_frame>To 6 months post-randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to the intensive care unit (ICU) 9yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay (days)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tracheostomy placement (yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrostomy tube placement (yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of mechanical ventilation (yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of renal replacement therapy (yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of cardiopulmonary resuscitation (yes/no)</measure>
    <time_frame>Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of health care after initial hospitalization</measure>
    <time_frame>3 months and 6 months post-randomization</time_frame>
    <description>Repeat hospital admissions, ICU admissions, nursing home says, hospice care stays, and use of home health care will be assessed, and if they occurred, duration will be recorded. A standardized value (costs, not charges) will be applied to these measures to determine overall cost.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (dead or alive)</measure>
    <time_frame>To 6 months post-randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Severe Life-limiting COPD</condition>
  <condition>Severe Life-limiting Heart Failure</condition>
  <condition>Severe Life-limiting Cirrhosis</condition>
  <condition>Severe Life-limiting Malignancy</condition>
  <condition>Severe Functional Impairment</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care with Attention Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Informed Assent Discussion</intervention_name>
    <description>Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps:&#xD;
Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated&#xD;
Description of CPR and dying process provided&#xD;
Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness)&#xD;
Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care with Attention Control</intervention_name>
    <description>Participants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.</description>
    <arm_group_label>Usual Care with Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;65 years old&#xD;
&#xD;
          2. English speaking&#xD;
&#xD;
          3. Must have one or more of the following:&#xD;
&#xD;
               1. Chronic life-limiting illness with median survival &lt;2 years defined as: 1)&#xD;
                  metastatic cancer or inoperable lung cancer; 2) COPD requiring oxygen; 3) New&#xD;
                  York Heart Association Class III or IV heart failure, 4) Child's Class C&#xD;
                  cirrhosis or MELD score of &gt;20, 5) End-stage renal disease (must be on dialysis&#xD;
                  and ≥ 75 years old), 6) Advanced pulmonary fibrosis/interstitial lung disease, 7)&#xD;
                  Advanced pulmonary hypertension&#xD;
&#xD;
               2. Severe functional impairment defined as dependence with &gt;4 activities of daily&#xD;
                  living (ADLs) on Katz Index of Independence in ADLs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has already definitively chosen DNR status&#xD;
&#xD;
          2. Unable to provide informed consent&#xD;
&#xD;
          3. Refused consent&#xD;
&#xD;
          4. Currently listed on a transplant list (awaiting transplant)&#xD;
&#xD;
          5. Inappropriate for study enrollment per clinician&#xD;
&#xD;
          6. Known to have a left ventricular assist device (LVAD)&#xD;
&#xD;
          7. Research team unavailable&#xD;
&#xD;
          8. Patient discharged from hospital prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renee Stapleton, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Renee Stapleton</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This study includes quantitative data that the investigators plan to share with other researchers with interests in the quality of care provided to older hospitalized seriously ill patients and their families. De-identified questionnaire data, medical record data, and administrative data will be made available in the form of datasets with no personally identifying characteristics retained, to protect the identity of the respondents.</ipd_description>
  </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/NCT02984124
org study id: CHRMS 16-227
nct id: NCT02984124
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This multicenter RCT of 200 hospitalized patients and their family members evaluates an
      "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual
      care, in older seriously ill hospitalized patients with severe life-limiting illness or
      severe functional impairment.
Increasing evidence suggests that high quality palliative care in older patients improves
      quality of care, patient and family satisfaction, and costs of care. However, while some
      specific palliative care interventions have been investigated, exactly how we should provide
      this care remains unclear. One important component of high quality provider-patient
      communication is discussing cardiopulmonary resuscitation (CPR) within the context of the
      patient's values and goals of care. Unfortunately, these conversations are often rushed,
      focused only on the procedure rather than the patient's goals and values, and CPR is often
      offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made
      decisions about CPR prior to hospitalization, and these discussions often leave patients and
      families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in
      chronically ill older patients continue to be very poor, despite decades of efforts toward
      improvement.

      The investigators aim to change the paradigm of CPR discussions with older adults unlikely to
      benefit from CPR. This study is a randomized controlled trial comparing an innovative
      "informed assent" approach to discussing CPR versus usual care with attention control for
      older hospitalized adults with life-limiting illness or severe functional impairment,
      enrolling patients and family members at three different study sites. Informed assent
      includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3)
      a caring statement that the patient should not receive CPR if values include avoiding
      burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values,
      convey information, and state an assessment, while allowing the patient or family to
      disagree. The investigators hypothesize that informed assent will improve quality of and
      satisfaction with communication about CPR; reduce the burden of potentially harmful CPR
      discussions, including reduced patient and family symptoms of depression and anxiety; and
      reduce intensity of care and health care utilization. The intervention builds on prior work
      investigating CPR outcomes in older adults and performing pilot studies of the informed
      assent intervention in both inpatients and outpatients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
description: Patient-Assessed Quality of Communication about CPR
measure: Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
description: Family-Assessed Quality of Communication about CPR
measure: 5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
description: Patient-Assessed Satisfaction with Communication about CPR
measure: 5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
description: Family-Assessed Satisfaction with Communication about CPR
measure: Hospital Anxiety and Depression Survey (HADS)
time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
description: Patient Depressive and Anxiety Symptoms
measure: Hospital Anxiety and Depression Survey (HADS)
time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
description: Family Depressive and Anxiety Symptoms
measure: Do-Not-Resuscitate Orders (yes/no)
time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
measure: Time to Do-Not-Resuscitate Orders
time frame: To 6 months post-randomization
measure: Admission to the intensive care unit (ICU) 9yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: ICU length of stay (days)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Tracheostomy placement (yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Gastrostomy tube placement (yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Receipt of mechanical ventilation (yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Receipt of renal replacement therapy (yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Receipt of cardiopulmonary resuscitation (yes/no)
time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
measure: Cost of health care after initial hospitalization
time frame: 3 months and 6 months post-randomization
description: Repeat hospital admissions, ICU admissions, nursing home says, hospice care stays, and use of home health care will be assessed, and if they occurred, duration will be recorded. A standardized value (costs, not charges) will be applied to these measures to determine overall cost.
measure: Mortality (dead or alive)
time frame: To 6 months post-randomization
arm group label: Intervention
arm group type: Experimental
description: Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor.
arm group label: Usual Care with Attention Control
arm group type: Placebo Comparator
description: Participants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.
intervention type: Behavioral
intervention name: Informed Assent Discussion
description: Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps:
Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated
Description of CPR and dying process provided
Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness)
Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered
arm group label: Intervention
intervention type: Behavioral
intervention name: Usual Care with Attention Control
description: Participants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.
arm group label: Usual Care with Attention Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Renee Stapleton, MD PhD
role: Principal Investigator
affiliation: University of Vermont
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Renee Stapleton
investigator title: Associate Professor of Medicine
mesh term: Kidney Failure, Chronic
sharing ipd: Yes
ipd description: This study includes quantitative data that the investigators plan to share with other researchers with interests in the quality of care provided to older hospitalized seriously ill patients and their families. De-identified questionnaire data, medical record data, and administrative data will be made available in the form of datasets with no personally identifying characteristics retained, to protect the identity of the respondents.