<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/NCT03256110</url>
  </required_header>
  <id_info>
    <org_study_id>5R21NR016611</org_study_id>
    <nct_id>NCT03256110</nct_id>
  </id_info>
  <brief_title>Palliative Care Communication With Alaska Native and American Indian People</brief_title>
  <acronym>PALL</acronym>
  <official_title>Exploring Palliative Care Communication With Alaska Native and American Indian People at Two Sites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southcentral Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southcentral Foundation</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>
      This mixed-methods study is culturally tailoring and evaluating a communication intervention&#xD;
      to increase the frequency and quality of advance care planning with diverse American Indian&#xD;
      and Alaska Native adults with serious, life-limiting illness in primary care at two sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Palliative care is an interdisciplinary field that aims to relieve emotional, spiritual and&#xD;
      physical suffering and improve quality of life in patients with serious, life-limiting&#xD;
      illness and their families. Unfortunately, palliative care is often introduced too late in&#xD;
      the course of care to maximize its potential benefits, in part because healthcare providers&#xD;
      and patients alike lack the knowledge and self-efficacy to initiate conversations about&#xD;
      advance care planning (ACP). ACP is an important component of palliative care in which&#xD;
      patients, families and providers discuss and plan for the patient's desired treatment goals,&#xD;
      including preferences for care and who can make decisions on the patient's behalf if needed.&#xD;
      Integrating ACP into treatment early, before serious, life-limiting illness advances to a&#xD;
      late stage, can improve patient and caregiver quality of life, length of survival, and health&#xD;
      care cost. Primary care is an ideal setting for early integration of ACP, as primary care&#xD;
      providers routinely diagnose and care for patients in the early stage of serious,&#xD;
      life-limiting conditions, such as chronic obstructive pulmonary disease. Alaska Native and&#xD;
      American Indian (AN/AI) people have disproportionately high prevalence of many serious,&#xD;
      life-limiting conditions, including cancer, coronary heart disease, and liver disease. Yet,&#xD;
      AN/AIs use ACP and other palliative care services significantly less than the overall&#xD;
      population. The reasons for this disparity are unclear, and AN/AIs are among the most&#xD;
      underrepresented groups in palliative care studies. Previous research indicates that when&#xD;
      given the opportunity, AIs will engage in ACP, and our preliminary data suggest strong&#xD;
      support among ANs for developing culturally congruent ACP interventions in primary care&#xD;
      settings. The need for timely and effective ACP is growing in AN/AI communities and there is&#xD;
      a pressing need for culturally-congruent, patient-centered palliative care interventions for&#xD;
      AN/AIs as tribal health systems manage rising numbers of AN/AI individuals with serious,&#xD;
      life-limiting illnesses. The aims of this collaborative, community-engaged, clinical study&#xD;
      are to: 1) conduct focus groups with 40 key stakeholders (patients, caregivers, providers,&#xD;
      administrators) in two tribal health systems to tailor an existing ACP communication&#xD;
      intervention for AN/AIs with serious, life-limiting illness; 2) evaluate the cultural&#xD;
      relevance and usability of the tailored ACP communication intervention among 20 AN/AI&#xD;
      patients using cognitive interviews; and 3) compare the impact of the tailored intervention&#xD;
      on frequency of ACP discussions, as well as quality of and satisfaction with ACP&#xD;
      communication between 30 AN/AI patients receiving individualized information to prompt ACP&#xD;
      discussions with providers and 30 AN/AI patients receiving usual care, with information to&#xD;
      prompt a discussion. Implementing effective, appropriate ACP is a high priority at&#xD;
      Southcentral Foundation (SCF) and First Nations Community HealthSource (FNCH), two tribal&#xD;
      health systems serving large, diverse populations of AN/AI people in Alaska and New Mexico.&#xD;
      This study will develop and evaluate a culturally congruent, patient- centered ACP&#xD;
      intervention at these sites and produce evidence for a large, multi-site clinical trial of&#xD;
      the intervention that could improve patient and caregiver outcomes in this diverse population&#xD;
      of more than 5 million Americans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</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>Cluster-randomized design with providers randomized to intervention or control and patients nested within provider.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACP communication occurrence</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Patient self-report of occurence of advance care planning communication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ACP communication quality</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Patient self-report of quality of advance care planning communication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Advance Directives</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Documentation of advance directives (i.e. health care agent and living will) in electronic health record</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intervention feasibility-provider</measure>
    <time_frame>up to 1 week</time_frame>
    <description>Provider self-report of ease of using advance care planning communication tool</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention feasibility-patient</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Patient self-report of ease of using advance care planning communication tool</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention acceptability-provider</measure>
    <time_frame>up to 1 week</time_frame>
    <description>Provider self-report of cultural acceptability of advance care planning communication tool</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention acceptability-patient</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Patient self-report of cultural acceptability of advance care planning communication tool</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and providers in this arm receive the culturally-tailored Improving Communication about Serious Illness (ICSI) Intervention. The ICSI involves providing the provider and the patient with an individualized, one-page summary of patient-specific preferences for advance care planning communication that prompts the patient and the provider to have a conversation about advance care planning at the next clinical visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients and providers in this arm receive usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Improving Communication about Serious Illness-AI/AN</intervention_name>
    <description>A one-page summary of patient-specific preferences, barriers and facilitators for engaging in patient-provider communication about advance care planning, provided to patient and provider prior to a clinical encounter with prompts for initiating and/or improving the quality of communication about advance care planning.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alaska Native and/or American Indian (patients)&#xD;
&#xD;
          -  Age 18 or older (patients and providers)&#xD;
&#xD;
          -  Employed at least 2 years as a primary care provider at one of the two study sites&#xD;
             (providers)&#xD;
&#xD;
          -  Have a primary care provider of record at one of the two study sites (patients)&#xD;
&#xD;
          -  Have had at least 2 visits with primary care provider in previous 12 months (patients)&#xD;
&#xD;
          -  Having at least one serious, life-limiting condition, including metastatic cancer,&#xD;
             primary lung cancer, chronic obstructive pulmonary disorder, heart disease, liver&#xD;
             disease or cirrhosis, renal failure, or being oxygen dependent. (patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under age 18 (patients and providers)&#xD;
&#xD;
          -  Not Alaska Native or American Indian (patients)&#xD;
&#xD;
          -  Not having a primary care provider at one of the study sites (patients)&#xD;
&#xD;
          -  Not being employed for at least two years as a primary care provider at one of the&#xD;
             study sites (providers)&#xD;
&#xD;
          -  Not having had at least 2 visits with a primary care providers at one of the study&#xD;
             sites in the previous 12 months (patients)&#xD;
&#xD;
          -  Not having a serious, life-limiting condition, such as metastatic cancer, primary lung&#xD;
             cancer, chronic obstructive pulmonary disorder, heart disease, liver disease or&#xD;
             cirrhosis, renal failure, or being oxygen dependent.&#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>Jennifer Shaw, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southcentral Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southcentral Foundation</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Nations Community HealthSource</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southcentral Foundation</investigator_affiliation>
    <investigator_full_name>Jennifer Shaw</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>Advance Care Planning</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Indians, North American</keyword>
  <keyword>Alaska Natives</keyword>
  <keyword>Health Communication</keyword>
  <keyword>Primary Health Care</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/NCT03256110
org study id: 5R21NR016611
nct id: NCT03256110
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This mixed-methods study is culturally tailoring and evaluating a communication intervention
      to increase the frequency and quality of advance care planning with diverse American Indian
      and Alaska Native adults with serious, life-limiting illness in primary care at two sites.
Palliative care is an interdisciplinary field that aims to relieve emotional, spiritual and
      physical suffering and improve quality of life in patients with serious, life-limiting
      illness and their families. Unfortunately, palliative care is often introduced too late in
      the course of care to maximize its potential benefits, in part because healthcare providers
      and patients alike lack the knowledge and self-efficacy to initiate conversations about
      advance care planning (ACP). ACP is an important component of palliative care in which
      patients, families and providers discuss and plan for the patient's desired treatment goals,
      including preferences for care and who can make decisions on the patient's behalf if needed.
      Integrating ACP into treatment early, before serious, life-limiting illness advances to a
      late stage, can improve patient and caregiver quality of life, length of survival, and health
      care cost. Primary care is an ideal setting for early integration of ACP, as primary care
      providers routinely diagnose and care for patients in the early stage of serious,
      life-limiting conditions, such as chronic obstructive pulmonary disease. Alaska Native and
      American Indian (AN/AI) people have disproportionately high prevalence of many serious,
      life-limiting conditions, including cancer, coronary heart disease, and liver disease. Yet,
      AN/AIs use ACP and other palliative care services significantly less than the overall
      population. The reasons for this disparity are unclear, and AN/AIs are among the most
      underrepresented groups in palliative care studies. Previous research indicates that when
      given the opportunity, AIs will engage in ACP, and our preliminary data suggest strong
      support among ANs for developing culturally congruent ACP interventions in primary care
      settings. The need for timely and effective ACP is growing in AN/AI communities and there is
      a pressing need for culturally-congruent, patient-centered palliative care interventions for
      AN/AIs as tribal health systems manage rising numbers of AN/AI individuals with serious,
      life-limiting illnesses. The aims of this collaborative, community-engaged, clinical study
      are to: 1) conduct focus groups with 40 key stakeholders (patients, caregivers, providers,
      administrators) in two tribal health systems to tailor an existing ACP communication
      intervention for AN/AIs with serious, life-limiting illness; 2) evaluate the cultural
      relevance and usability of the tailored ACP communication intervention among 20 AN/AI
      patients using cognitive interviews; and 3) compare the impact of the tailored intervention
      on frequency of ACP discussions, as well as quality of and satisfaction with ACP
      communication between 30 AN/AI patients receiving individualized information to prompt ACP
      discussions with providers and 30 AN/AI patients receiving usual care, with information to
      prompt a discussion. Implementing effective, appropriate ACP is a high priority at
      Southcentral Foundation (SCF) and First Nations Community HealthSource (FNCH), two tribal
      health systems serving large, diverse populations of AN/AI people in Alaska and New Mexico.
      This study will develop and evaluate a culturally congruent, patient- centered ACP
      intervention at these sites and produce evidence for a large, multi-site clinical trial of
      the intervention that could improve patient and caregiver outcomes in this diverse population
      of more than 5 million Americans.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster-randomized design with providers randomized to intervention or control and patients nested within provider.
primary purpose: Supportive Care
masking: None (Open Label)
measure: ACP communication occurrence
time frame: up to 2 weeks
description: Patient self-report of occurence of advance care planning communication.
measure: ACP communication quality
time frame: up to 2 weeks
description: Patient self-report of quality of advance care planning communication
measure: Advance Directives
time frame: up to 1 month
description: Documentation of advance directives (i.e. health care agent and living will) in electronic health record
measure: Intervention feasibility-provider
time frame: up to 1 week
description: Provider self-report of ease of using advance care planning communication tool
measure: Intervention feasibility-patient
time frame: up to 2 weeks
description: Patient self-report of ease of using advance care planning communication tool
measure: Intervention acceptability-provider
time frame: up to 1 week
description: Provider self-report of cultural acceptability of advance care planning communication tool
measure: Intervention acceptability-patient
time frame: up to 2 weeks
description: Patient self-report of cultural acceptability of advance care planning communication tool
arm group label: Intervention
arm group type: Experimental
description: Patients and providers in this arm receive the culturally-tailored Improving Communication about Serious Illness (ICSI) Intervention. The ICSI involves providing the provider and the patient with an individualized, one-page summary of patient-specific preferences for advance care planning communication that prompts the patient and the provider to have a conversation about advance care planning at the next clinical visit.
arm group label: Control
arm group type: No Intervention
description: Patients and providers in this arm receive usual care.
intervention type: Behavioral
intervention name: Improving Communication about Serious Illness-AI/AN
description: A one-page summary of patient-specific preferences, barriers and facilitators for engaging in patient-provider communication about advance care planning, provided to patient and provider prior to a clinical encounter with prompts for initiating and/or improving the quality of communication about advance care planning.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Shaw, PhD
role: Principal Investigator
affiliation: Southcentral Foundation
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Southcentral Foundation
investigator full name: Jennifer Shaw
investigator title: Senior Researcher
sharing ipd: No