<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/NCT03780816</url>
  </required_header>
  <id_info>
    <org_study_id>D18149</org_study_id>
    <nct_id>NCT03780816</nct_id>
  </id_info>
  <brief_title>Variation in Cancer Centers' End-of-Life Quality</brief_title>
  <official_title>Variation in Cancer Centers' End-of-Life Quality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</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 is a qualitative study of local organizational and provider practice norms, and how&#xD;
      these norms influence patient and family expectations and provider decision-making heuristics&#xD;
      for minority patients with advanced cancer at major US cancer centers. Outpatient visits with&#xD;
      oncologists will be observed and documented via hand-written field notes. Semi-structured&#xD;
      interviews with selected participating clinicians, patients, caregivers, and other informants&#xD;
      will follow the initial observation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to identify organizational and provider practice norms at major&#xD;
      US cancer centers, and how these norms influence patient and family expectations and provider&#xD;
      decision-making heuristics for later-line chemotherapy, hospice, and ICU admission among&#xD;
      minority patients with advanced cancer. Norms are rules about which there is at least some&#xD;
      degree of consensus, enforced through social sanctions. Heuristics are unconscious judgments&#xD;
      or rules of thumb.The study team will collect direct observation data from outpatient clinic&#xD;
      visits, and semi-structured interview data from selected participating providers, patients,&#xD;
      caregivers, and other informants following the initial observation.&#xD;
&#xD;
      The study team will perform 2-week, qualitative case studies of 3 theoretically sampled&#xD;
      National Comprehensive Cancer Network (NCCN) and NCI Comprehensive Cancer Centers. Oncology&#xD;
      practice managers' nominations of providers with particular cancer focuses, high volumes, and&#xD;
      high peer influence will be used to sample oncologic clinicians to shadow in outpatient&#xD;
      clinic settings. Observations will be hand-written during the clinic visit, and later&#xD;
      dictated and transcribed. Observed providers will be invited to be interviewed. Select&#xD;
      patients and caregivers will also be invited to be interviewed following initial clinic&#xD;
      observation. Other informants will be invited to be interviewed on an ad hoc basis. All&#xD;
      interviews will be audio recorded and transcribed, and interviews will be semi-structured to&#xD;
      allow for natural flow of conversation. Observations and interviews will all be done by the&#xD;
      study PI, project coordinator, and/or another research team member.&#xD;
&#xD;
      Clinical observations and semi-structured interviews will assess the following outcomes: 1)&#xD;
      formal and informal organizational norms influencing provider decision-making, 2) provider&#xD;
      decision-making heuristics, and 3) patient and caregiver expectations. All outcomes will be&#xD;
      assessed regarding receipt of chemotherapy in the last 14 days of life, intensive care unit&#xD;
      (ICU) admission in the last 30 days of life, and non or late hospice referral.&#xD;
&#xD;
      The investigators aim to to explore the how COVID-19 intersects with organizational and&#xD;
      provider norms, practices, and service delivery for patients with advanced cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2019</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Formal and informal norms influencing provider decision making as assessed using ethnographic observation</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider decision making heuristics as assessed using ethnographic observation</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient expectations as assessed using ethnographic observation</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Formal and informal norms influencing provider decision making as assessed using semi-structured interviews</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider decision making heuristics as assessed using semi-structured interviews</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient expectations as assessed using semi-structured interviews</measure>
    <time_frame>2-week site observation period</time_frame>
    <description>Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">473</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Pilot Site: Norris Cotton Cancer Center</arm_group_label>
    <description>Observation and interview protocols will be piloted at this site. The content of these observations and interviews will not be analyzed for content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Karmanos Cancer Institute</arm_group_label>
    <description>Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UNC Lineberger Comprehensive Cancer Center</arm_group_label>
    <description>Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UAB O'Neal Comprehensive Cancer Center</arm_group_label>
    <description>Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of provider-patient interactions and interviews</intervention_name>
    <description>Clinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation.</description>
    <arm_group_label>Karmanos Cancer Institute</arm_group_label>
    <arm_group_label>Pilot Site: Norris Cotton Cancer Center</arm_group_label>
    <arm_group_label>UAB O'Neal Comprehensive Cancer Center</arm_group_label>
    <arm_group_label>UNC Lineberger Comprehensive Cancer Center</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatient and inpatient oncology providers who meet inclusion criteria and are nominated&#xD;
        by their practice managers will be observed. If providers do not opt out after being&#xD;
        introduced to the study by cancer center leadership, providers will be contacted directly&#xD;
        for recruitment. A sub-sample of observed providers will be invited to participate in&#xD;
        semi-structured interviews.&#xD;
&#xD;
        A sub-sample of all patients (and caregivers) cared for by the shadowed provider who meet&#xD;
        inclusion criteria will be invited to participate in semi-structured interviews.&#xD;
        Recruitment will seek equal numbers of minority and non-minority participants.&#xD;
&#xD;
        Personnel involved in developing and enforcing organizational policies, procedures, and&#xD;
        practices, will also be invited to participate in semi-structured interviews.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Provider Inclusion Criteria:&#xD;
&#xD;
          -  Hospital-based providers (e.g., hospitalists, intensivists, emergency medicine,&#xD;
             advanced practice providers) or oncology providers (e.g. medical oncologists,&#xD;
             radiation oncologists, surgical oncologists, advanced practice providers)&#xD;
&#xD;
          -  Care for patients with advanced cancer&#xD;
&#xD;
          -  High clinical load&#xD;
&#xD;
          -  Have high peer influence&#xD;
&#xD;
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Advanced cancer&#xD;
&#xD;
          -  Provider &quot;would not be surprised&quot; if patient died in the next 12 months&#xD;
&#xD;
        Caregiver Inclusion Criteria:&#xD;
&#xD;
        -Self-reported caregiver of a patient meeting inclusion criteria&#xD;
&#xD;
        Other Informant Inclusion Criteria:&#xD;
&#xD;
        - Member of the cancer center, hospital, unit, or service line leadership&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
        - Potential medical malpractice cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amber E Barnato, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Amber Barnato</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  </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/NCT03780816
org study id: D18149
nct id: NCT03780816
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a qualitative study of local organizational and provider practice norms, and how
      these norms influence patient and family expectations and provider decision-making heuristics
      for minority patients with advanced cancer at major US cancer centers. Outpatient visits with
      oncologists will be observed and documented via hand-written field notes. Semi-structured
      interviews with selected participating clinicians, patients, caregivers, and other informants
      will follow the initial observation.
The purpose of this study is to identify organizational and provider practice norms at major
      US cancer centers, and how these norms influence patient and family expectations and provider
      decision-making heuristics for later-line chemotherapy, hospice, and ICU admission among
      minority patients with advanced cancer. Norms are rules about which there is at least some
      degree of consensus, enforced through social sanctions. Heuristics are unconscious judgments
      or rules of thumb.The study team will collect direct observation data from outpatient clinic
      visits, and semi-structured interview data from selected participating providers, patients,
      caregivers, and other informants following the initial observation.

      The study team will perform 2-week, qualitative case studies of 3 theoretically sampled
      National Comprehensive Cancer Network (NCCN) and NCI Comprehensive Cancer Centers. Oncology
      practice managers' nominations of providers with particular cancer focuses, high volumes, and
      high peer influence will be used to sample oncologic clinicians to shadow in outpatient
      clinic settings. Observations will be hand-written during the clinic visit, and later
      dictated and transcribed. Observed providers will be invited to be interviewed. Select
      patients and caregivers will also be invited to be interviewed following initial clinic
      observation. Other informants will be invited to be interviewed on an ad hoc basis. All
      interviews will be audio recorded and transcribed, and interviews will be semi-structured to
      allow for natural flow of conversation. Observations and interviews will all be done by the
      study PI, project coordinator, and/or another research team member.

      Clinical observations and semi-structured interviews will assess the following outcomes: 1)
      formal and informal organizational norms influencing provider decision-making, 2) provider
      decision-making heuristics, and 3) patient and caregiver expectations. All outcomes will be
      assessed regarding receipt of chemotherapy in the last 14 days of life, intensive care unit
      (ICU) admission in the last 30 days of life, and non or late hospice referral.

      The investigators aim to to explore the how COVID-19 intersects with organizational and
      provider norms, practices, and service delivery for patients with advanced cancer.
observational model: Ecologic or Community
time perspective: Other
measure: Formal and informal norms influencing provider decision making as assessed using ethnographic observation
time frame: 2-week site observation period
description: Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
measure: Provider decision making heuristics as assessed using ethnographic observation
time frame: 2-week site observation period
description: Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
measure: Patient expectations as assessed using ethnographic observation
time frame: 2-week site observation period
description: Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.
measure: Formal and informal norms influencing provider decision making as assessed using semi-structured interviews
time frame: 2-week site observation period
description: Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
measure: Provider decision making heuristics as assessed using semi-structured interviews
time frame: 2-week site observation period
description: Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
measure: Patient expectations as assessed using semi-structured interviews
time frame: 2-week site observation period
description: Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.
arm group label: Pilot Site: Norris Cotton Cancer Center
description: Observation and interview protocols will be piloted at this site. The content of these observations and interviews will not be analyzed for content.
arm group label: Karmanos Cancer Institute
description: Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.
arm group label: UNC Lineberger Comprehensive Cancer Center
description: Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.
arm group label: UAB O'Neal Comprehensive Cancer Center
description: Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.
intervention type: Other
intervention name: Observation of provider-patient interactions and interviews
description: Clinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation.
arm group label: Karmanos Cancer Institute
arm group label: Pilot Site: Norris Cotton Cancer Center
arm group label: UAB O'Neal Comprehensive Cancer Center
arm group label: UNC Lineberger Comprehensive Cancer Center
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amber E Barnato, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Amber Barnato
investigator title: Principal Investigator
mesh term: Death
sharing ipd: No